Best CAPA for slip in simple-yet-persistent oversight-review mechanism

there are number of procedures which a team must follow/adhere during course of development...
1) how do we ensure that teams follow-implement-adopt all the recommended practices (& document-record where required)
2) how to approach CA - PA for a repeat problems OR repeat causes in above scenario where we notice that non-compliance/deviation from recommended procedure?

note :- we are conversant and adopt the impact-assessment; risk based approach. incident management etc., but; the point is, what to do with repeat observations/causes?!!! especially when there are multiple products, teams, etc.,

Re: Best CAPA for slip in simple oversight-review mechanism

Train and re-train

Re: Best CAPA for slip in simple oversight-review mechanism

Start with training, yes. But I've had auditors that are resistant to 'Training' as CA because it suggests your process success is dependent on people not making mistakes. This is not the most robust process design.

If you've had a 'slip' you must've missed a milestone or decision gate somewhere and it wasn't caught until an audit. I'd recommend you look at how the program requirements are communicated and what information did not get to the right person to cause the event to happen as required.

In my engineering department we are using visual boards similar to production boards. These are controlled by program management and display, in a semi-public way, all the tasks assigned to each engineer along with the due date. They also show program milestones so everyone can see how their work relates to upcoming milestones. With the high visibility this provides we simply do not miss milestones.

Re: Best CAPA for slip in simple oversight-review mechanism

Poka Yoke (or error proofing) is the best choice depending on the type of incident.

Re: Best CAPA for slip in simple oversight-review mechanism of practices-documentatio

romit singh said:

Train and re-train

Click to expand...

Yes, PokaYoke, 'visual boards' 'task list' etc are great tools....for product/operational environment(& except for poka yoke, we have them in place...); how does the approach sound for an systems-procedures environment?
indeed, true, but that is starting point.....how many times retraining.....retraining for how many incidents/causes?
that reflects (very)poorly on the systems-investigation-capa-implementation.

we did think of certain alternatives....
1) having an additional&independent oversight (audit mechanism or supervision )==> but that affects the efficiency and even otherwise shifting the responsibility doesn't reflect great deal of effectiveness.;
2) inspection at/before next level/stage... this again is lag indicator; even if we are able to catch/identify it, the real timeline of implementation is past.
3) also thought about making the team summarize(checklist) by themselves; but this again is affecting the efficiency; also think, the team which is giving all non conformance, how does it cope with the checklist!!!
4) also thought about escalation(management), but it doesn't seem to work...cause they are waiting for some agency/external-auditor to specify the standards/requirements.

why do we always rely on expectations imposed through legitimization/legalization. (wait for an regulatory/standards agency to lay out the expectations/standards?)
why can't we realize the standards-practices are for standardization - harmonization-uniformity-traceability etc.,?
even if its an R&D, is it a great deal to expect the laid down procedures to be followed?(followed-documented)

Re: Best CAPA for slip in simple oversight-review mechanism

Well if after training and re-training, the issue still exists, then I will look into the effectiveness of the training and try modify the training and effectiveness criteria.

Re: Best CAPA for slip in simple oversight-review mechanism

romit singh said:

Well if after training and re-training, the issue still exists, then I will look into the effectiveness of the training and try modify the training and effectiveness criteria.

Click to expand...

i have noted that point, training-awareness-ability doesn't seem to be a problem, it doesn't seem to be a priority....consistent-priority.....at all!!!! ( in this case it is persistent oversight!!!)
what aspect of training takes care of the priority?
in R&D environment, the focus is on quality of product; which is determined by technical applicaiton, expertize etc., but the value of it preserved when we document it to the required details/extent?
hope i am able to show the point?

v9991 said:

there are number of procedures which a team must follow/adhere during course of development...
1) how do we ensure that teams follow-implement-adopt all the recommended practices (& document-record where required)
2) how to approach CA - PA for a repeat problems OR repeat causes in above scenario where we notice that non-compliance/deviation from recommended procedure?

note :- we are conversant and adopt the impact-assessment; risk based approach. incident management etc., but; the point is, what to do with repeat observations/causes?!!! especially when there are multiple products, teams, etc.,

Click to expand...

This will happen with some.... This will not happen with some other .... This will improve with a few others but may never become the perfect example.
So what ?
What are we trying to do here ... Perfection ?
The need is to see that the QMS is effective and ongoing towards meeting the business purpose. I guess we just need to understand that this will happen as long as people work and manage many dimensions. The need then is to keep correcting and moving ahead. Can each other cover up and highlight the missing link and move on.
The more we think about CAPA for slips, the more we spoil our good working day.
Have a good day ~~~