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5.4.2 b) Integrity of QMS in Change Management
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5.4.2 b) Integrity of QMS in Change Management
5.4.2 b) Integrity of QMS in Change Management
5.4.2 b) Integrity of QMS in Change Management
5.4.2 b) Integrity of QMS in Change Management
5.4.2 b) Integrity of QMS in Change Management
5.4.2 b) Integrity of QMS in Change Management
5.4.2 b) Integrity of QMS in Change Management
5.4.2 b) Integrity of QMS in Change Management
5.4.2 b) Integrity of QMS in Change Management
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5.4.2 b) Integrity of QMS in Change Management


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5.4.2 - top management shall ensure, audit observation, change(s) (general), integrity, qms (quality management system)
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  Post Number #1  
Old 21st September 2013, 06:37 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,251
Look! 5.4.2 b) Integrity of QMS in Change Management

At the completion of our survelliance assessment, we were made aware by our CB auditor to probe well and more into the IS09001:2008 5.4.2 b) when some changes in the QMS lacked depth in this aspect without rising it to a NC. We had discussions over this and thanked him for bringing up this point to our attention, when several examples of lack of integrity were explained out as examples by him, which were in a way eye opener to even a well set QMS.
Basics again, the process approach and the PDCA, about which we do discuss a lot but fail in its practice (Plan and Implement)
A great OFI and true value addition from an audit process.
Comments and examples of lacking integrity in QMS changes... can people share thoughts and case studies ~~~
Thank You to somashekar for your informative Post and/or Attachment!

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  Post Number #2  
Old 21st September 2013, 10:01 AM
treesei

 
 
Total Posts: 262
Re: 5.4.2 b) Integrity of QMS in Change Management

Could you kindly share one example first?
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  Post Number #3  
Old 21st September 2013, 10:20 AM
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somashekar

 
 
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Re: 5.4.2 b) Integrity of QMS in Change Management

Quote:
In Reply to Parent Post by treesei View Post

Could you kindly share one example first?
... ok
When a production capacity was to be increased, the need for a machine and its fixtures was discussed in the management review and outputs as approval was sought. When the budget was worked out, not much was looked into the design information of the fixtures, and methods to make them as the previous fixtures were old and customer supplied in the first place. The costs estimated and the progress further delayed the installation and validation as the fixtures needed a lot of reverse engineering and expert technical help in order to replicate exactly.
This plan and execution could have been done better.
  Post Number #4  
Old 21st September 2013, 11:50 AM
treesei

 
 
Total Posts: 262
Re: 5.4.2 b) Integrity of QMS in Change Management

Thank you for sharing . That was indeed a deep approach for a QMS audit and made us aware of all the details one must consider and plan out to implement a change.

One of the things this example made me think is: Where is the fine dividing line for QMS and business operations? It seems to me that once the decision of machine/fixture update was made, the details of planning and implementation will be led by the business side: A project manager who coordinates various functional groups to get things done effectively. Of course quality is one of the important functions but does the QMS need to specify/drive all the activities?

One example from me (hope it is on the subject): A product changes spec from Rev A to Rev B which involves the spec change of a purchased and custom-made component. Rev B is approved on Day 1 and becomes effective on the SAME day w/o thinking about inventory (both product and the component), shop orders in process, standing PO, goods in transition, communication with customer and supplier, documentation, etc.
  Post Number #5  
Old 21st September 2013, 12:08 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,251
Re: 5.4.2 b) Integrity of QMS in Change Management

Quote:
In Reply to Parent Post by treesei View Post

Thank you for sharing . That was indeed a deep approach for a QMS audit and made us aware of all the details one must consider and plan out to implement a change.

One of the things this example made me think is: Where is the fine dividing line for QMS and business operations? It seems to me that once the decision of machine/fixture update was made, the details of planning and implementation will be led by the business side: A project manager who coordinates various functional groups to get things done effectively. Of course quality is one of the important functions but does the QMS need to specify/drive all the activities?

One example from me (hope it is on the subject): A product changes spec from Rev A to Rev B which involves the spec change of a purchased and custom-made component. Rev B is approved on Day 1 and becomes effective on the SAME day w/o thinking about inventory (both product and the component), shop orders in process, standing PO, goods in transition, communication with customer and supplier, documentation, etc.
Some revisions need to be made with such immediate effect based on criticality and all losses absorbed. Is it such a revision ... or lacking of integrity in revision effective time, putting the QMS into disruption ? Missing integrity if so.
  Post Number #6  
Old 21st September 2013, 02:20 PM
treesei

 
 
Total Posts: 262
Re: 5.4.2 b) Integrity of QMS in Change Management

It was not such an urgent revision. In fact 1 year later since rev B, incoming inspection still rejects old revision component and the supplier keeps arguing that it was agreed to exhaust existing old-rev inventory. Lacking of integrity indeed.
  Post Number #7  
Old 21st September 2013, 08:20 PM
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Ajit Basrur

 
 
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Re: 5.4.2 b) Integrity of QMS in Change Management

I feel the Change Control mechanisms could address this requirement.
  Post Number #8  
Old 22nd September 2013, 12:57 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,251
Re: 5.4.2 b) Integrity of QMS in Change Management

Quote:
In Reply to Parent Post by Ajit Basrur View Post

I feel the Change Control mechanisms could address this requirement.
A change control mechanism must consider any one of the following implementation scheme
1. Change with immediate effect. All previous revisions are NC and scrap.
2. Change with immediate effect. All previous revisions are re-workable.
3. Change with effect from a future date. All previous revisions are like 1 or 2 above on said future date.
4. Change with effect from end of pipe line inventory. No new orders to be placed on previous revision with release of this change.
Thanks to somashekar for your informative Post and/or Attachment!
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