1./18./19.
Review specification
requirement, initiate FMEA
2. Is
characteristic
special?
Yes
2. Establish control plan and
note the characteristic and the
product/process/specification/
tolerance
4./17. Determine methods for
evaluation/measurement, list
technique & any measurement
device(s) selected
14. If a
device can it
discriminate
1/10 of expected
process
variation?
Yes
4. Note devices under
evaluation/measurement
technique in control plan
6./7. Select qualified internal/
external laboratory for PPAP
inspection/testing
Yes
6./7. Is
the inspection/test
on the Laboratory's
scope?
Yes
11. Conduct material/
performance tests
Agree/confirm process
capability or performance
requirements w/customer
12. Has
the level of initial
process capability or
performance been
determined?
Yes
12. Schedule significant
production run and conduct
initial process study:
· Ppk - Special causes of
variation present and/or less
than 100 readings from
consecutive parts.
· Cpk - No special causes of
variation and at least 100
readings from consecutive
parts.
Notify customer of unstable
processes that exist.
3./12. Select samples from ISO/TS 16949:2002
Significant Product Run
Links to “Core Tools”
Note
No 9./12. Conduct Numbers in boxes are not in sequential logic, they
measurement systems
are linked to "Requirements" listed below: www.jaegerholland.com
analysis
Requirements (not all inclusive)
ISO/TS 16949:2002
No 1. · 7.3.1.1 The organization shall develop and review FMEAs,
including actions to reduce potential risks
15. Do 2. · 7.3.2.3 The organization shall identify special characteristics and
MSA results meet
include all of them in the control plan.
acceptability 3. · 7.3.6.3 The organization shall conform with a product approval
criteria?
procedure recognized by the customer.
4. · 7.5.1.1 The organization shall:
- develop control plans
Yes - list controls used for process control
- include methods for monitoring of control exercised over
10. PerformYes
dimensional special characteristics
verifications
No - initiate the specified reaction plan when the process
becomes unstable or incapable
5. · 7.6.1
Statistical studies shall be conducted for each type of
11. Conduct material/
performance tests measuring and test equipment system referenced in the control plan.
Methods and acceptance criteria shall conform to those in customer
reference manuals or be otherwise approved by the customer.
6. · 7.6.3.1 The organization's internal laboratory shall have a
laboratory scope that includes it capability to perform the required
12./20. Is inspection, test or calibration services and it shall be included in the
process
capable or customer QMS documentation.
approved corrective 7. · 7.6.3.2 External/commercial/independent laboratory facilities shall
action plan? have a defined laboratory scope that includes it capability to perform
the required inspection, test or calibration services and either provide
evidence that it is acceptable to the customer or that it is accredited to
ISO/IEC 17025 or national equivalent.
Yes
8. · 8.2.3.1 The organization shall maintain process capability
[capability is determined using data from control charts] or
13. Identify one or more of
performance as specified by the customer part approval process
the parts as a "master
requirements.
sample" and retain
No
**PPAP** Fourth Edition
9. ·2.2.8 The organization shall have applicable Measurement
System Analysis studies … .
3. Confirm PPAP 10. 2.2.9 The organization shall provide evidence that dimensional
requirements have been verifications … indicate compliance with specified requirements.
met 11. 2.2.10 The organization shall maintain records of material or
performance test results.
12. ·2.2.11.1 The level of initial process capability or performance shall
No
be determined to be acceptable prior to submission for all special
characteristics and measurement system analysis shall be performed
3. PPAP to understand how measurement error is affecting the measurements.
Approved? 13. ·.2.2.15 The organization shall retain a master sample for the same
No period as the production part approval records … .
**MSA** Third Edition
14. · Pg 74 The instrument should have a discrimination that allows
Yes one-tenth of the expected process variation of the characteristic to be
read directly.
8. Verify 15. · Pg 77 Over 30% error - considered not acceptable.
No
on-going process **APQP** First Edition
capability 16. · Pg 26 The specified measurement devices and methods should
be used to check control plan identified characteristics … and be
subjected to measurement system evaluation during or prior to the
production trial run.
No
17. · Pg 43 Evaluation measurement technique, this could include
4. Is gages, fixtures, tools and/or test equipment required to measure the
characteristic part/process/manufacturing equipment.
unstable or non- **FMEA** Third Edition
capable? 18. · Pg 1 An FMEA is a systematic group of activities designed to
recognize and evaluate a potential failure of a product/process and its
effects as well as to prevent or reduce the risk of the potential failure
occurring.
Yes
19. · Pg 55 High severity, high RPN and other items of concern should
be addressed with preventive/corrective action.
4. Initiate reaction plan,
**SPC** Second Edition
develop corrective action
20 · Pg 20 To be acceptable, the process shall be in a state of
plan, review with customer
statistical control and the capability (common cause variation) shall be
if required
less than the tolerance.
The APQP, FMEA, MSA, PPAP, SPC Reference Manuals are Copyright of
DaimlerChrysler Corporation, Ford Motor Company, General Motors Corporation File: CoreTls.vsd Rev. 03/01/2006