How to avoid Nonconformance Reoccurrence problems

[Mark Meer]

It is possible to have a recurrence of a problem for DIFFERENT reasons. So, not always, problem recurrence signifies that we did not address a root cause. It might be the case that we did not address all of them.

So many possibilities...to add to the list: also possible the previous corrective actions could introduce other causes that were not anticipated...

The point is though, that evaluating previous corrective actions as ineffective is, in my opinion, acceptable, and does not indicate a systemic failure. Corrective actions are often an iterative process...data gleaned from ineffective (or partially effective) corrections is valuable and should just be fed back into the process...

 

[RoxaneB]

Let's face it, not everything is under an organization's ability to control. Steps may be taken to reduce the likelihood of recurrence, but reality happens and until an organization is an omnipotent entity, 100% prevention of recurrence is not achievable.

There is also the issue of feasibility and practicality when it comes to addressing root causes.

For example, I now work in community health care in Canada. Our front line staff includes nurses and care providers driving to the homes of individuals to provide health care services....even in winter. If we have a missed visit due to inclement weather, one could argue that the root cause was that our scheduling system was not utilized to provide sufficient driving time to the care provider in order to ensure an on-time arrive. However, we also need to consider the practicality of reducing the number of visits per day for a care provider (and thus their salary and our billing amount) to ensure a timely arrival, when our monthly Missed Visit performance is currently < 3% @ 11,000+ visits per day (which is well below our main funder's target set for us). To reduce the number of visits per front line staff will mean we bill less per care provider and they are paid less, and we have to hire more care providers to offset the workload, and that does not make financial sense. ... ... ... Yes, the other side can argue the case of putting a price on people's heath (but that turns this into an ethical debate and digresses from the point I'm trying to make).

So, let's face reality here...recurrence may happen. To address this, I'd recommend a document be created outlining the following:

• Process for demonstrating root cause analysis has been conducted.
• Action Plans are developed with feasible and practical steps addressing root cause(s).
• If the actions needed to address a root cause would adversely impact the organization's ability to provide services/products (i.e., implementation could bankrupt the company thus unable to provide services/products), sign-off from senior management is required, acknowledging that recurrence is accepted potential risk by/for the organization.

Another idea to consider the scope of the root cause analysis. A nonconformance happens...root cause analysis is done...action implemented. Another nonconformance happens...root cause analysis is done...action is implemented. And it repeats several times.

What about performing trend analysis on ALL of the nonconformance types or root cause categories? Pareto the results and then develop actions to focus on the types or categories as opposed to the individual nonconformance?

Obviously, there are other variables to consider here such as the legal and ethical aspects of a nonconformance, and my points above do not explore those possible rabbit holes, but an organization operates in the real world where nothing is 100% controllable and there are some actions that simply are not practical...and this needs to be recognized within the whole process of addressing corrective and preventive actions.

 

[normzone]

I clicked the [Thanks] button for the previous four posters on this page - they're all spot on regarding the nature of corrective action.

It's a highly valuable tool, and when effectively administered it's the most powerful tool in my toolbox, but it's not a flawless immediate cure-all.

 

[Raffy]

Hi
Indeed, it is so hard to avoid reoccurence of the problems.
I hope there will be a Top Management Commitment to drive all of these.
Best regards,
Raffy

 

[TPMB4]

My two thoughts on this matter are that sometimes you just can not prevent recurrence because the solution is prohibitvely expensive or there just isn't a solution without complete redesign.

The second is that corrective action process should allow sufficient evaluation of the corrective action carried out. If that period is too short then you might miss the event(s) that is the real root cause or a secondary issue that is involved.

This has been said earlier I think in one way or another but I commented because I had a question. What is your corrective action reporting format? There are several in common useage such as 8D? Also, were the corrective actions that are involved in the recurrence concerning internal defects or customer defects? If the latter were you working to the customer's defined timescale that prevented you to evaluate the corrective actions for sufficent time? Should there have been an extension to the customer's reporting timescale? Questions I think could have some bearing on why recurrence happened. Perhaps they could inform your responce to the TS standard NC the OP got.

