Indra: MHE-Demag (M) SDN BHD Nghi Son Refinery and Petrochemical LLC

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Total Sheet 62

Vendor’s name : MHE-Demag (M) SDN BHD


: Nghi Son Refinery and Petrochemical LLC.
Company 's name : JGCS Consortium
: SK Engineering & Construction Co., Ltd.
Plant Location : Nghi Son, Vietnam
Project name : NSRP Complex Project
P / Order No. : 0-6495-PS2155-501-A100
Equipment/Material name : Overhead Cranes
Item number : 011-CR-001 & 014-CR-001
Document title : QUALITY MANUAL

PROJECT (JOB No.: 0-6495-20)


DOCUMENT CLASS: X others
ISSUE PURPOSE: FI
RESULT CODE: A, B, R, F ( A )
NEXT STATUS: FA, FR, FI, FC, AB ( FC )
RESUBMISSION DATE: ( asap )
RESPONSIBLE DEPT./PERSON: ( QC/SCB )
Review Date: ( 6th Mar. '15 )
A: Approved without Comment; B: Approved with Minor Comment
R: Not Approved; F: Not Subject to Review
Approval or review hereunder shall not be construed to relieve Vendor/ Subcontractor of his
responsibilities and liability under the Contract

Purchaser ORIG. PURCHASE ORDER NO. SERIAL REV.


DOC. No.
V S2155-501-A- 600 1

1 23 FEB. 2015 FOR CONSTRUCTION KAMIL AKMAL KELVIN


0 12 JAN. 2015 FOR INFORMATION KAMIL AKMAL KELVIN
Rev. No. Date Description Prep'd Chk'd App'd
Vendor's Name MHE-Demag (M) SDN BHD

Vendor Logo & Name

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QMS.IN.03.00 - Content of our Quality
Create by: Kim Brix
Date created: 03/27/2001 Management System
Last Modified by: Jessie Ang
Last Modified date: 07/11/2012

MDI, MDIM, MDIT, MDLM, MDM, MDP, MDS, MDSM, MDT, MDTW, MDV, MHEM

QMS document overview-08-2012.xlsx

DOC. NO.: QMS.IN.03.00


EFFECTIVE DATE: 13.07.2012 ISSUED BY: Loo Tiong Kok
SUPERSEDES NO.: 20.06.2011 APPROVED BY: J Moeller
SUBJECT: Content of our quality management system

01) MHE Demag Quality Management System - Handbook.


File No. 1
1.4 Quality Management system.

- 01) Introduction QMS.IN.01.00


- 02) Quality Statement / Policy QMS.IN.02.00
- 03) Content QMS.IN.03.00
- 04) Definitions QMS.IN.04.00
- 05) Corporate structure QMS.IN.05.00
- 06) Scope of the Quality Management System QMS.IN.06.00
- 07) Overview of the Quality Management System QMS.IN.07.00
- 08) Process description & interaction QMS.IN.08.00

- 09) Control of Documents & Records QMS.PO.14.02

1.5 Management responsibility.

- 01) Management commitment. QMS.PO.15.01

1.6 Resource management

- 01) Human resources ~ Competence / Awareness / Training QMS.PO.16.01


- 02) Infrastructure QMS.PO.16.02
- 03) Working invironment QMS.PO.16.03

1.7 Product realization

- 01) Planning of product realization QMS.PO.17.01


- 02) Customer related processes QMS.PO.17.02
- 03) Design and Development QMS.PO.17.03
- 04) Procurement QMS.PO.17.04

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- 05) Production and Service provision QMS.PO.17.05
- 06) Control of measuring & Monitoring devices QMS.PO.17.06

1.8 Measurement, analysis and improvement

- 01) Monitoring and Measuring QMS.PO.18.01


- 02) Control of nonconforming product QMS.PO.18.02
- 03) Analysis of data QMS.PO.18.03
- 04) Improvement QMS.PO.18.04

02) MHE Demag Quality Management System - General Procedures.


03) Quality Manual - Cranes & Components.
04) Quality Manual - Warehouse Trucks.
05) Quality Manual - Industrial Products.
06) Quality Manual - Service.
07) Quality Manual - Resource Management
08) Quality Manual - Electrical Design & manufacturing.
09) Quality Manual - Procurement.
10) Quality Manual - Inventory.
11) Quality Manual - Production.
12) Quality Manual - Engineered Projects.
13) Quality Management System reference material.

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COMPANY QUALITY
MANUAL

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QUALITY
MANAGEMENT
SYSTEM

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QMS.IN.01.01 - Introduction(M)
Create by: Kim Brix
Date created: 23/01/2002
Last Modified by: Jessie Ang
Last Modified date: 05/26/2011

MDM

DOC. NO.: QMS.IN.01.01 VERSION: 00


EFFECTIVE DATE: 01.01.04 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Introduction

Welcome to this introduction to MHE Demag (M) Sdn Bhd’s


Quality Management System.
We have tried in the following, to provide a basic introduction to the Quality Management System,-
how it is managed and how it came about.

To allow for easy adaptation to the rest of the groups companies, MHE Demag (M) Sdn Bhd has been
substituted by "the company" in all subsequent documentation, (See QMS.IN.04.00 "Definitions" ==>
for etails).

In The Company the idea of becoming ISO 9001 certified, was brought up now and then - and
discussed,- for close to 10 years, before the decision to become certified was finally made.

We have a functional Management Information System (MIS) and a Regional Technical Information
system (RTI) covering most of our quality control and these system are continually
expanded/updated to include products presently under development or recently included in our
product portfolio.

These systems are also used to gradually introduce our Quality Management System to the rest of
the group companies.

What eventually triggered us to establish a Quality Management System and pursue a certification
under an accredited organisation like BVQI , was a need for a more systematic approach towards
ensuring consistency in our quality output with a higher degree of employee commitment and market
trends, where more and more companies/customers become ISO Certified and demand compliance
by their suppliers - to the ISO standard.

These demands and the release of the new edition of the ISO standard, 9001:2000 (and its successor
ISO 9001:2008) – taking a more process oriented approach, - convinced the Company Management
that the effort was well worth it.

We tried in our process description to isolate individual working phases (sales, project management,
design, production, etc.) and ensure proper hand-over procedures between these phases – to
nurture responsibility and ownership.

Beside this, we have taken a very individual approach, where the business processes for each
product group is described independently – only using policies and overall objectives as guidelines.

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This way we have avoided a lot of cross-references between divisions and procedures and are able
to add to - and extend the Quality Management System in different directions, with a minimum of
modification to the existing system.

This approach makes it easier for us to transfer the Quality Management System to our group
companies in its entirety OR in modules – implementing the system functional wise or based on
specific product groups.

Today our Quality Management System is certified according to the ISO 9001:2000 (and we will
proceed to have the certification updated in accordance with ISO 9001:2008) standard and covering
most of our products and services.

It is well implemented and developed by the people who use it in their daily working routines. It has
become a way of thinking, a way to approach a challenge and how we do things.

The elaboration of our working processes has made it easier to employ new people, as they can
familiarize themself with our business processes - through our Quality Management System - making
it an integral part of how they do things.

An employee can now study how things work and ask relevant questions to the business process, as
the outcome is defined and specified.

This is reducing the overall time spend on familiarisation.

The Company is committed to maintain and continually improve the Quality Management System, for
the benefit of the Products, the Customers, our Employees and Our Company’s success.

All Quality Management System documents issued before 17.05.02 has been approved through our
initial management review where the total Quality Management System was endorsed by the Group
Management.

Group Management Company Manager

Per A Magnusson - Regional Managing Director Frankie Chan - Managing Director

J. Moeller - Regional Director

C Y Wang - Regional Director

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Customer Care & Corporate Development

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QMS.IN.02.00 - Quality Statement
Create by: Kim Brix
Date created: 27/03/2001
Last Modified by: Jessie Ang
Last Modified date: 02/21/2011

MDS

DOC. NO.: QMS.IN.02.00 VERSION: 00


EFFECTIVE DATE: 01.01.04 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Quality Statement

Quality Policy Statement


The business activity of The Company is the Sales, Project execution, Design, Manufacture,
Installation and Servicing of a variety of material handling products as specified in the individual
Quality Manuals - being a part of The Company's Quality Management System.

It is The Company's objective to supply these products according to agreed requirements, with the
highest possible degree of application conformity, reliability and in compliance with statutory and
regulatory requirements.
This shall be achieved by focusing on capturing requirements during the sales phase, ensuring
systematic hand-over procedures between business phases to prevent distortion of requirements -
and application of systematic reviews of design processes.

To ensure that The Company's objective can be met, measurable Quality Objectives shall be
established for each product group to provide a benchmark from where continual progress can be
made.

These Quality Procedures are described in the Quality Management System and reviewed regularly to
ensure that the Quality Management System provides the best possible platform from where
customer requirements can be met.

Our success has been achieved by adhering to the highest level of professionalism and quality
consciousness.
We have interpreted our commitment to Quality as;

Meeting the expectations of customers,-


both internally and externally.
Quality is the responsibility of everyone and the management will ensure that quality remains one of
its highest priorities, by committing to the Quality Management System and its continual
development and improvement.

Every employee is obliged to ensure that contractual and agreed requirements are fulfilled - and that
functional, operational, statutory and regulatory requirements are being met.
The individual employee has a duty to address discrepancies from known requirements - to the
person responsible for the product.

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The Regional Director, a member of the Group Management,- also serves as Company's Management
Representative and shall report on the performance of Quality Management System during Group
Management meetings.

