Gap Analysis

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Year: 2007 Internal Quality Audit Schedule (Vertical) Jan. Feb. March April May June July Aug. Sept. Oct. Nov. Dec. √ √ √ √ Approved By: ____________________________ Date: _____/_____/_____ Quality Assurance Manager Note: Two complete batch records are selected at random and are followed through from donor assessment to final implantation of the processed cells. CH/QA/SOP/030 Ver. 1 Effective Date: ____/____/____ Att. 6.1 CENTRAL HOSPITAL
CH/QA/SOP/030 Ver. 1 Effective Date: ____/____/_____ Att. 6.2 CENTRAL HOSPITAL Checklist for Vertical Audit (Fertility Clinic) Audit No.: ______________ Date: ____/____/____ Auditor: ________________ Tissue/ Cell ID No.: _________ Type of Tissue/ Cell:________ Date Released: ____________ Tissue/ Cell ID No.: _________ Type of Tissue/ Cell:________ Date Released: ____________ Audit Checklist Activity Complies Y/N Evidence of Compliance/ Non Compliance 1. Review the donor assessment documentation including diagnosis and plan of action. 2. Review the contract with the contracted laboratories for Endocrinology and Virology markers and their recent performance in EQA schemes. 3. Review the detailed questionnaire for appropriateness relevant to best practice requirements. 4. Review IQC and EQA data for the period semen analysis was performed on the male donors. 5. Review the equipment file including PM schedules and calibration for the scanning equipment. 6. Verify based on objective evidence, that where further testing or surgery in advance or part of the treatment process was performed that the outcome is clearly documented. 7. Review the consent process for the agreed plan of action and where deviation occurs in treatment verify that this deviation was consented. 8. For the defined treatment plan, review the donation records. 9. Review the air velocity readings of the Class I Cabinets. Review PM visit data, including DOP test results. 10. Review temperature monitoring data on 2 selected incubators for the date(s) of processing. 11. Review the labelling of documentation, specimens and cells at all stages of the process. (Availability of barcode) 12. Review data to support the selection of embryos for transfer. (batch release) 13. Review and perform as appropriate a stock reconciliation. Actual versus documented inventory. 14. For frozen embryos, review the freeze curve and ensure the control rate freezing is as per specification. CH/QA/SOP/030 Ver. 1 Effective Date: ____/_____/_____ Att. 6.3 CENTRAL HOSPITAL
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Gap Analysis

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