How to avoid Nonconformance Reoccurrence problems

[luciano]

Dear friends,

This month we had the TS surveillance audit. We got a major nonconformity due to the fact that the auditor has found some deviation related to the Control Plan. Due to the fact that this was a recurrence problem from the last year he gave also another major nonconformity for reoccurrence. This second major nonconformity it is based on the previous one but is focused on our internal corrective and preventive actions system which is not effective because we had reoccurrence. Now, I have to write corrective actions related to the weakness of our corrective/preventive action system which allows having reoccurrence.
1. How do you address reoccurrence problems in your system ?
2. How should I include in include in our in quality system in order to avoid reoccurrence problems ?

Thank you very much.

 

[pldey42]

Re: How to avoid reoccurrence problems ?

Well, as ISO 9001 (upon which I assume ISO/TS 16949 is based) clause 8.5.2 says, "The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence."

That's typically done by addressing 8.5.2.b "determining the causes" with a root cause analysis technique, of which there are several described in quality management text books.

One simple example is "Five Whys."

Why did the product fail in the field?

Because it was wrongly assembled

Why was it wrongly assembled?

Someone made a mistake. Human error.

Who made the mistake?

According to the records, operator 456 made it, and got it wrong.

Why did operator 456 get it wrong?

No record of going on training course -> CA: Send operator 456 on training course

Which other operators did not go on training course?

Operators 450, 451 through operator 479 -> CA: send these operators on training courses too

Why did these operators not go on training courses?

New manager did not know they should be trained -> CA: send new manager on management training course with special attention to operator training

Which other managers do not know about training operators?

All six new managers that were hired over the last few months -> CA: send all new managers on management training course with special attention to operator training

Why do new managers not get sent on training courses?

HR thought the ops manager sent them, ops manager thought HR sent them -> CA: revise the new hire induction process to clarify who sends people on training courses

And, Preventive action: trace all products made by untrained operators and consider recalls

For more complex problems there are advanced techniques which are described in the literature.

Hope this helps
Pat

 

[luciano]

Re: How to avoid reoccurrence problems ?

Thank your for your answer.
This we already have. The problem is the concept of recurrence in the whole company. When you've recurrence, how will you approach the situation in that moment? Recurrence reveals that the root cause was not identified correctly or the corrective actions were not effective determined. My questions are related on, the one hand, from the moment when the reoccurrence it is identified. How do you treat this issue because it is obvious that something is not working well in the system of preventive corrective actions? Are there some specific practices to be applied when recurrence it is present (different from the previous ones who have identified the root cause and corrective actions)?
What information should take into account and how to manage them to avoid a new recurrence?

Well, as ISO 9001 (upon which I assume ISO/TS 16949 is based) clause 8.5.2 says, "The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence."

That's typically done by addressing 8.5.2.b "determining the causes" with a root cause analysis technique, of which there are several described in quality management text books.

One simple example is "Five Whys."

Why did the product fail in the field?

Because it was wrongly assembled

Why was it wrongly assembled?

Someone made a mistake. Human error.

Who made the mistake?

According to the records, operator 456 made it, and got it wrong.

Why did operator 456 get it wrong?

No record of going on training course -> CA: Send operator 456 on training course

Which other operators did not go on training course?

Operators 450, 451 through operator 479 -> CA: send these operators on training courses too

Why did these operators not go on training courses?

New manager did not know they should be trained -> CA: send new manager on management training course with special attention to operator training

Which other managers do not know about training operators?

All six new managers that were hired over the last few months -> CA: send all new managers on management training course with special attention to operator training

Why do new managers not get sent on training courses?

HR thought the ops manager sent them, ops manager thought HR sent them -> CA: revise the new hire induction process to clarify who sends people on training courses

And, Preventive action: trace all products made by untrained operators and consider recalls

For more complex problems there are advanced techniques which are described in the literature.

Hope this helps
Pat

 

[pldey42]

Audit the CA and PA processes?

With recurrence and root cause analysis in mind.

Questions to ask:

Are the right people involved in RCA? People who do the work, engineers, experts, inspectors, etc?

Are statistical data available on recurrent problems? Is the data used in RCA? Are those handling statistics competent? Are their conclusions rationally considered in the corrective action process? (Sometimes, managers or group think overrides statistically valid observations.)

Is enough time given to RCA? Do people understand how to do RCA?

Many such problems are cross-functional, departments blaming each other. Does RCA involve all departments concerned? Can people speak freely?

Are managers sabotaging RCA by encouraging blame games, not sending people to RCA sessions, ignoring the analysis and only funding the simple fixes that do not prevent recurrence?

Are managers understanding the costs of recurrence and funding the elimination of root causes?

Hope this helps
Pat

 

[AndyN]

Pat, the example was a "2 Whys and a Who"...

 

[pldey42]

Well at least there were a few whys. Bad managers only ask who!

 

[Ninja]

Looking at the root cause is always a need.

After that, prevention mechanisms are rated and one chosen.

If you have already had a recurrence, you may want to choose a prevention mechanism that PROHIBITS recurrence rather than trying to educate people as to what they should be doing.

For a mispick counting error on my line, we have installed a scale for the final package, and the label for it won't print unless the weight is close enough to what it should be.
This is the kind of thing that "Prohibits" the recurrence rather than stressing accuracy to the operator.

 

[Reg Morrison]

Well at least there were a few whys. Bad managers only ask who!

How right you are....The real bad managers use the 5-Who's technique to REGA (Root Escape Goat Analysis).

 

[Mark Meer]

Now, I have to write corrective actions related to the weakness of our corrective/preventive action system which allows having reoccurrence.

My read is that you simply did not allow enough followup time to evaluate the effectiveness of the previous corrective action.

I don't know if this is necessarily a systemic failure, as followup (and the potential to evaluate your corrective actions as ineffective) is just part of the process...

To me, it's acceptable to propose a corrective action, implement it, monitor, evaluate, and determine that your corrective action (or analysis) was ineffective. If there's a recurrence of the problem, back to the drawing board...

 

[Reg Morrison]

To me, it's acceptable to propose a corrective action, implement it, monitor, evaluate, and determine that your corrective action (or analysis) was ineffective. If there's a recurrence of the problem, back to the drawing board...

Good point. But, I think it is important also to remember that a nonconformity has, many times, multiple contributing causes. Sometimes, we focus solely on one cause and disregard contributing conditions.

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.