In Clause 220.127.116.11 of ISO/TS 16949:2009, “The organization shall conform to a product and manufacturing process approval procedure recognized by the customer”. Note that product approval should be subsequent to the verification of the manufacturing process. “This product and manufacturing process approval procedure shall also be applied to suppliers”.
Organizations subscribing to ISO/TS 16949 should clearly show full conformance to this requirement. How? The answer is PPAP.
Production Part Approval Process or PPAP defines the generic requirements to determine if all customer requirements have been attained. Also, PPAP ensures that the manufacturing process has the potential to continue meeting these requirements.
PPAP is a binding contract with the customer.
All internal and external supplier sites of production and service parts should apply PPAP unless otherwise specified by the authorized customer representative. PPAP covers all production and service commodities including bulk materials produced internally or externally.
PPAP has two (2) major process requirements. One is “significant production run” and the other is “PPAP requirements”.
Let us first discuss “Significant production run”. For production parts or product, PPAP shall be taken from a significant run based on:
– From 1 to 8 hours of production
– Minimum 300 consecutive parts, unless otherwise approved by the authorized customer representative
– Produced at the production site, at the production rate, using production tooling, gauges, operator, etc.
– Each unique manufacturing process shall be represented (lean cell, multiple cavity, die, mold, etc.)
PPAP parts must represent production parts
The next major requirement is called “PPAP Requirements”. This requirement pertains to the following which are necessary for each PPAP submission:
– Design record
– Engineering change documents, if any
– Customer engineering approval, if required
– Design FMEA
– Process flow diagrams
– Process FMEA
– Control Plans
– Measurement System Analysis Studies
– Dimensional Results
– Material, Performance Test Results
– Initial Process Studies
– Qualified Laboratory Documentation
– Appearance Approval Report (AAR), if applicable
– Sample Product
– Master Sample
– Checking Aids
– Records of compliance to customer-specific requirements
– Part Submission Warrant (PSW)
Apart from the requirements defined above, PPAP differentiates its process through “Customer Notification” and “Submission”.
In Customer Notification, the organization shall notify the authorized customer representative of any planned changes to design, process or site such as: use of material other than previously approved, upgrade or rearrangement of existing tooling or equipment, etc.
For Customer Submission, the organization shall be submitted for PPAP prior to the first production shipment unless waived by the authorized customer representative.
Submission levels are quantified from Level 1 to 5 depending on the level of confidence that the customer has for its suppliers.
-Sonny Tapia, Senior Process Consultant, ECCI