Appendix 2

Unique Requirements ChecklistISO/TS 16949

For use supplemental to ISO-9001: 2000 Requirements

UNIQUE REQUIREMENTS CHECKLIST FOR ISO/TS 16949

Auditor: Area/Dept. Audited: Date:

Clause Requirement What to look for: Objective Evidence 9

4.2.3.1 Review, distribution and Process for timely review
implementation of customer Process for distribution
engineering standards & Process for implementation
specifications Record of date of change
Associated documents update
4.2.4.1 Retention of quality related Defined retention periods
documents and records Complies with customer rqrts
Satisfies regulatory requirements
Disposition includes disposal
5.1.1 Monitor and support processes Process monitoring methods
to assure efficiency Process support examples
5.4.1.1 Objectives for achieving quality Objectives included the business
must be included in business plan
plan Measurements defined
Address customer expectation
5.5.1.1 Responsibility for quality in Do personnel have authority to
management and production stop production to correct
quality problems?
Quality responsibility designated
across all shifts
5.5.2.1 Designated customer Who are designated personnel for
representatives Setting quality objectives
Selecting special char.
Training
Corrective & Preventive Action
5.6.1.1 Reviews of quality management Includes all elements
system performance Metrics on performance trends
Monitoring of quality objectives
Reporting cost of poor quality
Evidence of achievement of
objectives in business plan
Evidence of customer
satisfaction
5.6.2.1 Management review inputs Does review include analysis of
actual & potential field failure?
What action plans?
6.2.2.1 Product design skills Are product design personnel
qualified with design skills?
Applicable techniques used?
6.2.2.2 Procedure for identifying Documented procedure
training needs. Training plan and records
Personnel performing specific Proof of job competence
tasks must be qualified Certified as applicable
Applies to all employees
affecting quality at all levels
6.2.2.3 Training on the job Is on the job training provided for
new jobs? (records)
Includes contract personnel?
Are personnel aware of job
related quality requirements?
6.2.2.4 Process for employee Is formal program established?
motivation and empowerment Does environment promote
innovation and quality?
Any incentives?
Includes continual improvement?
Do personnel have awareness of
relevance of their job to quality
objectives?
6.3.1 Multidisciplinary approach to Who makes up this team?
plant, facility and equipment Does layout optimize use of
planning space and material flow
Methods to monitor effectiveness
of operations
6.3.2 Contingency plans Are plans prepared, in event of
utility outage, key equipment
failure, labor shortage?
6.4.1 Policy to address personnel Is safety policy established?
safety to minimize risks Personnel training?
Applicable to design?
Applicable to manufacturing?
Hazard warnings?
6.4.2 Cleanliness of premises Inspection for state of order
State of repair
7.1.1 Inclusion of customer Must be components of the
requirements and technical quality plan
specs in quality planning
7.1.2 Acceptance criteria, especially Acceptance criteria defined?
for attribute data sampling Approved by customer, as reqd.
Zero-accept for attribute plans
7.1.3 Confidentiality of customer What methods are used?
contracted products and Non-disclosure agreements
projects under development Non-compete agreements
7.1.4 Process to control and react to What is the process for control of
changes that impact product supplier initiated change?
realization Assessment of impact
Verification & validation method
Review w/ customer as rqrd.
Applicable to manufacturing
changes
7.2.1.1 Customer designated special Methods for designation,
characteristics documentation and control of
7.2.2.1 Manufacturing feasibility Feasibility investigated during
contract review
Includes risk analysis
Documented feasibility
7.2.3.1 Communication of necessary Specified language ability
information to customer Specified format compatible
CAD data
Electronic data exchange, EDI
7.3.1.1 Multidisciplinary approach in Makeup of cross-functional team
product realization What is the quality planning
process?
Cross-functional review on:
Developing and finalizing special
characteristics
FMEA develop & review
Control plan development/review
7.3.2.1 Review of product design inputs Documented
to include specified Does review of inputs include
requirements, information and Customer requirements
targets Special characteristics
Use of information gained from
previous design
Targets for quality, reliability,
durability, maintainability, cost
Design FMEA
7.3.2.2 Review of manufacturing Documented
process design inputs as Does review of inputs include
specified Product design output data
Targets for productivity and cost
Targets for process capability
Customer requirements, if any
Previous experience
Use of error-proofing methods
7.3.2.3 Identification of special Are all special characteristics
characteristics included in control plan?
Complies with customer symbol
Identify process control
documents (drawings, FMEA,
operator instructions) with SCs
7.3.3.1 Design output expressed in Verify that design output includes
terms that can be verified and Design FMEA, reliability
validated Product special characteristics
Error-proofing as appropriate
Product definition (e.g. drawing)
Design review results
Diagnostic guidelines, as rqrd.
