8.3.2.1 Monitoring/Measurement Audit Finding

[John B.]

Any help is greatly appreciated.

During our last audit we could not produce any evidence of a feature called out on the CP was being measured.

An 8D has been started.

D3 (Interim Containment Action) - Correct Receiving Inspection Instructions to measure and record feature. Sample in house parts. If any are found to have this feature out of spec. Implement 100% inspection of all parts in house.

Question: How do i verify effectiveness of ICA? If no defects are found can I consider it verified?

Gratefully,
John

 

[AndyN]

Any help is greatly appreciated.

During our last audit we could not produce any evidence of a feature called out on the CP was being measured.

An 8D has been started.

D3 (Interim Containment Action) - Correct Receiving Inspection Instructions to measure and record feature. Sample in house parts. If any are found to have this feature out of spec. Implement 100% inspection of all parts in house.

Question: How do i verify effectiveness of ICA? If no defects are found can I consider it verified?

Gratefully,
John

No, you simply audit that the feature is being measured! End of story. You might want to see if other CPs are being followed closely - how did this get past your own internal audits? Does anyone do CP audits? Your root cause may also lie there!

 

[John B.]

Thanks AndyN.

What happened was that someone recently (between internal audits) made a change to the master CP without notifying anyone.

Our 5-why:

Why 1. Control Plan not followed
Why 2. Because nobody knew it changed
Why 3. No flow down of Control Plan to RII (Receiving Insp Instr)
Why 4. Control Plan modified outside of review process
Why 5. No requirement to review Control Plan accuracy to eng dwg and RII before release to floor

Root Cause: Unrestricted access to CP software

Comments/Thoughts?

Gratefully,
John

 

[AndyN]

Thanks AndyN.

What happened was that someone recently (between internal audits) made a change to the master CP without notifying anyone.

Our 5-why:

Why 1. Control Plan not followed
Why 2. Because nobody knew it changed
Why 3. No flow down of Control Plan to RII (Receiving Insp Instr)
Why 4. Control Plan modified outside of review process
Why 5. No requirement to review Control Plan accuracy to eng dwg and RII before release to floor

Root Cause: Unrestricted access to CP software

Comments/Thoughts?

Gratefully,
John

Surely the 5 Why's should be focused less on the CP and more on why someone changed the CP and followed the document control/CP change procedure and - it appears - no one knew?

Is this a deficiency of the change procedure? How do people become informed of CP changes? Didn't an alarm go off with someone?

I'm left wondering how your change control process works and if it should be beefed up or whether this individual plain just didn't follow it. I'm feeling like your own internal audit should do a deep dive on the story around this situation...

 

[John B.]

Thanks Andy.

The teams focus is initially on protecting the customer. Measuring and recording the missing feature.

Based on the root cause we are driving towards a PCA that addresses the change procedure.

We do not have a "Change Review Board". Honestly our system is a manual system consisting of "check sheets" and routers. Anyone with access can make a change without intiating the "check sheet" and router. The software does not require a new revision. You can type right over, delete or add anything to PFD, FMEA or CP.

Gratefully,
John

 

[bpritts]

I would reinforce Andy's comments - who changed the CP without then updating the appropriate inspection instruction? That seems to be the broken link.

In our company, the people updating the CP are the same ones accountable for developing the appropriate instructions. So the responsibility would be clear. Now, we're very small. So, if someone changes the CP in a bigger organization perhaps they should be responsible to advise the people creating and maintaining the inspection instructions, and doing the inspection -- to make sure that the CP "happens".

To verify the effectiveness, you might consider auditing several more CP's to verify that all of the specified inspections are included on inspection instructions, and being done. In particular, it might be good to check the most recently changed CP's to ensure that they were accurately implemented.

Verification of effectiveness is intended to focus on the root cause (broken link from CP - implementation) -- NOT the details of the inspection.

Hope this helps!

Brad

 

[AndyN]

Thanks Andy.

The teams focus is initially on protecting the customer. Measuring and recording the missing feature.

Based on the root cause we are driving towards a PCA that addresses the change procedure.

We do not have a "Change Review Board". Honestly our system is a manual system consisting of "check sheets" and routers. Anyone with access can make a change without intiating the "check sheet" and router. The software does not require a new revision. You can type right over, delete or add anything to PFD, FMEA or CP.

Gratefully,
John

John, you don't need a review board. What's needed is a key mechanism in your document control procedure and some other basic controls. In fact, having a manual system makes it good to instil some discipline in people before making it electronic. I'd suggest that the key mechanism is a "Document Change Request/Note" and this is walked around the various functions who should sign off on changes. Make only one or two (admin) people responsible for implementing the change in the document etc.