This document details the procedure for the Laboratory Self Inspection and Laboratory checklist inspection in Xyz Limited. It is the policy of Xyz Limited that the written procedure shall be followed for the self Inspection (Internal Audit).
It is the c-GLP and regulatory requirement that the company should have its internal audit system by which the company can assess the implementation of c-GLP norms.Â
An internal audit of the company is required during the routine functioning of the plant. At the time of conducting the internal audit in Xyz Limited. The frequency of conducting audits shall be twice a year.
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RESPONSIBILITY
The following persons are responsible for the preparation
and implementation of the SOP.
Executive - Corporate Quality Assurance:- To
prepare and follow the SOP accordingly. Maintain the record as per SOP.
Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To
follow the SOP accordingly
VP Technical Analytical Division: - To ensure implementation
of SOP.
Procedure of Laboratory Self-inspection
Audit Team
Self-inspection (Internal Audit) shall be carried
out twice a year by the self-inspection team in the operational departments
viz. Analytical Division, Quality Assurance, Quality Control, and HRD. It may
also be carried out in case of repeated failures in the procedures, product
recall, etc.
Quality Assurance, Director
Executive, GM Operation, and Personal In-charge shall constitute the Self
Inspection team.
Self Inspection team shall include a minimum of three members (from the following departments), excluding the audite
department.
- Head- Quality Assurance.
- Head- Quality Control.
- Head- HRD.
- Any other person, if required.
AUDIT PLAN/ SCHEDULE
Manager- Quality Assurance shall prepare an Audit plan/
Schedule for every six months, which shall be approved by Quality Assurance/
Director Executive/ VP Technical and be distributed in advance to all the
concerned department heads.
The audit plan shall declare the departments to be audited, the dates, and the team members from the self-inspection team, which shall conduct
the inspection. Refer to appendix XYZ/CQA/SOP-035/FR-01 Self Inspection Plan /
Schedule.
Any amendment in the self-inspection plan/ schedule shall be
circulated to the auditee and auditors.
The audit shall be conducted within the defined month of the
schedule. If an audit is not conducted within the due time period of the schedule a
justification is required in this regard.
Laboratory Audit Checklist
The self-inspection team shall take the
help from the ‘audit checklist’ as per XYZ/CQA/SOP-035/FR-03 Audit Checklist for the self-inspection report (Appendix III), however, the inspection
observations may not be limited to the checklist.
The audit team shall visit the functional area and inform
the auditee about the audit scope.
The audit team audits the development in the area using an audit checklist.
No routine work shall be kept on hold during the audit of the department.
The auditee shall provide all relevant documents (asked by an auditor) to the auditor at the time of audit within the appropriate time period.
The team during the inspection shall record the findings in
the checklist itself and get the auditee remarks for the findings on the checklist. All findings shall be categorized as non-conformance/ observation/ Area
of Improvement.
Type of major Non-conformances are mentioned below but not limited to the following:
- No written instructions.
- Failure to follow instructions.
- Unauthorized change in documents.
- Obsolete document not removed.
- Ineffective corrective actions.
- Un-calibrated equipment/ component.
- Expired product/ material in storage.
- Logbook not up to date.
- Status of equipment/ material not mentioned.
- No calibration record.
- Findings that do not have a direct impact on product quality shall be termed as Observations.
- Findings, where an auditor feels scope of improvement shall be termed as Area of Improvement.
AUDIT REPORT
A separate report shall be prepared for each individual
department.
The auditor shall prepare the report on XYZ/CQA/SOP-035/FR-02
Audit Report (Appendix II) categorizing the findings as
non-conformance/observation/Area of Improvement.
All non-conformances/ observations /Areas of Improvement of
checklist shall bring to notice of the person having the responsibility for the
respective department.
Corrective actions with target implementation date shall be
mentioned in the report in consultation of Section In-charge, VP Technical,
Director Executive of the respective department.
Corporate Quality Assurance shall review and circulate the
audit report to all concerned Section In-charge, VP Technical, Director
Executive for compliance, and Director Executive for necessary action.
Corrective Actions
The functional Head shall discuss the reports with other members of the department and plans to take corrective actions before the proposed date of implementation.
Non-conformances shall be handled as per SOP no. XYZ/CQA/SOP-015
Out of Specification Results.
If any change is required to implement the corrective
action, which may have an impact on the product quality, shall be handled as per
SOP no. XYZ/CQA/SOP-029 Change Control.
After implementation of corrective actions, the functional
Section In-charge, VP Technical, Director Executive shall submit the compliance
report with adequate evidence to the Manager-Quality Assurance.
Follow-up and CloseoutÂ
Manager-Quality Assurance and Corporate Quality
Assurance shall review the compliance report and evidence in support of the
report.
Corporate Quality Assurance shall decide whether a re-audit is
required or not by the concerned department.Â
If a re-audit is required, the audit team shall re-audit the
concerned department for the points raised during self-inspection.
If the auditing team is satisfied after an audit, the follow-up
report shall be submitted to Corporate Quality Assurance.
If Corporate Quality Assurance is satisfied with the report, he
shall make the remarks and close the audit report.
Storage of Document for laboratory audit
Finally approved document shall be stored in the
documentation cell of the Quality Assurance Department.
The self-inspection record shall be preserved for a minimum of five years.
