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Product Lifecycle Procedure Guidance

ukrainka85

Starting to get Involved
#1
Does anyone have suggestions on how best to structure a Product Lifecycle (PLC) policy vs SOP vs SWI? My organization provides medical and non-medical products and services in support of clinical trials. We currently have a PLC SOP which is very dense and at times overly descriptive/prescriptive. There are blurred lines between what is required for a 100% new product introduction vs. product updates.

We are trying to trim down the current procedure, but not sure how to structure it. One option is to structure around the process from investigation to retirement. Another option is to structure around requirements and how requirements are refined from high-level down to detailed level and how the Product Manager (PDM) is involved in this process. My instinct says that we need to account for both, the process end-to-end view, requirements and role of PDM vs teams.

I am curious if anyone has examples of well-defined and well-received Product Lifecycle policies or SOPs? Or if you have suggestions of other forums or resources where I can seek this information.

Thanks in advance for input.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Are you trying to comply with specific published quality management standards or regulatory schemes?
 

ukrainka85

Starting to get Involved
#3
Hi Ronen,

Mainly ISO 9001; we also have sites that manufacture under ISO 13485. But the PLC process should cover the whole organization
 

Ronen E

Problem Solver
Staff member
Moderator
#4
In the context of 13485 (and to a lesser extent 9001, which I don't have a lot of experience with), I don't normally come across a single SOP / process that covers the whole lifecycle. More often it's broken up to D&D (the front end) and other product realisation processes, such as Complaints, Postmarket Surveillance etc. I did see some orgs formally extending their D&D SOP well into production etc., but it always looked awkward/impractical to me, and I highly suspect that that back-end of the D&D process (i.e. everything after device launch, except maybe Design Change) wasn't actually being driven by that SOP anyway. In other words, it stayed mostly on paper.

Please feel free to PM me if you'd like me to have a look at your existing SOP and provide feedback.
 

ukrainka85

Starting to get Involved
#5
At this point, I am interested in seeing how others structure their PLC documents: policies and SOPs. We have a separate D&D process, but looking at the product lifecycle from idea to launch and ultimately retirement. I am looking at some examples of how other companies structure these things.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
At this point, I am interested in seeing how others structure their PLC documents: policies and SOPs. We have a separate D&D process, but looking at the product lifecycle from idea to launch and ultimately retirement. I am looking at some examples of how other companies structure these things.
I'm not sure I understand you. Is your D&D process seen as a subset of the PLC process? Or do you see it as external to it? I'm a little confused as to how you perceive the scope of the PLC process.
I understand now that you are interested in examples or views from several other organisations - let's hope that others will chip in quickly! I'm bound by confidentiality and can't help with SOP examples.
 

yodon

Staff member
Super Moderator
#7
Kind of in the same boat as @Ronen E in that I'm not fully understanding the question.

From a high-level perspective, it seems pretty common that the Quality Manual (which I realize isn't *required* under 9001) provides a general overview of the lifecycle, calling out the fact that you have D&D procedures, postmarket procedures, etc. Then the SOPs define what you do for those processes and any WIs supplement with how you do things.

From an individual product perspective, you may need to provide specific details about aspects such as maintenance (and possibly retirement) in a maintenance plan or some such document.
 
#8
I hope I'm adding to the discussion here, as I'm not fully understanding the question as well.

I can't provide a direct example, but I can say that our D&D activities are covered by a high-level engineering management procedure that links out to other procedures. So, it covers everything from conception to obsolescence. We have all our deliverables for the project (customer requirements, V&V activities, etc.), the requirements of each role in the organization that will be involved, as well as "maintenance" phases, which link out to clinical evaluation, a product lifecycle risk procedure, and post market surveillance procedures. It's stated in the SOP that these maintenance phases apply to existing product, and not just new products.
 
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