Root Cause - Nonconformance Procedure Content Requirements

[yscha]

Hi everyone!

We have separate procedures for Nonconformance and Corrective/Preventive Action in a Service based company. We go into great detail in our CPA procedure on root cause analysis; however, we currently have no guidance in our nonconformance procedure.

How much detail do we need for RCA in our nonconformance procedure and does anyone have a services based procedure they would like to share?

Thanks!

Yshca

 

[samsung]

Hi everyone!

We have separate procedures for Nonconformance and Corrective/Preventive Action in a Service based company. We go into great detail in our CPA procedure on root cause analysis; however, we currently have no guidance in our nonconformance procedure.

How much detail do we need for RCA in our nonconformance procedure and does anyone have a services based procedure they would like to share?

Thanks!

Yshca

There's no absolute requirement for a separate NC procedure. 'Nonconformance Procedure' (stating how a nonconformance will be resolved) per say, is basically part of the 'Corrective Action' procedure. You may combine both to make a single procedure to address the various requirements of 8.5.2 (if it relates to 9001). As for the details of RCA procedure, it should, as a minimum, have the description of:

- How the root cause (means methods like 5 Why, Fish Bone or 8D etc.) will be determined?
- Who will conduct RCA, effects of NC, criteria for determining it's potential severity and the actions needed ? It's not necessary that the person determining the RCA is capable to propose a CA as well.
- Who and how an action will be implemented?
- Who will review whether the actions have been implemented in the best possible way and were the action needed?
- How to proceed if the actions don't work? etc. etc.

Hope this help.

 

[AndyN]

Hi everyone!

We have separate procedures for Nonconformance and Corrective/Preventive Action in a Service based company. We go into great detail in our CPA procedure on root cause analysis; however, we currently have no guidance in our nonconformance procedure.

How much detail do we need for RCA in our nonconformance procedure and does anyone have a services based procedure they would like to share?

Thanks!

Yshca

Since they are two different requirements, I'd suggest that you keep them that way. How a non-conformance is managed shouldn't automatically imply that a full blown corrective action - including root case - is triggered. Having worked in service industry, as with most other types of industry, there are times when you'll just 'shrug your shoulders' and correct something. For example, sometimes, once in a number of occasions a binder of training materials would spring open and the pages spill into the shipping box. We weren't about to do a root cause analysis with FedEx or the binder makers to see why this happened. We'd document it, shrug our collective shoulders and replace the whole binder...

 

[RoxaneB]

Since they are two different requirements, I'd suggest that you keep them that way. How a non-conformance is managed shouldn't automatically imply that a full blown corrective action - including root case - is triggered. Having worked in service industry, as with most other types of industry, there are times when you'll just 'shrug your shoulders' and correct something. For example, sometimes, once in a number of occasions a binder of training materials would spring open and the pages spill into the shipping box. We weren't about to do a root cause analysis with FedEx or the binder makers to see why this happened. We'd document is, shrug our collective shoulders and replace the whole binder...

The issue of whether to have these topics addressed in a singular document or multiple is up to the organization ensuring it selects the method that best suits its needs. Those small companies with minimal people impacting the nonconformance resolution may want a nice, simple procedure. Those organizations where there multiple paths for a nonconformance to take, sometimes multiple documents is the way to go.

However, as AndyN said, a nonconformance does not always mean you'll be doing root cause analysis. It's a correction...a wham!bam!let's-get-back-to-doing-business kind of situation for the small stuff.

For example...

Let's say a supplier delivers the items requested but forgets to include the packing slip. Oh well. Call him up..have said packing slip faxed/emailed over. Item is received properly received.

However, if this supplier continually "forgets" to include the packing slip, that implies a systematic issue and a full blown corrective action may be the way to go.

Developing trigger points will help your organization know when to do correction versus corrective action...i.e., when to follow the nonconformance procedure or the corrective action procedure.

 

[samsung]

Yascha,

Since your actual question relates to the details of RCA (once you have decided to carry out anyway), please look for the post attachment list for "Drill Deep Root Cause Analysis Sheet" and also "Root Cause Analysis for Beginners" which I'm sure will be of some help to you.

 

[jkuil]

The non-conformance procedure primarily serves the purpose of determining the disposition of the non-conforming product or service. Which corrections need to be taken: repair, rework, additional service, scrap. Secondly, the need for a corrective action is determined. For this the frequency of occurance is determined based on historic non-conformance data. Also the severity of the consequences of the non-conformity are assessed. Basically, you perform a risk assessment. If the risk is deemed inacceptable, the corrective action procedure must be started by determining the root cause. If the non-conformity has low associated risk (incident with minor consequences) they is no need for RCA as you will not take any corrive actions to eliminate the cause. It is just wasted energy.