SOP For IQA

STANDARD OPERATING PROCEDURE
SOP NO:
IGPL/QA/GEN/018-06 DEPT: QUALITY ASSURANCE Page No 1 of 25
SUPERSEDE SOP NO:
AREA: DOCUMENTATION Effective date 03-01-2022
IGPL/QA/GEN/018-05
SUBJECT: SELF INSPECTION Review date 31-12-2024
1.0 OBJECTIVE
To lay down a procedure for conducting self Inspection.
2.0 SCOPE
This procedure is applicable to all the departments present in the XXX, Location and
City.
3.0 RESPONSIBILITY
3.1 Executive or above – To audit / execute compliance to audit findings /

observations.
3.2 Department Head – To audit / review audit findings / observations and coordinate
compliance to audit findings / observations, with other departments.
3.3 Head-QA– Plan and prepare audit schedule. Selection of Self inspection team.
4.0 PROCEDURE
4.1 Selection of Team for Self Audits
4.1.1 Self inspection team shall comprise of persons from various
departments / Heads of the Departments. The auditors shall be choose
from the departments other than the department to be audited.
4.2 Frequency of Self Audits

4.2.1 The Self audits shall be done on half yearly basis.
4.3 Planning for Self Audits

4.3.1 An ‘Self Inspection Plan’ shall be prepared as per Annexure-1 and
Head-QA shall finalize the schedule of the audit in consultation to the
other Heads of Departments.
PREPARED BY CHECKED BY APPROVED BY
SIGN AND DATE
NAME &
DEPARTMENT
Format No: IGPL/QA/F/QA/001-01
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
4.4 Conducting the Self Audits

4.4.1 The self inspection shall be conducted for all departments. The audit
schedule shall indicate the scope and shall be distributed to the respective
department Heads.
4.4.2 The team of auditors shall use appropriate audit checklist, considering the
scope of audit, requirements of the laid down systems, SOPs and observation
of earlier audits, if any as per Annexure-3 to Annexure-8.
4.5 The Internal Audit shall not be confined to points mentioned in the checklist. The
auditors may inspect all areas for compliance to cGMP, Regulatory requirements
of Quality Assurance in totality.
4.6 Reporting of Findings shall be done as follows
4.6.1 The audit report comprising of agreed, finding based, factual evidences shall
be prepared. It is necessary to record what, where and why the deficiency.
4.7 Following observations shall be treated as non-conformances, just to mention

few-
4.7.1 No written instructions.
4.7.2 Failure to follow instructions-Improper training
4.7.3 Failure to label and sign on equipments and materials
4.7.4 Improper cleaning & Documenting cleaning times
4.7.5 Bad personnel hygiene –Smokers, Tobacco & Gum chewers
4.7.6 Unauthorized document changes
4.7.7 Obsolete document not removed
4.7.8 Ineffective line clearances in Production & Packing
4.7.9 Ineffective corrective action
4.7.10 Un-calibrated equipment in use & Improper calibration documents
4.7.11 Overage (expired) product in storage
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
4.7.12 Repair operation not done

4.7.13 No documented evidence of the work
4.7.14 No calibration records
4.7.15 Bad record storage, back-up & Filling procedures
4.7.16 Bad and incomplete reconciliation statements of all materials
4.7.17 Outdated Environmental monitoring procedures & untimely recording
4.7.18 Non-compliance of regulatory requirements.
4.8 The observations shall be categorized by Head-QA as follows
4.8.1 Major – Observation has significant impact on product quality and / or

