Let me start by stating we are a manufacturing facility. While interviewing during our last internal audit, it was brought to our attention that during the last stages of assembly, a metal guard was supposed to be there ready to paint with the rest of the parts. It was also noted, the same guard (which we manufacture) is always assembled at shipping and does not always fit thus causing the product not to ship that day or causes havoc to find another one. So we have two issues; 1) The guard is not always manufactured correctly. 2) The guard is not on time causing the paint shop extra time and work. The audit team wrote this as an audit observation not a finding. The vice president of the company was very upset and wrote a note stating that we were not supposed to be looking at the processes just the ISO procedures. I just want to add, we just passed our third party audit and after the closing meeting, he told the top management his auditors were doing a great job. I need feedback!! What to do now?

Let me start by stating we are a manufacturing facility. While interviewing during our last internal audit, it was brought to our attention that during the last stages of assembly, a metal guard was supposed to be there ready to paint with the rest of the parts. It was also noted, the same guard (which we manufacture) is always assembled at shipping and does not always fit thus causing the product not to ship that day or causes havoc to find another one. So we have two issues; 1) The guard is not always manufactured correctly. 2) The guard is not on time causing the paint shop extra time and work. The audit team wrote this as an audit observation not a finding. The vice president of the company was very upset and wrote a note stating that we were not supposed to be looking at the processes just the ISO procedures. I just want to add, we just passed our third party audit and after the closing meeting, he told the top management his auditors were doing a great job. I need feedback!! What to do now?I think it is outside the scope of your audit, but certainly requires corrective action.

You might be better doing a corrective action on the problems you describe rather than to try to enforce rules using audits as a tactic. It is my opinion you cannot 'audit in' conformance. If people aren't doing their jobs, why is it? If there are quality issues causing timing problems, why is that happening? An investigation and derivation of Root Cause will do more good than trying to use audits to 'get people to do what they're suposed to be doing' which is what it seems to me is your goal. Of course, as I say - This is my opinion.

As food for thought see this discussion thread: Layered Process Audits - Getting Results? Show me the data! (http://elsmar.com/Forums/showthread.php?t=20189)

The thread I have linked to is somewhat specific to layered process audits, but the same principle applies. Note that a 'Layered' audit is one in which different layers of management do a process audit.

An interesting situation all around. Firstly, you've got a clear management issue of him not understanding the purpose of audits, which is very usual, IMHO. Did you involve the management in planning the audit? Is this something that there's a clear cost associated with? That manager may not understand but someone there does, like the finance person........

Secondly, how did you come across this issue? Was it volunteered? Does it say anything about this in the procedures that you were (supposed to be) auditing? It seems strange to me also, that if this is a common problem, why no-one has raised it as an issue for a corrective action. Which leads me to another thought, does the non-conforming guard ever appear on the top 10 items being rejected?

There's a pony in there somewhere..............you need to find it and report it in terms of $$$$$

Andy

I think it is outside the scope of your audit, but certainly requires corrective action.

Al, why so - "out of scope"?? This isn't a 3rd party audit now, y'know..........:rolleyes:
During an internal audit, everything's 'in scope', if it gets things fixed..........and the original audit can be completed too.
Andy

What do you do now? Is that the question?

Here you go. Do what you have been asked by who ever it has requested or authorized the audits to happen in the 1st place. The proper term for the authorizor/requestor is "Client". The audit is their property not the auditors. Continue to document in your notes or whatever what you find, but give him/them what they ask for.

Oh, a word of explanation, a "finding" in neither positive or negative, it is just the result of evidence weighed against criteria. You guys did develop a finding, it was the observation you reported.

