Clause 7.1.5 Monitoring and measuring resources

[eule del ayre]

Good Evening from the Philippines.

Hoping anyone will help me on this problem.

Can anyone help me answering to my NCCAR given by our Certifying Body.

Regarding on 7.1.5 Monitoring and Measuring Resources.

This is the statement given by our Certifying Body
Control of Monitoring and Measuring Equipment Procedure (LPC P-24) was established but procedure only talks about measuring equipment. The only activity identified to maintain measuring equipment is verification. It is not clearly evident if difference of Monitoring Equipment vs. Measuring equipment is clear to the organization. This is also true for Verification vs. Calibration

LPC-P-24 is our Procedure, yet I am new to the process and this was the Procedure when I was transferred to Calibration.
The Procedure meant only to Measuring and did not discuss any Monitoring in it.
It only tackle verification only and no Calibration in it.

Can you guys help me answering the NCCAR I'm having a trouble answering it by myself.

Please and thank you, any root cause will help, I will make any 5 whys to it after.

 

[Randy]

Please and thank you, any root cause will help, I will make any 5 whys to it after.

Only you and others familiar with your situation, organization, activities and history can do your root cause.

Your request is the same as saying "I'm hungry" and expecting satisfaction from someone else eating a meal for you.

 

[eule del ayre]

Your request is the same as saying "I'm hungry" and expecting satisfaction from someone else eating a meal for you.

Sorry for being greedy but yes, that's the same thing for the NCCAR should be send within 7 working days.
what I'm trying to say is, IS THERE ANY EXCUSES THAT THOSE LISTED ABOVE WAS NOT ON THE PROCEDURE?
I mean I can't think of any, because I was just transferred to Calibration, and yet my supervisor is giving me the responsibility to answer the NCCAR

 

[Mike S.]

All I can do is speculate, and if the person who wrote the procedure is unavailable for you to ask, maybe all you can do is speculate as well. Is that person unavailable (i.e. no longer with the company)?

If that is the case, I would state in my CAR response that since the original author of the procedure is unavailable, all I can do is speculate on the root cause, and that the most likely cause is that the author did not thoroughly understand the requirement of the standard.

 

[eule del ayre]

If that is the case, I would state in my CAR response that since the original author of the procedure is unavailable, all I can do is speculate on the root cause, and that the most likely cause is that the author did not thoroughly understand the requirement of the standard.

Well this is one of my so many root causes sir, but hear me out, before the certification audit (surveillance audit) we had the so-called internal audit right. Before the internal audit I was transferred to calibration, which little did I know the procedure was lacking. But didn't really study well the procedure because the one handling the calibration got no endorsement.

But if I will do that, didn't the internal audit was lacking? not my procedure? that's why I needed you guys to give me insights.

Before Calibration, I handle Chemicals under QA (MSDS, GHS, PCO stuffs)

But I really appreciate your answer, the problem is if I do that, wouldn't that reflect first to Internal audit, that's what I'm thinking sir.

 

[Mike S.]

Personally, I think you're over-thinking this, making it harder than it needs to be.

Just because an external auditor finds a NC doesn't mean the internal audit process failed. All auditors are just sampling, not auditing everything. And internal auditors generally audit to the company's procedures and documents, not to the standard itself.

Unless this was the very first audit by the "certifying body" didn't they, too, fail to detect this as a NC in the past?

If it were me, I would just move on. I'd say since the original author of the procedure is unavailable, all I can do is speculate on the root cause, and that the most likely cause is that the author did not thoroughly understand the requirement of the standard. The corrective action is that you are the new person in charge of the area, you now understand the requirements, and you have done x, y, and z to fix the problem.

 

[eule del ayre]

If it were me, I would just move on. I'd say since the original author of the procedure is unavailable, all I can do is speculate on the root cause, and that the most likely cause is that the author did not thoroughly understand the requirement of the standard. The corrective action is that you are the new person in charge of the area, you now understand the requirements, and you have done x, y, and z to fix the problem.[/QUOTE]

- Nicely done sir, you're right I am over-thinking.

Unless this was the very first audit by the "certifying body" didn't they, too, fail to detect this as a NC in the past?
- Yes, after my supervisor said in the meeting this morning (Philippine time) they fail to detect this in the past, so they now give us an NC (minor) over it. Since we have the procedure yet focusing on Measuring tools only neglecting the monitoring tools, and No Calibration statement whatsoever on the procedure just verification.
For what I remember in the morning meeting, my supervisor said, "The Auditor are leveling up and need thorough auditing, reflecting Standards to our Procedures"

But thank you sir for helping me enlighten and understand what I will gonna do to this NCCAR.

Well Appreciated.

 

[BradM]

Hello there!!

I'm confused. Are you saying you were issued a CAR because your procedure didn't have the word "calibration" in it?
Your instrumentation... are you performing... checks/ calibrations/ verifications with traceable standards?

What exactly is the deviation?

 

[eule del ayre]

I'm confused. Are you saying you were issued a CAR because your procedure didn't have the word "calibration" in it?
Your instrumentation... are you performing... checks/ calibrations/ verifications with traceable standards?

What exactly is the deviation?

Good Morning From Philippines sir,

Sorry about the confusion sir, well the procedure indicates just verification only, but what the supervisor told me to do was to initiate the calibration.
On the day of Third Party Audit, when they review the procedure, the procedure indicates verification only, and tried questioning me, "So you're in-charge in the calibration, let me see your procedure and understand it".
What we really do, technically was calibration (external service provider) for small tool and measuring equipment, and they started to question me about, if I understand the word Calibration vs. Verification.
To make it short Sir, we perform calibration (external service provider) but on the procedure it says verification only, we didn't include external service provider.

Another Problem is that the our procedure LPC-P-24 called Control of Monitoring and Measuring Equipment Procedure, does not include the Monitoring Equipment.

 

[BradM]

I fixed your quote in the last post; it makes is so much easier to read.

Good Morning From Philippines sir,

Sorry about the confusion sir, well the procedure indicates just verification only, but what the supervisor told me to do was to initiate the calibration.
On the day of Third Party Audit, when they review the procedure, the procedure indicates verification only, and tried questioning me, "So you're in-charge in the calibration, let me see your procedure and understand it".
What we really do, technically was calibration (external service provider) for small tool and measuring equipment, and they started to question me about, if I understand the word Calibration vs. Verification.
To make it short Sir, we perform calibration (external service provider) but on the procedure it says verification only, we didn't include external service provider.

Another Problem is that the our procedure LPC-P-24 called Control of Monitoring and Measuring Equipment Procedure, does not include the Monitoring Equipment.

Ok... for the moment.... set aside your procedure and the CAR.

You have a facility with instruments that are used that need to have their accuracy verified. So someone uses a traceable standard, makes checks on them against some procedure/ work instruction, and documents that somehow.

Regardless of this main procedure or the CAR, is that currently happening?