The endorsement signifies The Company Management’s commitment to this Quality Policy Statement

Per Anders Magnusson J. Moeller C Y Wang


Regional Managing Regional Director Regional Director
Director Customer Care & Corporate Development

Frankie Chan Tai Chau Peng G A Setiabudi


Managing Director President Director Assistant General Manager, Fulfillment
Malaysia Indonesia Indonesia

K C Foong Torben Christensen Somporn K Michael Nielsen


General Manager General Manager Managing Director General Manager
Singapore Philippines Thailand Vietnam

Raymond Ng K M Niemann J R Hansen


President Regional Manager Regional Manager Regional Manager
Taiwan Cranes & Components Industrial Products Service

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QMS.IN.04.00 - Definitions
Create by: Jessie Ang
Date created: 11/02/2011
Last Modified by: Jessie Ang
Last Modified date: 04/21/2011

MDS

DOC. NO.: QMS.IN.04.00 VERSION: 00


EFFECTIVE DATE: 21.04.11 ISSUED BY: Jessie Ang
SUPERSEDES NO.: 01.01.11 APPROVED BY: JM
SUBJECT: Definitions

The company: MHE-Demag Group of companies: ISO Certified ?


Singapore: MHE-Demag (S) Pte Ltd Yes
Malaysia: MHE-Demag Malaysia (M) Sdn Bhd (SA) Yes
MHE-Demag Logistics (M) Sdn Bhd Yes
MHE-Demag Malaysia (M) Sdn Bhd (SR) Yes
MHE-Demag Industries (M) Sdn Bhd -
Philippines: MHE-Demag (P) Inc Yes
Thailand: MHE-Demag (T) Ltd Yes
Electra (T) Ltd
MHE-Demag Industries (T) Ltd
Indonesia: PT MHE-Demag Indonesia Yes
Vietnam: MHE-Demag Vietnam Company Limited Yes
Taiwan: MHE-Demag Taiwan Company Limited -
Group Management: Regional Managing Director
Regional Director
Company Management: Country Manager
Divisional managers
Regional Management: Group Management
Regional Managers
Regional Product Managers

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QMS.IN.06.00 - Scope of the QMS
Create by: Kim Brix
Date created: 28/03/2001
Last Modified by: Joergen Moeller
Last Modified date: 09/09/2009

MDS

DOC. NO.: QMS.IN.06.00 VERSION: 00


EFFECTIVE DATE: 20.02.01 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Scope of the Quality Management System

Scope of The Company's Quality Management System.


Disciplines and functions to be covered by the Quality Management System - are provided by the ISO
9001:2008 standard, and can be read there.

The Company's scope of the certification is limited to sales, project execution, design,
manufacturing, installation and servicing of products listed in the Quality Manuals in the Quality
Management System and detailed here below;

 03) Quality Manual - Crane & Components,


 04) Quality Manual - Warehouse Trucks,
 05) Quality Manual - Industrial products,
 06) Quality Manual - Service,

Exclusions from the ISO 9001:2008 standard.


There is no exclusions from clause 7 in the ISO 9001:2008 standard to the Company's Quality Management
System.
The accounts and finance department's business processes, are however not described within the Quality
Management System as they are not directly influencing the company’s ability to fulfill requirements and meet
customer's expectation.

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QMS.IN.07.01 (M)
Create by: Kim Brix
Date created: 01/04/2002
Last Modified by: Jessie Ang
Last Modified date: 05/04/2010

MDM

DOC. NO.: QMS.IN.07.01 VERSION: 00


EFFECTIVE DATE: 01.01.06 ISSUED BY: Kim Brix
SUPERSEDES NO.: 01.02.01 APPROVED BY: JM
SUBJECT: Overview of the Quality Management System

Overview of The Company’s Quality Management System.


1. Objective

The objective with the company's Quality Management System is to have a documented
system which enable the company to fulfill its obligation to its customers as laid down in the
company's "Quality Policy Statement". To consistently provide products and services of high
quality, which conform with our own pre-set standards and specifications or with contractual
standards and specifications as agreed upon with our clients for specific projects.

2. Scope
See QMS.IN.06.00 (scope of the Quality Management System) for details.

3. Responsibility

The group management is overall responsible for the establishment, implementation, and
maintenance of the "Quality Management System". The Group Management Representative,
who also is a member of the Group Management, is the Group Management’s executing body
in these matters.

The Group Management Representative represent the Group Management on the


performance and any need for improvement of the Quality Management System and reports
directly to the Group Managing Director.

The respective Company (country) Management Representative is reporting to the


Management Representative on the status of establishment, implementation, maintenance
and suggested improvement of the "Quality Management System".

The maintenance of the Quality Management System pertaining to individual quality Manuals -
resides with the individual division/department manager as defined in the “Responsibility -
Matrix” shown later in this document.

The responsibility for upkeep of the Quality Management System is further elaborated on in
the procedure for “document control”

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QMS.GP.24.01 – according to the ISO 9001:2008 standard, section 4.2.3

4. Definition

The Company : See QMS.IN.04.00 (definitions) for details

5. Outline of the "Quality Management System"

The company's "Quality Management System" is designed under consideration of and in


compliance with the ISO 9001:2008 standard’s requirements” for Quality Assurance in Sales,
design, development, production, installation and services and it shall cover all products and
services as applicable.

The "Quality Management System" shall also ensure that: -

- Our clients are satisfied with our products and services.

- Our present and future clients are having confidence in our abilities.

- The quality parameters set by the Company Management are fulfilled.

- The company's operation under the "Quality Management" is executed economically.

- Specific contractual obligations are considered and fulfilled.

- Our activities are executed cohesively by the various departments involved.

6. Employee Commitment

The "Quality Management System" is committing all employees of The Company to execute
their work in accordance with the Quality Management System requirements specifically for
each in their field of work.

“Handbook” Management’s
Overview & General procedures,
Management's Providing guidelines for
directions. individual
Quality plans

Sales/product conceptual Design/projecting Procurement Fabrication Installation


realization phase phase phase phase phase

7. Quality Management System - Handbook

The “Handbook” section of the Quality Management System provides customers, new
employees and other with an interest in our Quality efforts, an overview of The Company's
Quality Management System.

This is to provide a reader with a sufficient level of confidence in the products sold, designed,
manufactured, delivered, installed and serviced by The Company.

The “Handbook” section also provide directions for the development of the Quality
Management System by stating Management’s objectives and overall intention in relation to

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the topics covered by the ISO 9001:2008 standard.

8. Quality Management System – General procedures

The “general procedure” section shall as a minimum, provide guidelines for the six mandatory
procedures required by the ISO 9001:2008 standard.
Being:

- Control of documents, (QMS.GP.24.01),


- Control of records, (QMS.GP.24.02),
- Internal audits, (QMS.GP.28.01),
- Control of nonconforming product, (QMS.GP.28.02),
- Corrective action, (QMS.GP.28.03), and –
- Preventive action, (QMS.GP.28.04).

In addition to these procedures, Management can add generic business procedures to this
section, to ensure compliance with management policies and directives, to provide a uniform
approach to customer’s requirement or to simplify internal audits of the Quality Management
System, by centralizing business procedures.

Initially these procedures are:

- Management review, (QMS.GP.25.01)


- Identification & traceability, (QMS.GP.27.01)
- Control of measuring & monitoring devices, (QMS.GP.27.02)

9. Quality Manuals

Each section of the "Quality Manual" shall specify Quality Objectives for each field of activity.
The Objectives shall reflect client/market expectations from a market leader in the material
handling product field covering industrial safety, industrial standards as applicable,
environmental friendliness and our technical and commercial obligations to our principals.

The objectives shall be measurable and provide a reference from which improvements can be
measured.

Individual Quality Manuals shall provide sufficient documentation to ensure the effective
planning, operation and control of the divisions business processes.
This is done by means of:

- Quality Plans – providing an overview of the general business process.


- Quality Procedures - outlining the individual business processes and their interactions with
other processes.
- Quality Activity Plans - specifying product specific quality activities specific for
manufacturing, assembly and test activities related to a specific product or product group.

10. Quality Control Inspection reports

To control of the division’s business processes, as called for above, Quality Control Inspection
reports will be established.

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This is to capture critical activities in our processes - to ensure that these activities are being
carried out as planned, to ensure the process is under control and to provide The Company
with a means for systematic feedback to evaluate and improve the processes.

Irrespective of whether a Quality Control report provides for fields for "Inspected by",
"Reviewed by" and "Approved by", all Quality Control reports shall as a minimum be signed off
by an "Inspector" and an "Approver".

The "Quality Control Inspection reports" shall be written and updated as required in either the
Quality Plan's or the Quality Activity Plans.

11. Work Instructions

Where required, specific operations and/or work task being performed by individual
employees or a group of employees shall be described in form of a "Work Instructions". All
"Work Instructions" shall form an integral part of the "Quality Management System" and the
affected employees shall be trained accordingly.

The "Work Instructions" shall be written, approved and updated according to the general
procedure “Control of documents”, (QMS.GP.24.01).

The "Work Instructions" shall carry sufficient details in order for the personnel performing
procedural activities to understand the requirements when carrying out their work functions.

Department/division heads as lined out in the responsibility matrix, shown later in this
document, shall approve working instructions.

12 Other Documents

Besides the "Quality Management System", the company and its owners have developed and
do maintain other documents covering various subjects. Where references to such
documents are made in the "Quality Management System" in the "Work Instructions", "Quality
Procedures", "Quality Plans" and / or "Quality Activity Plans". Such documents referred to
shall form an integral part of the "Quality Management System".

13 Quality Management System - document format

Documents covered by the "Documentation - control of documents" QMS.GP.24.01 procedure


shall be written on the pre-designed formats, found in "13) Quality Management System
reference material", to ensure consistency and ease of document control.

All documents is provided with a unique document number.

