What would you give up to prove conformity and honesty?

somashekar

Staff member
Super Moderator
#11
I think the adjective "readily" modifies "identifiable" but not "retrievable." I think this not only because of sentence structure, but because there might well be times (for example) when records have been archived off-site and can't be immediately retrieved, but are indeed retrievable.

I agree with you about effectiveness, though, if there's even an issue here.
Very true ...
Still the response remains that it is either presented for evidence or mentioned that it is archived. The situation explains lack of timely record presentation.
 
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Ka Pilo

#12
It's not at all apparent (to me, at least) what question is being asked here. I look at the thread title, the question that forms the last sentence of your post, and the mystifying bit about egg-cutting and I'm lost. Can you clarify your question?
I'm interested about auditor's point of view on auditee's bet. A testicular offer for insurance shows enough confidense that inspection happened and batch number of product was indicated in the Fill Weight Monitoring Form. But, of course, it will not be relevant to the quality management system. What can an auditee guarantee that could be acceptable to an auditor why he should be given extention to look for the record of Fill Weight Monitoring? If he will be cited nonconformity on it, then the implication would be the filled up forms were not reviewed by Supervisor and there was a problem regarding monitoring. Therefore, the Audit Report to be submitted to management would contain specific deviation he (supervisor) alledgedly committed. Supervisor was trying to argue that he did not deviate any monitoring and review activities. It's fine by him if the nonconformity is related to retrieval of records.
 
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Jim Wynne

Staff member
Admin
#13
<snip> What can an auditee guarantee that could be acceptable to an auditor why he should be given extention to look for the record of Fill Weight Monitoring. If he will be cited nonconformity on it, then the implication would be the filled up forms were not reviewed by Supervisor. Therefore, the Audit Report to be submitted to management would contain specific deviation he (supervisor) alledgedly committed. Supervisor was trying to argue that he did not deviate any monitoring activities. It's fine by him if the nonconformity is related to retrieval of records.
I think we're getting closer to a question. Leaving aside metaphorical pledges to sever one's own anatomical appendage, it appears that the problem is that the supervisor is concerned that the auditor will report that no record exists (thus reflecting poorly on the auditor) rather than the actual observed fact that no record was produced.

Auditors should report what they observe, not what the implications of the observation might be. The effectiveness of records management might rightly be called into question, but maybe not, depending on the nature of the record and the general ongoing need to be able to retrieve it in a reasonable amount of time.

Furthermore, the reason(s) given by the auditee for inability to produce the record should be taken at face value unless there's good reason not to. If the auditee honestly says "I can't get to right now it because the guy in charge of it isn't here," it's a different thing than his saying that his dog ate it or that it was spirited off in the night by record-stealing demons.
 

Wes Bucey

Quite Involved in Discussions
#14
I would not stop an audit because a record could not be found...however, if the auditee required 2 days to find the record AND the audit was still on-going, I would accept the record as evidence to the original issue but I'd have new concerns regarding training, designates and the records management process overall.

What would have happened if this was a customer asking for a record as evidence in a legal or high-priority issue? Do you think the customer would accept a 2-day wait period?
Probably not much would happen. Over the course of my lifetime, I have had subpoenas for records served on others and also had them served on me. The reality is that there are myriad reasons why retrieving and surrendering records takes time, sometimes even months as attorneys wrangle over whether they are legally required to obtain or surrender the requested records. Retrieving alone can present a lot of stumbling blocks. Are the records on computer? stored off site in an archive? not yet reviewed for sufficiency before being archived?

Rarely will courts enforce even contract terms requiring "instant" production and surrender of records. I once filed a freedom of information request which the federal government delayed for eight months while several layers of officials went through deleting (blacking out) data they thought "privileged."

Records shall remain legible, readily identifiable and retrievable.
....from the ISO9001
Records Custodian took an Absence Without Leave.....or with leave, or resigned from the organization..... still records shall remain legible, readily identifiable and retrievable.
As we often hear in the USA, "S--- happens!" Computers break down. Employees are absent and remaining employees cannot be spared from their own duties to answer someone's whim instantly. A request for time to comply is not out of line.

What's the time limit between request and retrieval?
I am not questioning the standard. I am, in fact, adhering to it. As Jim asked, what is the time limit between requesting a record and retrieving it for presentation? 5 minutes? 30 minutes? 1 business day? 2 business days? Does it depend on the record being retrieved?

What I am questioning, however, is the effectivess of the Original Poster's system for records management. If, for example, a customer was requesting a record for a high-priority issue, would the organization (or the customer) accept a 2-day retrieval time? Many would not...in my opinion. Common sense does imply that 2-days is perhaps contrary to use of the of the word "readily" in the Standard.

The organization's process for records management could use some improvement, that is a given...but the actual finding is still subject to being defined.
I think the adjective "readily" modifies "identifiable" but not "retrievable." I think this not only because of sentence structure, but because there might well be times (for example) when records have been archived off-site and can't be immediately retrieved, but are indeed retrievable.

I agree with you about effectiveness, though, if there's even an issue here.
I think the issue should not be the elapsed time between request, then retrieval, then surrender. I understand from the discussion to this point that the requested documents are RECORDS (evidence of past activity) and NOT documents needed to assure production to meet customer requirements. I agree documents necessary to assure production meets customer requirements need to be readily accessible to point of production, but I'm pretty sure the Standard is silent about accessibility of records, specifically whether they must be accessible within any period of time.