safety and likely to have serious and / or harmful effect on the patient (e.g.
Product mix up, Label mix up, adverse drug reaction)
4.8.2 Moderate – Observations other than critical, that is likely to result in a
failure or reduction in suitability of use of a unit for its intended purpose
(e.g. Reduction in potency, change in disintegration time, dissolution,
broken tablets, particle counts in vials, sterilization failures etc.)
4.8.3 Minor- Observation that is not likely to feasibility of the unit of product for
its intended purpose or departure from established standards having little
bearing on the effective use or operation of the unit (e.g. Missing tablets/
capsules, smudging of over printed matter, missing blisters, missing cartons
etc.).
4.9 The findings shall be summarized, after completion of self inspection by auditors,
to the Head of the concerned department, and shall be reported and classified as
major, moderate and minor in Annexure-2.
4.10 Head-QA shall review and send Self Audit report to all the concerned Heads of
departments.
4.11 Corrective Action
4.11.1 If required the Head of department shall consult the Heads of other
department about the corrective action plan and Target Completion Date.
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
4.11.2 The compliance of the audit observation shall be submitted to the Head-QA
by the respective departments on or before the target completion date, for
the follow up audit.
4.12 Follow Up Audit and Closing of Observations
4.12.1 On receipt of compliance report from the auditee, the concerned auditor
shall verify the compliance report with respect to the target completion
date.
4.12.2 After being satisfied with corrective & preventive actions, the auditor shall
close the non-conformance.
5.0 ABBREVIATIONS
5.1 QA-Quality assurance
6.0 ANNEXURE
6.1 Annexure-1: Self inspection plan
6.2 Annexure-2: Audit findings
6.3 Annexure-3: Quality Assurance Check List
6.4 Annexure-4: Quality Control Check List
6.5 Annexure-5: Production Check List
6.6 Annexure-6: Warehouse Check List
6.7 Annexure-7: Utilities Check List
6.8 Annexure-8: Administration Check List
6.9 Annexure-9: Microbiology Check List
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
SELF INSPECTION PLAN [ANNEXURE-1]
Month: _______ Date: ________ to ________
Scope of Audit: ____________________________________________________________
Department /
Date Time Auditors Auditee sign
Area
Prepared by Approved by
QA Executive Head- QA
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
SELF INSPECTION REPORT [ANNEXURE-2]

QUALITY ASSURANCE DEPARTMENT
Date of Audit
Department
Responsible Remarks
Proposed person
S. No. Observations Type* corrective Target Dates
action
Auditors Auditee
Name: Name: Name:

Sign & Date: Sign & Date: Sign & Date:
Audit remarks: The observations noted during the inspection were resolved and closed on
________________ QA(sign/Date) _______________
Note: *Type: Minor, Moderate and Major
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
QUALITY ASSURANCE CHECK LIST (ANNEXURE-3)
S.No Checklist Observation Remarks

1 All SOP’s are up to date Yes No
2 Does Quality Assurance have the authority to Yes No
approve/reject plant, equipment, process and
procedural changes?
3 Are all components, manufacturing materials, in- Yes No
process materials, packaging materials and labelling
tested prior to release to production? (Check test
records)
4 Is there a thorough investigation of any discrepancies Yes No
found during the final review of the production
documents?
5 Is the product checked for correct expiration dating? Yes No
6 Are there control samples of finished products Yes No
maintained for a period of at least 3 months after date
of expiry?
7 Is an adequate product complaint/product failure Yes No
handling system in effect and are investigations
facilitated properly? (Check complaints file)
8 Is there an adequate stability/shelf life determination Yes No
programme?
9 Does Quality Assurance approve reject product Yes No
manufactured, processed, packaged or held under
contract for another company?
10 Are operators allowed adequate breaks from Yes No
inspection?
11 Are there disinfectants and detergents used monitored
for microbial contamination?
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05