7.3.3.2 Manufacturing process design Verify that design output includes
output expressed in terms that Specifications & drawings
can be verified and validated. Process flowchart
Process FMEA
Control plan
Work instructions
Process study basis and
approval criteria
Production process parameters
Quality, reliability, maintainability
Error-proofing, examples of
Methods for rapid detection of
process nonconformities
7.3.4.1 Stages of design and Defined measurements/stages
development shall be monitored Evidence of analyses
with results to management Status report to mgmt. (records)
7.3.6.1 Design and development Customer specified validation
validation in accordance with method
customer requirements Within program timing
7.3.6.2 As required, a prototype Prototype example
program and control plan Control plan
Use of same suppliers, tooling
and manufacturing process
Leadership over outsourced
prototyping services
7.3.6.3 Conformance to customer PPAP or equivalent customer
specified procedure for product specified method
approval and process approval Includes product and process
approvals
Application to suppliers as well
7.4.1.1 All purchased materials satisfy Responsible party
applicable regulatory Awareness of applicable
requirements regulatory requirements
7.4.1.2 Supplier quality management Suppliers to organization must
rd
systems and development be 3 party registered to ISO-
9001:2000 (by 15 Dec. 2003)
Records in supplier files
Prioritization plan for
development of suppliers
7.4.1.3 Use of customer approved Use of specified sources
sources as specified in contract Includes tool/gauge suppliers
Responsibility for ensuring
quality of purchased products
7.4.3.1 Process to assure the quality of Defined methods for incoming
purchased product product test or verification, e.g.
Receipt & evaluation of supplier
statistical data
Receiving inspect or test
Assessments of supplier site
Part evaluation by laboratory
Other agreed method
7.4.3.2 Monitoring of supplier Method for performance monitor:
performance Delivered part quality history
Customer disruptions
Delivery schedule performance
Premium freight incidents
Special status notifications
7.5.1.1 Development of control plans Are control plans developed for
for product supplied, including System and sub-system level
customer required information Component or material level
and review/update Pre-launch and production
Considering FMEA
Do control plans address
Manufacturing process controls
Method for monitor of special ch.
Customer required information
Reaction plan
Evidence of update if significant
product or process change
7.5.1.2 Work instructions for employees Documented
having process operations Accessible at the work station
responsibility Derived from sources such as
control plan, quality plan
7.5.1.3 Verification of job set-ups, Check set-up verifications at
according to set-up work Initial run of job
instructions Material changeover
Job change
Are work instructions available?
Are statistical methods of
verification used?
7.5.1.4 Preventive maintenance Identification of key process
programs for key process equipment
equipment; Resources provided
Predictive maintenance Preventive maintenance plan
programs to continually improve PM plan includes:
efficiency of production Planned activities
equipment Packaging and preservation of
equipment, tooling, gauging
Includes maintenance Availability of replacement parts
objectives Documented maintenance
objectives
7.5.1.5 Production tooling Resources for tool and gauge
management, including monitor design, fabrication, verification
of any outsourced work Tooling management program
includes:
Maintenance and repair
Set-up, storage, recovery
Tool change, for perishable tools
Tool modification documentation
Tool identification & status
7.5.1.6 Production scheduling must Defined customer requirements
meet customer requirements Just-in-time or Order-driven
Real-time information system on
production status at key stages
7.5.1.7 Process for feedback of Established process
information from service Includes service concerns
Includes manufacturing,
engineering/design functions
Personnel awareness of issues
external to the organization
7.5.1.8 Verifying effectiveness of How does organization verify
servicing agreement with effectiveness of
customer Service centers
Special purpose tools/measure
Training of servicing personnel
7.5.2.1 Requirements of 7.5.2 must Verify scope of application
apply to all processes for Verify actual examples from
production & service provision products offered/jobs running
7.5.3.1 Requirements for identification Defined method
of product must apply through Suitable means
entire product realization Traceability identification, as rqrd
7.5.4.1 Marking of customerowned Marking must be permanent and
production tooling visible for following:
Customer owned tools
Manufacturing equipment/tooling
Test or inspection equipment
7.5.5.1 System to control product in What is inventory management
stock, storage and inventory system?
How is stock rotation ensured?
How is obsolete product
controlled?
Is condition of stock assessed at
intervals?
7.6.1 Requirement for statistical System must conform to those in
studies to analyze variation in customer reference manual
measuring/test equipment. (such as MSA, GR&R)
Statistical basis and analysis
Applicable to IMTE systems
referenced on control plan
7.6.2 Specific requirements for Must include gauges, measuring
records of calibration activity and test equipment including
employee-owned and customer-
