Gap Analysis
Gap Analysis
Gap Analysis
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Audit Checklist<br />
15. Review storage of liquid N 2 including<br />
alarm systems.<br />
- Review the thawing record.<br />
16. Select 3 standard operating procedures at<br />
random and review for document control<br />
requirements.<br />
17. Review gowning up procedures and entry<br />
and exit procedures for product, patient and<br />
personnel.<br />
18. Review security procedures for<br />
compliance. (Product, patient, staff,<br />
engineers and visitors)<br />
19. Review the outcome (current status)<br />
20. Review training records of personnel for<br />
activities performed.<br />
- Review external training records.<br />
21. Review validation data for a selected<br />
process and/ or piece of equipment.<br />
22. Review calibration data for 3 selected<br />
pieces of equipment.<br />
23. Check that selected equipment has an<br />
asset ID number and is on the asset register.<br />
Activity<br />
Complies Y/N<br />
Evidence of Compliance/ Non<br />
Compliance<br />
For each item on the checklist reviewed, refer to the relevant procedure.<br />
Audited by: ________________________<br />
Date: ____/____/____<br />
CH/QA/SOP/030 Ver. 1 Effective Date: ____/_____/_____ Att. 6.3<br />
CENTRAL HOSPITAL
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