Responsibility - Matrix
Owner Section in the Company's Quality
Management System (QMS)
Superior Department Function / Product group
J. Moeller Group Management 01) QMS - Handbook

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J. Moeller Group Management 02) QMS - General Procedures
Richard Chan / Sales & Marketing/Technical 03) Quality Manual - Crane & Components
Wong Hong Wai
Richard Chan / Sales & Marketing/Technical 04) Quality Manual - Warehouse Trucks
Wong Hong Wai
Richard Chan / Sales & Marketing/Technical 05) Quality Manual - Industrial Products
Wong Hong Wai
Tan Mei Fatt Service Division 06) Quality Manual - Service
07) Quality Manual - Resource Management
Rahmath Human resource Competence, Awareness & training
Steven Ng Administration Infrastructure
David Goh EHS Working environment
Law Kok Wai Production 08) Quality Manual - Electrical Design & Manufacturing
Lee Yew Hoong Purchase Department 09) Quality Manual - Procurement
Lee Yew Hoong Purchase Department 10) Quality Manual - Inventory
Law Kok Wai Production 11) Quality Manual - Production
Frankie Chan Company Management 12) Quality Manual - Engineered Projects
J. Moeller Group Management 13) QMS Reference Material

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QMS.IN.08.00 - Process description and
Create by: Kim Brix
Date created: 28/03/2001 interaction overview.
Last Modified by: Woei Wen Lou
Last Modified date: 26-11-2004

MDS

DOC. NO.: QMS.IN.08.00 VERSION: 00


EFFECTIVE DATE: 20.02.01 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Process description and interaction overview.

Process description and interaction overview


This document is created to provide the reader a basic understanding of how the Company’s business
processes have been described and how they interact with each other, how they are influenced by requirements
and how they are altered to reflect a new reality (customer needs adaptation).

The Company’s Product groups (Cranes & Components, Warehouse Trucs, Industrial Products and
Service) are guided by product realization processes, covering all phases from Inquiry/sales - to final hand
over of the product and creating service provisions.

This process (product realization process, in short: PRP) will in principle consist of the phases seen here below:

Sales Design Fabrication Documentation Commissioning


Phase Phase Phase Phase Phase

1 2 3 4 5 6 7 8 9 10

Projecting Procurement Assembly Installation Warranty -


Phase Phase Phase Phase /servicing Phase

This is a “customer to customer” process, (starts with a customer inquiry and ends with a hand –over to the
customer).

The overview of the process is provided via the Quality Plan, which show which phases/element is active in the
PRP and which quality control documents is used to document this phase/element of the process.
Each of these phases/elements are documented in details, either individually or combined, - by means of the
“Quality Procedure Specific”.

The Quality Procedure Specific provides a “walk through” of the working procedure – from start to end. It
provides details on why decisions are made and which actions are recorded.
Quality Procedures Specific is linked, and refers to each other to ensure the best possible overview of the Entire
PRP.
Where an “outside” service is required to complete the PRP, “hand-over” documentation is paramount to
ensure that requirement and responsibilities are transferred flawlessly.

These “outside” services can be acquired from either in-house, (Centralized Services) or by sub contractors.

The “PRP” initiate these Centralized Service processes, (centralized service process, in short CSP).
They are initiated by one of the phases in a “PRP”, either automatically or upon request from the process

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owner.
The “CSP” is completed with a hand-over in one of the phases in the “PRP”.

The CSP is documented as the PRP – using Quality Plans (QP), Quality Activity Plans (AP), Quality Procedures
Specific (PS), Quality Control (QC) documents and Working Instructions (WI).

Sales Projecting Design Procurement Fabrication Documentation Installation Warranty -


Phase Phase Phase Phase Phase Phase Phase /servicing Phase

1 2 3 4 5 6 7 8 9 10

Assembly Commissioning
Phase Phase

* **
1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9
• Procurement of local • Installation by
and overseas subcontractor
components. 1 2 3 4 5 6 7 8 9
• Inventory processes
• Fabrication and assembly in house of
structures and products.
• Fabrication and assembly by 1 2 3 4 5 6 7 8 9
subcontractor.
• Warranty obligations and service of the
product.
*
The procurement is handled centrally and documentation to ensure that the correct component/service can be
purchased, at the correct price with the right quality, at the right time, - is formally handed over and
acknowledged by both parties.
(Services here refer to subcontracting) .

**
Once the component/service is purchased, they are handed over to the requestor or as specified. Both parties
acknowledge the completion of this process.

The same procedure also applies when an outside service is used for other phases in the PRP.
The initialization is documented and mutually agreed upon and the transfer of requirements and responsibility is
recorded.

The Product Realization Process (PRP) is as described above, static.


To allow for improvement and ensure that the business processes always reflects current requirements, the
process must be measured and analyzed.

This is done by ensuring that internal & external audit results, customer feedback, non-conformities, corrective
and preventive actions and incoming suggestions are channeled back to the Quality Manager for analysis – to
pinpoint problem areas which can be used to gauge the Quality Management System during Management
review’s

Schematically this could look as shown here below - example:

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Customer Management review Customer
Resource Quality Manager
Management Compilation of
data for analysis

QC reports Non- Audit results Internal/exter- Feed-back


conformances nal feedback

Design Fabrication Documentation Commissioning


Phase Phase Phase Phase

1 2 3 4 5 6 7 8 9 10

Sales Projecting Procurement Assembly Installation Warranty


Phase Phase Phase Phase Phase Phase

Customer Product/Service
requirement receipt

Regulatory Statutory
requirements requirements

The processes are described by means of:

• Quality Plans used as an index, providing an overview of the entire process.


• Quality Procedure (specific), which refer to the elements in the Quality Plan and defines objectives,
scope, responsibilities and provide a process description (visual as well as written) either in its entirety
or broken down in logical elements.
• Quality Activity Plans established for the individual product variant, and provides information on the
Quality Control requirement during manufacturing, assembly and testing. The individual design
department establishes this document, which is product specific.
• Quality Control reports used to capture progress or verify specifications, which is required later to
document the process or the product requirement.
• Working Instructions to provide detailed information on how to carry out a process or a part of a
process.

All documents in the Quality Manuals are numbered according to the following system [aa.aa.aa.nn.nn]:
aa = alphabetic values
nn = numeric values

All document starts with [QM.aa.] QM = Quality Manual, aa = abbreviation for product group name (HC = Hoist
& Cranes).

Documents are then provided one of five codes, depending on the nature of the document:
QP = Quality Plan, PS = Quality Procedure (Specific) = PS, AP = Quality Activity Plan,
QC = Quality Control document, WI = Working Instruction.

ALL documents first two digits, is guided by the Quality Plan or the Quality Activity Plan
Next two digits are forth running numbers from 00 to 99.

Example: QM.HC.QP.09.00 (ninth quality plan established for cranes & hoists)
QM.HC.PS.09.03 (third quality procedure under QM.HC.QP.09.00).

Documents are organized in an ascending order – with no preference to product or process.

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QMS.PO.14.02
Create by: Kim Brix
Date created: 12/02/2001
Last Modified by: Jessie Ang
Last Modified date: 15/11/2012

MDS

DOC. NO.: QMS.PO.14.02


EFFECTIVE DATE: 15.11.12 ISSUED BY: Loo TK
SUPERSEDES NO.: 04.09.07 APPROVED BY: J Moeller
SUBJECT: Documentation - Control of documents & records.

1. Objective

The objective of this policy is to provide a framework for the control of documents and
records as required by the ISO 9001:2008 standard, for the Company’s Quality
Management System.

2. Scope

The scope of this policy shall be limited to all documents belonging to – or created as a
result of our Quality Management System.
This being our Quality Manual, the Procedures, Quality Inspection Reports, Working
Instructions, records and drawings - or documents referred to, which form an integral part
of our Quality Management System. Documents of external origin such as specific
customer requirements, international design standards, etc are project related and shall
not be covered by this policy. Use of such documents shall be controlled via the policy on "
Customer - related processes”, document no. QMS-PO.17.02 and "Design &
Development", document no. QMS-PO-17.03, - as applicable and on a contract-to-contract
basis.

3. Responsibility

It is the responsibility of the Company appointed Management Representative(MR) to


ensure compliance with this policy.

The responsibility for compliance and upkeep of issued records and drawings - belong to
the individual departments and divisions issuing them. They will be used, kept and
maintained here.

The responsibility of maintaining and up-keeping Quality Management System documents,


rest with the persons/entities defined in the responsibility matrix, as shown in
QMS.IN.07.00 ”Overview of the Quality Management System”

4. Definition

None

5. Element Policies
5.01 General

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All documents under our Quality Management System shall, as far as it is practically
possible, follow the defined formats – as provided for in the Quality Management
System. All documents shall state document number, effective date, superseded
document date as applicable, document title, name of the creator of the document and
name(s) of the approving authority.

Where documents need not comply with this format, they should carry a title or number
for traceability.

5.02 Document Maintenance.

Documents in the Quality Management System, handbook, - shall be reviewed during


the management review, which will be taking place once a year.
General procedures shall be reviewed during internal audits and evaluated for continued
suitability.

6. Reference

For further description of the company’s management of documents and records, a


please refer to the procedures here below;

Documentation – Control of documents, QMS.GP.24.01


Documentation – Control of records, QMS.GP.24.02

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- 2 0
MANAGEMENT
RESPONSIBILITY

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QMS.PO.15.01
Create by: Kim Brix
Date created: 23/05/2001
Last Modified by: Jessie Ang
Last Modified date: 15/11/2012

MDI, MDIM, MDIT, MDLM, MDM, MDP, MDS, MDSM, MDT, MDTW, MDV, MHEM

DOC. NO.: QMS.PO.15.01


EFFECTIVE DATE: 15.11.12 ISSUED BY: Loo TK
SUPERSEDES NO.: 23.05.01 APPROVED BY: J Moeller
SUBJECT: Management commitment

1. Objective
To define the management responsibilities in respect to the Quality Management
System.

2. Scope
Management activities in relation to the Quality Management System as described
here below.

3. Responsibility
It is the Group Management’s responsibility that the Quality Management System is
developed, communicated, understood, followed, maintained, continuously improved
and in compliance with the Company’s Quality Statement and the ISO 9001:2008
standard.