owned gauges
Records must include following:
Equipment identification
Revisions after engineering chg
Out-of-spec readings as received
Assessment of impact
Statement of conformance to
spec after calibration
Notification to customer if
suspect product shipped
7.6.3.1 Internal laboratory must have a Laboratory scope defined
defined scope, and meet listed Documented in quality system
technical requirements Meet technical requirements for:
Adequate procedures
Qualification of lab personnel
Testing of commodities
Capability to perform tests
Traceability to standard
Quality records
7.6.3.2 External laboratory must have Use of external/commercial lab
 appropriate scope for capability facilities, e.g. calibration
to perform inspections, tests or Records of lab scope
calibrations Accreditation to ISO/IEC 17025
Evidence of lab acceptable to the
customer
8.1.1 Determination of appropriate Methods cited
statistical tools during advance Included on control plan
quality planning
8.1.2 Knowledge of basic statistical Interview employees on basic
concepts concept/applications of:
Variation
Control/stability
Process capability
Over-adjustment
Evaluate charts for interpretation
8.2.1.1 Performance indicators for How is customer satisfaction
customer satisfaction monitored?
Does objective data include:
Delivered part quality
Customer disruptions
Delivery schedule performance
Incidents of premium freight
Customer notification on quality
or delivery issues
8.2.2.1 Internal audits must cover entire Does the audit plan provide for
quality system and verify audits of the entire quality
compliance with all TS16949 management system to TS
and additional requirements 16949, including any additional
requirements, such as customer
Interview audit manager
Review audit reports
Audit reports on specific
customer requirements
8.2.2.2 Manufacturing process audit Does audit program include
audits of each manufacturing
process for effectiveness?
Scope of audit plan
Links to related objectives
8.2.2.3 Product audit Does audit program include
audits of products at
appropriate stages of
production and delivery, e.g.
Product dimensions
Functionality
Packaging/labeling
8.2.2.4 Scope of internal audit plans Verify internal audit plan covers...
Quality management processes
Quality activities
All shifts
Is there an annual plan?
Is audit frequency adjusted if
complaints/nonconformities?
8.2.2.5 Qualifications of internal Auditor training records
auditors Appropriate content of training
Interview auditors, for familiarity
with ISO/TS 16949 criteria
8.2.3.1 Monitoring and measurement of How are process studies done?
manufacturing processes, to Does this include all new
verify and maintain process manufacturing processes
capability and include Are process study results
objectives and acceptance documented, with specs?
criteria. Objectives for process capability,
such as Cpk
 Objectives for reliability,
maintainability
Defined acceptance criteria
Is process operated per control
plan and process flow diagram?
Notation of significant events on
process control charts
Reaction plans, established and
initiated when needed
Corrective action plans
Records of effective date of
process changes
8.2.4.1 Layout inspection and Performed on all products at
functional testing sufficiently frequent intervals?
Per control plan and customer
performance standards
Layout results documented
8.2.4.2 Appearance items Appropriate resources, e.g.
lighting evaluation
Masters, for color, grain, gloss
Control of appearance masters
Qualified personnel
8.3.1 Supplemental controls over How is suspect product treated?
nonconforming product How is unidentified product
treated?
8.3.2 Controls over reworked product How are rework instructions
to include instructions for provided?
rework and re-inspection Verification of use of instructions
8.3.3 Customer information Any examples of nonconforming
product having been shipped?
How was customer notified?
8.3.4 Customer waiver, whenever Examples?
product or process is different Customer deviation permit
from that approved Record of expiration date or qty
Compliance to original spec
afterwards
Applies also to purchased
product
8.4.1 Analysis and use of data to lead What data is gathered on quality
to action toward objectives and operational performance?
How is this trend-analyzed?
Examples of actions generating
priorities for prompt solutions to
customer related problems
Decision making regards key
customer-related trends
Information system for timely
reporting
Are data compared to
benchmarks?
8.5.1.1 Continual improvement How is the process of company
wide continual improvement
implemented?
8.5.1.2 Manufacturing process Examples of product
improvement must focus on characteristics, from control
control and reduction of plan, with improvement
variation Examples of process parameters
related to above
8.5.2.1 Problem solving Defined problem solving process,
in customer prescribed format
Examples of root-cause
identification and elimination
8.5.2.2 Use of error-proofing Examples of error-proofing
applications
Related to corrective actions
8.5.2.3 Corrective action impact Examples of application of
corrective action to other similar
products/processes
Method of control implemented
8.5.2.4 Returned product test and Returned product log
analysis, with records and Records of analyses of returns
associated corrective action Examples from rejected parts,
dealerships
Records of associated corrective
action
Minimization of cycle time