Professional Documents
Culture Documents
Doc.No.MR/F/01
Date Of Audit: 12.04.2023 Department: CPP QC Name of Auditee: Susanta Name Of Auditor: Pratigya
Sr No Ref.Doc No Clause no Title Details Observation / Findings Remarks
Training was conducted for various topic related to quality complant training and evalution and Observation
1 HR/F/08 7.2 Competence Norm
effectiveness complited.Training plan 2022-23 also updated
Checked six month objective target( complant ) 0.05%, last six month target 0.15%,action plan Verified
2 QMS/F/16 6.2.1/6.2.2 Quality Objective
checked
External calibration of instrument mailed to instrument for calibration, FDA,EU product certification Verified
3 FQ/F/07 7.1..5.2 Calibration Record
updated
FDI updated,Migration test,SML Test conducted and verified.MAN:HL:1048001111 checked white cast Verified
4 Compliance
film for Overall migration checked and verified.
5 QMS/F/15 5.1..2 Risk & opportunity Risk & Opportunity for quality function verified. Verified
6 QMS/L/01 Master list Master list updqated,Visitors control,product safety ,SOPs, Verified
Total 21 complant registered with CAPA and Target 12,action plan checked and updated. CAPA Verified
7 8.7..1 Non-Confirmance
checked updated till date.31.03.2023
8 7.5..3 Documents control Documents are Revew /Revised /updated on 03.08.2022,Copy of revised documents available. Verified
9 HHR/F/19 5.3 Organization Responsibility Role and Responsibility document revewed and updated. Verified
10 FQ/F/14 8.5..2 Identification & Tracebility Conducting Tracebility and updated .last updated 16.04.2023 Verified
11 7.5..2 Creating & Updating Appropriately identified ,verified,competency norm Doc HR/F/08 Verified
12 QMS/F/12 7.1..6 Organizational Knowledge Checked updated and implimented, last updated 28.12.2022 Verified