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Answer the questions below as they relate to your firm. If your firm has multiple locations, fill out the survey for the location where you are located.

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* 1. What is the approximate number of US-based employees in your firm?

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* 2. What sources of quality data do you examine within your CAPA systems? Check all that apply

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* 3. What volume of nonconformances for the source errors above do you track on average per month?

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* 4. On average what percent of the above nonconformances are escalated to a CAPA?

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* 5. Do you use risk management in determining when to open a formal CAPA investigation of observed deficiencies?

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* 6. What risk management tools do you use?

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* 7. To whom do send the results of the statistical tools (trending, pareto charts, histograms, etc.) that
you use to analyze your quality data?

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* 8. What criteria do you use to open a formal CAPA investigation of observed deficiencies?

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* 9. How many days does your SOP allow for investigating a CAPA?

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* 10. What is your goal for closing CAPAs?

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* 11. What criteria do you use to make the determination that a CAPA is closed?

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* 12. How do you monitor CAPAs that are open for an extended period of time?

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* 13. What department is in charge of CAPA?

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* 14. How are your CAPA system SOPs being used within your organization?

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* 15. What types of CAPA data are included in your management reviews?

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* 16. How often are “changes” generated as a result of Management Review?

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* 17. When a decision is made not to open a CAPA, is that justified in writing?

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* 18. What criteria that do you use to make the decision referred to above.

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* 19. What is your biggest challenge investigating CAPA events?

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* 20. Describe the techniques you use to get cooperation of all departments to investigate and close CAPAs.

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* 21. Do you use an electronic nonconformance and CAPA system?

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