APQP PPAP Dogma Must Change

Dogma - a strong belief that its adherents are not willing to discuss rationally

For example, here is a recent comment to one of my posts - “I don't get it. Why is the focus on PPAP? It's a collection of documents. I can understand the leadership team having little motivation or excitement about the subject. The focus should be on APQP. Get APQP right, and PPAP is a formality. Now we are talking about a business improvement tool worth getting excited about!”

Calling “PPAP a collection of documents” is harmful and a clear misunderstanding of the PPAP process.

First, we must agree that APQP and PPAP are two distinct business processes:

?????????????APQP – New Product Design and Launch by Design / Product Engineers – the new design basically ends with the new product launch

?????????????PPAP – Production Process Approval by Manufacturing / Quality Engineers – this is a recurring, never ending loop

Second, it varies by industry, but the cause of warranty claims, recalls, and scrap are rom three general sources:

????????????? Design flaws: APQP

????????????? Manufacturing defects: PPAP

????????????? Supplier issues: every market blames the supply chain and Supplier PPAP is the solution as most of the suppliers do not have design responsibility.? In addition the adoption of PPAP across industries that have been doing FAI, ISIR, or any another 1 piece inspection verification, shows that simply inspecting one part does not demonstrate the ability to produce the rest of the parts

In recent times, manufacturing defects appear to be a major cause of medical device product recalls, especially

????????????? A recent report indicates that faulty manufacturing has become the primary reason for medical device recalls in the United States.? (PPAP)

????????????? Approximately 20-30% of FDA recalls can be attributed to quality management issues in manufacturing or processing/contamination concerns. (PPAP)

In my opinion, PPAP – “Now we are talking about a business improvement tool worth getting excited about!”

Hoping to start discussing PPAP rationally.

John Cachat

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