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Record Management - Does the QMS need to control templates of records?

#1
Hello everyone, this forum has been a huge support for me while planning and revising existing procedures in my company!
I've only recently started in quality as a total novice and it's been a learning curve till now, I've figured out key procedures that are essential for the standard our company follows (ISO 9001:2015). Although I can't wrap my head around a practical and easy to follow procedure for Record management.

Our company is a manufacturer of cosmetics so we have a lot of records for maintaining batch manufacturing information, packing and filling details, etc. Now I have obtained templates for these existing records and which are currently under no control, the employees sometimes change the template without following a proper change control procedure.

My question is - how do I implement an effective record management system?
Along with details such as Template no, Issue date, Revision no, and revision date, do I need to get a "signature" as approval for the template?
and finally - Do I need to control these templates under document control (master copy, controlled copies, reference copies)?

Essential to add: our company doesnt have a software or online system, so I'm going to have to maintain all these templates manually.
Cheers!
 
#2
Hello everyone, this forum has been a huge support for me while planning and revising existing procedures in my company!
I've only recently started in quality as a total novice and it's been a learning curve till now, I've figured out key procedures that are essential for the standard our company follows (ISO 9001:2015). Although I can't wrap my head around a practical and easy to follow procedure for Record management.

Our company is a manufacturer of cosmetics so we have a lot of records for maintaining batch manufacturing information, packing and filling details, etc. Now I have obtained templates for these existing records and which are currently under no control, the employees sometimes change the template without following a proper change control procedure.

My question is - how do I implement an effective record management system?
Along with details such as Template no, Issue date, Revision no, and revision date, do I need to get a "signature" as approval for the template?
and finally - Do I need to control these templates under document control (master copy, controlled copies, reference copies)?

Essential to add: our company doesnt have a software or online system, so I'm going to have to maintain all these templates manually.
Cheers!
Hi Bonsaissi

Start with simple things you can change, set up a Document Change Request form or log, nothing too complicated, I have attached my DCR form, I don't keep a log but I keep a Master doc spreadsheet,
 

Attachments

Randy

Super Moderator
#3
MS Word has all you need to control any document in use especially a Template.

What you control and how you control it is your decision, your QMS doesn't control anything you do through the effective use of the QMS you establish according to the requirements contained within it.

Quit trying to overthink a simple activity and make things more complicated than they need to be.
 

John Broomfield

Staff member
Super Moderator
#4
No signature is required by ISO 9001 on any controlled document.

It has to be reviewed and approved before issue. And users need to know they have the applicable issue.

These document controls include your templates (aka forms).
 
#5
Hello everyone, this forum has been a huge support for me while planning and revising existing procedures in my company!
I've only recently started in quality as a total novice and it's been a learning curve till now, I've figured out key procedures that are essential for the standard our company follows (ISO 9001:2015). Although I can't wrap my head around a practical and easy to follow procedure for Record management.

Our company is a manufacturer of cosmetics so we have a lot of records for maintaining batch manufacturing information, packing and filling details, etc. Now I have obtained templates for these existing records and which are currently under no control, the employees sometimes change the template without following a proper change control procedure.

My question is - how do I implement an effective record management system?
Along with details such as Template no, Issue date, Revision no, and revision date, do I need to get a "signature" as approval for the template?
and finally - Do I need to control these templates under document control (master copy, controlled copies, reference copies)?

Essential to add: our company doesnt have a software or online system, so I'm going to have to maintain all these templates manually.
Cheers!
Maybe you are overthinking this
First off, define exactly what needs a record, based on the Standard , your requirements or what your customers need.
Once is defined, they are documents which need control according to 7.5.
The important thing is to identify why is the real use of such records, if they add value, if not, you are overloading your qms turning it in a non effective system.
Remember in this version, the standard requires very few records.
Hope this helps.
 
#7
Things should be controlled as close to the point of use as possible. So let the employees change the templates as they see fit without a lot of bureaucracy. Sounds like all you need to do is have the template name and revision print out, which word can easily do. And keep an updated list of the current revision in use. Don't over complicate it. Good luck.
 
#10
This is a topic that is starting to show a lot of heartburn for our management team.

They want a clear explanation of when to control forms. For example in our system, we have a blank production inspection form, this form is the base template on how the layout needs to be for adding the required inputs from the operator. They're wanting to prefill forms for each individual part number that is being machined and control each of these forms. So the original blank form is already controlled and then having a prefilled form for each part number has its own control.

Is this the correct process? Or is this adding too many headaches to the system and we should only be controlling the blank form? If you were to only control the blank for as the base template for the design and layout, are the prefilled forms for different part numbers considered uncontrolled until filled in to become a record?

Thanks for any information. Everyone has their own idea of these technicalities here and I'm trying to move us to a straight forward, this is how it's needing to be to conform.
 
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