some hints for QMS audit -5[分享]

4.4.7 Design verification/design

[]Is it regulated that at appropriate design stages, design verifications are being performed[/]

This is satisfied by completion, in stages, of the Design Review form.

[]Are the design verification measures being recorded[/]

Yes - As part of the Design Review form.

4.4.8 Design verification/design

[]Is it defined under which conditions the design validation[/]

On the final product or

Prior to product completion has to be performed?

Design validation criteria is based upon customer requirements and other issues such as similarities to existing products. For example, a slight shift in a raw material added as a per cent by weight, may not require a critical design evaluation. Customer requirements plays the largest part here. Each design effort is different. Timing, including at what stage of the process validation will take place, is project dependent.

[]Do unambiguous requirements exist for the performance of the design validation[/]

The VP of Production ensures requirements are as unambiguous as appropriate and possible for each design project with consideration of product use intent and customer requirements.

4.4.9 Validation/Design changes

[]Are the procedures and responsibilities for design changes defined[/]

Yes - They are limited to the Vice-President of Operations who coordinates with the Vice-President of Operations and other personnel as necessary.

[]Are design changes[/]

Reviewed

Unambiguously characterized

Reported to the involved organizational units

Documented?

Yes - They are by the Vice-President of Operations who coordinates with the design change project.

[]Are design changes approved by authorized personnel before their implementation[/]

Yes - They are limited to the Vice-President of Operations.



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4.5 Document and Data Control

　

4.5.1 General

[]Does the quality manual contain regulations for the control of all documents and data[/]

The systems manual defines or points to appropriate systems for control of applicable documents and data.

[]Are documents/data of external origin controlled, such as[/]

Statutory and regulatory requirements

Standards

Technical rules

Drawings/specifications of customers?

Yes - As detailed in the systems manual.

4.5.2 Document/data approval and issue

[]Are responsibilities assigned for the[/]

Establishment

Review

Release

Identification

Distribution of
a) System-related - for example, quality manual/quality procedures/work instructions / inspection instructions.
b) Order-/product-related - for example, drawings/specifications/recipes/work plans.
c) Governing - for example, laws, regulation, standards.

Yes - In accordance with the systems manual, document control system flow chart and the controlled document matrix.

[]Are lists/tables of valid quality documents/electronic data maintained[/]

Yes - See the controlled documentation matrix.

[]Are all documents clearly marked[/]

Documents are marked clearly as appropriate for the individual document.

[]Is it ensured that the current revision status of documents/files is identifiable[/]

It does for revision sensitive documents as appropriate to a company of this size.

[]Is it ensured that the current revision of[/]

a) System-related - for example, quality manual/quality procedures/work instructions/ inspection instructions.
b) Order-/product-related - for example, drawings/specifications/recipes/work plans
c) Governing - for example, laws, regulations, standards. documents/data are available at the relevant places?

Yes. Each person who uses a controlled document is responsible for knowing and understanding how to verify they are using the appropriate version. Each person is also responsible for ensuring they are using the appropriate version.

[]Is a distribution index defined for[/]

a) System-related - for example quality manual/quality procedures/ work instructions /inspection instructions.
b) Order-/product-related - for example, drawings/specifications/recipes/work plans.
c) Governing - for example, laws, regulations, standards. documents/data?

Distribution lists are not used. Each document has a point of presence denoted on the controlled document matrix as it's 'Location'. Each person who is responsible for a document (as defined on the controlled document matrix) is responsible for appropriate distribution of the document and notifying affected employees of revisions when they occur.

[]Are procedures established to ensure that obsolete[/]

a) System-related - for example quality manual/quality procedures/ work instructions /inspection instructions.
b) Order-/product-related - for example, drawings/specifications/recipes/work plans.
c) Governing - for example, laws, regulations, standards.

Documents/data are removed from all locations of use or are clearly marked as "invalid"?

Yes - the employee responsible for the document is responsible for ensuring the obsolete document is removed from its point of use as defined by the controlled document matrix.

4.5.3 Document and data changes

[]Are responsibilities defined for handling changes regarding[/]

Reviews

Releases

Identifications

Distributions of
a) System-related - for example, quality manual/quality procedures/inspection instructions/detailed instructions.
b) Order-/product-related - for example, drawings/specifications/recipes/work plans
c) Governing - for example, laws, regulations, standards document/data?

The responsibility for handling changes is that responsible employee listed in the controlled document matrix. Each of these elements is addressed.

[]Can changes of[/]

System-related (for example, quality manual/quality procedures/inspection instructions/detailed instructions).

Order-/product-related - for example, drawings/specifications/recipes/work plans

Governing (for example, laws, regulations, standards documents/data)

be reviewed/approved by organizational units different from those who performed the original review/approval?

This is not applicable to Company X Chemicals as everything is in one location and only 15 employees total are involved.

[]Are procedures, responsibilities and the time for storage of the quality documents defined[/]

The VP of Operations is responsible for storage of records for the period defined in the controlled documents matrix.
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