This document details the procedure for Self-inspection and Self-inspection in manufacturing at XYZ Limited. It is the policy of XYZ Limited that written procedure shall be followed for self-inspection (Internal Audit).
It
is a c-GMP and regulatory requirement that the company should have its internal
audit system by which the company can assess the implementation of cGMP norms. An
internal audit of the company is required during the routine functioning of the
plant.
At
the time of conducting the internal audit of XYZ Limited. The frequency of
conducting audits shall be twice a year.
>Standard Operating procedure Audit Checklist
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.
Director
Production: - To ensure implementation of SOP.
Procedure of Self-Inspection
5.1 Audit Team
5.1.1 Self-inspection (Internal Audit) shall be carried out twice a
year by the self-inspection team in operational departments viz. Analytical
Division, Quality Assurance, Quality Control, Warehouse, HRD, Production, and Engineering. It may also be carried out in case of repeated
failures in the procedures, product recall, etc.
The external audit shall also be conducted at least once a year, by the external
auditor(s).
The Quality
Assurance Manager, Director of Production, and Quality Control Incharge shall constitute
the Self Inspection team.
The self-inspection team shall include a minimum of two members (out of the following
departments), excluding the audited department.
Head-
Quality Assurance
Head-
Quality Control
Head-
Production
Head-
Warehouse
Head-
Engineering
Head-
HRD
Any
other person, if required
AUDIT PLAN/ SCHEDULE
Manager-
Quality Assurance shall prepare an Audit plan/ Schedule every six
months, which shall be approved by Quality Assurance/ Director Production
and to 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 XYZSOP-034/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 in the due time of schedule a justification is required in
this regard.
AUDIT
The self-inspection team shall take the help from ‘audit
checklist’ as per XYZ/SOP-034/FR-03 Audit Checklist for Self Inspection for
Warehouse(Appendix III), for Manufacturing as per XYZ/SOP-034/FR-04(Appendix
IV), for Packaging as per XYZ/SOP-034/FR-05(Appendix V), for Quality Assurance
as per XYZ/SOP-034/FR-06(Appendix VI), for Quality Control as per XYZ/SOP-034/FR-07(Appendix
VII), for Engineering as per XYZ/SOP-034/FR-08(Appendix VIII) and for Human Resource
Department as per XYZ/SOP-034/FR-09(Appendix IX), however, the inspection
observations may not be limited to the checklist.
The audit team shall visit the functional area and inform
the audited about the audit scope.
The
audit team audits the work in the area using an audit checklist.
No
routine work shall be kept on hold during the audit of the department.
The auditor
shall provide all relevant documents (asked by an auditor) to the auditor at the time
of audit within a reasonable time period.
The
team during the inspection shall record the findings in the checklist itself
and get the audited remarks for the findings on the checklist. All findings
shall be categorized as non-conformance/ observation/ Area of Improvement.
The
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.
The logbook is not up to date.
The status of equipment/material is 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 the 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 the SOP Audit Report categorizing the findings as non-conformance/ observation/ Area of Improvement.
All
non-conformances/ observations/Areas of Improvement of the checklist shall be
brought to the notice of the person having the responsibility of the respective
department.
Corrective
actions with a target implementation date shall be mentioned in the report in
consultation with the Section Incharge of that department, the Director Production of
the respective department.
Corporate
Quality Assurance shall review and circulate the audit report to all concerned
Sections Incharge for compliance and Director Production for necessary action.
Corrective Actions
The functional Head shall discuss the reports with other members of the department and plan to
take corrective actions before the proposed date of implementation.
Non-conformances
shall be handled as per SOP XYZ/SOP-015 out of Specification Results.
If
any change is required to be implemented the corrective action, which may have an impact on the product quality, shall be handled as per SOP XYZSOP-029 Change Control.
After the implementation of corrective actions, the functional Section in Incharge, VP
Technical, shall submit the compliance report with adequate evidence to
the Manager-Quality Assurance.
FOLLOW-UP and closeout
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 or not a re-audit is required or not of
the concerned department.
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 re-audit, the follow-up report shall be
submitted to Corporate Quality Assurance.
If
Corporate Quality Assurance is satisfied with the report, it will make the remarks
and close the audit report.
Storage of Documents
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.