Cove,

Having experience in many industries, with different quality systems, I felt comfortable with the nonconformance vs. corrective action scenario.

Here is the disagreement:

My position - Think about an excel spreadsheet logs for Product NCR, Process NCR, Internal Audits, etc... with a unique number for each. With every normality you have a response, for instance, the NCR identified at 1:100,000 with no previous activity, and no risk to the customer, and consistent with a FMEA expected failure rate may yield a corrective action response of continue to monitor (or something less severe - depends on industry). This NCR - Corrective Action may follow the 8D process with a local corrective action. However, a trend of many elevate this concern to a true CAPA level investigation. The only exception here is customer compliants that are immediately elevated to a system CAPA.

My peers - Each internal audit finding, 3rd party findings are elevated to the System CAPA. Because this is a system CAPA, the expectation from auditors is a full blown system investigation. However, at any time we have somewhere between 45 and 70 open CAPA's. How can you assign resources to this many CA's?

How do you handle Nonconformance C/A, Internal Audit C/A, 3rd Party C/A, and Process C/A as it relates to SYSTEM Corrective Action?

I have a question. Why do you have that many open CAPAs?

I am with Jennifer on this one.

The system here is 2 years old (been registered since the start of the year). I have only had 55 CAPA's since inception. There are currently 4 open CAPA's.

Why? No CAPA is issued for a single nonconformance or single customer complaint (although the option is there for more severe complaints).

I keep all CAPA's on a system level. This seems to gain more acceptance as management can see a potential benefit by dealing the issue outlined on the CAPA request.

Just my :2cents:

Cove,

Having experience in many industries, with different quality systems, I felt comfortable with the nonconformance vs. corrective action scenario.

Here is the disagreement:

My position - Think about an excel spreadsheet logs for Product NCR, Process NCR, Internal Audits, etc... with a unique number for each. With every normality you have a response, for instance, the NCR identified at 1:100,000 with no previous activity, and no risk to the customer, and consistent with a FMEA expected failure rate may yield a corrective action response of continue to monitor (or something less severe - depends on industry). This NCR - Corrective Action may follow the 8D process with a local corrective action. However, a trend of many elevate this concern to a true CAPA level investigation. The only exception here is customer compliants that are immediately elevated to a system CAPA.

My peers - Each internal audit finding, 3rd party findings are elevated to the System CAPA. Because this is a system CAPA, the expectation from auditors is a full blown system investigation. However, at any time we have somewhere between 45 and 70 open CAPA's. How can you assign resources to this many CA's?

How do you handle Nonconformance C/A, Internal Audit C/A, 3rd Party C/A, and Process C/A as it relates to SYSTEM Corrective Action?


The standard states very clearly:

8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.

If your method will achieve this, (and it can if done correctly), then it meets the requirement. Why use a "one-size-fits-all" approach to problem solving?

...No CAPA is issued for a single nonconformance or single customer complaint (although the option is there for more severe complaints).




Your approach may be pretty good, but most customers expect a CA in their preferred format for each official complaint, not just the most severe ones. You may apply your approach for trends to PAs, but CAs are failures already occuring.

Our system does allow for responding to customers that demand a corrective action for each complaint. However, it tends to result in an incomplete corrective action (instinct is to ensure that particular customer is happy - instead of analyzing the entire process that was used for that customer).

I have seen too many CA systems that require a CA for each and every nonconformance! :mg: That is NOT the intent of the standard (to quote 2 members of 176 that I deal with on a regular basis).

"Corrective actions shall be appropriate to the effects of the nonconformities encountered" means that the odd production line error/nonconformity does not necessarily require a CA; however, if that error is being repeated and/or may have a major impact on your business then a CA is absolutely required.

Granted - in Automotive or Aerospace this may be different; however, there is no requirement to have a CA for every nonconformance. It would be extremely cumbersome with little to no ROI.

Until the ISO g-ds strike me down - I will stick to this. I do not develop systems that create paperwork to the level that nobody wishes to complete the forms or process. I meet the requirements and use the system to improve the business over time (with the exception made for moves of advancement).

:2cents:

Cove,
How do you handle Nonconformance C/A, Internal Audit C/A, 3rd Party C/A, and Process C/A as it relates to SYSTEM Corrective Action?

Internal audit C/A: it's not a C/A, strictly speaking, because you must remove the cause of the audit NC, whereas you may decide to do nothing about other types of NC, as already described in this thread.

Otherwise, can somebody explain these categories (Nonconformance C/A, Process C/A, System C/A)? Don't they complexificate an otherwise simpletudinous conceptualizationment?

Until the ISO g-ds strike me down - I will stick to this. I do not develop systems that create paperwork to the level that nobody wishes to complete the forms or process. I meet the requirements and use the system to improve the business over time (with the exception made for moves of advancement).


This is great. Thank you. :applause::applause::applause:

Cove,
...............
How do you handle Nonconformance C/A, Internal Audit C/A, 3rd Party C/A, and Process C/A as it relates to SYSTEM Corrective Action?

I have one C/A system. Supplier NCR data, Process NC data, internal audit NC data, and 3rd Party or Customer NC data all feed into the same C/A system.

Internal audit and Customer NC's always create a C/A. For supplier and process NC data C/A is created on significant or repeated events. This helps limit the # of open C/A's at any one time.