I'm interested about auditor's point of view on auditee's bet. A testicular offer for insurance shows enough confidense that inspection happened and batch number of product was indicated in the Fill Weight Monitoring Form. But, of course, it will not be relevant to the quality management system. What can an auditee guarantee that could be acceptable to an auditor why he should be given extention to look for the record of Fill Weight Monitoring? If he will be cited nonconformity on it, then the implication would be the filled up forms were not reviewed by Supervisor and there was a problem regarding monitoring. Therefore, the Audit Report to be submitted to management would contain specific deviation he (supervisor) alledgedly committed. Supervisor was trying to argue that he did not deviate any monitoring and review activities. It's fine by him if the nonconformity is related to retrieval of records.
WOW! I've been guilty of florid and purple prose, but this exceeds any of my wildest excesses. I'm not sure I even understand what a "testicular offer for insurance" entails, and I'm pretty sure I don't want to. To the point of the post: Nobody but the auditor has a say in exactly what NC the auditor may write, if any.

I think we're getting closer to a question. Leaving aside metaphorical pledges to sever one's own anatomical appendage, it appears that the problem is that the supervisor is concerned that the auditor will report that no record exists (thus reflecting poorly on the auditor) rather than the actual observed fact that no record was produced.

Auditors should report what they observe, not what the implications of the observation might be. The effectiveness of records management might rightly be called into question, but maybe not, depending on the nature of the record and the general ongoing need to be able to retrieve it in a reasonable amount of time.

Furthermore, the reason(s) given by the auditee for inability to produce the record should be taken at face value unless there's good reason not to. If the auditee honestly says "I can't get to right now it because the guy in charge of it isn't here," it's a different thing than his saying that his dog ate it or that it was spirited off in the night by record-stealing demons.
Yep. Auditors don't guess. They're like Sgt. Joe Friday, "Just the facts, ma'am."

Actually, though, some auditors might appreciate hearing a delay in retrieval was caused by something like "his dog ate it or that it was spirited off in the night by record-stealing demons.";)
 
#16
I think we'd need to know a lot more about why this audit is being conducted, the scope etc., before any substantial answer can be given! Is this audit of another process, of which records are a small (important, maybe) part? Do we have issues of records not being there, when needed for analysis, in preparation for a review of performance, for example? Was this just one of those things the auditor stumbled over? 1 record?

Simply because one person wasn't available, at short notice - real life situation - does that mean the records process is broken, in need of management's attention, including having someone act as 'back up'? What's wrong with looking into a documented procedure to see what that says to assist the remaining folks standing there?? Frankly, I see a lot of mountain being made from even less of a molehill... Methinks the auditor is in need of some heavyweight coaching!
 

Wes Bucey

Quite Involved in Discussions
#17
I think we'd need to know a lot more about why this audit is being conducted, the scope etc., before any substantial answer can be given! Is this audit of another process, of which records are a small (important, maybe) part? Do we have issues of records not being there, when needed for analysis, in preparation for a review of performance, for example? Was this just one of those things the auditor stumbled over? 1 record?

Simply because one person wasn't available, at short notice - real life situation - does that mean the records process is broken, in need of management's attention, including having someone act as 'back up'? What's wrong with looking into a documented procedure to see what that says to assist the remaining folks standing there?? Frankly, I see a lot of mountain being made from even less of a molehill... Methinks the auditor is in need of some heavyweight coaching!
We don't have a statement a NC was issued. All we know about the auditor is that he asked for records and further, since a guy was absent, could the auditee find the record within two days. We don't have any evidence of the auditor being a hardass about the request. All of the drama is in the heads of the supervisor being audited and in our OP's head. The charged language (AWOL, "cut one egg," "testicular insurance"), while beyond my normal usage, give me the impression folks at the auditee are wound a little too tightly. If I were the auditor, the slang and panic at a simple request would stir my curiosity that I had missed something really important and that this excitement was an attempt to distract me from that.
 
#18
We don't have a statement a NC was issued. All we know about the auditor is that he asked for records and further, since a guy was absent, could the auditee find the record within two days. We don't have any evidence of the auditor being a hardass about the request. All of the drama is in the heads of the supervisor being audited and in our OP's head. The charged language (AWOL, "cut one egg," "testicular insurance"), while beyond my normal usage, give me the impression folks at the auditee are wound a little too tightly. If I were the auditor, the slang and panic at a simple request would stir my curiosity that I had missed something really important and that this excitement was an attempt to distract me from that.
I suspect that, like a lot of internal audits, they are conducted without the correct planning and preparation necessary to prevent this type of situation developing. Most audits tend to foster an air of 'gotcha' in such a situation. I'd be very surprised if the auditor had met with the supervisor before hand to discuss the purpose etc of the audit. As a result, the auditee 'looks' like they are 'out to get' the auditee and, the result is what we (apparently) have described here...

Time for an adjustment in the way the audits are planned and performed to get away from external audit techniques...hence my comment about coaching.
 
K

Ka Pilo

#19
If the auditee honestly says "I can't get to right now it because the guy in charge of it isn't here," it's a different thing than his saying that his dog ate it or that it was spirited off in the night by record-stealing demons.
I agree and if he hosnestly says "I can't get to right now it because the guy in charge of it isn't here," his balls will not be put in compromise position. I have heard someone giving an arm and a leg for a loved one, but internal auditing is a different thing.
 
K

Ka Pilo

#20
I think we'd need to know a lot more about why this audit is being conducted, the scope etc., before any substantial answer can be given!
To check if the plant is in compliance with ISO 22000, ISO 9001, HACCP, and GMP requirements.
Is this audit of another process, of which records are a small (important, maybe) part? Do we have issues of records not being there, when needed for analysis, in preparation for a review of performance, for example? Was this just one of those things the auditor stumbled over? 1 record?
The internal Auditor picks up a random material from the storage and noted that there was no lot/batch code from the supplier. So, he asked the auditee to show a record showing batch number of product or any internally generated lot number indicated in the Monitoring Form for traceability purposes e.g. where the product was delivered, etc.
 
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