Who does the Analysis of Nonconformances and other Data Analysis?

[ced001]

I would suggest that QA and operations people who identify non-conformances typically don't have the skills to analyze the data collected (e.g. trend analysis). I would also suggest that members of review boards that look at non-conformance information either don't have the time or the skills to analyze it either. So somewhere between the gatherers and the deciders there needs to be an analyst role in my view.

My question is: In your organization, before a CA/PA exists, who is responsible for rolling up their sleeves and doing analysis of QC/NCMR data, preparing (often complex) presentations and making CA/PA recommendations? What skill sets are involved?

Is it a QC manager, QA, manufacturing engineering, R&D - a committee of them all?

Regards,

ced001

 

[Hodgepodge]

I would suggest that QA and operations people who identify non-conformances typically don't have the skills to analyze the data collected (e.g. trend analysis). I would also suggest that members of review boards that look at non-conformance information either don't have the time or the skills to analyze it either. So somewhere between the gatherers and the deciders there needs to be an analyst role in my view.

I don't agree with your suggestions. In my limited experience, the process owners are usually best equipped to understand causes of non-conformance.

 

[sjared]

I don't agree with your suggestions. In my limited experience, the process owners are usually best equipped to understand causes of non-conformance.

I would add that it might depend upon the size, volume, and complexity of the product. If you are dealing with multiple shifts and multiple lines and a long supply chain it might take an analyst to sort through and compile all the data. I agree with Hodgepodge that the process owners will have valuable insights and they should be consulted first.

 

[QAMTY]

In my organization is involved the process owner (who caused the NC)
this person must have enough skills to analyze the problem, suggesting the remedial action and doing the CA (preparing the plan, including participants, providing a schedule, a timeframe) implementing it and closing it when is successful.
The process owner, when is needed asks for help for what is needed, maybe looks an electrical Engineer, a civil, maybe a supplier, so that they together can take the right decision.

For the side of Quality, we have a coordinator, who logs the nc´s received, keeping track of them, assigning an ID for every NC for traceability, supporting the Process owners in the methodology about how a PA/CA should be achieved.
Also having a control list of the NC´s status, and reporting it to Director.

Sometimes Quality Coordinator supports owners when a statistical analysis is needed.

Hope tis helps

 

[ced001]

I don't agree with your suggestions. In my limited experience, the process owners are usually best equipped to understand causes of non-conformance.

We need to clarify. I did not mention the process owners. My suggestion didn't pertain to them. The data gatherers I'm referring to are QC folks and manufacturing folks who follow protocols and report results as per a script they are trained to.

The reviewers are department heads and managers who oversee such processes.

Perhaps what you are calling the process owners are the answer to my question. Who are the process owners from your experience?

Please elaborate on how you see the process owners fitting between data gathering (i.e. follow protocols and report results) and reviewing (e.g. looking at summary/trend data provided by ???).

 

[sathishthantri]

Depends on organisation / structure / availability of knowledge / veracity of the 'data' being analysed.
Ideally the process owners (those who are in charge of the process being anlaysed) should analyse if they are technically competent on KNOW WHYs, whereas generally they will DOERS, good in KNOW HOWs. The data of course will be generally provided by the process owners themselves.
A small team comprising of process owners + technical experts (usually designers of the product / process + quality personnel would help in analysing critical problems / issues as this leads to better acceptability of the decision, lesser pre-judged bias and inputs from more / differing brains.

 

[Steve Prevette]

My own role is that of the company statistician, supporting such reviews. I actually reside in the safety department, thought there is some talk of transferring me to QA. Regardless, I work in conjunction with the quality department, even participated in an audit of trend reports. I am currently working on rewriting the performance analysis procedure, to include interfaces with CAPA.

Generally speaking, we have a set of routine charts that are updated monthly from the CAPA data, and event /injury data. As a group (functional owner or facility owner) sees the need to, I can dive into the data to lower levels.

The key is to have (or have access to) a degreed statistician / industrial engineer / operations researcher. You can also look for the ASQ CQE certification.

 

[somashekar]

We need to clarify. I did not mention the process owners. My suggestion didn't pertain to them. The data gatherers I'm referring to are QC folks and manufacturing folks who follow protocols and report results as per a script they are trained to.

The reviewers are department heads and managers who oversee such processes.

Perhaps what you are calling the process owners are the answer to my question. Who are the process owners from your experience?

Please elaborate on how you see the process owners fitting between data gathering (i.e. follow protocols and report results) and reviewing (e.g. looking at summary/trend data provided by ???).

Analysis of Nonconformances from the raw data by suitable stratification and applying the statistical techniques and other reasoning techniques has to be a trained learning across the organization. A core team is always formed depending upon the type of non conformance that has to be handled, and when several personnel have been trained, the core team is sure to have the skilled people for NC data analysis. There can also be some statistical expert who can lend some help when things get stuck, but this depends upon the way an organization is structured.

 

[Hodgepodge]

We need to clarify. I did not mention the process owners. My suggestion didn't pertain to them. The data gatherers I'm referring to are QC folks and manufacturing folks who follow protocols and report results as per a script they are trained to.

The reviewers are department heads and managers who oversee such processes.

Perhaps what you are calling the process owners are the answer to my question. Who are the process owners from your experience?

Please elaborate on how you see the process owners fitting between data gathering (i.e. follow protocols and report results) and reviewing (e.g. looking at summary/trend data provided by ???).

There isn’t a one size fits all answer to who should be responsible for determining root cause, whether by a process owner or an engineer/statistician/quality type. Every process that contributed to the nonconformance should be involved. Start with those closest to the process, they usually know it best. The more a process owner understands what he/she is doing and how the output of the process relates to the input of the next process, the more likely they are to be able to determine the cause of a nonconformance. As sjared said earlier, “it might depend upon the size, volume, and complexity of the product.” I would also add that it can depend on the way the business is managed. In an environment of process owner responsibility and empowerment, the process owner is typically the one best equipped to understand the causes of nonconformance.​

There should be someone that is responsible for the CAPA process, to train others in the correct methodology, to coordinate collaboration with process owners, to review the CAPA output for suitability, and to follow up for effectivity. If the process owner(s) are having difficulty determining the root cause, statistical analysis may be required. If the statistician isn’t knowledgeable in the process(es) where the nonconformance occurred, then the statistician will be able to offer guidance on how to interpret the data, not in how to keep the nonconformance from recurring. Keep it as simple as you can. Start with the process that caused the nonconformance (or that discovered it) and audit the process with knowledgeable personnel (your local experts in their processes). Who does the paperwork is a business decision and relates to the individual business.

 

[ced001]

Thanks to all for the feedback its been very helpful.

Again I want to clarify since some seem to be speaking to CAPA handling. I'm not asking about how to process CAPAs. I'm asking about the skills sets and roles necessary for the organization to be able to recognize when there is a problem from data generated by operations (e.g. non-conformance reports, customer complaints).

I've seen at least two helpful examples of how others do this. The "process owner" role, which I do not believe we have codified in our OPs. The second being a statistician resource in operations available to support this kind of analysis as needed, we don't have one of these either to my knowledge.

It doesn't appear that the folks in this forum think that the job description of the "QC Manager" or some other role in operations should include the skills necessary to do this kind of analysis.

Thanks again.