SD-SCD-QF75 Factory Audit Checklist Rev.0
SD-SCD-QF75 Factory Audit Checklist Rev.0
BUREAU OF
PHILIPPINE SD-SCD-QF75: Factory Audit Checklist
STANDARDS Effectivity Date: 01 June 2021
Revision No. 00
Name of Auditor/s
Date of Audit
e. Product/s covered by the audit
Product Type/Model Standard
2.2 Does this verification also include the verification of any Certification Marks?
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BPS PRODUCT CERTIFICATION BODY
BUREAU OF
PHILIPPINE SD-SCD-QF75: Factory Audit Checklist
STANDARDS Effectivity Date: 01 June 2021
Revision No. 00
Description of the procedure or reference of documented procedure and revision or issue date:
2.3 If the manufacturer relies on Certificates of Conformity, do they clearly identify the product,
quantity of items covered, the specification to which the products conform, the production date and are
they properly issued?
2.4 Is there a procedure covering the way to handle non-conforming components and materials?
Description of the procedure or reference of documented procedure and revision or issue date:
2.5 Are the procedure and the way in which it is applied satisfactory? (e.g.: components and materials
clearly identified and/or segregated to prevent unauthorised use?)
2.7 Are records of the incoming inspection kept at least up to the validity of certificate?
Description of the procedure or reference of documented procedure and revision or issue date:
3.3 Are products inspected at appropriate stages of manufacture? (Production Line Inspection)
3.4 Do the Routine Tests entered on the Test Data Sheet sufficiently cover all routine test requirements?
Description of the procedure or reference of documented procedure and revision or issue date:
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BPS PRODUCT CERTIFICATION BODY
BUREAU OF
PHILIPPINE SD-SCD-QF75: Factory Audit Checklist
STANDARDS Effectivity Date: 01 June 2021
Revision No. 00
3.7 Are repaired and reworked (corrected) items again subjected to appropriate tests/inspections in
accordance with procedures?
Description of the procedure or reference of documented procedure and revision or issue date:
3.8 Are test records of the routine tests maintained and satisfactory?
3.9 Are records of the routine tests kept at least up to the validity of certificate?
Type reference
Calibration reference
number
Date of last calibration
Calibration due date
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BPS PRODUCT CERTIFICATION BODY
BUREAU OF
PHILIPPINE SD-SCD-QF75: Factory Audit Checklist
STANDARDS Effectivity Date: 01 June 2021
Revision No. 00
4.5 Are the records for calibration/verification of test and measuring equipment maintained and
satisfactory?
5.2 Are the finished products stored and handled in such a way as to ensure that they will continue to
comply with the applicable standards?
6.2 Are the product identical in line with the product described in Technical Documents?
7. Management Systems
If the manufacturer has a QMS certified/registered or assessed by an accredited certification body, please
provide details of QMS standard, scope, name of certification body/registrar and certificate expiry date, or
provide copy of the certificate.
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BPS PRODUCT CERTIFICATION BODY
BUREAU OF
PHILIPPINE SD-SCD-QF75: Factory Audit Checklist
STANDARDS Effectivity Date: 01 June 2021
Revision No. 00
Does the scope of the certification/registration cover the production of the certified product:
Yes No
Name of certification
body/registrar:
Certificate no.:
Certificate issued date:
Certificate expiry date:
7.1 Does the manufacturer controls the documents and records satisfactorily?
7.2 Does the manufacturer regularly performs internal audits and the audit non-conformities had been
followed-up satisfactorily?
7.3 Are the records from internal audit and corrective actions available?
8. Human Resources
8.1 Are the quality assurance and manufacturing personnel adequately briefed on their duties?
8.2 Are personnel performing work affecting conformity to product requirements competence in
accordance with determined necessary competent by manufacturer?
9. Traceability
9.1 Are product identified by suitable means throughout product realization and control the unique
identification of the product?
10.2 Are the received complaints reviewed on a regular basis regarding whether they are related to
single errors or system errors?
Actual case checked
Procedure checked
10.3 Are corrective actions and decisions regarding customer complaints recorded?
Actual case checked
Procedure checked
10.4 Is the originator of the complaint informed about the handling and the result of the complaint?
Actual case checked
Procedure checked
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BPS PRODUCT CERTIFICATION BODY
BUREAU OF
PHILIPPINE SD-SCD-QF75: Factory Audit Checklist
STANDARDS Effectivity Date: 01 June 2021
Revision No. 00
12.1 Are all corrective actions from previous surveillances completed and implemented?
No unsatisfactory findings.
Observation(s)/recommendation(s)
13.1 Recommended for issuance/recertification/extension
for improvement in the scope of certification/continued use of PS
License
Manufacturer’s corrective action(s) shall be checked
at the next visit.
13.2 Minor unsatisfactory finding(s) Recommended for issuance/recertification/extension
in the scope of certification/continued use of PS
License
Manufacturer shall confirm the corrective action(s).
Major unsatisfactory finding(s). PS License (if any) may be issued/renewed/
13.3 extended/continued after confirmation by BPS
Safety not directly affected.
(Special or early routine Surveillance recommended for
checking corrective action(s)).
Repeated factory Surveillance recommended after
the manufacturer has confirmed implementation of
Critical unsatisfactory finding(s). the corrective action(s).
13.4 (The corrective actions might include total re-
Safety directly affected.
evaluation of the product).
Recommended for PS License suspension by BPS
Audit Team:
Member/s: _____________________________________
Name and Signature
_____________________________________
Name and Signature
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