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Quality System Procedure Audit Programme Proforma: Form No.21 QSP-17 02 Dated 08/02

This document is an audit programme proforma that contains check points to audit a quality management system. It includes sections to audit quality management, management responsibility, resource management, product realization, measurement, analysis and improvement. Auditors will use the check points and remarks section to evaluate the quality system and ensure requirements are being met.

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Unmesh Unnikrishnan
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86 views7 pages

Quality System Procedure Audit Programme Proforma: Form No.21 QSP-17 02 Dated 08/02

This document is an audit programme proforma that contains check points to audit a quality management system. It includes sections to audit quality management, management responsibility, resource management, product realization, measurement, analysis and improvement. Auditors will use the check points and remarks section to evaluate the quality system and ensure requirements are being met.

Uploaded by

Unmesh Unnikrishnan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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QUALITY SYSTEM PROCEDURE

AUDIT PROGRAMME PROFORMA

Check Points Yes No Remarks


4 Quality Management Systems
4.1 Is the organisation chart showing the
hierarchy of responsibilities up to date?

4.2 Is there any new processes identified with


respect to the operations of the company,
to achieve product quality?

4.3 Are the identified and defined processes


monitored and measured?

4.4 Are any of the processes defined within


the system outsourced?

4.5 Is there any change in the quality Policy


and quality objectives?

Formatted: Left
Audit No. ………………….. Audit Area …………………………………
Personnel Seen ……………………………………………………………….
Auditor …………… Date ……………
Audit Area Representative………………………

Document Code Prepared By Approved By Revision No.


Form No.21 02 dated 08/02
QSP-17
2 of 7

4.6 Do the documents bear an indication of


issue status?

4.7 Are the updated documents, if any


authorised?

4.8 Is there a defined circulation list for each


document?

4.9 Are there any obsolete documents in


use?

4.10 Does the system maintain records for the


stated retention period of?

4.11 Does the Master Index of list of


documents identify the latest
specifications of International standard,
Licensors and that of Customers.

4.12 Is the Quality Plan in job cards regularly


followed?

Formatted: Left
Audit No. ………………….. Audit Area …………………………………
Personnel Seen ……………………………………………………………….
Auditor …………… Date ……………
Audit Area Representative………………………

Document Code Prepared By Approved By Revision No.


Form No.21 02 dated 08/02
QSP-17
3 of 7

5 Management Responsibility
5.1 Does the Management review include
necessary inputs?

5.2 Is the Management review conducted


regularly?

5.3 Is the product identified during each


process?

5.4 Does the Management review indicate


the regular involvement of top
management?

5.5 Is the Customer satisfaction monitored by


the top management?

5.6 How is the level of awareness of Quality


policy within the organization?

5.6 Does the Management review records


the decision reached on Quality
management issues?

Formatted: Left
Audit No. ………………….. Audit Area …………………………………
Personnel Seen ……………………………………………………………….
Auditor …………… Date ……………
Audit Area Representative………………………

Document Code Prepared By Approved By Revision No.


Form No.21 02 dated 08/02
QSP-17
4 of 7

6 Resource Management
6.1 Do the people involved in the resulting
product quality posses appropriate
qualifications?

6.2 Are there records to demonstrate the


skills of the people involved?

6.3 Are the training needs identified?

6.4 Do the personnel files include the latest


training certificates?

6.5 Any new additions in the infrastructure


needed for achieving product quality
since the last audit?

Formatted: Left
Audit No. ………………….. Audit Area …………………………………
Personnel Seen ……………………………………………………………….
Auditor …………… Date ……………
Audit Area Representative………………………

Document Code Prepared By Approved By Revision No.


Form No.21 02 dated 08/02
QSP-17
5 of 7

7 Product Realisation
7.1 Do the planning activities address the
need for records to show control of
processes?
7.2 Are the existing regulatory and legal
requirements if any, related to the product
identified during the planning of
processes?
7.3 Are the orders of the customers checked
before issuing for processing?

7.4 Are the customers requirement assured if


they do not document them?

7.5 Are design requirements documented?

7.6 Have designs been tested and recorded?

7.7 Are there cases of design change on


delivered products?

7.8 Are foreign purchase orders reviewed?

7.9 Is the approved vendor list detailed and


updated?

7.10 Is the performance of the vendors


reviewed?

7.11 Are the properties of customer, both


material and intellectual well maintained?

Formatted: Left
Audit No. ………………….. Audit Area …………………………………
Personnel Seen ……………………………………………………………….
Auditor …………… Date ……………
Audit Area Representative………………………

Document Code Prepared By Approved By Revision No.


Form No.21 02 dated 08/02
QSP-17
6 of 7

7.12 Does the product carry identification on


various stages of processes?

7.13 Do the traceability required by the


contract followed for the products and its
variants, if any?

7.14 Are there work instructions where


appropriate?

7.15 Are the process equipment maintained?

7.16 Are the products handled in accordance


with the relevant procedures?

7.17 Are controls in place for the stored


products?

7.18 Is the protection of products in transit


addressed?

7.19 Does the calibration schedule show the


latest status?

7.20 Does the measuring equipment carry a


label indicating the calibration status?

7.21 Are the measuring equipments well


protected?

7.22 Are the records of calibration of


measuring equipment maintained?

Formatted: Left
Audit No. ………………….. Audit Area …………………………………
Personnel Seen ……………………………………………………………….
Auditor …………… Date ……………
Audit Area Representative………………………

Document Code Prepared By Approved By Revision No.


Form No.21 02 dated 08/02
QSP-17
7 of 7

8 Measurement, Analysis and Improvement


8.1 Is the customer satisfaction survey
periodically carried out?

8.2 Is there a forward audit programme?

8.3 Have internal quality audits been carried


out as per the programme?

8.4 Are the audit records complete?

8.5 Are there pending corrective actions?

8.6 Has the need for statistical techniques


reviewed?

8.7 Are actions taken to prevent problems


and its recurrence?

8.8 Are corrective and preventive actions, if


any discussed in the management
review?
8.9 Are there any non-conformity recorded
since the audit?

Formatted: Left
Audit No. ………………….. Audit Area …………………………………
Personnel Seen ……………………………………………………………….
Auditor …………… Date ……………
Audit Area Representative………………………

Document Code Prepared By Approved By Revision No.


Form No.21 02 dated 08/02
QSP-17

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