Major NC from last audit not fixed not sure how to fix

#1
Last audit we had a system put in place by upper management that was slow to get going (physically signing routers in conjunction with electronic signoff).

Auditor found multiple routers unsigned. We got a Major. We are 9001-2015 and a manufacturing job shop.

There are no ramifications for employees not signing and the process is failing. We did have companywide training that it HAD to be done, and people signed off on lots of training.... But good old 2020 came and now 2021 employees that actually show up are more concerned about the WIFI and what's on their phone. Upper management is worried about people walking out to the next shop in the industrial park and zero discipline happens. I report in MR, meetings, emails , and more that people are not doing this process. It's failing, our CAPA failed, and I'm at my wits end.

Our recertification audit is coming up in a few months and my internal auditors are telling me that process is not working too.

What are my options? Internal audit Major NC for the CAPA and the process? How do I handle this in the audit? I have always loved audits and handle them well.
This year I swear it's affecting my health and I'm sick to my stomach about it.
Thanks in advance.
 
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Johnny Quality

Quite Involved in Discussions
#2
Dan,

Write this up through your internal audit process against CAPA. You could also write it against training and leadership.

We don't know what your organization is like but I will ask is double signoff needed? What's the purpose?

I'd also consider your CV/resume if that is an option for you.
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#3
Last audit we had a system put in place by upper management that was slow to get going (physically signing routers in conjunction with electronic signoff).

There are no ramifications for employees not signing and the process is failing. We did have companywide training that it HAD to be done, and people signed off on lots of training.... But good old 2020 came and now 2021 employees that actually show up are more concerned about the WIFI and what's on their phone. Upper management is worried about people walking out to the next shop in the industrial park and zero discipline happens. I report in MR, meetings, emails , and more that people are not doing this process. It's failing, our CAPA failed, and I'm at my wits end.
Okay, let's skip the "ramifications for employees" piece and go straight to organizational risk. What are the risks if there is no signoff? If the risks are nonexistent, I'd question why there is a signoff process in the first place. If the risks are minimal, maybe it's time to review the overall signoff process and develop something that adds more value to the organization, while minimizing those risks. If the risks are significant, then upper management (this is not a job just for you) likely needs to step up and explain those consequences (e.g., no signoff...part fails...customer refuses to pay...company shuts down...folks are out of a job).

There's usually a reason for signing off on things. The 'why' needs to be explored and resonate with employees.

As for folks leaving...let them. You don't need nor want people who don't fit with the direction of the organization. That said, if people are threatening to leave because they might get in trouble, your organization might have bigger issues than routers that aren't signed off. I find myself curious about staff moral and engagement at this point - do they feel safe and appreciated? Honestly, if they don't, the lack of signed off documentation could be a symptom of these feelings.

dan8152 said:
Our recertification audit is coming up in a few months and my internal auditors are telling me that process is not working too.

What are my options? Internal audit Major NC for the CAPA and the process? How do I handle this in the audit? I have always loved audits and handle them well.
This year I swear it's affecting my health and I'm sick to my stomach about it.
Thanks in advance.
I apologize, but I'm a bit confused here. Am I correct when I read that your internal audit process is also not working?

When you say "last audit" in regards to the router finding, are you talking an internal audit or external? Because, if it was external, I would have thought some form of response, including an action plan, was sent to the organization that completed your external audit. If so, what happened to that?

FWIW, classifying findings as major/minor in internal audits is overkill. That labelling is best left to the external type of auditing. That said, I can fully appreciate having such a classification internally if only to help determine when to do a correction versus a full-blow corrective action.

My own take at this point is:
  1. Log it in your internal corrective action process.
  2. Reach out to your external auditor organization and ask for an extension - play the COVID-19 card if you need to.
  3. Pull in key stakeholders involved in the signoff process - this includes front line staff - and identify causes (yes, I made that plural) that are creating this perfect storm. Ishikawa may be very helpful here.
  4. Prioritize actions and blitz through the low-hanging fruit items first, because, come external audit time, you may not have this fully fixed, but you will at least be able to demonstrate some progress.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Roxane's post was spot on. The only thing I would add is for you to determine if the lack of discipline on sign offs were due to the pandemic challenge or, if it is a sign of a dysfunctional culture where process discipline is not enforced. If it is the latter, nothing you can do without top management intervention.
 