12 Are the disinfectants frequently rotated to discourage Yes No
the development of resistant microorganisms?
13 Are change rooms designed and used so as to Yes No
minimize contamination of protective garments?
14 Is there an adequate disposal collection system? Yes No
15 Is the plant layout conducive to smooth product Yes No
flow? (e.g. uni-directional flow, avoiding back and
forth movement)if the raw materials or intermediates
are stored in tanks or other large containers , are the
vents adequately protected to prevent entry of water ,
birds, and insects?
16 Are SOPs available for critical GMP compliance? Yes No
17 Is annual quality review performed as per the Yes No
documented procedure?
18 Is there a system to verify that currently used Yes No
documentation is the latest?
19 Does the written procedure specify the titles of the Yes No
qualified and responsible persons who are the
authorized signatories for approval of SOPs?
20 Do SOPs have self-explanatory titles and serialized Yes No
identification number?
21 Does each current SOP show the number of the Yes No
previous SOP that was superseded?
22 Does each SOP clearly state its objective?
23 Are all persons responsible for implementing the Yes No
SOP specified?
24 Do the SOPs clearly indicate that any changes must Yes No
be approved before implementation?
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05

25 Are there instructions in a step-by step manner and Yes No
sequentially numbered?
26 Are SOPs readily available to all persons involved in Yes No
the procedures?
27 Is there retrieval of superseded SOPs controlled by a Yes No
responsible person
28 Is there an authorized standard operating procedure to Yes No
define the action to be taken if any of the result of the
tests indicates that the environmental standard of the
area is out of specified limits?
29 Is there a system to verify that currently used Yes No
documentation is the latest issue?
30 Check the BMR retrieval system Yes No
31 Verify the MFR for few products Yes No
32 Verify the QA Executive during the in-process Yes No
activity
33 Verify the all the records maintained by QA Yes No
34 Verify the validation documents Yes No
35 Line clearance SOP is available and up dated Yes No
S.NO ANY OTHER COMMENTS
1
2
3
4
5
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
QUALITY CONTROL CHECK LIST (ANNEXURE-4)

1 Verify training record of all the personnel is properly Yes No
maintained.
2 Are training given to new personnel? Yes No
3 Are the personnel having knowledge of current GMP Yes No
requirements?
4 Is Instruments are calibrated at regular intervals? Is Yes No
there any calibration schedule available?
5 Is calibration standards are available for calibrating Yes No
all the instruments
6 Is the calibration certificate available for standard Yes No
weights?
7 Verify Standard Operating Procedures for the Yes No
operation, maintenance and calibration of
instruments.
8 Is the control copy of QC department SOPs Yes No
available?
9 Are the status labels available on each instrument? Yes No
10 Check all the log books available or not Yes No
11 Verify progress register for non-functional Yes No
equipments and action for procurement of spares and
accessories, monitoring thereof, shall be maintained.
12 Check for Standard Operating Procedure for Yes No
preventive maintenance of machine or equipment or
apparatus available or not?
13 Verify equipments such as burettes, pipettes, Yes No
volumetric flasks, weight boxes, thermometers, etc.,
shall be thoroughly checked for accuracy of
calibration before acceptance for use.
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05

14 Check the temperature and humidity record. Yes No
15 Are all the sampling devices properly stored? Yes No
16 Are the specifications available for raw material, Yes No
packing material, in-process samples, intermediates
and finished products?
17 Check the in-process testing record. Yes No
18 Check the raw material testing record. Yes No
19 Check the final product testing record. Yes No
20 Check the stability record. Yes No
21 Check the stability chamber record. Yes No
22 Are all reagents and solutions in the laboratory are Yes No
properly identified with a label.
23 Are a standardization register maintained by the Yes No
laboratory along 'with its raw data and Standard
Operating Procedure for preparation and
standardisation on stock solutions, standard solutions,
volumetric solutions must be prepared for the
guidance of staff.
24 Are Standard Operating Procedure for safety, house- Yes No
keeping and loss prevention shall be maintained
25 Verify that safety data sheets must be made available Yes No
to staff before testing is carried out;
26 Check whether staff must wear laboratory coats or Yes No
other protective clothing including gloves and face
masks and eye protection wherever required;
27 Verify first aid kit and-fire fighting equipments Yes No
located at the right places and the staff must be
familiar and trained with the use of fire fighting
equipment including fire extinguishers, fire blankets
and gas mask
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05

