Auditing strategy

Golfman25

Trusted Information Resource
Hello All,

This question I'm looking for feedback on.

For context, I'm in a senior position at my company that is ISO:9001 accredited, I've previously been audited to NADCAP and ISO: 9100.

It's my opinion that our Quality system as it stands is weak at best, we're talking hundred's of NCR's a year, loads of repeaters- it's extremely bad. I guess the main positive would be that we've got a good reporting culture... we're leaking profits due to Quality issues.

We're going to be audited on the 5th & 6th of July to ISO:9001 this year and I have every intention of pushing the auditors buttons and leading them in the direction towards Quality holes and toward potential Non-conformances. I want to shine a very bright light on the Quality problems that we face as a company.

It baffles me that we pass audits every year, I'm not even certain we're getting value for money. I think that the previous QM always had an answer but that's really not my style. I understand the purpose of audits and it would benefit me massively to find NC's and Opportunities for improvement.

My question- previous QM's and Audit leaders, what has your approach been?
This is a very bad idea. Your job is to show the system in it's best light to the auditor and then work on the problems as you see them, a bit at a time.

Now, question. You have "hurdreds of NCR's a year" -- why does the "number" matter? Are they open or closed? And are they really hundreds of substantive NCRs or a bunch of "got ya's."
 

N.galt

Starting to get Involved
Are the NCRs similar in nature?

I have a lot more NCRs than you sitting in my system so don't worry about it, with most of them existing before I entered the organisation and gets worse by the day and i'm eager to get them closed and see some actual improvement. It's an organisation that's very late to the world of Quality and thus struggle greatly.

As you're probably aware, not all NCRs require Corrective Actions, I'm assuming you have some sort of trend analysis? I use this to aid what I find worthy of Corrective Action using sound judgement, some problems just ain't worth the time or money, apply the correction & move on.

Though i've never had that approach questioned, I do wonder if it's the right thing to do sometimes.
Yes they are similar in nature.

You sound like you're in a very similar situation to me! I'm on a journey of convincing my colleagues that Quality is a good thing too. We're extremely late to the quality party.

Yeah, I've been using Power Bi to trend analyse, so I've got some really good work to show the auditor. When I posted previously on this forum, they suggested that I "Triage" my NCR's so that I could tackle the NCR's in a productive way and that has been really useful advice.

I use this to aid what I find worthy of Corrective Action using sound judgement, some problems just ain't worth the time or money, apply the correction & move on
Definitely I'm the same, we're fighting fires unfortunately and I'm trying to put foundations in place to stop us sinking.
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
I did a lot of "common cause analyses" for organizations, spending time reading events and/or corrective actions (including NCR's) and teasing out the commonalities. Usually I'd create a grid as I accumulated "common phrases" (such as the procedure was not in use during the job) and check off those additional items that used those prhases or words to that effect. Usually there also are data that can be "trended" such as did the corrective action get done by the due date, was there an effectiveness review on the action completion, what were any category or cause codes assigned. Even - was there a corrective action at all? Going after common causes / systemic causes can be a lot more effective than fighting the most recent fire.
 

Kronos147

Trusted Information Resource
Yes they are similar in nature.
I did a lot of "common cause analyses" for organizations, spending time reading events and/or corrective actions (including NCR's) and teasing out the commonalities.

Usually there also are data that can be "trended"

A good approach is to look for common issues and bundle them into a single action (maybe not on paper, but your activities, anyway). If you see PN 12345 got mixed with part 45678 on one NCR, then PN ABC123 & ABC456 on another order, find the root cause of why parts are being mixed. If you can effectively address the underlying issue, you can close the individual NCR's out.

Another consideration it to Pareto the issues to see what the heavy hitters are, to better apply your resources. Fix the biggest problems first then work your way down the list.

Good luck!
 

Johnnymo62

Haste Makes Waste
I have solved some cultural issues with upper management by speaking their language. Most executives don't speak Quality, they speak MONEY. I have used cost of poor quality, COPQ, to get their attention. N.galt, it sounds like your company is wasting alot of money that upper management should care about.
 

Big Jim

Admin
It would occur to me that you need to educate and beef up your internal auditors instead of making the external auditors the fired gun.

Even better though would be something more like what Steve Prevette advises. You are going to make enemies in the company by trying to blast away from the hired guns.

You want top management to look at you as something beneficial, not a pest.

Not quite the same, but a friend that was the logistics manager for a very large candy company discovered that they were working at a loss with huge big box chain. Top management didn't want to hear it. It took over a year for top management to finally look over his analysis and change their approach with the big box chain. It took a while for his research to be appreciated.
 

Mike S.

Happy to be Alive
Trusted Information Resource
Lots of good advice above, especially post #23 from Steve.

We don't know your circumstances as well as you, and even you don't know much of the "rest of the story". Sometimes external auditors are like the 3 blind mice and are inexcusably incompetent or lazy or "on the take". Sometimes they do a good job and their perspective is just different. I hope it is the latter.

Your power to force change (improvement) in your position is limited. Take it from a hardheaded fool who is still learning this lesson after over 30 years in this profession: if you care about something more than your management and/or ownership group you can drive yourself crazy and/or into bad health trying to do the impossible for people who won't notice or don't care. Do what you can, make an honest good effort, and at the end of the day if it's not good enough, either learn to accept it or move on to another job.
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
To add to MIke S's post 29: I did end up working for 28 years (after my stint in the US Navy) for two major Department of Energy contractors. I was originally hired as a maintenance supervisor, but got diverted very quickly into performance analsysis. On my transition from contractor A to B, I got told - Steve we don't know why contractor A employed a statistician, we don't do statistics" As it works out, I found various organization who needed help (or they found me), In 28 years, I had at least 24 different managers. They never quite knew what to do with me, but there was always stuff to do. At one point I was working for four different locations simultaneously. It seems as one facility got so they no longer liked me, another filled in with requests. This rather "free lance" approach worked well for 26 years, but then seemed like I was hitting a wall (and knew it) aound 2018. Some of it was a new generation of leaders who were about my same age who did not want to hear my message. I did one last lateral hop, and when that specific contract came to an end, my employer put me on "leave of absence awaiting assignment". However, through the years they paid a very good salary, and I put a lot of that away into 401k. When they took their final action, I looked at my 401k balance and said - why am I even working? So have been semi retired teaching for Southerin Illinois University remotely for the past two years.

Bottom line - doing the 'right thing' sometimes was difficult, somewhat stressful (but no one really understood what I was doing to really stop me from what I was doing), paid off in a lot of improvements and good relations with the government (DOE and AECL) client, and set me up for a good, early (if unplanned) retirement. By the way, leaving for a Japan cruise in July.
 
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