API Spec Q1 (clause 5.7.2); specify that when required by contract, the organization shall develop a product quality plan that specifies the processes of the quality management system (including the product realization processes) and the resources to be applied to a product.

Does that mean a Product Quality Plan need to be maintained by the organisation all the times? And if not maintained; can an auditor raise a non-conformance?


No; the intent of the API Spec Q1 is; when required by contract, then only a Quality Plan needs to be established and implemented as per requirement of API Spec Q1  (clause 5.7.2). If there is no such customer requirement; then there is no need to establish a Quality Plan as per this clause.

On above basis, auditor can’t raise an NCR for non-availability of PQP or a PQP not covering all the requirements of this clause. However it is the responsibility of the organization to establish the process control documentation to ensure conformance to applicable API product specifications, customer requirements and/or other applicable product standards.

Disclaimer: This interpretation is given only for guidance and is solely based on the author’s learning experience in API eco system. Before making any judgment, readers are advised to use their own understanding based on their own organisation’s requirements.

Note: API doesn’t endorse this interpretation as a part or in totality.