A final-year student who needs help conducting an external audit using ISO 9001:2015

[Knifenat]

Well, the politeness is appreciated but Jen is a Ma’am.
I also admire your interest in this topic but it from what you’ve said it like trying to boil an ocean you can’t see. I do’t want to discourage you as I think this is a very important research topic, but it is probably beyond the scope of a student - even in their final year.

Compliance to the QMS is a difficult thing beyond finding a few things based on an audit that is a sample for which the organization usually tries to only sho you the positive stuff. Then correlating that to actual debt levels in manufacturing and the field is impossible as that is kept private by most companies. Sending out requests to various companies will probably yield few results as this is a lot of work on their part for no return. IF you were an intern with a cooperating organization you might be able to do this for that company.

Having done exactly this for 40+ years in industry to improve a company’s quality levels I can say that only control charts and paretos will help quantify the degree of defects. This isn’t a sophisticated statistical exercise.

Is there any way to narrow the scope of what you want to do?

Hello, thanks so much for the response, and I am sorry for using the wrong pronouns for the admin.
So I basically decided to consider the scope of my project this way and please, I would really appreciate your thoughts.
So I am going to be using gap analysis to determine non-conformalities among the ISO 9001:2015 clauses and then using a method (control charts and paretos as you mentioned) to determine the extent to which the non-conformalities have affected how the organization has been able to satisfy the customers and suggest solutions to that.

I would really appreciate your response about this scope I have decided to go with.

 

[Mike S.]

Auditors don't do statistical sampling. They don't have time. For a 100 person company they might have 3 days to audit dozens of shalls. Your scope looks to be way too broad if you intend to audit against the entire ISO 9001 standard..

 

[Ed Panek]

Are you suggesting trying to determine the exact cost of each nonconformity to the organization? Use caution. You are trying to play both auditor and auditee here. A nonconforming label (wrong font) could have a vastly different impact from (Wrong support email) but the QMS might handle them in a similar process.

 

[Jean_B]

There is no way for you to achieve any meaningful effect. The parties most suited for what you are looking for are certification bodies.

If you can get one that would be willing to anonymize the information, and provide you with the metadata surrounding their audits (Amount/grade of NC and time to resolve, perhaps area of NC derived from clause it was written against) and the relevant companies (FTE, amount of products under certification, amount of mfg sites, complexities in play that increase or decrease audit time), you might be able to come to some abstract (though not necessarily practicable) conclusion. It would result in the panel data format for which you can look up relevant statistical techniques.

However, the customer perspective is hard to flow into this, as it is not in the scope of the audit.

The other way around is to find a huge player in some field, and ask to work with them on the SCAR (Supplier Corrective Action Request) side, and see how long business lasts. You are then reviewing one big customer, and how they compare and treat multiple certified and uncertified customers. However, you'll have to code to ISO 9001 clauses yourself, as most SCAR's don't care for that aspect process-wise.

 

[Jen Kirley]

Have you already done your analysis of audit questions and held your interviews?

We discourage auditors from "grading" nonconformities, but I can tell you that registrars issue major NCs if they find one or more is true:
1) The nonconformity was found in multiple places in the organization, such as calibration not being done anywhere
2) The nonconformity was repeated from the last audit, signaling failure of the previous corrective action process
3) The nonconformity has a clear potential to adversely impact acceptability of product or service being delivered to the customer

The last would incur the greatest cost, which is measurable directly in many COPQ ways, and potentially affect market share by reducing customer confidence. Other QMS failures are measurable qualitatively but could be analyzed in terms of quantity of such failures. The organization, not the auditor is responsible for this analysis but they need to understand it and too often do not. I sense this is the theme of your project. Am I correct?

 

[Michael_M]

I totally get it I just want guidance on how to properly carry out the audit. Thanks I would really appreciate that sir.

Is there an ISO9001 company near you that you can 'audit'. Some companies might be willing to allow you to come in and do an 'audit' if they know that they are helping someone learn.

 

[Randy]

A useless and wasteful endeavor as you're putting it.

What's your field of study again?

If you'd take the time to research (learn to fish) you'd see a TAB that says "ATTACHMENT LIST" at the top, you can get copies of gap analysis and all other types of stuff there that you can use to your heart's content.

