Gap Analysis

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Audit Checklist 15. Review storage of liquid N 2 including alarm systems. - Review the thawing record. 16. Select 3 standard operating procedures at random and review for document control requirements. 17. Review gowning up procedures and entry and exit procedures for product, patient and personnel. 18. Review security procedures for compliance. (Product, patient, staff, engineers and visitors) 19. Review the outcome (current status) 20. Review training records of personnel for activities performed. - Review external training records. 21. Review validation data for a selected process and/ or piece of equipment. 22. Review calibration data for 3 selected pieces of equipment. 23. Check that selected equipment has an asset ID number and is on the asset register. Activity Complies Y/N Evidence of Compliance/ Non Compliance For each item on the checklist reviewed, refer to the relevant procedure. Audited by: ________________________ Date: ____/____/____ CH/QA/SOP/030 Ver. 1 Effective Date: ____/_____/_____ Att. 6.3 CENTRAL HOSPITAL
Workshop Exercise 4 Service Level Agreement Clause 1 Parties to this Agreement Clause 2 Duration and Renewal of the Agreement Clause 3 Objectives of the Agreement Clause 4 Testing Clause 5 Results Reporting Clause 6 Turnaround Time Page 1 of 3
Page 1 and 2: • Internal audit • Bring in Con
Page 3 and 4: Gap Analysis • Create a relaxed e
Page 5 and 6: Gap Analysis Carry out gap analysis
Page 7 and 8: Gap Analysis Tissue March 07 Horizo
Page 21 and 22: Internal Quality Audit Schedule (Ho
Page 23: CH/QA/SOP/030 Ver. 1 Effective Date
Page 27 and 28: Workshop Exercise 4 Service Level A
Page 29: Gap Analysis Tissue March 07 Page 2

Gap Analysis

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