It is the Group Management’s responsibility to ensure the availability of resources.

4. Definition
The company: See QMS.IN.04.00 - Definitions ==>
Management definitions: See QMS.IN.04.00 - Definitions ==>

5. Element Policy
5.01 Customer focus
The requirements stated in the ISO 9001:2008 standard is addressed in the
following policies:

QMS.PO.17.02 "Customer related processes", and


QMS.PO.18.03 "Analysis of data"

5.02 Quality Policy

The company’s Quality policies shall be reviewed during the yearly Management
review of the Quality Management System.

5.03 Objectives

The main objective as stated in the Company's Quality Statement/Policy

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QMS.IN.02.00 shall be disseminated out and applied specifically for individual
products and services.

The individual divisional manager is responsible for establishing measurable quality


objectives and performance indicators – consistent with the Quality
Statement/Policy, and shall ensure that directions are clear and that individual efforts
are channelled in the same direction.

Quality objectives shall be reviewed at least once a year during system review of the
Quality Management System and performance figures shall be analyzed to gauge if
we are improving as required.

5.04 Responsibility, Authority and Communication

Management responsibility and authority is described in QMS.IN.07.00 "Overview of


the Quality Management System".

Communication between the Management (group, regional and company


management) and the employees pertaining to the operation and the effectiveness
of the Quality Management System shall be arranged at regular intervals and always
in conjunction with internal and external audits and management reviews, to ensure
that all employees are aware on how the Quality Management System is performing
and where we are having problems.

QC is everybody’s responsibility and when a need arise, the employee have a


responsibility to ensure that the necessary documentation is available or is
established - to meet quality requirements.
This can be a change to a quality procedure, establishment of a working procedure,
a Quality Control document or a simple working instruction.

The authority to approve such documents typically resides with the


divisional/department manager – as shown in the responsibility matrix in document
no. QMS.IN.07.00 "Overview of the Quality Management System".

5.05 Management review

The Quality Management System is reviewed yearly to address continued suitability,


adequacy and effectiveness.

For details see general procedure; QMS.GP.25.01 "Management review"

6. References
None

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RESOURCE
MANAGEMENT

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QMS.PO.16.01
Create by: Kim Brix
Date created: 23/05/2001
Last Modified by: Jessie Ang
Last Modified date: 05/26/2011

MDS

DOC. NO.: QMS.PO.16.01 VERSION: 00


EFFECTIVE DATE: 23.05.01 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Resource management - Human resource ~ Competence / Awareness / Training.

1. Objective

The objective of this policy is to set organisational directions for the company’s Human
Resource Management, pertaining to competence requirements, training and promotion of
self-awareness for the individual employee.

2. Scope

This policy provides guidelines on how the Company deals with Competence and training in
relation to working areas directly affecting product quality.
It sets guidelines on measures to be addressed by Human Resource, to enhance individual
awareness of the employee’s effort in the overall process and to ensure that focus is
channelled towards a common objective.

The scope also covers managing of records of education, training, skills and experience, -
and provide guidelines on how these are kept, reviewed and updated at regular intervals.

3. Responsibility

It is the Human Resource Manager’s responsibility to ensure that this policy is being
followed and to suggest measures to which will increase the awareness of the Quality
Management System and quality objectives in general.
Such measures shall be in accordance with the ISO 9001:2008 standard.

4. Definition

The company: See QMS.IN.04.00 - Definitions ==>

5. Element policies

5.01 General

A large part of the scope described above, is covered under the People Developer
Niche Standard (Business Excellence) and reference to this standard will be made
where applicable.
See Quality Plan for Human resource for details.

5.02 Competence

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Employees will have to be competent and have the necessary competence for the job
they are employed to do.
This competence will have to covers necessary/specific job skills, attitude towards
quality assurance and personal convictions in relation to company objective.

We will strive to employ people who can demonstrate that they have an attitude, which
is compatible with the company’s overall objective.

5.03 Training

Training will have to be employed to bridge knowledge gaps between trained skills and
required or necessary competence, - or to provide the employee with knowledge
specific for a product or our type of business.

In as much as this is possible, initial training requirement will have to be established


during preliminary discussions with the employee – and prior to actual employment.

Training targets will have to be set and measured to determine the effectiveness of the
training and if the employee have bridged the knowledge gap and can perform in a
specific job function.
See Procedure QM.HR.PS.01.02 "Post Training Activities" ==> for details.

5.04 Awareness

Information on the individual employee’s role in the company’s business process and
his or hers direct influence on quality – in relation to the objectives guiding the specific
position, should be explained during the employment confirmation or if impractical, at
least within the probation period.

Effort will have to be made to ensure that this information is re-communicated at regular
intervals throughout the employee’s association with the company, when chances are
made to the organisation or job scopes are changed.

Awareness of the individual employee’s role in non-conformities will also have to be


established and communicated – to ensure that gaps between competencies and
necessary skills are uncovered and bridged.

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QMS.PO.16.02
Create by: Kim Brix
Date created: 13/02/2001
Last Modified by: Jessie Ang
Last Modified date: 05/26/2011

MDS

DOC. NO.: QMS.PO.16.02 VERSION: 00


EFFECTIVE DATE: 20.09.01 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Resource management - Infrastructure.

1. Objective

The objective with this policy is to address maintenance issues relating to infrastructure.
Ultimately to reduce down time on services effecting daily works procedures, indirectly or
directly related to our ability to conform to product requirements.

2. Scope

The scope will cover basic maintenance of buildings, utility installation, IT hardware and
software, phone installations and vehicle maintenance.

Process equipment and service vehicles are treated as tools and covered under the
department or division responsible for this equipment.
Where use of such equipment is governed by regulatory requirements, records of
inspections and approval must be kept.

Supporting (external) services is dealt with under purchasing and set-up & review of
suppliers, - and based on individual departments and divisions specific requirements.

3. Responsibility

The financial controller is responsible for overseeing these tasks.


The Administration manager is directly responsible for the administration of buildings, utility
installations and phone installations.

Individual department and division managers are responsible for equipment and vehicles
managed and used by their employees.

IT hard and software is managed by the IT manager.

4. Definition

The company: See QMS.IN.04.00 - Definitions ==>

5. Element policies

5.01 Building, utility and phone system maintenance.

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The building and utility-installations maintenance will as a minimum have to comply with
regulatory requirements and should cover the following areas:

• Cleaning of office facilities and surrounding areas.


• Maintenance of air-condition system including bacterial control of water in cooling
towers.
• Drinking/consumable water quality check.
• Pest-control.
• Security.
• Provision for daily maintenance.

5.02 Vehicle maintenance.

Is carried out by the departments using the vehicles and records of maintenance is kept
here.

5.03 IT hardware and software maintenance.

Procedures will have to be set up to ensure that our two main software management
systems:
• SAP – and
• Lotus notes
Can run uninterrupted during office hours.

Such procedures will have to include:


• Maintenance of software.
• Maintenance of data and provisions for backups.
• Maintenance of hardware; servers, network, workstations, etc.

5.04 General.

Down time of our systems shall be recorded to ensure that improvements can be
measured.

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QMS.PO.16.03
Create by: Kim Brix
Date created: 20/09/2001
Last Modified by: Joergen Moeller
Last Modified date: 09/09/2009

MDS

DOC. NO.: QMS.PO.16.03 VERSION: 00


EFFECTIVE DATE: 20.09.01 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Resource management - Work environment.

1. Objective

The objective with this policy is to address the issues in the ISO 9001:2008 standard -
relating to work environment, via MHE Demag Group’s EHS program, which provide
guidelines on how the company manage Environmental, Health and Safety issues and as a
derivative thereof, how the environment potentially effecting our ability to conform to
product requirements - is managed.

2. Scope

The scope of the EHS program is as follows:

1. Corporate priority
2. Continuous improvement
3. Employee education
4. Product and services
5. Facilities and operations
6. Emergency preparedness
7. Customer advice
8. Promotion
9. Compliance & reporting

Details or references to these topics can be found in the Corporate Manual –


Management, MS 009/03

3. Responsibility

See MS 009/03

4. Definition

EHS: abbreviation for “Environment, Health and Safety”

5. Policy

See MS 009/03

6. References

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See MS 009/03

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PRODUCT
REALIZATION

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QMS.PO.17.01
Create by: Kim Brix
Date created: 23/05/2001
Last Modified by: Jessie Ang
Last Modified date: 05/26/2011

MDS

DOC. NO.: QMS.PO.17.01 VERSION: 00


EFFECTIVE DATE: 01.01.06 ISSUED BY: Kim Brix
SUPERSEDES NO.: 23.05.01 APPROVED BY: JM
SUBJECT: Planning of product realization.

1. Objective

The objective of this policy is to ensure that the product realization process is documented
according to the ISO 9001 requirements and documented sufficiently to ensure that the
process can be explained, understood and analyzed by an auditor.

2. Scope

This policy sets guidelines for how we plan, document and eventually record product
realization process outcome for existing and future products.
It describes the tools to be applied for these processes and minimum requirements for
documentation.

3. Responsibility

It is the department manager’s (as indicated in QMS.IN.07.00 "Overview of the Quality


Management System") responsibility to ensure that planning of the product realization
process is carried out according to this policy.

4. Definition

The company: See QMS.IN.04.00 - Definitions ==>

Product realization: The process of realizing a product, from Idea to finished


product.

Process element: A specific and predefined activity in the product realization


process.
See QMS.IN.08.00 "Process description & Interaction"

5. Element policy

5.01 Quality objectives and product requirements.

For each product a set of quality objectives will have to be established, (measurable
targets to be achieved and gauged at regular interval), to ensure improvements can be
measured.
Product requirements are established during the product conceptualization phase, and

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used to ensure that part-results obtained during the product realization phase are
guided towards a common target.

