Production part approval process

Production part approval process (PPAP) (GM, Ford, Chrysler)... 

Automotive Industry Action Group (AIAG) (1995c), Production Part Approval Process, 2nd Ed., AIAG, Detroit, 1995. 

Companies have processes for the approval of new vendors but that should be ignored at this point in the analysis. A good example of this is the production part approval process (PPAP) for the automobile industry. Other companies have different processes for getting materials on the approved lists. If a supplier is selected that is not on the list, the supplier will be required to go through the approval process and get the material on the approved list. 

NOTE A change in these standards/specifications requires an updated record of customer production part approval when these specifications are r erenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc. 

D-samples (ready for series production phase), should be produced in a qualified series production process including all machines and test facilities as defined in the control plan and during PPAP (Production Part Approval Process). During Run-at-Rate a defined number of samples should be produced so that the quality characteristics and the performance of the production process can be assured also during series development conditions. The produced sample is then seen as the basis for the customer (e.g. the vehicle manufacturer) for the release for serial production. 

PPAP AIAG]. PPAP Production Part Approval Process AIAG 4th Edition, Automotive Industry Action Group, PPAP, 2006... 

The RP must ensure that system documentation in general is comprehensive, current, and readily available to users. In terms of the RP s responsibility for assuring adequate acceptance procedures for software and hardware changes, documentation of acceptance testing can be a part of the approval process preceding the integration of new or changed software into laboratory production. Test data, with anticipated and actual results, should be permanently filed. 

The FDA has published a guideline for use by industry that outlines general principles considered acceptable parts of process validation [1], Pharmaceutical firms have been inspected against this standard and those found wanting have been cited or had approval to manufacture product denied. Indeed, statistics compiled by the FDA for fiscal year 1997 show inadequate process validation as one of the top 10 reasons for withholding approval [3], One way for a firm to satisfy the requirement for validated processes is to identify those products that have been on the market for some time and use the wealth of production,... 

In the polymerization process initiators are used in small quantities and by definition they decompose on purpose to highly reactive radicals which start chain reactions and consequently become part of the final polymer. Other side reactions of the radical occur, for example with solvents, and then lead to non-reactive products of low concern. The use of the final polymer products by the consumer will generate a negligible exposure to initiators due to the fact that the amount is very small and the mobility of these substances in the polymeric matrix is greatly reduced. Nevertheless, when initiators are used in applications like materials intended to come into contact with food some EU countries like e.g., Germany [115] request that initiators and their reaction products have to pass an approval process. Producers are asked to assess the migrants from the final polymer product and the amounts in terms of exposure. 

Performance Qualification is carried out in accordance with a preapproved written protocol. The specific PQ attributes to be verified during the performance of the protocol will be developed from the finished product specifications, research and development data, cGMP requirements, and other specific documentation. They, along with the acceptance criteria, will be approved as part of the protocol approval process. 

As part of the new drug approval process of biologicals, FDA reviewers must inspect and approve the facilities to ensure the safety and quality of the processes that will be used in production. 

Batch Packaging Records should be kept for each batch or part-batch processed and should be based upon the currently approved version of the Master Packaging Instruction and prepared from it by a method designed to avoid transcription errors (photocopying or some similar method is to be preferred). The Record should carry the quantity of bulk product to be packed, the planned quantity of finished product and should bear a batch reference number, which is specific to a particular packaging run. The batch number which appears on the finished product should be this number, or one which may be easily related to it... 

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