By Rocky Kimball and Brandon Kerkstra

 Revised manuals have been released. Both manuals become effective November 1, 2008.  They should be implemented on new programs and programs that are in early development.

 While the changes are more evolutionary than revolutionary, it would be a great time to train newer quality, engineering and production staff and / or hold a refresher course.

 Background:

TS 16949, PPAP, and Customer Requirements state that you must perform APQP & FMEA, but since they are reference documents you have more discretion as to “How” you implement the processes. The requirement is that APQP & FMEA processes are effectively implemented – Customer and Company metrics can provide information of Customer Satisfaction and effectiveness.

 Some of the changes were just to bring the manuals up-to-date with other requirements.  Here is an overview of the changes specific to each manual. 

FMEA change highlights

• There is increased Emphasis on Management Support
• There are Additional “Real world” examples in the manual
• Reduced emphasis on the RPN value – alternate methods available
• Focus on Process Approach
• Focus on sustained improvement
• Alternative methods to reduce design risk
• Reinforced linkage between DFMEA & PFMEA as well as control plans and DVP&R
• Risk Ranking Tables were improved for Severity, Occurrence, and Detection making them more realistic and meaningful
• There is more information on Alternative FMEA formats and identifies the minimum information that should be contained.  This allows companies to customize the process to their organization.  The standard form is still the best starting point.

 A couple of additional points made by the OEMs

• FMEA is a document of good discussion & analysis along with documentation and actions.  Provides clarification of FMEA intent for in use in later reviews.
• If issues are identified, they must be addressed or justified.
• Engineering Changes require evaluation of PFMEA and / or related documents

 APQP change highlights

• Basic Structure and timing has NOT changed
• Aligned with PPAP and Customer Requirements etc.
• Aligned with the Process Approach
• Aligned with other updated manuals and processes (MSA, FMEA, PPAP…)

 Additional points made by the OEMs

• Pass-through characteristics; components that are supplied to the Tier 1 with characteristics or features that are not used by the Tier 1, but are needed by the customer.  Ensure that system is in place for verification. 
• If APQP process is effective the PPAP is just a coalition of the required documents
• Focus on Management Support – early in the program
• OEM Plant issues are normally basic issues that should have been effectively addressed and contained within the APQP / FMEA process.

TS 16949: 2002 requires that Engineering and Quality staff be competent within their areas of responsibility.  Additionally the Internal auditors that audit the core tools must also be competent.  This may be a good time to refresh or train your staff.

 In addition, the Certification Body Auditors will be looking to see that the new manuals are implemented on the required date and will also be more likely to look at these areas more in-depth. The IAOB has stated that there will be more focus on the Certification Bodies & their auditors to ensure APQP & FMEA are thoroughly assessed during certification and surveillance audits.  They also stated that the time for “OFI’s” is over.

 Please give us a call if you have any questions or would like training information.