Who does the Analysis of Nonconformances and other Data Analysis?

[Hodgepodge]

In Reply to Parent Post by ced001

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.

[JAltmann]

At my organization i preform such a high level analysis for my department. I get involved sometimes with continuous improvement and CA/PA in the manufacture, not often enough but that is a decision that comes from above myself.

My title is Quality Engineer. The other QE's here do not do the same as i do, for their respective departments, that is their choice. This type of analysis should be able to be preformed by sr QE's, QM's, BB's, MBB's, IE's or the company statistian IMO.

[ced001]

In Reply to Parent Post by JAltmann

This type of analysis should be able to be preformed by sr QE's, QM's, BB's, MBB's, IE's or the company statistian IMO.

Just to make sure I'm interpreting this right:
QE - Quality Engineer (with appropriate skill set)
QM - Quality Manager
BB - Black Belt (Six-Sigma process improvement)
MBB - Master Black Belt
IE - Industrial Engineer (ops research, manuf eng, systems eng...)

I think the "company statistician" and "process owner" roles described by others is consistent with the BB/MBB role here.

Thanks.

[JAltmann]

In Reply to Parent Post by ced001

Just to make sure I'm interpreting this right:
QE - Quality Engineer (with appropriate skill set)
QM - Quality Manager
BB - Black Belt (Six-Sigma process improvement)
MBB - Master Black Belt
IE - Industrial Engineer (ops research, manuf eng, systems eng...)

Correct, sorry i should have spelled those out.

In Reply to Parent Post by ced001

I think the "company statistician" and "process owner" roles described by others is consistent with the BB/MBB role here.

Thanks.

I disagree here slightly, process owner could be a line supervisor or manager who has no statistics training. And unfortunely i run into many who have the title and possibly cert as a BB/MBB who do not understand statistic's very well or beyond the use of software and it's outputs.

Please if your a BB/MBB i am not trying to offend, this is my opinion of dealing with those holding that title.

I define a company statistian as someone who holds a dgree in statistics from an accreditted university and who primarily works in statistics based projects.

[sathishthantri]

In Reply to Parent Post by 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.

What exactly is the "analysis of NC" and "other data analysis" ?
If there is a gap between the needs and the performance, you carry out NC analysis. For this, most of the times you do not look at statistics - except when either someone has to show off his "competence" in statistics (being a QE / QM / GB / BB / MBB ....) or when some trends (or huge data) are available. Most of the NCs can be solved, if we can track the process performed and know the intended process. And I am not talking about a solution leading to real CORRECTIVE ACTION.
Statistics just lead us to the pathway for actions. And, Statistics is also the easiest tool to manipulate results to one's conveneience.
7 basic tools of QC (which are not at all hardcore statistics) and 5 WHY analysis. are more than sufficient and anyone having some interest in them (THAT's THE REAL PROBLEM !!) can do the job of analysis in most cases.

Coming to "other data analysis", I really don;t know what you mean - I presume it is also on series of measurements done on some PPMs. If so, this also requires some sound rudimentary acumen and hands on works on numbers. Smart functional managers are there in many companies who analyse data within minutes (laughing on their own at the efforts put in the "statistical analysis"}.
I am not demeaning statistics or experts in statistics. They are good in their own way. But please do not look at a supporting activity as the main activity,

There is nothing special about "process owners". If you have an issue with your sales, your sales manager is the process owner If you have a designing problem, the design manager is the process owner. Process owners are those who are responsible and / or accountable for the process outputs.

QC manager will be responsible and / or accountable for mitigating or eliminating problems (but mainly in operations) and hence should be a part (in full or partially) of the analysis

[ced001]

In Reply to Parent Post by sathishthantri

...or when some trends (or huge data) are available.

These are the cases I'm referring to.

Most of the NCs can be solved,...

Agreed. I'm not talking about solving NCs. I'm talking about analysis of the collection of NC data that describes the nature and frequencies of NCs that had to be solved for a given product, sub-assembly or whatever.

[somashekar]

In Reply to Parent Post by ced001

These are the cases I'm referring to.

Agreed. I'm not talking about solving NCs. I'm talking about analysis of the collection of NC data that describes the nature and frequencies of NCs that had to be solved for a given product, sub-assembly or whatever.

Microsoft Excel has the tools and someone who knows .xls well enough can do that