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Validation procedure, Major NC CAP - Equipment Validation process is not effective

#1
Good Day Everyone!

First post here on the forum, I work as the Quality Manager of small ISO 13485:2016 certified facility that is a contract manufacturer for surgical instruments (non-sterile). We recently underwent our recertification audit and a Major NC was found and described as " Equipment Validation process is not effective because the organization does not document procedures for validation of process including:
a) defined criteria for review and approval of processes;
b) equipment qualification and qualification of personnel;
c) use of specific methods, procedures and acceptance criteria;
d) as appropriate, statistical techniques with rationale for sample sizes;
e) requirements for records;
f) revalidation, including criteria for revalidation;
g) approval of changes to the processes"

My reason for joining posting here, is to request help for how to proceed with my CAP. My current SOP specifies what processes we deem special internally, what specifics must be included in the report for special process validations, the other aspects of the validation program are captured in our MVP which is a controlled document. The MVP specifies re-validation frequencies, protocols, record keeping requirements, approval/change requirements for the document to be revised, and RPN scores for processes.

Could any one please provide some guidance on how to go about generating an acceptable Corrective action plan? This is my first audit to actually have a major NC. I know I will need to revise my procedure to encompass the above listed elements, but I am on a very short time table for the corrective action plan submission and want to be thorough to ensure its acceptance.

edit: I am in process on performing a 5 why root cause analysis now

Thank you all in advance for your help!
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
I don't understand what further guidance you need.
Fixing your PV SOP would be the correction. Make sure that your SOP covers all that's required of the MVP as well, even if you already have a template that contains all required elements.
As for the CA, it shouldn't be different from any other CA. Identify the root cause (seems like you already started working on that) and then define and implement the CA, verify implementation and verify effectiveness (=successful elimination of identified root causes). IMO the failure/problem you need to look for the root cause of is a failure to identify and address an applicable ISO 13485 requirement for a documented procedure.
 
#3
I don't understand what further guidance you need.
Fixing your PV SOP would be the correction. Make sure that your SOP covers all that's required of the MVP as well, even if you already have a template that contains all required elements.
As for the CA, it shouldn't be different from any other CA. Identify the root cause (seems like you already started working on that) and then define and implement the CA, verify implementation and verify effectiveness (=successful elimination of identified root causes). IMO the failure/problem you need to look for the root cause of is a failure to identify and address an applicable ISO 13485 requirement for a documented procedure.
Hi Ronen,
Thank you for the reply. Allow me to elaborate and clarify my request, after reviewing I can see why you say that. After performing my 5 why analysis, root cause can be attributed to my procedure not clearly specifying validation requirements for non-special processes. I am in process on revising my procedure to meet the requirements set fourth, but am struggling with sub section(s)
c) use of specific methods, procedures and acceptance criteria
d) as appropriate statistical techniques with rationale for sample sizes

Since this portion of the procedure I am writing will apply to all non-special processes how do I go about specifying specific methods to be used when the procedure will apply to different processes. Also what statistical techniques are they referencing in regard to the validation process?
I can verify the procedure meets all requirements except C and D, those are the two sub sections I am seeking guidance on how to adjust my procedure to meet.

Thanks
 
Last edited:

Al Rosen

Staff member
Super Moderator
#4
Hi Ronen,
Thank you for the reply. Allow me to elaborate and clarify my request, after reviewing I can see why you say that. After performing my 5 why analysis, root cause can be attributed to my procedure not clearly specifying validation requirements for non-special processes. I am in process on revising my procedure to meet the requirements set fourth, but am struggling with sub section(s)
c) use of specific methods, procedures and acceptance criteria
d) as appropriate statistical techniques with rationale for sample sizes

Since this portion of the procedure I am writing will apply to all non-special processes how do I go about specifying specific methods to be used when the procedure will apply to different processes. Also what statistical techniques are they referencing in regard to the validation process?
I can verify the procedure meets all requirements except C and D, those are the two sub sections I am seeking guidance on how to adjust my procedure to meet.

Thanks
Your procedure is a description of what you will do in general. You can state that a Validation plan will be developed (this is process or equipment specific) that will include:

  • Criteria for review and approval of the process
  • Approval of equipment and qualification of personnel
  • Approval and use of specific methods and procedures and instructions
  • Statistical techniques with rationale for sample size
  • Requirements for records
  • Requirements for revalidation
  • Approval of changes
 
#5
Your procedure is a description of what you will do in general. You can state that a Validation plan will be developed (this is process or equipment specific) that will include:

  • Criteria for review and approval of the process
  • Approval of equipment and qualification of personnel
  • Approval and use of specific methods and procedures and instructions
  • Statistical techniques with rationale for sample size
  • Requirements for records
  • Requirements for revalidation
  • Approval of changes
Hi Al,

Thank you very much for the clarification, that seems to be at better approach that will still allow the necessary flexibility to fit the validation to specific equipment and processes.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
@needinginfo, Thanks for elaborating.
You've asked some more specific questions that I can try to answer, but you've also got me a little more confused in general.
root cause can be attributed to my procedure not clearly specifying validation requirements for non-special processes.
To me that seems not like a root cause but like a more pin-pointed rephrasing of the NC.
I'm also not sure what you mean by "non-special processes". In the context of process validation (PV), "special processes" are those for which the output can't be (or just isn't, for whatever reason) 100% verified - in these cases a PV is required. Following this line, "non-special processes" don't require a PV.
c) use of specific methods, procedures and acceptance criteria
This means that your SOP needs to state in some reasonable detail (but still in a manner general enough to fit all/most of the relevant manufacturing processes) how you will go about validating, what are the steps etc. You also need to state the acceptance criteria in general terms such as stability, capability etc.
d) as appropriate statistical techniques with rationale for sample sizes
For an example of stating and rationalising statistical techniques / sample sizes without relying on input specifics, you can refer to my article about Design Verification. The details in there might not be relevant to PV, because it's a different beast from Design Verification, but the general yet prescriptive approach to statistical techniques might be of some help.
 
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