Best Root Cause for Nonconformance

[Quality_Goblin]

Hi All,

I am having difficulty finding the most appropriate root cause analysis and 5 Why's for this minor NC from our audit.

The statement was that our Training process is partially ineffective. And the evidence was that the Training SOP referenced a document that wasn't released into the QMS yet. The auditor sited ISO 13485:2016, clause 6.2: The organization shall document the process(es) for establishing competence, providing needed training, and ensuring awareness of personnel as the standard requirement for the finding.

It was observed that the Training SOP references DOC-X which is intended to establish guidelines for the hiring and utilization of temporary workers. However, it was communicated that this policy has not been officially approved or released into the Quality Management System (QMS). Consequently, the organization currently employs six temporary employees whose training does not align with established practices beyond what is specified in the unreleased documents.

Now here's my dilemma. Is this a training issue or is this a doc control issue? Is it both?

The Training SOP was approved and released the same day that DOC-X was also submitted for approval. There was a step on the change request form which requires ensuring all referenced documents are cross verified in the doc log to their current doc titles and effective dates. This was checked off as completed. But obviously it failed based on the assumption that DOC-X was going to be approved at the same time.

Other than that, DOC-X references a procedure that we do that until its creation, was an informal practice - hence the creation of DOC-X.

I feel like this is more of a Doc Control issue, but because the auditor references a different section of the standard, I am also led to believe it's also a training policy issue.

Any advice would be great!!

 

[d_addams]

the auditor has it right, your procedures failed to establish appropriate controls because the document you 'intend' to use isn't released therefore it doesn't exist. In this case you say thank you, release Doc-X and close the non-conformance/finding.

You'll need to assess the risks associated with any work product these people completed while 'untrained'. But since it sounds like they unofficially went through the process that was eventually released that assessment would presumably not find anything out of sorts.

 

[Quality_Goblin]

the auditor has it right, your procedures failed to establish appropriate controls because the document you 'intend' to use isn't released therefore it doesn't exist. In this case you say thank you, release Doc-X and close the non-conformance/finding.

Thanks, that confirms that this is a doc control issue.

 

[d_addams]

Thanks, that confirms that this is a doc control issue.

Its not clear what you mean by that, its a failure to establish appropriate procedures around training requirements. Why is that a doc control issue?

 

[Bev D]

The referenced document was mentioned in one SOP but not yet released. This is NOT a training issue it is a document control problem in that documents that mention that other documents must be simultaneously released. It may be a ‘training problem’ in that some people may not have been trained to the unreleased document and the training process didn’t detect the missing procedure…

 

[Golfman25]

Ok, my take is start with the real issue. You have 6 "temporary" employees. Where they trained and are they competent? If so, what is their training/competence based on? How does what they were trained/competent on compare with Doc-X? In other words, was Doc-X just a formalization of what they were trained on? Or is there another document they where trained on? Once you establish that your temps are adequately trained and competent, then it becomes more of a document control issue.

Now your issue is in the real world documents are rarely issued at the same time, especially if approved by different people. It would be nice, but things get in the way. Has Doc-X been issued? Why was it delayed? Was it "hidden" because someone checked off that it had been taken care of?

 

[Jen Kirley]

Please excuse me while I adjust my face. Okay it seems trivial but the outcomes could be severe depending what was being done as per unapproved documents.

It is a document control issue. The question of training is a dysfunction in the training process as a result of the nonconformity. In addition to @Golfman25's questions, I am wondering how people were able to access the unapproved documents? There needs to be a way to keep unfinished documents like these "locked away" from unauthorized users. If that isn't possible, are they clearly marked as Draft and if not, can they be?

 

[Bev D]

So let’s take an even bigger step back. The phrase “finding the most appropriate root cause” has stuck in my head for awhile now. There is so much we don’t know yet about this NC. I think the real focus here might be on what the appropriate problem statement is and not what the root cause is. This a muddled problem statement/scapegoat cause situation - at least as far as the posting goes.

We start with the actual finding - what situation was called out and what object evidence existed? Forget the standard that the auditor cited… Not some sparse NC statement like “ineffective training”. Then we move understand the sequence of actual events that occurred, then - and only then - we can determine the actionable causes. The idea that only one single thing caused a problem is mythology. Then we can determine effective solutions.

I would have several paths to explore (questions) at this point. Were the operators trained on the unreleased document? If not why not? Was the missing document not noticed by the trainer? If it wasn’t noticed how did this happen? If the trainer did notice the missing document and train to it, how did they do this? Did the trainer obtain a copy of the missing document? Did the unreleased document contradict an established process? Or did it merely supplement or add to it?
Why was the released document released without the referenced document released? Just a few initial question paths for a real 5-why.

In my past organization we had many controls in place to ensure that linked documents were either issued a the same time or if one was rejected for non-substantial reasons that did not affect the work to be done we would at least issue a temporary change notice to cover the actual work to be done. If the reason for rejection was substantial the two procedures would be held until the changes were made. We had a ‘committee’ of approvers who met together to review and approve - or reject - all changes. (And it did save time as everyone was together and there was no serial gauntlet of ‘telephone game’ approvers. It also reduced failed changes that created other problems that the originators did not anticipate. Teh group met twice a week and could be convened within hours for an emergency). Training plans were also reviewed and approved during this process as ‘read and understand’ is a very ineffective training for substantial changes. We often provided training prior to the official release of documents - especially for substantial salaried personnel work changes…just an example of how these two problems can be intertwined and effectively controlled.