Role of Quality Function in Approving Work Instructions

[Notnimdab2009]

Hello To All ,

currently our company is creating work intructions and the approver is only the manufacturing function. The author is also from manufacturing. Does the quality function needs also to approve the document? What are the areas or the role of the quality in approving the work instruction?

Appreciate your inputs.

Thanks,
Nea

[somashekar]

In Reply to Parent Post by Notnimdab2009

Hello To All ,

currently our company is creating work intructions and the approver is only the manufacturing function. The author is also from manufacturing. Does the quality function needs also to approve the document? What are the areas or the role of the quality in approving the work instruction?

Appreciate your inputs.

Thanks,
Nea

We had a system where in the WI consisted of PI (Process instructions) and QI (Quality instructions) and work stages were set accordingly. A Doc review team consisting of Manufacturing and Quality functions engineers would review this and recommend for the approval which was by the Head manufacturing.
This worked well for us.

[qusys]

In Reply to Parent Post by Notnimdab2009

Hello To All ,

currently our company is creating work intructions and the approver is only the manufacturing function. The author is also from manufacturing. Does the quality function needs also to approve the document? What are the areas or the role of the quality in approving the work instruction?

Appreciate your inputs.

Thanks,
Nea

You should establis roles and responsibilities for this item and include in your documented procedure for document control. This is up to your organization . My personal advice is to proceed taking into account the risk associated to the approval and the impact on customer and product quality.
Besides, establish the workflow of the approval and distribution also taking into account the complexity and the dimensions of your organization. From a general standpoint, Quality could be notified but as to work instruction I personnaly see that the process owner should approve, depending on the nature of the instruction.
Try to work in team and multidisciplinary approach to establish responsibilities.

[kgott]

In my view, the process owner is repsonsible for achieving the process results and should therefore be the only person who approves documentation because its the documention that helps in reducing variation in the process, achieves the proces outcomes and the records that prove the process requirements were achieved.

[Notnimdab2009]

Thank you all for your inputs. Appreciate them very much. Will have a meeting with with manufacturing and quality to discuss this point.

Regards,
Nea