To answer a couple of questions and clarify some things...the auditors originally came across the guard issue from an interview with a shipping employee. The audit team was not trying to enforce rules, two departments (shipping and painting) both brought this issue up. The audit team thought if this was brought to the attention of the "VP" (he is responsible for production and is the coach of this area) he may or may not feel this was a severe enough issue to pursue, as in root cause etc.... As far as the top ten items being rejected..I know this would not fall into that catagory. Each product we make is almost a custom product. In other words we probably have 200 styles and sizes of this guard. As far as Management being involved...the Quality Manager was directly involved and encouraged the team to act on this. This being said, the QM and VP does not see eye to eye. Randy, the question is; 1) What to do now? 2) Was the team out of line? 3) With this happening, there is a breakdown in the process somewhere, right? 4) What to do about him not wanting us to perform any process audits?

Randy, the question is; 1) What to do now? 2) Was the team out of line? 3) With this happening, there is a breakdown in the process somewhere, right? 4) What to do about him not wanting us to perform any process audits?


1..Do what is required and asked of you according to the way requested.

2...To answer #2 requires a question. What was the objective of the audit? Every audit has to have an objective or purpose. We don't audit for the sake of auditing. What were you trying to find out? If there was no predefined objective then you have initiated an audit to serve no purpose.

3..You are correct, there is a breakdown and it seems to start with your management by what you have stated.

4...Is he the boss or does he serve someone else? Is he the client or is someone else the client? Auditing whether internal, like yours, or external, like the ones I perform should be guided by 5 basic principles from ISO 19011:

a) Ethical conduct: the foundation of professionalism
Trust, integrity, confidentiality and discretion are essential to auditing.

b) Fair presentation: the obligation to report truthfully and accurately
Audit findings, audit conclusions and audit reports reflect truthfully and accurately the audit activities.

c) Due professional care: the application of diligence and judgement in auditing
Auditors exercise care in accordance with the importance of the task they perform and the confidence placed in them by audit clients and other interested parties. Having the necessary competence is an important factor.

d) Independence: the basis for the impartiality of the audit and objectivity of the audit conclusions
Auditors are independent of the activity being audited and are free from bias and conflict of interest. Auditors maintain an objective state of mind throughout the audit process to ensure that the audit findings and conclusions will be based only on the audit evidence.

e) Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process
Audit evidence is verifiable. It is based on samples of the information available, since an audit is conducted during a finite period of time and with finite resources.

Did you apply these principles? Did you conduct your audit as a value added process?

To answer a couple of questions and clarify some things...the auditors originally came across the guard issue from an interview with a shipping employee. The audit team was not trying to enforce rules, two departments (shipping and painting) both brought this issue up.
Without even being there I can tell that the shop floor had an issue to push and everyone pushed it to the audits. This means that no one has listened to them before and could mean a number of things. The reporting/action chain for suggestions/continuous improvements (CI) is not good enough, CI is not taught and therefore not understood, The CI is not sold correctly (benefit to the company/$$$ etc) or the people up the chain cannot see a good suggestion when they see one...this works in most of the companies I have dealt with.
The audit team thought if this was brought to the attention of the "VP" (he is responsible for production and is the coach of this area) he may or may not feel this was a severe enough issue to pursue, as in root cause etc....
I knew the VP had some direct involvement with the process from the FIRST post. He doesn't want to fix it because then he would have to admit he has a problem in HIS area. This is another recurring theme. Was he involved in the close out meeting? has he had any formal QA training because if he had he would know that auditing the process IS part of the ISO standard!!
As far as Management being involved...the Quality Manager was directly involved and encouraged the team to act on this. This being said, the QM and VP does not see eye to eye.
Are you sure you don't work at my old plant?:lol: The amount of good audits and auditors I have seen scrapped because of turf wars is too long to list

