Control of Records - Lets talk about modern methods

[Gman2]

I have done some digging around on this topic and a lot of the stuff I have found on here has been older information. Some of the examples I like were the matrix type procedure that lists the documents, department, retention, storage and disposal listed.

But what I have also found opens up anyother huge can of worms I think.
Other folks were recommending that the PROCEDURE that referenced the FORM or RECORD should state the record requirements.

For me that is just unthinkable for one major reason, I do not have a procedure that relates back to all of the forms and documents we use. Not even close.

For example I do not have a procedure for management review. I's not required and we do not need one. I have an AGENDA that we stick to that complies with the requirements but it is not a procedure and is not referenced anywhere.

Another example is our purchase order requests, they are controlled, but I dont have a procedure for how to fill out a PO request. The form itself handles that.

I guess take those two examples and multiply it by every document/record we keep that is NOT a part of the required 6 procedures and you will see what I'm saying.


I am really striving here to eliminate as much documentation as possible becaused the last system here was so overblown it killed everyones interest and utimatly itself. It was really bad, for instance, the CFO of the company had a 3" binder FULL of full blown procedures along with full color graphics and screen shots filled with everyting from starting his computer to the step by step usage of his PHONE! And I am dead serious.
Now I have the job of bringing eveyone back on board. I am not going to create a procedure just to have one, if it does not benefit us at all and its not required then it will not exist.

Thoughts?

 

[John Broomfield]

Gman2,

A spreadsheet works fine as the filing and archiving procedure.

It informs record-keepers and record-users what to do, where to go and what to look for in making sure the records are retrievable.

Or you can digitize your records to make use of modern search engines (provided they become searchable PDF records instead of JPEG images).

As to when and how records are kept in the first place you can rely solely on your forms (electronic or hardcopy) for this.

Where you need to analyze the data collected by a form then consider making the form a fillable PDF.

Forget about specifying every form in a documented procedure, but of course you'll specify the form if the process risk assessment tells you the procedure must be documented.

John

 

[Marcelo]

Just some generic comments:

Something was not clear to me, when you mention "procedure" you mean "documented procedure", right?

If so, it seems that your records are in fact a mix of a documented procedure (remembering that the definition is: specified way to carry out an activity or a process) and a record (definition: document stating results achieved or providing evidence of activities performed).

Also, please note the "6 required documented procedures" are usually overshadowed by the other procedures that fit on "documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes" - those are the ones in big numbers.

Regarding the number of documents, something which is important (and most people do not do) is to ask, for each process , which documents are required for its effective planning, operation and control. This generally is done during the process mapping of the QMS. This is made very clear on this document: http://isotc.iso.org/livelink/livelink/fetch/-8835176/8835194/3541460/APG%2DMinDocumentation.doc.pdf?nodeid=3556498&vernum=-2 on auditing QMSs with minimum documentation.

 

[Pancho]

I have done some digging around on this topic and a lot of the stuff I have found on here has been older information. Some of the examples I like were the matrix type procedure that lists the documents, department, retention, storage and disposal listed.

But what I have also found opens up anyother huge can of worms I think.
Other folks were recommending that the PROCEDURE that referenced the FORM or RECORD should state the record requirements.

For me that is just unthinkable for one major reason, I do not have a procedure that relates back to all of the forms and documents we use. Not even close.

You do have a procedure that relates back to each of the forms and documents that you use. They may not be documented procedures, but they exist. Without such procedures, folks wouldn't know how to do their jobs.

Such undocumented procedures are partly implicit in your forms and partly reside in your employees minds. The part that resides in your employees minds is called "tacit knowledge", as opposed to the "explicit knowledge" found in documents.

The new Draft International Standard for ISO 9001:2015, in its Annex A (A.7) clarifies that "The balance between knowledge held by competent people and knowledge made available by other means is at the discretion of the organization, provided that conformity of products and services can be achieved."

While you may achieve conformity with lots of tacit knowledge, such conformity is fragile: Training and growth are difficult, knowledge leaves with people, and improvement doesn't stick.

Therefore, you should strive to convert tacit knowledge into explicit knowledge. This can be done over time if you have a functional continuous improvement process, with the accompanying required tools and organizational discipline.

For example I do not have a procedure for management review. I's not required and we do not need one. I have an AGENDA that we stick to that complies with the requirements but it is not a procedure and is not referenced anywhere.

Another example is our purchase order requests, they are controlled, but I dont have a procedure for how to fill out a PO request. The form itself handles that.

I guess take those two examples and multiply it by every document/record we keep that is NOT a part of the required 6 procedures and you will see what I'm saying.

As Marcelo says, the infamous "required 6 procedures" are a misreading of the standard. You need to have the documents "necessary to ensure the effective planning, operation and control of [your] processes". They should swamp the "required 6". If they don't, then your system is either immature or wallpaper.

I am really striving here to eliminate as much documentation as possible becaused the last system here was so overblown it killed everyones interest and utimatly itself. It was really bad, for instance, the CFO of the company had a 3" binder FULL of full blown procedures along with full color graphics and screen shots filled with everyting from starting his computer to the step by step usage of his PHONE! And I am dead serious.
Now I have the job of bringing eveyone back on board. I am not going to create a procedure just to have one, if it does not benefit us at all and its not required then it will not exist.

Thoughts?

Striving to "eliminate as much documentation as possible becaused the last system here was so overblown" may throw out the baby with the water. Inches of binder is not a good measure of knowledge, and nowadays, paper is not the best medium in which to hold your knowledge.

Use the right tools, document your processes and then improve on the documentation as you improve your processes themselves.

Good luck!

 

[Julie O]

Striving to "eliminate as much documentation as possible becaused the last system here was so overblown" may throw out the baby with the water. Inches of binder is not a good measure of knowledge

It's not a good measure of whether a system is "overblown," either. I'm not sure what that measure might be. I think most of the time it probably means that the system exceeds the capacity and/or willingness of the company to manage it.

 

[Julie O]

I dont have a procedure for how to fill out a PO request. The form itself handles that.

Purchasing departments usually maintain procedure(s) that reference purchase orders. These procedures tend to describe "how to purchase" rather than "how to fill out a PO," and therefore don't contain step-by-step instructions on how to complete the form.

The final step in processing a PO is to put it somewhere for long-term retention. The purchasing procedure usually includes this step.