Medical Device Industry Corrective Action Techniques - Is 8D valid method?

[senna]

Hi Ya'll,

I was browsing through the Cove and came across the 8D technique associated with corrective action. Is this useable in the medical device community? If not, any recommendations?

Also, I am in a quandry about how to establish threshold limits associated with CAPAs for facets other that process control. I assume that at a certain level, when evaluating non SPC CAPA data there reaches a point when you say "that's it - we have to do something" How are these threshold points set? I am assuming that you have to have some statistical basis for it. What do you think?

Finally, I know that SPC is a good method of evaluating your process controls for established threshold levels where corrective/preventive action must be initiated. But how do you set your upper and lower control levels? Again, any stats involved? If so, where can I find info on how to set these?

Thanks,

Senna

[Al Rosen]

In Reply to Parent Post by senna

Hi Ya'll,

I was browsing through the Cove and came across the 8D technique associated with corrective action. Is this useable in the medical device community? If not, any recommendations?

I can't think of any reason why not.

In Reply to Parent Post by senna

Also, I am in a quandry about how to establish threshold limits associated with CAPAs for facets other that process control. I assume that at a certain level, when evaluating non SPC CAPA data there reaches a point when you say "that's it - we have to do something" How are these threshold points set? I am assuming that you have to have some statistical basis for it. What do you think?

Collect the data and prioritize it based on an appropriate pareto analysis. Safety issues are critical and a top priority.

In Reply to Parent Post by senna

Finally, I know that SPC is a good method of evaluating your process controls for established threshold levels where corrective/preventive action must be initiated. But how do you set your upper and lower control levels? Again, any stats involved? If so, where can I find info on how to set these?

Limits are +/- 3 standard deviations. This is not the only criteria for instituting corrective action. Look at "Which detection rules should you use". Are you also looking for more comprehensive information on the subject?

[senna]

Al,
Yes, I would like some more detailed info on SPC and control charting in relation to corrective action. Also, can you expand on how Paretos can be used to set threshold limits. I am assuming their use would be at a high level (say, managemnt review) to see where the majority of your CAPAs are coming from. But could they be used "in the trenches" of performing an individual CAPA? If so, how?

Thanks in advance.

Senna

[Jim Wynne]

In Reply to Parent Post by senna

Al,
Yes, I would like some more detailed info on SPC and control charting in relation to corrective action. Also, can you expand on how Paretos can be used to set threshold limits. I am assuming their use would be at a high level (say, managemnt review) to see where the majority of your CAPAs are coming from. But could they be used "in the trenches" of performing an individual CAPA? If so, how?

Thanks in advance.

Senna

I think the problem here might be that you're expecting the data to make decisions for you. People have to be able to evaluate the available data and then make decisions based on the circumstances. Al suggested Pareto analysis, which is simply a way of prioritizing. Take action on the problems that are likely to cause the most trouble, whether in terms of safety or money spent, or some combination of the two.

The help that you get here will be of a general nature, because no one here knows your particular situation and what's most important to your company. You should never set triggers or thresholds; action should be taken based on relative importance and significance. If CAPA emanates from upper-level management review, it's probably too late. Upper management should be reviewing to insure that the system is working as designed, which would include making sure that problems are being solved at the lowest possible level.

[Al Rosen]

In Reply to Parent Post by senna

Al,
Yes, I would like some more detailed info on SPC and control charting in relation to corrective action. Also, can you expand on how Paretos can be used to set threshold limits. I am assuming their use would be at a high level (say, managemnt review) to see where the majority of your CAPAs are coming from. But could they be used "in the trenches" of performing an individual CAPA? If so, how?

Thanks in advance.

Senna

I think you may benefit from a short course in statistical techniques. Your local section of ASQ my have some short courses on SPC. Also look at "The Quality Tools Cookbook". It's not a substitute for a course, but it may give you insight as to how some of the tools are used.