28 Are rubber suction bulbs must be used on manual Yes No
pipettes and siphons
29 Is there appropriate facilities for the collection, Yes No
storage, and disposal of wastes shall be made
available.
30 Are staff must be aware of methods for safe disposal Yes No
of corrosive or dangerous products by neutralisation
or deactivation and of the need for complete disposal
of mercury and its salts.
31 Check reference and working standards and their Yes No
storage conditions and usage?
32 Check a register pertaining to reference and working Yes No
materials must be maintained by the laboratory.
33 Are the relevant pharmacopoeia available or not Yes No
34 Raw data available for raw materials, finished Yes No
products etc..
35 Corrections shall be done with single line strike Yes No
through the data being changed; the correct
information shall be recorded along with the old data
and the reason of change.
36 Check whether residual sample shall be retained in Yes No
proper storage condition for a period of one year after
the final report.
37 Is the laboratory established and maintained Yes No
procedures for the identification collection, indexing
retrieval, storage, maintenance, and disposal of all
documents.
38 Verify whether time for which records are retained Yes No
prescribed in the documents.
39 Verify whether Paper documents kept for long Yes No
periods under high humidity
40 Verify whether all the master documents kept under Yes No
lock and key and preserved under good conditions
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
1
2
3
4
5
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
PRODUCTION CHECK LIST (ANNEXURE-5)
AREA: PARENTERALS

2 All Equipments are identified with Equipments ID Yes No
3 All the Equipments are having Operation and Yes No
calibration SOP
4 Calibration records are up to date Yes No
5 Verify the environmental monitoring data is available Yes No
6 Verify the employee training records Yes No
7 Verify the packing procedures in tablet section Yes No
8 Verify the online entry of BMR is available or not Yes No
9 Ask any one SOP for production chemist Yes No
10 Verify the cleaning procedures in tablet section Yes No
11 Verify the entry and exit procedure for personnel
12 Verify the inprocess requisitions are raised as per Yes No
BMR
13 Check the product labels for current packing product Yes No
14 Verify the finished product analytical report is Yes No
available or not before dispatch
15 Verify the packing operations Yes No
16 Verify the product handling rooms. Yes No
1
2
3
4
5
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
AREA: TABLETS

calibration SOP
7 Verify the packing procedures in tablet section Yes No
10 Verify the cleaning procedures in tablet section Yes No
BMR
14 Verify the finished product analytical report is Yes No
available or not before dispatch
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
AREA: LIQUIDS

calibration SOP
7 Verify the packing procedures in liquid section Yes No
10 Verify the cleaning procedures in liquid section Yes No
BMR
13 Verify the balance is available in filling room or not Yes No
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
WAREHOUSE CHECK LIST (ANNEXURE-6)

1 Is the control copy of store department SOPs Yes No
available?
2 Is the personnel having knowledge of current GMP Yes No
requirements?
3 Is the incoming raw materials entry register Yes No
available?
4 Is the housekeeping maintained? Yes No
5 Is the sampling booth area cleaned? Yes No
6 Is the weighting balance having proper tag of Yes No
calibration status?
7 Is the balance calibration record available? Yes No
8 Are the calibrated standard weights available? Yes No
9 Is the calibration certificate available? Yes No
10 Is the standard weights are properly stored? Yes No
11 Is the quarantine, approved and rejected area
designated?
12 Are the UNDER TEST label pasted on all the Yes No
incoming raw materials?
13 Are the SAMPLE label pasted on all the sampled raw Yes No
materials?
14 Are the APPROVED labels pasted on all the Yes No
approved raw materials?
15 Are the raw materials stored at their respective place? Yes No
16 Check the cleaning and housekeeping condition Yes No
record of quarantine, approved and rejected area.
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05

