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Changes vs CMO - How can we simplify this process?

Romane

Starting to get Involved
#1
We are virtual manufacture, legal manufacturer. Design, manufacturing, distribution, etc. are externalized. We only have 1 product but with many parts.
1) we currently initiate 1 ECO for every change notice (for DWG, WI, LHR, test protocols, etc.) the CMO sends us. Mainly to assess the risk and if we need to advise the NB. There are a lot of notices. How can we simplify this process? Are you using a scale (critical, not critical)?
2) we currently have SOPs for production/ design/ process validation/ statistical analysis/ work environment/ infrastructure/ etc. even if we don't do those activities (they are externalized). Could we simply refer to our CMO procedures into either the Quality manual or a quality plan?
How do you manage those 2 items?
Thanks in advance,
Romane
 
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Romane

Starting to get Involved
#3
Good day John.
Thank you for asking. So use to use them that I probably think other people will read my mind!
In our Quality management System ECO stands for Engineering Change Order and CMO stands for Contract Manufacturing Organisation.
Thanks,
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#4
Sounds extremely labor intensive indeed @Romane .

There are a lot of notices. How can we simplify this process? Are you using a scale (critical, not critical)?
Difficult for "us" to answer this for you @Romane. Yes, delineating between levels of criticality is one possible method. Be careful, however, to ensure that any delineated categories are objectively defined so there is no confusion as to what change control category applies.

we currently have SOPs for production/ design/ process validation/ statistical analysis/ work environment/ infrastructure/ etc. even if we don't do those activities (they are externalized)
I infer you are questioning why your organization maintains documentation for work your organization does not do. Yes, I agree...I also wonder why your organization would keep try to maintain such documents and do not recommend it.

Could we simply refer to our CMO procedures into either the Quality manual or a quality plan?
I would not recommend it. Not sure if your organizations follows the guidelines of an specific management system, but you could simply consider what is stated in clause 8.4 of ISO 9001:2015. It describes controls to consider/apply for ensuring there is a framework for your external provider (supplier, CMO, etc....) to work within so your organization can maintain a level of control over their separate autonomous methods. You certainly don't need to use ISO 9001. Your organization can simply establish the rules of engagement with your supplier/CMO. Obviously this will need to include your sales team and the CMO to ensure that any required pricing or contractual agreements are considered.

Hope this helps.
Be well.
 
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