Thursday, April 7, 2011

QA DOCUMENTATION

Checklist Documentation
Here are some of the important documents included in a checklist and the vital documentation procedures that a company has to fulfil
o Quality Manual – This document includes comprehensive details related to the quality management system of an organization. It defines each procedure, process, expectation and justification if there are exclusions for a procedure. It also describes how the quality assurance checklist can help the organization monitor its records and management reviews. Generally, the quality manual - that can be either in a hard copy or soft copy form – provides a guarantee that assurance of quality has been achieved.
o The complete list of documented activities – This document helps define the appropriate measures to create, implement, endorse and review the quality processes included in the system.
o Records regulation – The regulation or control of records in an organization is necessary to establish that it satisfactorily conforms to the defined procedures. Since it helps determine and confirm if the quality programs in QA checklist are still effective, records regulation is an important aspect of the checklist.
o Management responsibilities – This record is a declaration of the company commitment to quality as well as a reference to their role in implementing quality management policies. It includes planning, communication - both external and internal - and customer focus. It also describes the responsibility and authority rules established by the management.
o Human resources – This aspect of the checklist deals with the personnel who are involved in the quality programs of the organization. It also establishes the qualifications required by the personnel to be able to ensure the competence specified in QA checklist. This section of the checklist also details the necessary education, skills, training and work experience required of each employee in order to efficiently carry out quality improvement tasks.
o Product realization – This is another significant component of the checklist that details the processes involved in manufacturing a product. Since product realization must fulfil the criteria included in the quality manual, it is a very useful guideline during the design and manufacturing process. If any deviations are found, the product will be classified as non-compliant.
o Measuring the outcome – In this part of the checklist, the organization offers evidence of performance in QA checklist activities - including how they assess, analyze, amend and advance their quality processes. This analysis of the actual outcome also shows how much the company conforms to the quality management system. This document must be able to provide proof of compliance in an easy-to-follow format such as statistical data.
1. Finished Product Inspection Report
2. Report Date:
3. Vendor Name:
4. Style :
5. Inspector Name:
6. Factory Name/Address:
7. Description:
8. Order Due Date:
9. Est. Ship Date:
10. Colour:
11. City/ State/Prov. P.O. :
12. Ship method:
13. Country of Origin:
14. Order Quantity:
15. Report accepted by:
16. (Authorized factory manager)
17. Visual Product ( ) Pass ( ) Fail ( ) Waived ( )
18. Measurement ( ) Pass ( ) Fail ( ) Waived ( )
19. Packaging ( ) Pass ( ) Fail ( ) Waived ( )
20. Overall ( ) Pass ( ) Fail
21. Visual Inspection (Visual, Construction, and Packaging)
22. Sample Size:
23. Major Defects Allowed:
24. Minor Defects Allowed:
25. List Each Defect found
26. Defect Description: Critical( ) Major( ) Minor ( )
27. Corrective Action to be taken:
28. Authorised signatory

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