5.02 Resources.

Resources will have to be considered in every aspect of the product realization phase.
There has to a “red line” through our efforts.
This have to be seen in our commitment to a customer, through our project execution,
design, purchasing, manufacturing, packing, delivery and installation, and ensure that
we have the time, the necessary know-how, tools and the equipment to meet OR
exceed quality objectives and product requirements.

5.03 Control of the product realization process.

The product realization shall be planned in such a way that progress can be monitored
and where required - recorded for later verification of compliance to product
requirements.
See also QMS.PO.18.01-5.1 "General application of monitoring and measuring
processes"

The product realization efforts shall include verification intervals to ensure product
requirements are being met.
To ensure that a product is suitable for the application it is being realized for, any design
phase will have to include a validation, where suitability of the product in relation to the
environment it will be functioning in is considered.
This validation shall as a minimum include considerations to:

• Safety aspects of operation, (risks for operators or environment).


• Environmental impacts.
• Suitable operation of equipment or system.
• Passage to equipment or system components.
• Access to serviceable parts or components.

During the actual manufacturing of the products, inspection and test activities will have
to planned to ensure that the materials used are according to specifications, that
process requirements are fulfilled, that component specifications are correct and that
functional requirements can be met.

Such inspections and tests shall be recorded.

5.04 Tools.

The main tool used in the product realization planning is quality plans, quality activity
plans, quality procedures specific, quality control reports and working
instructions.

The quality plan is used for planning of the entire business process. Here critical
activities pertaining to individual business phases (see QMS.IN.08.00,"Process
description & interaction" for details on business phases) is listed and control activities
and type of verification indicated.

The quality activity plan is used as the quality plan, but for planning activities
pertaining to production, assembly and installation, which are product variant specific.

These forms shall be referred back to for a complete overview of Quality Control

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activities.

Once a quality plan for an entire business process has been completed, individual
business phases are elaborated on in Quality Procedure - specific.

This quality procedure - specific will outline the processes by means of flow-charts
and provide details on objectives, scope, responsible, definition and a detailed
description of the business process.

Quality control reports is used to capture data and confirm a commitment.


Irrespective of whether a Quality Control report provides for fields for "Inspected by",
"Reviewed by" and "Approved by", all Quality Control reports shall as a minimum be
signed off by an "Inspector" and an "Approver".

Working instructions is used to explain a process or a task which cannot be assumed


to be known via general education or training.

6. References

Related information to product realization planning;

 Product catagory: See QMS.PO.18.01 - 5.5.02 "Type of product"


 Incoming goods inspection: See QMS.PO.18.01 - 5.5.03 "Receiving Inspection and
Testing"
 Inhouse inspection of products: See QMS.PO.18.01 - 5.5.04 "In-process and final
inspection & testing"
 Site inspection & testing: See QMS.PO.18.01 - 5.5.05 "On site inspections and
testing"

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QMS.PO.17.02
Create by: Kim Brix
Date created: 01/10/2001
Last Modified by: Jessie Ang
Last Modified date: 05/26/2011

MDS

DOC. NO.: QMS.PO.17.02 VERSION: 00


EFFECTIVE DATE: 01.10.01 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Customer - related processes.

1. Objective

The objective of this policy is to ensure that the company always knows product and
customer requirements, before they commit themselves to a contract or acknowledge an
order.

That the company do not commit itself to a set of requirements, technically, quality wise or
commercially, - which involve financial risks exceeding those stipulated in the Corporate
Manual – RS 009/03

2. Scope

This policy governs all sales processes executed in the name of the Company.

3. Responsibility

It is the sales responsible and his superior’s responsibility to ensure that requirements are
captured, reviewed and evaluated according to “delegation of authority” as stipulated in the
Corporate Manual – FA007/006.

It is the Division and the Product manager’s responsibility to ensure that this policy is
implemented.

4. Definition

The company: See QMS.IN.04.00 - Definitions ==>


Authorized personnel: Employee authorized to confirm an order or commit to a
contract
According to RS 009/03 in the Corporate Manual.
Senior Management: See Corporate Manual – Management MS 006/04.

5. Element Policy

5.1 Review of tenders, contracts, purchase and change orders

A "contract/product/application" review shall be included in sales procedures related


to all products covered under the Quality Management System.
This is to uncover customer's requirements and ensure that the Company know

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what the customer really wants.

Beside the requirements stated by the customer, the Company has to decide if
there are other requirements to consider.

5.2 Review of requirements related to the product

Before accepting an order or submitting a tender we will need to know that ALL the
requirements there is to the product in question, as indicated under 5.1, can be met
or discrepancies can be resolved.
.
Once customers requirements is known, a thorough review of the product in
question and the application it is meant for, will have to be carried out to ensure that
we can fulfill these requirements, technically, resource wise, capacity wise and at
the specified quality.

The review and the actions taken to resolve discrepancies between customers
requirements and our product requirements shall be recorded.

5.3 Customer communication.

Communication between The Company and our Customers, present and future, - is
managed through four functional areas and at different stages in our business
process.

Our marketing department manages communication between future customers and


The Company.
This communication cover surveys, product promotions, advertising and other
activities related to promote The Company and our products.

This does not directly influence The Company’s ability to consistently provide
products that meets customers requirements or enhance their satisfaction, - and as
such this is not further elaborated on in our Quality Management System.

During the inquiry and sales phase, the communication between The Company and
the customer is handled by the Sales representative.

Once an order have been confirmed or a contract signed, the Sales representative
will hand-over the project to a Project engineer.
Such a hand-over will include a proper introduction to the customer’s representative
and if practically, a review of customer’s requirements as handed over from the
sales representative.
This is done with the customer to ensure that customers requirements are correctly
understood.

The Project engineer now manages communication between the Company and the
customer, until the project has been completed, handed over and accepted by the
customer.

Now the Project engineer will hand-over warranty details and project documentation
to the customer and our service department, who will manage the warranty
agreement.
During this hand-over, the customer is either presented for the responsible Service
representative or advised how the warranty agreement is managed and how the
service department is contacted.

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QMS.PO.17.03
Create by: Kim Brix
Date created: 10/10/2001
Last Modified by: Jessie Ang
Last Modified date: 29/04/2013

MDI, MDIM, MDIT, MDLM, MDM, MDP, MDS, MDSM, MDT, MDTW, MDV, MHEM

DOC. NO.: QMS.PO.17.03


EFFECTIVE DATE: 29.04.2013 ISSUED BY: Loo TK
SUPERSEDES NO.: 10.10.2001 APPROVED BY: J Moeller
SUBJECT: The design and development process

1. Objective

The objective of this policy is to provide guidelines on how design is managed in The
Company and to ensure that customer and product requirements are met and that a design
is suitable for the application it was made for.

2. Scope

The scope of this policy apply to the following;

 Engineered cranes - "Structural design" QM.HC.PS.01.04


 Building maintenance units - "Design execution QM.IP.PS.01.02
 Regional Electrical Department - "Design planning & control for hardware equipment"
QM.RE.PS.01.00
 Regional Electrical Department - "Electrical design for hardware equipment"
QM.RE.PS.01.01

It does not cover products that apply, modify or adapt proven designs and processes, such
as Standard Cranes, to meet various customer requirements.

3. Responsibility

The relevant managers responsible for Project and Design activities, shall ensure that this
policy is implemented and complied with.

4. Definition

The company: See QMS.IN.04.00 - Definitions ==>

5. Element Policy

5.01 Design and development planning

As described under QMS.PO.17.01 "planning of product realization", then there is some


basic guidelines for planning of the product realization and requirements for how it is
documented.

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In addition, design and development activities shall be planned to provide the highest
possible degree of transparency in the process itself and incorporate progressive
reviews of the "decision process" to eliminate potential shortcomings and allow for
alternative ideas and concepts.

Design and development procedures shall address and document organizational and
technical interface activities within a design and development process and with other
inter-company departments, statutory bodies, customer, sub-contractor, third parties
and any other applicable group, where such exist.

Design and development input shall be unambiguous. Any change to this input shall be
reviewed to confirm if such changes are according to customer’s requirements,
contractual obligation and company and quality standards.

5.02 Design and development input

Design and development input information obtained from orders, specifications, contract
documents, contract reviews, regulatory requirements, operational and environmental
conditions and design support data, shall be documented and reviewed to ensure that
adequate information is available for design and development activities to proceed.
Such information should include, but not be limited to, - functional and performance
requirements, and considerations for statutory and regulatory requirements.

This activity shall be carried out by the respective project engineer and verified and
acknowledged by the responsible design engineer during a hand-over attended by both
parties and signed of to ensure that customers requirements and the responsibility for
continuing the process has been accepted.

The Hand-over shall be captured via a quality control report and maintained.

Incomplete, ambiguous or conflicting requirements shall be resolved with the customer


or others, as applicable, before relevant aspects of the design and development are
commenced and before hand-over is accepted.

5.03 Design and development output

Design and development output shall be documented by means of drawings,


calculations or specifications and shall be in a form that allows verification against
design and development input. It shall be complete and unambiguous and contain the
information necessary for purchasing, production and for service provision. Design and
development output shall contain reference to the relevant acceptance criteria.

Crucial characteristics of the design and development, essential to the safe and proper
functioning of the product shall be identified recorded (preferably on a dedicated quality
control report) and maintained. Design and development output shall comply with
relevant regulatory requirements whether or not these were called for within the design
and development-input information.
Design and development documents shall be reviewed by qualified personnel and
signed to verify acceptance, prior to release.

