Seeking: Process Change Control Sample Procedure / Help

[qsmso]

Process Change Control

Dear all Cove members,
In order to handle manufacturing process change such as material change, inpection method change, some Identification code change, process parameter change, do you have some idea for how to handle this systematically.
We do have Engineering Change Procedure. But I don't think it really apply to process change.
I need some sample procedure or suggestion.

Thank you very much

QSMSO

 

[Teri - 2011]

We use an engineering change notice,,,, for us, it applies to process change also. All dept. managers must sign this notice, that they were made aware of it. Then each has a "cheat" sheet, to remind them of all the documents that they need to look at to see if they need updated due to the change.

 

[Geoff Cotton]

Do the process changes impact on any automotive customers. If yes you need to consider Customer Specific Requirements relating to SREA.

 

[ralphsulser]

Dear all Cove members,
In order to handle manufacturing process change such as material change, inpection method change, some Identification code change, process parameter change, do you have some idea for how to handle this systematically.
We do have Engineering Change Procedure. But I don't think it really apply to process change.
I need some sample procedure or suggestion.

Thank you very much

QSMSO

I will attach a sheet we use to request and track related changes. Hope this helps.

 

[Greg B]

QSMSO

I have attached part of our Procedure for Change. It is called a 'Continuous Improvement Suggestion' and we use it for all chnage be it Quality, Safety, Environment etc. People make a suggestion and justify it, it must be evaulated and agreed upon and signed off etc before being implemented. I have also attached the form. It is very basic yet the operators use it constantly. I have an average of 10 x CISs submitted each month ranging from submissions for new chairs in the lunch rooms (cost us a few thousand dollars) to purchasing electricity from the national grid in 30 minute intervals rather than fixed price contracts (Saved us $100's of thousands of dollars). Each suggestion is given the same treatment and each originator gets feedback. The majority of the CISs submitted deal with change to documentation and processes. After crews review documents and procedures they submit them via a CIS with a marked up copy of the change required attached. Simple.

https://elsmar.com/elsmarqualityforum/attachment.php?attachmentid=1843

https://elsmar.com/elsmarqualityforum/posts/68282/

Hope you get some use or ideas.

Greg B

 

[qsmso]

Change Criteria

Thank you for all reply.
As the quality control, I would like to set the rules for manufacturing about process change criteria.
Can you please recommend what items that when change, Mfg. need to inform QC to verify or approve.
Right now, Mfg just indicate their process change in term of revise WI and get approval from QMR only. We set this rule and we follow, but I feel like not quite suitable. So, I am willing to change, but need some good advice.

Thank you.
QSMSO

 

[Sam]

Thank you for all reply.
As the quality control, I would like to set the rules for manufacturing about process change criteria.
Can you please recommend what items that when change, Mfg. need to inform QC to verify or approve.
Right now, Mfg just indicate their process change in term of revise WI and get approval from QMR only. We set this rule and we follow, but I feel like not quite suitable. So, I am willing to change, but need some good advice.

Thank you.
QSMSO

Refer to 7.1.4 Change control; . . . ."the effects of any change , . . . . "
Also refer to 7.3.1.1 Multidisciplinary approach; . . " shall use MA to prepare for product realizaton . . "

Any and all changes require evidence of assessment, verification and validation.
This assessment is a team effort, not a one department effort.