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Sop-Special Characteristics Identification

This document outlines a process for identifying and documenting special characteristics throughout a product's lifecycle. The process involves: 1. Forming a cross-functional team to review requirements and identify special characteristics. 2. Listing the identified special characteristics and planning to use a symbol to denote them. 3. Incorporating the special characteristics into design documentation, process documentation, control plans, prototypes, and production documents to ensure they are properly addressed.

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Saravana kumar Nagarajan
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850 views

Sop-Special Characteristics Identification

This document outlines a process for identifying and documenting special characteristics throughout a product's lifecycle. The process involves: 1. Forming a cross-functional team to review requirements and identify special characteristics. 2. Listing the identified special characteristics and planning to use a symbol to denote them. 3. Incorporating the special characteristics into design documentation, process documentation, control plans, prototypes, and production documents to ensure they are properly addressed.

Uploaded by

Saravana kumar Nagarajan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 3

IDENTIFICATION OF SPECIAL CHARACTERISTICS

Doc. Ref : SOP/SC Rev. No. 0 Page: 1 of 3

Prepared By : Reviewed/Approved By : Issued By : Date :

Purpose To establish and identify and document Special Characteristics throughout the product lifecycle
(development, pre-launch, mass production )
Start of Process: Review of the Requirements for Products. / Formation of Cross Functional
Team
Finish of Process Manufacturing process
Interfaces : Multi-disciplinary

Process Manager Inputs : Requirements for Products Output : Deployment of special


characteristics.in Quality plan

FLOW CHART – SEQUENCE AND INTERACTION OF PROCESSES


P-D-C- Seque TASK NAME DESCIRPTION Responsibility Document Remark
A Stage nce Reference
Form cross functional team (MK / PU / DP/TX,
1
QA / Engg.).
Review the following to identify special
characteristics :-
• historical warranty and quality data
• whether customer has specified any
characteristic as special characteristic
and any special symbol for same
• which characteristic can affect
(i) functionality (fit, form, function,
performance, further processing).
PLAN (ii) relevant safety aspects
2
(iii) compliance with regulations.

List such of those characteristics as special List of Special See NOTE


Characteristics Guidelines-
characteristics
Hpw to identify
Plan to use customer specified symbol. If not special
specified, use “SC” as the symbol for special characteristics
characteristics

Design phase FMEA


• Identify special characteristics
• Incorporate them into the Design failure
mode and effects analysis (DFMEA),
DO 3 including engineering drawings
• validate special characteristics during
the design validation
• ensure special characteristics / symbols
are incorporated into the design record
Page 2 of 3
P-D-C-A Seque TASK NAME DESCIRPTION Responsibility Document Remark
Stage nce Reference
• identify relevant process-related special
characteristics (process parameters)
such as temperature, pressure etc. that
impact product special characteristics
• incorporate the process / product
4 special characteristics into the process
failure mode and effects analysis
(PFMEA);
• ensure special characteristics / symbols
are incorporated into the relevant
documents / records
Control Plan
• Develop capable processes and controls
Including robust controls for all process
/ product special characteristics in the
5 Control Plan;
• ensure special characteristics / symbols
are incorporated into the control plan
documents / records

Prototype
• Conduct initial process studies for
capability analysis; compiling
documents and information to prepare
PPAP; and submitting PPAP to the
6 customer.
• ensure special characteristics / symbols
are incorporated into the Prototype
documents / records
When required, obtain customer-specified
approvals for special characteristics and symbols
Mass Production
• Produce the product in accordance with
the controlled process documented
7
• Ensure special characteristics / symbols
are incorporated into the production
documents including Work Instructions
/ records, inspection and testing plans.
CHECK Review performance If any additional special
8 characteristics may be found, review the list of
special characteristics for use in future programs
ACT Focus on Process improvement for reduction of
variation in product characteristics and process
9
parameters, particularly for special
characteristics.
Page 3 of 3
NOTE :
Guidelines - How to identify special characteristics
Function relevant special characteristics (fit, form, function, performance, further processing).
• The variation of this characteristic significantly affect fit, form, function, performance or subsequent processing.
• High impact on customer satisfaction!
• Moderate / High risk
• FMEA severity: 5 – 8

Safety relevant / Governmental regulated special characteristics


• The variation of this characteristic significantly affects safety, or compliance with governmental regulations.
• High impact on safety, environment, function or various governmental regulations! Non-conformance of characteristic
may cause serious failure!
• Very high risk
• FMEA severity: 9-10

CHANGE MANAGEMENT / REVISION HISTORY


LAST REV. No. DETAILS BEFORE CHANGE (LAST Rev) DETAILS AFTER CHANGE REASONS FOR REVISION
(CURRENT Rev)

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