5.04 Design and development Review

Reviews shall be carried out as planned, refer to clause 5.01, to identify progress,
evaluate the ability of the design to meet requirements, to identify problems and ensure

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all specified requirements are covered.

Participants in functions concerned with the specific design and development shall be
present during design and development reviews.
This shall also include specialists where specialist participation has been identified or
requested by contract.

Design and development reviews shall be recorded and maintained by those identified
as being responsible for conducting a specific review.

In circumstances of high technical risk and major projects undertaken, management


may request for reviews to be conducted by suitably qualified persons who are
independent of the original design and development activities.

These review activities shall be documented and maintained.

5.05 Design and development Verification

All design and development output shall be verified by qualified personnel.


Design and development verification shall ensure that design output meets the design
and development-input requirements.

Results of design and development verification shall be recorded and maintained by the
design responsible.

Upon completion of design development activities, all design and development


documents shall be subject to final verification prior to endorsement by the Design
Manager or his appointed qualified deputy before release to the Project Department.
Such authorisation or revision details, if any, shall be provided on design documents
according to standard format.

5.06 Design and development Validation

Design and development validation shall be done by appropriate authorised and


qualified personnel and to ensure the product is capable of meeting the requirements for
the specified application or intended use.

Validation test shall be carried out, either at the workshop or at the installation location.
Results of such tests shall be recorded and filed by the responsible Project Engineer.

5.07 Control of design and development Change

Request for a design or development change through corrective or preventive action,


customer requirement, change of specification, perceived improvements, or any other,
shall be submitted and reviewed by the respective Project engineer and responsible
Design engineer.

Design and development change details shall be documented and submitted to the
Design Manager for processing.

All changes to design and developments shall be documented and follow the element
policies stated above 5.01-5.06.
Review of design and development changes shall include the effects these changes can
have on constituent parts and products already delivered.

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Records of the result of such review and necessary changes shall be maintained.

6. References

Nil

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QMS.PO.17.04 - Purchasing.
Create by: Kim Brix
Date created: 11/10/2001
Last Modified by: Joergen Moeller
Last Modified date: 09/09/2009

MDS

DOC. NO.: QMS.PO.17.04 VERSION: 00


EFFECTIVE DATE: 11.10.01 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Purchasing.

1. Objective

The first objective is to establish some guidelines to ensure that purchased products and/or
services conforms to specified purchase requirements and to ensure the company comply
with ISO 9001:2008 requirements.

The second objective is to ensure that suppliers are regular evaluated and selected based
on their ability to supply product and services according to purchase requirement, and that
such evaluation is maintained.

2. Scope

The Company's Purchasing Policy shall be applicable to all purchased goods and services
(including processes and product potenti .

3. Responsibility

3.01 It is the responsibility of the Regional Financial Controller to ensure that the
Company's Purchasing Policy and the associated procedures consistently comply with the
requirements for purchasing, outlined by the Group and the requirement stated in the ISO
9001:2008 standard.

3.02 The Purchasing Manager is responsible for the constant monitoring of the
implementation of the Company's Purchasing Policy and the associated procedures.

3.03 It is the responsibility of all management personnel to ensure that the Company's
Purchasing Policy and the associated procedures are understood, implemented and
maintained at all levels in the organisation.

4. Definition

LVO: Limited Value Order for purchases not exceeding $2000 (exclusive of Goods and
services Tax) and excluding any purchase of goods for stock or from the Company's
established principals.

5. Element Policy

5.1 Assessment Of Sub-Contractors

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5.1.01 The Company shall establish and maintain an approved list of acceptable
sub-contractors of all goods and services for which any non-conformance
would adversely affect quality of products. Sub-contractors shall be classified
according to the degree of control being exercised on them.

5.1.02 To ensure conformance to quality requirements, the Company shall


endeavour to select sub-contractors having formal recognition of externally
assessed Quality Systems.
Where these do not exist, sub-contractors shall be required to supply either
details of their Quality Assurance Systems, or other documented evidence,
which confirms the conformance of their product to specification.

5.1.03 The master list of acceptable sub-contractors shall be available in the


Purchase Department together with records verifying conformance of their
Quality Assurance System, to the Company's requirements.

5.1.04 Sources proposed for inclusion on the approved list of acceptable


sub-contractors, shall be evaluated and approved according to
pre-determined procedures.

5.1.05 Where appropriate or required by contract, the extent of control over


purchasing activity shall include subsequent control audits and monitoring at
the sub-contractor's facility as required.

5.1.06 Records shall be maintained of all non-conformance findings, for use when
reviewing the list of approved sub-contractors.

5.2 Purchasing Data

5.2.01 A Purchase Requisition containing all relevant information and validated by an


authorised person shall be issued prior to any purchasing action being
confirmed.

Purchase Orders shall be reviewed and verified by the Purchase Department


or by the appropriate functions in accordance with FA007/06 “delegation of
authority”.
This is to ensure traceability and that detail of all pertinent documents
including all relevant data and drawings necessary for the complete
specification of the product is included.

Purchase Order review shall include but not be limited to requirements for
technical, commercial and financial details.

5.2.02 No Purchase Order shall be released before the required review activities
have taken place.

5.3 Verification Of Purchased Product

5.3.01 Verification at sub-contractor's premises


If verification of a purchased product is required at the sub-contractor's
premises, suitable qualified personnel shall carry out such verification. The
purchasing documents shall specify verification arrangements and the
method of product release.

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5.3.02 Verification of purchased product by customer
Where specified in the contract, the customer or his representative, shall
afford the right to verify at source in the sub-contractors facility, or upon
receipt that purchased product complies with specified requirements.
Verification by the customer shall not be used as evidence of product
compliance, nor shall it preclude subsequent rejection by the customers.

The sub-contractor shall not use verification of product conformance by the


customer in the sub-contractor’s plant, as the basis of evidence for total
control of quality activities.

6. Reference

MHE Corporate Manual FA 007/09 Delegation of authority.


MHE Corporate Manual FA 007/09 Appendix B, Authorisation level.

5.1 see: QM.PC.PS.06.00 "Setup and review of suppliers"


5.2 and 5.3: See specific quality manuals for interface details to purchasing

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QMS.PO.17.05 - Production & service provision
Create by: Kim Brix
Date created: 13/02/2001
Last Modified by: Jessie Ang
Last Modified date: 05/26/2011

MDS

DOC. NO.: QMS.PO.17.05 VERSION: 00


EFFECTIVE DATE: 24.10.01 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Production & service provision.

1. Objective

The objective with this policy is to ensure that the production and service process is planned
and carried out under controlled condition.

That tools, equipment, materials and components are suitable for the production and
service process, well documented and available with such documentation, where needed.
That materials and components are controlled and maintained to prevent deterioration or
damage during internal or external processing.

That identified critical manufacturing or service processes are sufficiently controlled and
traced to ensure confidence in process outcome.

2. Scope

This policy shall be applicable to all manufacturing and service done by the company or by
its subcontractors and cover the actual manufacturing and service processes and the
preservation of the product.
It shall also apply to inventory or anywhere else where materials, components or
sub-assemblies for our products are being processed.

3. Responsibility

It is the responsibility of the individual division and department manager, to comply with this
policy and ensure that procedures are set up to fulfil the above objective, (see
QMS.IN.07.00 "Overview of the Quality Management System" for details).

4. Definition
The company: See QMS.IN.04.00 – "Definitions" ==>
NCR: Non Conformance Report
Work Norm Handbook: Set of minimum requirements relating to commercial,
“Environment –
Health and Safety”, mechanical, electrical and “Transportation
– Packaging and Storage” standards.

5. Element Policy

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5.1 Control of production & service provision

5.1.01 The production and service operations is planned following the directions
provided by QMS.PO.17.01 "Planning of the Product realization Process"
This planning includes considerations for working instruction related to specific
process equipment and use of measuring devices.
For "Control of measuring & Monitoring devices" see QMS.GP.27.02

5.1.02 The products manufactured or serviced, either internally or externally, shall be


governed by the Documentation provided by the product owners.
For production this is the Quality Activity plans - related to the products,
providing details on QC activities including requirement for tests - , release and
approval activities.
For service it is the hand-over documentation - provided by the project
responsible upon closure of individual projects and the specific component
documentation provided by our principle

5.2 Validation of processes for production & service provision

"Production" shall establish a procedure to ensure that our welding processes is


controlled according to the AWS standard and complies with article 7.5.2 in the
ISO 9001:2008 standard.

5.3 Identification and traceability

Where there is a requirement for product traceability, measures shall be taken to


ensure such traceability.
Where a material requirement deviate from our standard material requirement,
specified in our “work norms handbook”, such material shall be traced for later
identification.
For further details see QMS.GP.27.01 "Identification & Traceability"

5.4 Customer property

Customer property shall be identifiable anywhere in the company.


Any damages to a customer product shall be covered by our NCR and informed
to the owner.
See QMS.GP.28.02 "Control of nonconforming product" for details

5.5 Preservation of products

Any material, sub assembly or product in production or under service shall be


preserved and handled in such a way, that deterioration is prevented.

This shall also cover internal storage and delivery operations.

6. Reference

None.

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QMS.PO.17.06 - Control of measuring &
Create by: Kim Brix
Date created: 24/10/2001 monitoring devices
Last Modified by: Jessie Ang
Last Modified date: 05/26/2011

MDS

DOC. NO.: QMS.PO.17.06 VERSION: 00


EFFECTIVE DATE: 24.10.01 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Control of measuring & monitoring devices

1. Objective

The first objective of this policy is to provide directions on how adequate storage,
maintenance and calibration of monitoring and measurement equipment is provided.
The second objective is to provide guidelines on how we deal with non-conforming
monitoring and measuring equipment and how we subsequently trace and correct potential
non-conforming products as a result of faulty monitoring and measuring equipment.

2. Scope

The scope of this policy shall cover all inspections and the measuring and test equipment,
requiring calibration, -employeed by the company.