Randy, the question is; 1) What to do now? 2) Was the team out of line? 3) With this happening, there is a breakdown in the process somewhere, right? 4) What to do about him not wanting us to perform any process audits?
1: There are many suggestions I could make and they include, as Andy said, turn it into a dollar figure and sell the CI that way. Management can't ignore dollars!
2: I don't think the team was out of line but maybe they did not sell it right either. Maybe their training could be improved. Maybe you could have an in-house training session for managers and auditors together and discuss what it is the company wants and needs from audits.
3: There is a definite process breakdown
4: Management ,and the VP in particular, needs to see the gaps in the process that are costing THEM dollars and this can only be done by auditing the process. I don't audit the process via the standard but rather I walk it thru with a flow chart. I flow chart each and every step (sometimes with a tech/operator from the area), I ask why each step is done and after it is over I find the redundant, misaligned and time consuming steps and see if they can't be removed or fixed in some way. If I can show that a certain step takes five minutes but is redundant and the step is performed 50 times a day I can show that we are costing the company 250 minutes (over 4.1 manhours) a day, 365 per year (1,520 m/hrs per year...it starts to add up). If you take 60 seconds to putt on every hole in golf it will take up 18 minutes of your round. It doesn't sound much but if you have a foursome doing it, it takes over an hour of putting...every second costs money!!! YES, I audited a golf course once and it had nothing to do with ISO anything. The club captain wanted to improve revenue and to do that he had to increase the amount of players in each day...so we audited what happened...simple really.
I have attached a simple flow chart of a non conformance (http://elsmar.com/Forums/attachment.php?attachmentid=1868&d=1076373280) for an order. We use this as a step guide to costing our NCs. It was the first chart I used to show management the dollars that it was costing us. I then used it to convince them that although our teams reviewed their work instructions they did not audit the process from a third party perspective. We needed to look at the steps but also the gaps between the steps. What isn't being done? What could be done better before and after each step? What did the customer or next step holder require from the previous step owner? It changed everyone's thinking.
I had to do a lot of homework and a lot of 'off the record' work to prepare for this change. I had to SELL it to them and as in all change it required a lot of preparation. These people needed to know how it benefited them and the company. Why it needed to be done? It needed their involvement? The usual change steps had to be employed but it was worth it.
PS: It took me about six months of solid work and a lot of headaches but it was worth it :) Good luck.

How can the team be 'out of line'? Internal audits must determine that the QMS conforms to planned arrangements, meets the requirements of the standard and is effectively implemented.

The QMS is designed to ensure that conforming product is produced and customers are satisfied.

The audit team discovered an ineffective process and potential for dissatisfied customers.

Randy, 2)"What was the objective of the audit?" the objective was to make sure we are meeting the requirements of our procedures and to the standard. The auditors were asigned areas that would cover a process, i.e., assy., testing, painting, final inspection, and shipping. 4) "Is he the boss or does he serve someone else?" he is supposed to be an equal to the QM. I work for the QM. The VP and QM work directly for the Pres. As far as ISO is concerned..I get a feeling the Pres. feels the same way as the VP. They do it cause they have to. 4)" 5 basic principles from ISO 19011" were all used and was carried out very professional.

Greg, " Was he involved in the close out meeting?" no, he has not attended any closing meetings, and would not. "has he had any formal QA training " no he has not had any QA training.

Colpart, "ineffective process and potential for dissatisfied customers." this was almost the auditors exact words. If this part is wrong or late, we have the potential to miss ship dates.

With the greatest respect to Randy and everyone else (professional auditors that is), conducting an audit to ISO anything isn't going to get management excited. In this particular case, I wouldn't have written a 'finding' of any type, but I would be using the 'tip off' to do another audit on the process to discover why the parts are off spec and late, look into the data of frequency of occurence etc and put some $$$ to it. (Greg, thanks for the comment)

I've encountered a very similar situation, which could have been written up under all manner of ISO clauses, but it wasn't until the internal auditor did some research into what it was costing (and no-one could prove him wrong) did it get management (read the President's) attention. The bottom line was $M8 savings! Could you imagine the response we got? The Pres. went all evangelical over it! And we never mentioned a clause number from the standard or a procedure - sure the nc statement did, but that's for the MR or an audit 'boss' to worry about!

I believe that what's missing here is some data and objectivity - while everyone's getting emotional about it - and avoiding it too - the numbers will tell you if it needs to be fixed and how soon. Of course, there's even senior folks who won't wake up and smell the roses too, but in that case an audit findings isn't going to be fixed either way.......

