some hints for QMS audit -4[分享]

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4.4 Design Control (This Quality System Element is not part of ISO 9002)

　

4.4.1 General

[]Does the quality manual contain regulations for the design control[/]

The company systems manual specifically details Company X Chemicals design control methodology.

[]Is there a list available specifying on-going design and development projects (If necessary)[/]

We do not maintain a list of active design projects as there are not enough (numerically) for a need for such a list.

[]Is the current design and development status evident[/]

Yes - By review of the records associated with the project, the status can be determined.

4.4.2 Design and development planning

[]Are there provisions for the planning of the design and development activity[/]

Yes - There is a design planning form and system defined which addresses required provisions.

[]Do these provisions contain:[/]

Responsibilities for each phase
Not for each phase. The VP of Production defines responsibilities, organizes and oversees the entire project.


Product requirements
These are detailed on the design review form.


Descriptions of activities
These are detailed on the design review form.


Including design review/verification/validation
These are detailed on the design review form.


Personnel requirements
These are detailed on the design review form.


Resources requirements
These are detailed on the design review form.


Responsible staff for the implementation?
Implementation is organized and overseen by the VP of Production.

[]Is it assured that plans for the development activity are continuously updated as the design evolves[/]

The VP of Production ensures that design evolution is addressed as appropriate for each individual design project. Company X Chemicals does not have critical designs involving complex development activities.

[]Are qualified personnel assigned to these activities For example, qualification profile, plan for training requirements, training records (certificates).[/]

Yes - qualified personnel are identified and assigned by the VP of Production. There is no 'qualification profile' as one is not necessary. Training plan is limited to appropriate training for each job.

[]Are adequate resources available to carry out these activities For example, information systems, software, experimental equipment, test equipment.[/]

Adequate resources are available as determined by the VP of Operations and/or the VP of Production with consideration to the size and complexity of Company X Chemicals operations.

4.4.3 Organization and technical interfaces

[]Are the requirements for design/development activities that are carried out by external groups[/]

Defined by descriptions and

Are the requirements reviewed?

External inputs and activities are limited to customer interfaces. These are determined specifically for each design effort. Company X Chemicals has not determined a need for a standard customer interface for every design effort.

[]Are the organizational and technical interfaces between different people which are involved in the design process defined[/]

Design is carried out principally by the VP of Production with the VP of Operations. There are no defined interfaces. Each area is addressed, including the appropriate people, with consideration to the design needs by the VP of Operations and/or the VP of Production.

[]Is the information documented, distributed to the involved people and regularly reviewed[/]

Company X Chemicals design system is not complex enough to require 'regular reviews' and such. Appropriate documentation is kept and appropriate people are updated as required by the specific design project. There are 3 points on the Design Process flow chart where reviews are made, however they are only documented to the extent deemed necessary by the VP of Production.

[]Do unambiguous input requirements exist for the development based on contract reviews or similar[/]

Yes - see the design review form.

[]Are individuals appointed who are responsible for the design input[/]

This is always the VP of Production.

[]Are the product requirements reviewed for completeness and clarity[/]

Yes - by the VP of Production.

[]Is it ensured that applicable standards are being complied with[/]

Yes - by the VP of Production.

[]Is it defined how problems due to ambiguous, conflicting, and incomplete requirements can be resolved[/]

This is the responsibility of the VP of Production as detailed in the systems manual.

4.4.5 Design output

[]Is it defined in which way design output is documented For example, in drawings, calculations, specifications, safety analyses, etc.[/]

Yes - as detailed in the systems manual.

[]Does acceptance criteria exist for the design output[/]

There are defined design outputs (see Design Process flow chart) one of which is Test Procedure which is the acceptance test (criteria determined earlier in design process).

[]Are those design characteristics that are crucial to the safe and proper functioning of the product identified For example, operating/storage/maintenance/disposal requirements.[/]

Yes - as appropriate. See the Design Review form - Employees Concerns, etc.

4.4.6 Design review

[]Is it defined how the design output shall be reviewed[/]

Design output is reviewed by the VP of Production as detailed in the systems manual.

[]Is the design output being reviewed and evaluated[/]

It is - By the VP of Production as appropriate to the design project.

[]Does the design output meet the input requirements[/]

They do. This is ensured by the VP of Production.

[]Does the review/verification of design output cover, for example:[/]

Checking clarity and completeness in regards to the requirements

Undertaking quality inspections/tests

Performing alternative calculations

Comparing the new design with similar designs?

It does as appropriate to the design project as determined by the VP of Production.

[]Are verifications done by assigned personnel and are they traceable[/]

Verification is by the VP of Production. They are documented (and traceable) as appropriate to the design project.

[]Are the single review results being documented[/]

Design review is seen as a continuous process. The VP of Production is constantly aware of all elements of the design process. The design process is not a complex process with consideration to the product and customer requirements.

[]Are the documents stored in accordance with the requirements[/]

Yes. They are stored (filed) appropriately with retention defined on the Controlled Documents Matrix.