17 Are the packing materials stored separately? Yes No
18 Is the cleaning and housekeeping maintained at Yes No
packing material store area?
19 Is the temperature and relative humidity record Yes No
maintained for all respective area?
20 Is the approved vendor list available? Yes No
21 Is the FIFO system follow? Yes No
22 Check the production requisition slip record? Yes No
23 Check the issuance record. Yes No
24 Check the dispatch record. Yes No
25 Check the general cleaning and housekeeping of Yes No
store.
26 Check the personnel hygiene. Yes No
27 Check the safety equipments. Yes No
28 Check the drum storage yard for cleaning, Yes No
housekeeping and status.
29 Check the proper segregation at drum storage yard? Yes No
30 Check the other records. Yes No
31 Is line clearance activity performed? Yes No
1
2
3
4
5
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
UTILITIES CHECK LIST (ANNEXURE-7)

1 Is the control copy of Maintenance department SOPs Yes No
available?
requirements?
3 Is the preventive maintenance schedule available? Yes No
4 Check the preventive maintenance records. Yes No
5 Are equipments labelled with last maintenance date Yes No
and next due maintenance date?
6 Are the equipment qualifications available? Yes No
7 Check the equipment qualification record. Yes No
8 Is the temperature gauges calibration record Yes No
available.
9 Check the temperature gauges calibration record. Yes No
10 Are the pressure / vacuum gauge calibration record Yes No
available?
11 Check the calibration record.
12 Check the break down maintenance record. Yes No
13 Check the DM water generation record. Yes No
14 Check the AHU maintenance record. Yes No
15 Check the AHU’s filter cleaning record. Yes No
16 Check the AHU’s differential pressure record. Yes No

17 Is there any training schedule for new entrant in Yes No
maintenance department?
18 Are new entrant trained after join maintenance Yes No
department?
19 Are there any documents for postponement of the Yes No
schedule maintenance?
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05

20 Is the department follow the postponement of the Yes No
schedule maintenance and send it to review by QA
department?
21 Is there check list for each equipment for preventive Yes No
maintenance?
22 Check the equipment check list. Yes No
23 Are all electrical motor labelled and well maintained? Yes No
24 Check the status of the electrical motor. Yes No
25 Check the maintenance status of DG Set. Yes No
26 Is the maintenance store area clean? Yes No
27 Check the housekeeping of maintenance store area. Yes No
28 Are all storage tanks properly labelled? Yes No
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
ADMINISTRATION CHECK LIST (ANNEXURE-8)

1 Is there a quality control department independent of Yes No
other departments with defined responsibility and
authority
2 Does the organization chart reflect independent Yes No
reporting relationships of production and quality
control departments?
3 Is there a GMP organization? Yes No
4 Is there an audit team comprising of one member of Yes No
each department that performs periodic GMP audits?
5 Are there job descriptions for key production and Yes No
quality control personnel?
6 Are the Head of production and Head of Quality Yes No
Control different persons neither of whom is
responsible to the other?
7 Are the General Manager, Pharmacists, technicians, Yes No
maintenance staff and all personnel engaged in
production and quality control trained in Good
Manufacturing practice in relation to the work they
are doing?
8 Is there any GMP training performance indicators? Is Yes No
GMP training given on a continuing and progressive
basis?
9 Are records of GMP training retained to verify that Yes No
training/retraining has taken place and the results
obtained?
10 Do the records show that the GMP instructors are Yes No
qualified?
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05

11 Is there a written policy/SOP dealing with hygiene Yes No
and health?
12 Are there personnel in direct contact with products Yes No
medically examined in accordance with a specified
procedure upon recruitment and records kept?
13 Are the specified tests repeated annually and records Yes No
kept?
14 Do the specific tests include tests for adequate Yes No
eyesight?
15 Do the specified tests include tests for communicable Yes No
diseases? E.g. (Tuberculosis, Typhoid fever, viral
hepatitis)
16 Are clean working garments worn over, or in place of Yes No
street clothing, in all production and quality control
areas?
17 Are personnel instructed on sanitation and health Yes No
requirements?
18 Are personnel instructed to report to management any Yes No
apparent illness or open lesion that might affect
product quality?
19 Are there adequate controls for insects and rodents? Yes No
and records for the same?
20 Does the training programme include reference to Yes No
hygiene and the basic elements of microbiology?
21 Are the tops of the employee lockers clean? Yes No
22 Are waste containers with lids located in appropriate Yes No
areas?
23 Any safety training is provided to the employees on Yes No
regular basis?
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
MICROBIOLOGY CHECK LIST (ANNEXURE-9)