#5
Thanks all for the replies.
No the internal audit process is working fine. they are finding out that the sign off was not working.
The organizational risk is bad parts escaping to the next operation and possibly customer.

The problem with letting people leave is that in our area we can't replace them. People don't want to work at even unskilled jobs that are paying $20+ and hour. I agree I wish we could replace the ones that don't want to align with the company. We have people that wanted to get laid off so they could make more on unemployment. Strange times.

Our "last" external Audit we did submit and action plan and corrective action that got closed.

Thanks again everyone. I am opening a CAPA (once I get some time today)
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#6
The following advice may help to craft your auditor response.

Covid-19 is a generational disaster and impacted business operations globally. 2020 was not normal business operations. Even the strict FDA changed operations to allow emergency use of drugs and medications and vaccines. The FDA fell WAY behind on audits from COVID-19. Does your company have a disaster recovery process? Many companies had radical impacts to their business from COVID-19. Their Disaster plans have accommodations for this, priorities changed from expansion to survival. Maybe you dont have that to fall back on. If you can, pull a Management Review to cover just COVID-19 impact to QA operations.

I reread your post and wanted to delete my post since you appear to have systemic problems. If you have problems, its better for you to document it than the auditor. The posts above me are good advice.
 

Jim Wynne

Staff member
Admin
#7
The problem is that if you answered the major last year and your corrective actions didn't work, you now have nearly a year of additional evidence that the process still isn't working. I don't think pleading for Covid relief is going to help at this point, as the problem clearly isn't related to the pandemic. I suppose it wouldn't hurt to ask, but your problem is with upper management and failure to enforce the rules. Ask them if they would rather lose a few employees or lose their ISO certification.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#8
Reading Jim's post I am reminded of "The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. " Its up there with "Who is our customer?" How do we sell?" level decisions.
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#9
Thanks all for the replies.
No the internal audit process is working fine. they are finding out that the sign off was not working.
The organizational risk is bad parts escaping to the next operation and possibly customer."
A signoff process with no consequences or meaning will not reduce the risk of bad parts escaping to the next operation and possibly the customer. Again, it might be time to re-investigate. As @Jim Wynne said, your organization now has additional evidence that the process isn't working. Savvy leadership would take this as an opportunity to re-think the approach.

dan8152 said:
The problem with letting people leave is that in our area we can't replace them. People don't want to work at even unskilled jobs that are paying $20+ and hour. I agree I wish we could replace the ones that don't want to align with the company. We have people that wanted to get laid off so they could make more on unemployment. Strange times.
While my background is manufacturing, I now work in healthcare. I realize that this is a completely different field, however, allow me to say that we have a staff shortage in our province (this was in place before COVID-19). All healthcare providers are struggling to find qualified, competent personal support workers, as an example. Does this mean that we'll keep the underperforming ones who put our clients (and subsequently the organization) at risk? No.

In my post above, I said that people might be leaving because there are bigger issues than a fear (or lack of caring about) being disciplined and you have confirmed that. If people can make more by NOT working, what's the incentive to work? It might be time for your organization to rethink compensation, remuneration, benefits, etc....and showcase how folks earn more (plus have a healthcare safety net if there are benefits). And in order to keep said $$$, folks need to perform to expectations.

Again, going back to the personal support worker dilemma we face in healthcare, it pays a low wage, is considered to be a less-than-glamourous job, and we have a staff shortage. It is up to organizations to find creative ways to recruit and retain talent. I honestly think that the lack of signed off routers is actually just a symptom of cultural and leadership deficiencies - apologies if that sounds harsh, but from my own experiences, this sounds familiar.

dan8152 said:
Our "last" external Audit we did submit and action plan and corrective action that got closed.
Are the actions that were submitted the ones that continue to show a failure within the process? Or were they not sustained? If the former, then the actions appear to have not sufficiently addressed the root cause(s). If the former, then you have a different issue...and we return again to the culture and leadership concerns.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#10
May I suggest that after issuing the internal CAR you call a meeting to include the various supervisors/managers of the people who are not doing what they are supposed to be doing, as well as their boss if possible. Tell them you want to help solve this problem but you need their input. Explain to them that it was an external major finding and will be again if you don't get it fixed, and what that may mean to the company.

Many "unsolvable" problems can be solved if the right people meet together in a room instead instead of exchanging emails or pieces of paper.
 
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