Andy

i don't have my standard with me, and I don't know if the scope of your audit had any limitations on which elements you were supposed to audit. That being said, you have found problems with control of nonconforming material, control of your processes, and it looks like delivery (late) not meeting customer requirements and customer satisfaction (disatisfaction). Looks to me like you are spot on, and your management either needs to get behind you on this or quit pretending they want to be ISO certified.

Thunder Head, it sounds as though your top management are still referring to older versions of ISO 9001 where the emphasis (wrongly) was put on having a system which met a standard rather than having a system which to run the business and meets the standard as an added bonus.

I don't envy you but I think you have a long education process to undertake in order to convince your top management of the real purpose of the QMS. As a number of people have suggested, money is often a good motivator for them and certainly catches their attention.

Thanks everyone for all of the responses, its nice to hear from others that are in the "business". :applause:

The vice president of the company was very upset and wrote a note stating that we were not supposed to be looking at the processes just the ISO procedures.The VP is simply wrong. Internal audits, when conducted with the appropriate mind set and competence can identify significant areas for improvement and preventive actions. Your audit team was 100% correct in identifying this and the VP should thank them (unless s/he has motives to keep the process ineffective) instead of being upset by the discovery of an opportunity for improvement. Maybe the VP is upset because "lowly auditors" uncovered process deficiencies that his little feud should have uncovered first...

Kudos to the audit team.

The VP is simply wrong. Internal audits, when conducted with the appropriate mind set and competence can identify significant areas for improvement and preventive actions. Your audit team was 100% correct in identifying this and the VP should thank them (unless s/he has motives to keep the process ineffective) instead of being upset by the discovery of an opportunity for improvement. Maybe the VP is upset because "lowly auditors" uncovered process deficiencies that his little feud should have uncovered first...

Kudos to the audit team.

:agree1: :thanx:

How can the team be 'out of line'? Internal audits must determine that the QMS conforms to planned arrangements, meets the requirements of the standard and is effectively implemented.

The QMS is designed to ensure that conforming product is produced and customers are satisfied.

The audit team discovered an ineffective process and potential for dissatisfied customers.
I don't want to rain on your parade but a QMS does not in itself ENSURE that a company will make conforming product or that their customers will be satisfied. What usually happens (because of VPs like the one in question) is that an auditor, if auditing the standard alone and its clauses, will ensure that the company is doing what they say they are doing...NOT that they are making product that conforms to a customers specifics.
We tend to do 2 types of audits. One that checks that the clauses of the standard are met (and these are few and far between as we leave these up to our registrar) and the other checks that our processes are both effective and efficient. Some people tend to look at ALL audits as if they were conducting an external audit rather than an internal audit.

P.S: For reference we have been certified for over 15 years and never had an NC...although we have had a few observations. Also, we are not in the automotive, medical or aircraft business :)

Greg, of course the QMS alone will not ensure conforming product but if it is not set up with that intent, then it stands no chance of doing so. It also requires commitment on behalf of the organisation - starting at the top - which is what appears to be in short supply in the OP.

Internal audits should not be checking the clauses alone, they should also be checking that the processes are being complied with and are doing what the company wants them to - which is presumably - helping them to achieve conforming product. The scope statement of ISO 9001 tells us that much on its own.

I don't know your company but this touches upon the independence of your quality group. They should be independent branch reporting into "top mgt". Luckily in my company our audit group is seperate from businesses. (That is not to say they don't upset some managers during their audits).

If this guy is your top management, he should take on for the team and accept opportunity for feedback.

An "ISO" audit can include a process audit in my eyes. Question I would have picked around here is the existance of a documented procedure requiring a guard to be there or not when the material arrives. If it was, then there is a non-compliance. If not, then it maybe a an OFI under continual improvement part of ISO. Production planning would be natural owner to managing this. It could lead to customer disatisfaction under delivery indices.

If top manager continues to be like this, consider dusting out your resume.