Records are a special type of document - Can anyone clarify this statement? 4.2.3

Jim Wynne · Aug 24, 2005

Wes Bucey said:
Even I agree to the "no harm, no foul" aspect. In the case of the data recorded with an erroneous part number cited earlier, "scratching out" is close, but the ideal is a single line through the error, allowing readability, but signifying deletion, together with the correct part number, plus a notation of why the change is made is preferable to redoing or total scratch out.

As a manager of folks who may make such an error, I'd like to know the errors occur and look for a root cause so our organization can do either CA or PA (including "mistake proofing") to prevent recurrence.

I have no problem with correction of an error, so long as there is an audit trail of the error, who corrected it, when, and why. Without such data, how do I know whether the change was legitimate?

In lab and invention scenarios, patents have been lost on such minutiae as white out, erasure, unnotated changes.

In the case I cited, the only important thing is that the correct data gets filed. If you don't trust people to file the correct data, then you have a different problem, and if you play the CA/PA card every time a harmless error is made, you'll drive everyone crazy. Our job as managers includes the responsibility to understand the difference between problems and creating them.

Randy · Aug 24, 2005

tarheels4 said:
Well my original thought related to a record of aspects and impacts. Not results recorded by a machine operator taking refactometer measurements.

Some companies have aspects and impacts recorded electronically and review and change as needed. And may record any changes on the bottom of the form as a change record.

This is a little different than changing paper copies that are covered with oil and grease.

There is a requirement to review and revise, when that's done the old list actually becomes a record of previously id'd A&I's and the revised list becomes....a list in active use. In other words a systems document subject to review and revision.

Wes Bucey · Aug 25, 2005

JSW05 said:
In the case I cited, the only important thing is that the correct data gets filed. If you don't trust people to file the correct data, then you have a different problem, and if you play the CA/PA card every time a harmless error is made, you'll drive everyone crazy. Our job as managers includes the responsibility to understand the difference between problems and creating them.

If the notation for the correction is sufficient, no CA/PA gets triggered. What drives ME crazy is to come across a correction with no notation of who made it, when it was made, or why.

Wouldn't you be the least bit curious "how" the wrong part number ended up on the previously cited document?

Anal retentive business managers ALSO recognize when a mistake is just a mistake, but the best ones look to improve the process and NEVER punish people for mistakes. The curse is the incompetent manager who looks to blame people instead of processes. If you can remove FEAR of reprisal from the situation, a worker won't be driven to cover up an error by making a surreptitious correction.

One of the reasons I am such a champion of mistake proofing is because I fervently believe in prevention of nonconformance versus detection of nonconformance.

nickh - 2011 · Aug 25, 2005

vinaynin said:
can any one clarify regarding above- which type of Records should considered as documents and how it will controlled as per 4.2.4 (Control of Records)

While there have been a lot of good points made here, I'm not sure the question was ever answered.

Vinaynin, did you mean the general concept of "what is a record?" or were you looking for specific examples of what types of quality records should be included in a formal records retention policy?

If it's the latter, then you can find a few records retention example files in the elsmar attachments: https://Elsmar.com/Forums/fileslist.php

The matrices at the bottom of that page should give you a pretty good idea of what you need to retain. Additionally, your policy should also stipulate how long the records shall be retained and in what form (e.g., electronic vs. hardcopy). For some records, there are also legal considerations to take into account when deciding this.

Baldrick · Aug 25, 2005

Define what you do

I'm pretty much with Randy throughout this thread. Essentially, documents are living things and records are historical evidence. This is taken from ISO9000:

2.7.2 Types of document used in quality management systems

The following types of document are used in quality management systems:

a) documents that provide consistent information, both internally and externally, about the organization's quality
management system; such documents are referred to as quality manuals;

b) documents that describe how the quality management system is applied to a specific product, project or contract;
such documents are referred to as quality plans;

c) documents stating requirements; such documents are referred to as specifications;

d) documents stating recommendations or suggestions; such documents are referred to as guidelines;

e) documents that provide information about how to perform activities and processes consistently; such documents
can include documented procedures, work instructions and drawings;

f) documents that provide objective evidence of activities performed or results achieved; such documents are referred to as records.

I think the only advice I would add is that if Vinay is worried about being "dinged" during an audit for confusing records and documents, then the best thing to do is make sure you define in your procedures what YOU believe to be documents and what YOU believe to be records.

That way, the worst you should get out of an auditor is a minor NC or an OFI, possibly after a debate.

This approach works for other clauses where the intent of the standard is not always clearly defined (e.g. supplier development). If you're unsure what is wanted, don't do nothing...state what you believe to be right (and why), and let the auditor challenge your philosophy.

vinaynin · Aug 25, 2005

Again my question is which type of records are special type of documents ? in our quality management system we have already differentiate between Documents & Records. All the records are controlled through Master List of Records- contents are Sl. No., Record Description, Record No. ,Form/ Format No., Location, Responsibility , Filing Method, Retention Period.- but we have not addressed in our QMS, Records- Special type of documents?

I just wanted to know the intent of writing this-“Records are special type of documents” is it Records like –Trial Runs, Capability Reports etc. used for future referance and it’s retention period should have more compare to general records and also it should have distribution matrix like master list of documents.

Please guide me further.

Vinay

Cari Spears · Aug 25, 2005

vinaynin said:
Again my question is which type of records are special type of documents ?
I just wanted to know the intent of writing this-“Records are special type of documents” ... it’s retention period
should have more compare to general records and also it should have distribution matrix like master list of documents.

Not at all, V. Sounds like your controlling your records just fine. They are saying "records are a special type of document" - they only mean that records are special because they are "filled out" and retained as evidence. They do not mean that you have to further describe "special records".

Welcome to the cove! :bigwave:

SteelMaiden · Aug 25, 2005

Cari won't lead you wrong...all records are a special type of document, they provide evidence of what has happened, and need to be controlled so that you can read them, get to them in a reasonable amount of time, and also make a decision on how long you need to retain them, what is their life span? There is no need to keep a record for 20 years if the lifespan of the "product" or useful life of the information recorded is only 6 months. Don't make this stuff too hard.

Documents vs. Records seem to deal a lot of people fits in the beginning. You are not the first, nor will you be the last. I just think of it this way, the blank form is a document, but once I fill it out it becomes a record.

ddunn · Aug 25, 2005

SteelMaiden said:
I just think of it this way, the blank form is a document, but once I fill it out it becomes a record.

Let me qualify this statement a little

Once you fill it out and validate the information it becomes a record.

ralphsulser · Aug 25, 2005

SteelMaiden said:
I just think of it this way, the blank form is a document, but once I fill it out it becomes a record.

I agree with Steel on this one. Every recorded piece of informattion or data cannot possibly be validated, there is way too much. Sampling of the info can be validated.

Records are a special type of document - Can anyone clarify this statement? 4.2.3

Jim Wynne

Randy

Wes Bucey

Prophet of Profit

nickh - 2011

Baldrick

vinaynin

Cari Spears

Super Moderator

SteelMaiden

Super Moderator

ddunn

ralphsulser

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