API Spec Q1 Readiness Assessment

1. Do you have a documented quality policy and measurable quality objectives that are communicated and reviewed?

2. Has top management defined responsibilities and authorities, and appointed a management representative for the QMS?

3. Do you define competence requirements and keep training and qualification records for personnel affecting quality?

4. Are procedures and forms controlled for review, approval, revision status, and distribution?

5. Are quality records kept legible, identifiable, retrievable, and retained for defined periods?

6. Do you have a documented process to identify, assess, and mitigate risks to product quality and delivery?

7. Are customer requirements reviewed and documented before you accept an order or contract?

8. Is product realization planned, including design and development controls where applicable?

9. Do you have a documented contingency plan for disruptions that could affect delivery or quality?

10. Are suppliers evaluated and controlled, with defined criteria for critical purchases and outsourced activities?

11. Are production and service activities controlled, including work instructions, identification, traceability, and preservation?

12. Is testing, measuring, and monitoring equipment calibrated, identified, and recorded?

13. Is nonconforming product identified, segregated, dispositioned, and recorded?

14. Do you assess and control changes to processes, organization, or product before they're implemented?

15. Are internal audits performed on schedule, covering all requirements, by qualified and independent auditors?

16. Is management review held at planned intervals with all required inputs and documented outputs?

17. Do you monitor customer satisfaction and analyze quality data to find trends?

18. Do corrective actions include root cause analysis and verification of effectiveness?

19. Do you identify potential nonconformities and take preventive action before problems occur?