APQP & FMEA

The current AIAG Advanced Product Quality Planning (APQP) manual was released in 2008 and describes the 5 phases of Advanced Quality Planning for product launch.

• There are additional supporting “Reference Manuals” for IATF including
• Measurement System Analysis (MSA)
• Statistical Process Control (SPC)
• Failure Modes and Effects Analysis (FMEA)
• Production Part Approval Process (PPAP)

There is a new AIAG / VDA FMEA 1st Edition manual and process that the supply chain is transitioning to from the 4th Edition AIAG FMEA manual and process

While the changes are more evolutionary than revolutionary (Except for the new FMEA process), it would be a great time to train newer quality, engineering and production staff and / or hold a refresher course. The new FMEA process will require additional training for auditors and practitioners.

IATF 16949 Background:

IATF 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, efficiency and effectiveness.

IATF 16949: 2016 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.

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 (AIAG / VDA FMEA 1st Edition)

• Seven-Step FMEA Process which includes: Planning & Preparation, Structure Analysis, Function Analysis, Failure Analysis, Risk Analysis, Optimization, and Results Documentation
• Totally revised Severity, Occurrence and Detection Tables
• Replacement of RPN with Action Priority calculations and values for action
• Two types of Recommended actions: Preventive Action and Detection Action
• New FMEA for Monitoring and System Response (FMEA-MSR) guidelines
• Use of foundation and family FMEAs
• There are also OEM requirements to use software for FMEA management

APQP 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.
• Safety requirements must be identified on all internal documents

IATF 16949: 2016 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 reference manuals, customer specific requirements, and sanctioned interpretations are implemented as required.  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 are pushing for more nonconformances to be identified.

Please give us a call at  (616) 365-9822 if you have any questions or would like training information.

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