Old thread the OP probably solved their problem but thought I'd post since it got ressurected.

 

[Helmut Jilling]

My two thoughts on this matter are that sometimes you just can not prevent recurrence because the solution is prohibitvely expensive or there just isn't a solution without complete redesign.

The second is that corrective action process should allow sufficient evaluation of the corrective action carried out. If that period is too short then you might miss the event(s) that is the real root cause or a secondary issue that is involved.

This has been said earlier I think in one way or another but I commented because I had a question. What is your corrective action reporting format? There are several in common useage such as 8D? Also, were the corrective actions that are involved in the recurrence concerning internal defects or customer defects? If the latter were you working to the customer's defined timescale that prevented you to evaluate the corrective actions for sufficent time? Should there have been an extension to the customer's reporting timescale? Questions I think could have some bearing on why recurrence happened. Perhaps they could inform your responce to the TS standard NC the OP got.

Old thread the OP probably solved their problem but thought I'd post since it got ressurected.

It is common in automotive to use broad solutions, same rules for every situation, regardless of the circumstances, just do it...etc. That is a naive approach. Smart customers work with their suppliers to craft solutions to specific problems and root causes, and recognize that sometimes unique situations require more unique solutions.

 

[Kronos147]

1. How do you address reoccurrence problems in your system ?

I try to add specific follow up items to the Internal Audit to check for reoccurrence.

2. How should I include in include in our in quality system in order to avoid reoccurrence problems ?

Reference the Internal Audit program as your main source of ongoing CAPA verification. Make sure you review your CAPA Log and add items to the IA accordingly.

 

[RoxaneB]

I try to add specific follow up items to the Internal Audit to check for reoccurrence.

How do you know what to look for? And do you issue a finding if there is a recurrence? Or do you look deeper to see if there is a justification for the recurrence. As I posted earlier, some recurrences are simply a matter of doing business.

Reference the Internal Audit program as your main source of ongoing CAPA verification. Make sure you review your CAPA Log and add items to the IA accordingly.

With all due respect, I disagree with using the Internal Audit program for CAPA verification. The reliance on an audit as the basis for identifying insufficient actions resulting in recurrence is too "hands off" in my opinion.

The review of open corrective action issues is a process that can occur at various levels depending on the nature and scope and severity of the nonconformance. However, I believe in process owners truly owning their processes, and that includes the performance of their processes. They need to know if corrective actions are recurring and understand why. They need to understand the status of their corrective actions, ongoing processes, etc.. To wait for an internal audit to give them a thumbs-up (or the opposite) adds little value other than to give auditors a job.

An internal audit, however, may identify at a higher level that the process does not exist (or is inadequate) for verifying adequate actions were taken or that there is a process for justifying certain recurrences.

 

[Kronos147]

ISO 9001 8.5.2 Corrective Action - "A documented procedure shall be established to .... f) review the effectiveness of the corrective action taken."

One may not audit their own process. Would you expect the process owner to evaluate the effectiveness of the corrective action?

How do you know what to look for?

Not to over simplify, but I would look at the CAPA report and see what the process owner offered as a fix and their continual improvement.

Example: If the process owner said they revised the training program and put in a tickler system to insure it stays up to date, I audit the training records and see if it is up to date.

...do you issue a finding if there is a recurrence? Or do you look deeper to see if there is a justification for the recurrence. As I posted earlier, some recurrences are simply a matter of doing business.

Yes, I would issue a new finding. Reference to old finding and solutions to refrain from repeating the last failed attempt.

With all due respect, I disagree with using the Internal Audit program for CAPA verification. The reliance on an audit as the basis for identifying insufficient actions resulting in recurrence is too "hands off" in my opinion.
...
I believe in process owners truly owning their processes, and that includes the performance of their processes. They need to know if corrective actions are recurring and understand why.

I have been assuming that the process owner filled out the CAPA. I look at the audit process as a check and balance for the process owners Corrective Action.

ISO 9001 8.2.2 Internal Audit - "An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits."

To me this means reviewing the effectiveness of any/all CAPA's issued. That is what our registrar does when they audit.