1 Is the control copy of microbiology department SOPs Yes No
available?
requirements?
3 Check the log books for instruments in microbiology Yes No
4 Check the sub-culturing records of master cultures Yes No
5 Check the media preparation records Yes No
6 Check the media growth promotion test records Yes No
7 Check the laminar flow cleaning and usage records Yes No
8 Check the Water monitoring records Yes No
9 Check the fumigation records Yes No
10 Verify the practice related to the gowning Yes No
11 Check the Environmental monitoring plates Yes No
12 Check the Cleaning records Yes No
13 Check the balance calibration records Yes No
14 Check the labelling followed in Microbiology Yes No
15 Verify general practices in the microbiology area. Yes No
16 Please check the personal hygiene Yes No
17 Operators carrying out sterility tests shall wear Yes No
sterilized garments including headgear, face masks
and shoes;
18 If the cultures have become non-viable or mutant, Yes No
proper procedure shall be followed to destroy these
cultures by autoclaving under an authorised
personnel for biological testing. Preferably not more
than five passages may be prepared.
19 The laboratories shall perform standard biochemical Yes No
tests on the sub-culture as given in literature to ensure
their viability,
SIGN AND DATE
NAME &
DEPARTMENT
SOP NO:
SUPERSEDE SOP NO:
IGPL/QA/GEN/018-05
7.0 CHANGE HISTORY
Supersede SOP No. CCR No. Reason for revision

IGPL/QA/GEN/018-00 CCR/001/12 Periodic Review
END OF DOCUMENT
SIGN AND DATE
NAME &
DEPARTMENT

SOP For IQA

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STANDARD OPERATING PROCEDURE

3.1 Executive or above – To audit / execute compliance to audit findings /

4.2 Frequency of Self Audits

4.3 Planning for Self Audits

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

4.4 Conducting the Self Audits

4.6 Reporting of Findings shall be done as follows

4.7 Following observations shall be treated as non-conformances, just to mention

SIGN AND DATE

4.7.12 Repair operation not done

4.8.1 Major – Observation has significant impact on product quality and / or

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

SELF INSPECTION PLAN [ANNEXURE-1]

Month: _______ Date: ________ to ________

Scope of Audit: ____________________________________________________________

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

SELF INSPECTION REPORT [ANNEXURE-2]

Name: Name: Name:

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

QUALITY ASSURANCE CHECK LIST (ANNEXURE-3)

S.No Checklist Observation Remarks

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

S.No Checklist Observation Remarks

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

S.No Checklist Observation Remarks

S.NO ANY OTHER COMMENTS

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

QUALITY CONTROL CHECK LIST (ANNEXURE-4)

S.No Checklist Observation Remarks

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

S.No Checklist Observation Remarks

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

S.No Checklist Observation Remarks

SIGN AND DATE

S.NO ANY OTHER COMMENTS

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

PRODUCTION CHECK LIST (ANNEXURE-5)

S.No Checklist Observation Remarks

S.NO ANY OTHER COMMENTS

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

S.No Checklist Observation Remarks

S.NO ANY OTHER COMMENTS

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

S.No Checklist Observation Remarks

S.NO ANY OTHER COMMENTS

PREPARED BY CHECKED BY APPROVED BY

SIGN AND DATE

WAREHOUSE CHECK LIST (ANNEXURE-6)

Month: _ Date: to __