Corrective Action and Control of Nonconforming Product

Question from a Wellhead Manufacturing Company Q: I would like to know the difference in application between Clauses 6.4.2 (Corrective Action) and 5.10 (Control of Nonconforming Product). When you detect a nonconforming product, there is a nonconformity, and Clause...

ISO 9001:2015 and Q1

Q: How much of ISO 9001:2015 will we be able to adopt into Q1? A: API Spec. Q1 has mandatory requirements for documented procedures, whereas ISO 9001:2015 discusses the term “documented information.” 3.8.6 documented information “information (3.8.2) required to...

Interpreting API Q1, Clause 5.10.2

Q: Can you please explain API Q1, Clause 5.10.3? A: This section of Q1 has always been a bit confusing. As you will notice, there is no “accept-as-is” disposition in API Spec. Q1. API addresses this condition as “acceptance under concession.” Acceptance under...

External Documents and Revisions

Q: On external documents, do revisions only apply to API product specifications? A: API Spec. Q1, Clause 4.4.4 states: 4.4.4 Use of External Documents in Product Realization “When API product or other external specification requirements, including addenda, errata, and...

Risk and Nonconforming Product

Q: Risk assessment associated with product quality shall include: delivery of nonconforming product; is this about risk involved after a nonconforming product is delivered, or is this about risks which cause nonconforming product? A: Q1 states in part . . . 5.3 Risk...

Welder Continuity Records

Q: During an API audit, an auditor wrote an audit nonconformity stating that we had disposed of welder continuity records that were older than 5 years; do you think this is really a finding since API Spec. Q1, Section 4.5 states in part “…Records shall remain legible,...