To wait for an internal audit to give them a thumbs-up (or the opposite) adds little value other than to give auditors a job.

Are you an expert on their job? If everyone (anyone?) in my facility knew what I did they wouldn't need me.

The value added is a quality professional with our perspective and background adds value to the process by reviewing the work of the process owners. Even if it is only to give them an "atta' boy."

The Quality Professions (that us!) have to help promote, and enforce the QMS.

 

[RoxaneB]

ISO 9001 8.5.2 Corrective Action - "A documented procedure shall be established to .... f) review the effectiveness of the corrective action taken."

One may not audit their own process. Would you expect the process owner to evaluate the effectiveness of the corrective action?

Yes, I would expect the process owner to be accountable for their process, including the effectiveness of the actions taken. This evaluation of the action plan developed to address the root cause of nonconformance is not the same thing as an internal audit.

The evaluation could be something as simple as no recurrences of this nonconformance for three months to something more complex such as achievement of 50% improvement in XXX by YYY.

Not to over simplify, but I would look at the CAPA report and see what the process owner offered as a fix and their continual improvement.

Example: If the process owner said they revised the training program and put in a tickler system to insure it stays up to date, I audit the training records and see if it is up to date.

That makes sense and is perfect normal to do. The process owner said they would do XXX and you are confirming that they did XXX. Their validation to close it could be no out-of-date training records for six months...but I would take it upon them to confirm this internally.

As an internal auditor, I would - at some point I'm sure - look at training records. If I find some that are out of date, now we have a bigger issue that may call into question the effectiveness of the corrective action process.

Yes, I would issue a new finding. Reference to old finding and solutions to refrain from repeating the last failed attempt.

I suppose we shall agree to disagree here. Issuing a finding because of a recurrence may add little value to the overall system and simply, in my opinion, perpetuates the belief that auditors are merely out on a witch hunt to find things that are wrong within a management system.

I would rather review the nature of the recurrence and understand if there is justification for it recurring. Read my post on Page 2 (Post #12). There are some nonconformances that are a "cost of doing business" and will recur.

It adds more value to an organization to have a process in place that allows for such evaluation and justification. By no means does this say nonconformances are allowed, but rather it provides the organization with the ability to focus their resources (time, money and people) on issues that matter rather than every single hiccough that crops up.

I have been assuming that the process owner filled out the CAPA. I look at the audit process as a check and balance for the process owners Corrective Action.

ISO 9001 8.2.2 Internal Audit - "An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits."

To me this means reviewing the effectiveness of any/all CAPA's issued. That is what our registrar does when they audit.

If you are only issuing CAPAs out of internal audits, then I see why you have this approach. Again, I disagree. CAPA's should be for the SYSTEM not because of one process (in this case, internal audits). CAPAs could be customer complaints, internally identified quality issues, failure to achieve targets on process metrics, etc. and should include the possibility of being self-issued.

Are you an expert on their job? If everyone (anyone?) in my facility knew what I did they wouldn't need me.

No, I am not an expert on their job...which is why they should be the ones to determine if the validation plan was effective and to justify if a recurrence is acceptable based on the organization's parameters for the "cost of doing business".

The value added is a quality professional with our perspective and background adds value to the process by reviewing the work of the process owners. Even if it is only to give them an "atta' boy."

The Quality Professions (that us!) have to help promote, and enforce the QMS.

I agree with positive promotion of strengths within a process. I agree with advocating. I disagree with "enforcing" it. That is the role of senior management; that being said, one does not enforce a culture into succeeding.

Corrective action is a process typically *owned* by one department/team, yet *applied* by many. When doing an assessment, you are evaluating their ability to effectively and efficiency apply the activities within the process. However, I see little value in issuing a finding on a recurrence. The value is more in understanding (for all parties involved) WHY the recurrence occurred and determining if this is an acceptable recurrence (again, "cost of doing business"). The process owner and the team are already dealing with the recurring nonconformance, what benefit is served by hitting them with another nonconformance for having a recurring nonconformance?

I think sometimes quality professionals become too tangled up in the details of the system. It is helpful to take a step back, look at the bigger picture and consider ourselves as business system professionals.