What TYPES of documents are in your QMS (Quality Management System)?

L

lrl116

#1
My organization is trying to redefine our documentation types because there is always confusion with the staff on how to classify/identify a document. We currently classify documents as one of the following from highest to lowest level documentation: processes; workflows; desk level procedures; work instructions; letters; forms; logs; and templates.

There is always confusion on the difference between a desk level procedure and a work instruction. Also, we do not have good definitions to explain the difference between a form, letter, log, template. I am looking for definitions that others use for these types of documents.

Does anyone have advice on how we can simplify this documentation process?

Also, do other organizations consider a log a "document" or a "record"?
 
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CarolX

Super Moderator
Super Moderator
#2
lrl116 said:
My organization is trying to redefine our documentation types because there is always confusion with the staff on how to classify/identify a document. We currently classify documents as one of the following from highest to lowest level documentation: processes; workflows; desk level procedures; work instructions; letters; forms; logs; and templates.

There is always confusion on the difference between a desk level procedure and a work instruction. Also, we do not have good definitions to explain the difference between a form, letter, log, template. I am looking for definitions that others use for these types of documents.

Does anyone have advice on how we can simplify this documentation process?"
We use the following
QMS Document - this is our quality manual (some may call the policy manual).
Procedures
General work instructions and forms(department applicable)
Specific work instructions and forms(part applicable)
Records

lrl116 said:
Also, do other organizations consider a log a "document" or a "record"?
I consider it neither. I keep a log of activities in the inspections departments. Weekly this information is summerized. Then the logs are destroyed.

Hope this helps a bit.
 
D

donaghadee - 2008

#3
We adopt:

Quality Manual
Quality Procedures (as required for ISO9001)
Business Procedures – vertical business processes
Support Procedures – HR, Security etc
Work Instructions – specific to tasks
Documents – record forms etc
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Quality Manual
(Policies)
Procedures
Work Instructions
Forms

Policies in Parentheses because most policies are in the Quality Manual. We have other policies, though, that are not "part of the QMS" but are still controlled. It helps keep auditors away from things they shouldn't care about - like vacation and internet usage policies.
 
S

Sleepless

#5
I've never set any form of priority on any of the document "types" before so that's something I couldn't comment on other than MAYBE that's what might be causing some confusion??

We use the Quality Manual as the primary entry point into our QMS, and it contains the policies. To reinforce the QMS, we have processes and templates which are required for each project. As proof of the QMS, we have records (such as logs, minutes, and test results).
 

Helmut Jilling

Auditor / Consultant
#6
lrl116 said:
My organization is trying to redefine our documentation types because there is always confusion with the staff on how to classify/identify a document. We currently classify documents as one of the following from highest to lowest level documentation: processes; workflows; desk level procedures; work instructions; letters; forms; logs; and templates.

There is always confusion on the difference between a desk level procedure and a work instruction. Also, we do not have good definitions to explain the difference between a form, letter, log, template. I am looking for definitions that others use for these types of documents.

Does anyone have advice on how we can simplify this documentation process?

Also, do other organizations consider a log a "document" or a "record"?

It's ok to do it, but do you really need to define different kinds, or levels? If you were not doing ISO, would you still need to do that? A document is any item that captures and communicates information. A Log is kind of halfway in between a docuemnt and record. You keep adding additional lines to it, but the previous in doesn't change. Most people control it as a record.
 
L

lrl116

#7
It sounds like it is ok not to document control logs and just track them as records. I always thought that the blank log had to be document controlled and the filled out log is the record. The confusion for me is, what if the log is on-going and never ends? In this case, when is it a record?

From all of these suggestions I am also leaning toward calling all controlled documents that will end up as a record a "form". Whether it is a template, letter, form, or log in general they are all document controlled as forms.
 

Jim Wynne

Staff member
Admin
#8
lrl116 said:
It sounds like it is ok not to document control logs and just track them as records. I always thought that the blank log had to be document controlled and the filled out log is the record. The confusion for me is, what if the log is on-going and never ends? In this case, when is it a record?

From all of these suggestions I am also leaning toward calling all controlled documents that will end up as a record a "form". Whether it is a template, letter, form, or log in general they are all document controlled as forms.
Whether or not a log becomes a controlled form or not is either a matter of preference or necessity on the part of the individual company. You might choose to control a form if it's important for some reason that fields and format don't get changed without being reviewed. If a form is a matter of convenience, and all that's important is the information written on it, regardless of format, then there's no need to control the form. For example, where I work we use a PPAP review form but it's not controlled because the only requirement is that the person doing the review write down the findings and send them on to the people responsible for final approval. A form is used for convenience, but the same could be accomplished without a form.
 
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