 

[qualitymanagerTT]

Well, the politeness is appreciated but Jen is a Ma’am.
I also admire your interest in this topic but it from what you’ve said it like trying to boil an ocean you can’t see. I do’t want to discourage you as I think this is a very important research topic, but it is probably beyond the scope of a student - even in their final year.

Compliance to the QMS is a difficult thing beyond finding a few things based on an audit that is a sample for which the organization usually tries to only sho you the positive stuff. Then correlating that to actual debt levels in manufacturing and the field is impossible as that is kept private by most companies. Sending out requests to various companies will probably yield few results as this is a lot of work on their part for no return. IF you were an intern with a cooperating organization you might be able to do this for that company.

Having done exactly this for 40+ years in industry to improve a company’s quality levels I can say that only control charts and paretos will help quantify the degree of defects. This isn’t a sophisticated statistical exercise.

Is there any way to narrow the scope of what you want to do?

I agree with the above post, and my experience is that you need a project supervisor who is a subject-matter expert to guide you.

It sounds like you don't know enough about the subject (ISO 9001) to develop a proper scope, and this is where a project supervisor (usually an industry expert, with academic experience, or vice versa) can set you on the right path.

 

[Knifenat]

There is no way for you to achieve any meaningful effect. The parties most suited for what you are looking for are certification bodies.

If you can get one that would be willing to anonymize the information, and provide you with the metadata surrounding their audits (Amount/grade of NC and time to resolve, perhaps area of NC derived from clause it was written against) and the relevant companies (FTE, amount of products under certification, amount of mfg sites, complexities in play that increase or decrease audit time), you might be able to come to some abstract (though not necessarily practicable) conclusion. It would result in the panel data format for which you can look up relevant statistical techniques.

However, the customer perspective is hard to flow into this, as it is not in the scope of the audit.

The other way around is to find a huge player in some field, and ask to work with them on the SCAR (Supplier Corrective Action Request) side, and see how long business lasts. You are then reviewing one big customer, and how they compare and treat multiple certified and uncertified customers. However, you'll have to code to ISO 9001 clauses yourself, as most SCAR's don't care for that aspect process-wise.

I appreciate your response but honestly don't think I have the time, knowledge and resources to pull this through.
What better way do you think I can do it, even with the little knowledge I have?. The goal is to consider organizations with a QMS (not necessarily ISO 9001:2015, because I am sure very few of them have one over here) and utilize ISO 9001:2015 in a simple way, but I can still marvel at my supervisor. I honestly need help and wish I had found this forum earlier. Thanks and I await your response.

 

[Knifenat]

Have you already done your analysis of audit questions and held your interviews?

We discourage auditors from "grading" nonconformities, but I can tell you that registrars issue major NCs if they find one or more is true:
1) The nonconformity was found in multiple places in the organization, such as calibration not being done anywhere
2) The nonconformity was repeated from the last audit, signaling failure of the previous corrective action process
3) The nonconformity has a clear potential to adversely impact acceptability of product or service being delivered to the customer

The last would incur the greatest cost, which is measurable directly in many COPQ ways, and potentially affect market share by reducing customer confidence. Other QMS failures are measurable qualitatively but could be analyzed in terms of quantity of such failures. The organization, not the auditor is responsible for this analysis but they need to understand it and too often do not. I sense this is the theme of your project. Am I correct?

No I have not but I have the questionnaires for each clauses
The reason I have not done that is because I am yet to devise a methodology that I can use ISO 9001:2015 to solve as my supervisor asked of me.
Yes, its along that part, but I really don't know how to go about it. Also, my reality here is that most companies in my vicinity are not ISO 9001:2015 certified, but most will have a QMS that works for them.

In summary
1. I am totally new to ISO 9001:2015 because I just started reading about it in barely 6 weeks, and that's because my supervisor asked me to work on it (I could not reject it, and just a little glance earlier made me think it was simple).
2. I really need help working with ISO 9001:2015 to help a company solve a problem. It doesn't have to be complex, but it requires my effort to carry it out.
3. I am currently working on the methodology, and I have little idea of how to make use of the ISO standard.
4. And finally, as I said earlier, sir, most companies here are not ISO certified but would definitely have a QMS. So my plan is to help a company probably examine their quality problems using ISO 9001:2015, or if there is another way, I am open to everyone's opinion because I JUST NEED HELP UNDERSTANDING HOW I CAN DO IT.

I would really appreciate your response. Thanks sir.