3. Responsibility

The company's Production manager, Service manager, Quality engineers and


department/division managers who employ equipment which require calibration, shall
adhere to this policy.

4. Definition

The company: See QMS.IN.04.00 "Definitions" ==>

5. Element Policy

5.1 Planning of Monitoring and measuring activities

Is done during the initial planning of the product realization process and stated in
Quality PLans and Quality Activity plans.
For details related to planning of the product realization process, see QMS.PO.17.01
"Planning of product realization"

5.2 Division / Department responsibilities


Each division / department in the company using monitoring and measuring
equipment, is responsible for the equipment and that measurements taken with
these equipments can be traced.

5.3 Procedures

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A procedure shall be established to ensure that measuring equipment, requiring
calibration, - is controlled, handled, preserved, calibrated and maintained
according to equipment specifications, see QMS.GP.27.02 "Control of measuring &
monitoring devices" for more details.

5.4 Responsible for Measuring equipment


Each division / department shall appoint and name a person / function in the
procedure mentioned under 5.3, to handle measuring equipment,
associated calibration records, user manuals and any other reference materials
required to use the equipment.

5.5 Availability of technical data pertaining to the equipment


Technical data pertaining to the equipment, referred to in 5.4 shall be made available
to customers or their representative on request.

5.8 Corrective action


When measuring equipment is found to be out of calibration, an evaluation of
consequences for the products tested with this equipment, will
have to be carried out.
If there is a risk of consequences to a product due to faulty measuring equipment,
the product shall be re-measured and if necessary, corrective action will have to be
taken, see QMS.GP.28.03 "corrective actions" for details.

6. Reference

None

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MEASUREMENT /
ANALYSIS
IMPROVEMENT

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QMS.PO.18.01
Create by: Kim Brix
Date created: 23/05/2001
Last Modified by: Jessie Ang
Last Modified date: 15/11/2012

MDI, MDIM, MDIT, MDLM, MDM, MDP, MDS, MDSM, MDT, MDTW, MDV, MHEM

DOC. NO.: QMS.PO.18.01


EFFECTIVE DATE: 15.11.12 ISSUED BY: Loo TK
SUPERSEDES NO.: 30.10.01 APPROVED BY: J Moeller
SUBJECT: Monitoring and Measurement - General

1. Objective

The first objective of this policy is to provide directions on how the company applies
methods for monitoring, measuring, analyzing and improving “product realization” processes
to ensure conformity to requirements of the product and the Quality Management System
and provide a base for continual improvement.

The second objective is to ensure that any product designed, manufactured and delivered
does comply with contractual specification and requirements or company product standards,
as applicable – and that they are tested to ensure this.

2. Scope

This policy shall cover all areas of our Quality Management System, where monitoring and
measuring is done to ensure compliance with a specific procedure.

3. Responsibility

It is the process owner’s responsibility to implement monitoring and measuring activities to


ensure the quality and consistency of the process output.
It is the product owner’s responsibility to implement monitoring and measuring activities to
ensure that product requirement and specifications are met.

4. Definition

FAI: First Article Inspection.

5. Element Policy

5.1 General application of Monitoring & Measuring processes

During the initial planning of a product realization process, considerations will have to
made on how the process is monitored and how process output is measured, analyzed
and used to improve the particular process and the Quality Management System as a
whole.

As a guideline, QC reports will have to be established to capture customer requirements,

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during hand-over from one process phase to the next, during hand-over to a customer
and anywhere else where consistency of a process output is critical.

These QC reports form the basis for later measuring, analysis and eventually
improvement of our product realization process.
For details on product realization planning see QMS.PO.17.01 "Planning of product
realization"

5.2 Customer satisfaction

One of the objectives of implementing a Quality Management System is to ENHANCE


CUSTOMER SATISFACTION through the effective application of the Company’s Quality
Management System. To ensure that we meet this objective, measures shall be taken to
ensure that customer satisfaction is measured, analyzed and used to improve our
product realization phase and the Company’s Quality Management System.

QMS.PO.18.03 - 5.1 "Analysis of data" provide directions on how we achieve this.

5.3 Internal Audit

Internal audits of the product realization process shall be conducted at least once a year
to ensure that the product realization process is working efficiently and as planned.

Internal audits shall ensure, that the Quality Management System, as a tool, - allow us to
capture deviations from planned arrangements and as a guide be clear in it’s directions
on how we conduct our business and capture measurements of critical elements in our
product realization phase.

Internal audits shall be initiated and planned by the Management representative or the
Quality Manager (if different personnel carry out these two functions) and conducted by
qualified internal auditors. The result of the internal audits shall be made available to the
personnel effected Group, Company and Regional Management.

A general procedure shall be established to provide specific guidelines on


responsibilities and scope of the people involved in the Internal Audits, qualifications of
personnel and report format for the internal audit.

See QMS.GP.28.01 "Internal audits" for details.

5.4 Monitoring and measurement of processes

Determination of monitoring and measuring “points” at specific areas of the product


realization process shall be done during the initial product realization planning, see
QMS.PO.17.01 "Planning of product realization", and used to verify that the process is
running consistently.
These measuring "points" are planned during the planning stage and shown in all
Quality Plans and Quality Activity Plans.
See individual Quality Manuals for details.

Other areas where the Quality Management System processes is measured to ensure
that they can meet planned results includes;

 Customer feedback - see QMS.PO.18.03 "Analysis of data - customer satisfaction".


 Management reviews - see QMS.PO.15.01 "Management commitment -
management review"

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 Internal Audits - see 5.3
 External Audits - as advised by BVQI

5.5 Monitoring and measurement of product

5.5.01 General

All incoming products and products undergoing manufacturing and/or assembly work
and/or installation and commissioning work shall be subjected to inspection,
verification of dimensions and testing to ensure compliance with contractual and/or
standard specifications as applicable, prior to delivery and/or hand-over to the
customer.

"Inspection and Testing" activities shall be stated in our Quality Plans/Quality Activity
Plans and planned according to QMS.PO.17.01 "Planning of product realization"

“Inspection and Testing” activities shall be carried out using the designated QC reports
for the activity. The QC forms shall provide evidence of inspection and/or test, whether
the product has passed or failed the inspection and/or test according to defined
acceptance criteria.

5.5.02 Type Of Products

Our company is trading in technical products, and design and manufacture products,
some of which are of a standardised nature and some of which are tailored for specific
requirements.
They are always manufactured on a project basis.
Products subject to Inspection and/or Testing can therefore be categorized as follows:
-

Trading products which require no inspection/testing prior to delivery.

Trading products which require assembly and PDI prior to delivery, in some cases,
subsequent to installation and commissioning, and in some cases additional
inspection/testing prior to hand-over to a customer.
A combination of standard pre-prepared QC forms shall be applied.

Standard engineering products which require design, project related purchases,


receiving, manufacturing, in-process and final inspection and testing and in some
cases, subsequent to installation and commissioning on site, additional
inspection/testing prior to hand-over to a customer.
A combination of standard pre-prepared QC forms shall be applied.

Special engineering products which require design, project related purchases,


receiving, manufacturing, in-process and final inspection and testing and in some
cases, subsequent to installation and commissioning on site, additional
inspection/testing prior to hand-over to a customer.
A combination of standard pre-prepared and purposes made QC forms shall be
applied.

5.5.03 Receiving Inspection And Testing

Supplies from companies with a certified or approved Quality Management Systems


where supplies comes in original sealed packing

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Material and components received in original and sealed packaging, from companies
having a Quality Management System certified by a certification body accredited by an
acknowledged accreditation counsel or approved by the company, shall be subject to
verification of compliance with purchase orders in respect of quantities and possible
transport damages.
It shall remain in their original sealed packaging.

Supplies from companies without a Quality Management System

Material and components received from companies without approved Quality System
shall be subject to inspection of compliance with purchase orders in respect of
quantities, technical specifications and shall be inspected for possible transport
damages.

Supplies from sub-contractors

As far as possible and practical, all work executed /supplied by sub-contractors shall
be subject to our own Inspection And Test requirements, as if the sub-contractor was
an "extension" of the company's own production.
As and when our own Inspection and Test requirements cannot be applied, the
supplies from sub-contractors shall be subject to inspection of compliance with
purchase orders in respect of quantities, technical specification and where applicable,
functionally tested and shall be inspected for possible transport damage.

Release of products for delivery or production

Only products which have passed the receiving inspection and testing shall be
released for delivery or production.
In the case of products being released to production, or in the case of products being
delivered directly to site prior to inspection and testing, then the receiving documents
and the products shall be marked accordingly. Action to apply the receiving inspection
and testing shall be taken soonest possible after the receipt.

Test certificates supplied with products

The Purchasing/Inventory department shall retain all test certificates received from
suppliers for products/components supplied.
It shall be kept here until the products/components are issued to production, service or
installation department or shipped to clients (including inter-company customers) at
which point, the certificates shall be passed on to the recipient of the product and
retained.
See QMS.GP.24.02 "Documentation - Control of records" for details.

Receiving inspection and testing documents

Where no QC form has been prepared for verification of receiving inspection and
testing, the respective shipping documents can be used with an authorized stamp,
verifying the inspection and testing.

Non Compliance

Products which do not pass the receiving inspection and testing shall be separated
from products in compliance and they shall be identified accordingly. Non complying

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products shall be subject to separate action plan.
See QMS.GP.28.02 "Control of non-conforming product" and QMS.GP.28.03
"Corrective actions" for details.

5.5.04 In-Process and, Final Inspection and Testing

All products identified in 5.5.01, except those not requiring in-process and final
inspection and testing and those being delivered in their original sealed packaging
shall be subject to in-process and final inspection.

For projects where contractual requirements apply beyond what is stated in Quality
Plans/Quality Activity Plans, The Quality Engineer/Project responsible shall establish
QC reports to cover such contractual requirements prior to the commencement of
manufacturing.

5.5.05 On Site Inspection And Testing

For all projects which scope includes installation, QC shall be carried out at the
installation site according to applicable Quality Plans/Quality Activity Plans.

For projects where contractual requirements apply beyond what is stated in Quality
Plans/Quality Activity Plans, The Quality Engineer/Project responsible shall establish
QC reports to cover such contractual requirements prior to the commencement of the
installation work.

6. References

None

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QMS.PO.18.02
Create by: Kim Brix
Date created: 13/02/2001
Last Modified by: Woei Wen Lou
Last Modified date: 26-11-2004

MDS

DOC. NO.: QMS.PO.18.02 VERSION: 00


EFFECTIVE DATE: 05.10.01 ISSUED BY: Kim Brix
SUPERCEDES NO.: 1st. edition. APPROVED BY: JM
SUBJECT: Control of nonconforming product

1. Objective

To provide direction for a procedure to ensure that a product, which does not conform to a
specified requirement, is reviewed and actions are taken to ensure compliance, before any
use or installation of the product.

2. Scope

This policy shall apply to the Company’s Quality Management System and the products
covered by the Quality Management System.

3. Responsibility

The management personnel listed in QMS.IN.07.00 "Overview of the Quality Management


System" as responsible, shall ensure that this policy is understood and implemented.
The Quality Engineer/Project responsible shall ensure this policy is complied with.

4. Definition

Non Conformance: When a product or service is intended for customer use, and results
pertaining to the activities or processing of such products or service do
not conform to specified requirements.

5. Element Policy

5.1 General
A product that has been identified as being not in compliance with a specific
requirement shall not be used, installed or processed further, until actions have been
taken to resolve the non conformance issue.
The criterion for “Actions” is stipulated within this policy. The actual procedure for
dealing with non-conformities, is stipulated in QMS.GP.28.02 "Control of Non
conforming Product”

5.2 Identification

5.2.01 It is the responsibility of all trained and/or qualified personnel who in his/her
daily work needs to comply to specified requirements to identify
non-conformance issues, when discovered.

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5.2.01 On identification, the nature of the non conformance shall be documented and
the product shall be physically identified as a "Non conforming Product" and
when practical to do so, segregated from other conforming products, in order
to prevent from unintended use or installation. The personnel responsible for
the activity or process shall ensure this is complied with.

5.3 Evaluation

The evaluation is described in the procedure QMS.GP.28.02 "Control of


nonconforming product".

5.4 Review of Non conforming Product

The review of a non-conformance finding shall determine the solution in order for the
product to comply with specified requirements.
The product may be: -

- Reworked or modified.

- Accepted with or without repair by concession. Where required by contract,


the intended use or repair of such products shall be reported to the customer
or his representative for concession.

- Re-graded for alternative applications.

- Rejected and scrapped.

5.4.01 The content of the solution shall be documented in sufficient detail for
implementation and shall be approved by the Department/Division manager -
responsible for the product or the appointed representative, prior to
distribution of the documents.

5.5 Records

Documents relating to non-conforming products shall comply with the Quality


Procedure QMS.GP.24.02 “Control of Records"

5.6 Conforming Product Verification

Repaired and/or reworked product shall be re-inspected in accordance with the


quality plan/quality activity plan and/or as per instructions issued in conjunction with
the solution presented under clause 5.4.01.

6 References

QMS.QP.34.02 “Control of Quality Records"


QMS.QP.38.02 “Control of Non Conforming Product"

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QMS.PO.18.03
Create by: Kim Brix
Date created: 06/11/2001
Last Modified by: Jessie Ang
Last Modified date: 07/09/2007

MDS

DOC. NO.: QMS.PO.18.03 VERSION: 00


EFFECTIVE DATE: 04.09.07 ISSUED BY: J Moeller
SUPERCEDES NO.: QMS.PO.18.03/05.08.02 APPROVED BY: J Moeller
SUBJECT: Analysis Of Data

1. Objective

To ensure that measurable data is channelled back to the Company appointed Management
Representative (MR) pertaining to customer satisfaction, conformity of product
requirements, process performance data and supplier performance data.
This to analyse the effectiveness of the Quality Management System and the organisation
as a whole and provide a platform from where improvements can be made.

2. Scope

This policy shall cover all QC activities and business processes as identified by the Group
Management Representative in cooperation with other process owners and stakeholders in
the QMS System.

3. Responsibility

In conjunction with Management Reviews and during analysis of recurring problems, audit
results or other feedback, the Management Representative shall decide if the Quality
Management System is sufficiently effective to address the problem or suggest and
introduce new QC activities as required, to ensure that the objective of this policy can be
fulfilled.

It is the process owner’s responsibility to comply with the Management Representative’s


request for systematic feedback of QC activities.

4. Definition

None

5. Element Policy

5.1 Customer satisfaction

Customer satisfaction shall be measured through systematic feedback from our


customers.
This shall initially be arranged via a general customer surveys, minimum every two
year and always prior to the Management Review.

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The survey will typically be arranged by our marketing department in accordance with
a pre-determined system and the marketing department will forward a copy of the
result to the Management Representative and to the Company Management.

The survey should contain questions, as applicable, related to our performance in


sales, project execution, installation, testing, commissioning and final hand-over.

5.2 Conformity of product requirement

Product test discrepancies between measured and specified performance,


constitutes as a non-conformance according to QMS.PO.18.03 "Control of
nonconforming product" and shall be reported to the Management Representative.
Details on how the non-conformance was detected, where it was detected and who
(function) was responsible shall be included in the report.

5.3 Process feedback

Production shall report non-conformances related to specific processes, directly to


the Management Representative.
This type of feedback shall also include reports on non-conformances related to
processes where parts of our products are manufactured at subcontractors.

Again, details on how this non-conformance was detected, where it was detected and
who (function) was responsible shall be included in the report.

5.4 Suppliers

Analysis of supplier’s performance is carried out at least once every three years by
the purchase department (Refer QM.PC.PS.06.00)
Any non-conformances detected, relating to the performance of a supplier, shall be
forwarded to purchasing to assist them in their evaluation.

Results of the annual supplier evaluation shall be forwarded to the Management


Representative.

6. References

Management review: QMS.GP25.01

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QMS.PO.18.04
Create by: Kim Brix
Date created: 05/11/2001
Last Modified by: Jessie Ang
Last Modified date: 10/12/2010

MDS

DOC. NO.: QMS.PO.18.04 VERSION: 01


EFFECTIVE DATE: 15.10.2010 ISSUED BY: Loo Tiong Kok
SUPERSEDES NO.: 06.10.2001 APPROVED BY: J Moeller
SUBJECT: Improvement

1. Objective

To provide directions on how we handle Corrective and Preventative Action against actual or
potential non-conformities.
To ensure continual improvement of the Quality Management System through the use of our
Policies, Quality Procedures, QC reports, management reviews, audits, data analysis results
and corrective and preventive action.

2. Scope

Corrective and Preventive Actions shall be applied to non-conformances related to products,


manufacturing processes and customer complaints acknowledged by the company as
non-conformances.
The continual improvement process shall apply to the Quality Management System.

3. Responsibility

The respective division/department heads shall ensure that this policy is implemented and
complied with for activities within their respective boundaries.

The Quality Manager is responsible for updating of the Quality Management System.

4. Definition

Corrective Action: - Bring into conformity.

Preventive Action: - Advance measures against something which possibly or probably


would result into a situation of non-conformity.

5. Element Policy

5.1 Corrective action

A documented procedure shall be established to handle corrective actions in


accordance with the ISO 9001:2008 standard.
See QMS.GP.28.03 "Corrective action"

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Where results of Corrective Action require changes to any content of this Quality
Management System, the changes shall be carried out in accordance with the policy
QMS.PO.14.02 "Control of documents & records”.

Any Corrective or Preventive Action taken shall be to a degree appropriate to the


magnitude of a problem and proportional to possible or probable risks encountered.

Customer complaints and reports of product non-conformities shall be recorded.


The affected department/division manager or his representative shall process the
information to determine whether the non-conformity is correct.
Non-conformance findings shall be analysed to identify the cause. Authorised
or/and-qualified personnel shall determine and implement the Corrective Action
needed to eliminate the cause.

To prevent recurrence, qualified personnel shall review the effectiveness of the


action taken.
Any action taken shall be recorded.

5.2 Preventive Action

A documented procedure shall be established to handle preventive actions in


accordance with the ISO 9001:2008 standard.
See QMS.GP.28.04 "Preventive action"

Where results of preventive action require changes to any content of this Quality
Management System, the changes shall be carried out in accordance with the policy
QMS.PO.14.02 "Control of documents & records”.

Possible or probable causes of non-conformities are detectable through analysing


concession notices, design documentation and manufacturing processes, audit
results, quality records, service reports, customer feedback and applicable
procedures or work instructions which reflect product quality.

This shall be carried out by the respective department/divisional managers or his


representative, with the view to take action against a situation in order to prevent
potential non-conformities.

To achieve this, all relative information and advice shall be collected, to determine
the actions needed to deal with identified possible or probable problems.

The respective division/departmental managers shall ensure proper implementation


and verify the effectiveness of preventive action taken in order to eliminate a
potential non-conformity.

Any action taken shall be recorded.

5.3 Continual improvement

To ensure that the problem issues picked up during management reviews (see
QMS.GP.25.01), is addressed, - and ensure that the Quality Management System
reflects the actual business procedures, that objectives are adjusted and our Quality
Policy reflects the company's intentions,- the annual management review reports
with proposals for changes shall be presented to the Department/Division manager
for endorsement, they will then be implemented in accordance with the policy
QMS.GP.24.01 “Documentation - Control of documents”

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