How often will I update the quality records list? We have about 189 quality records

C

cokyat

#1
Help... we have about 189 quality records including forms and controlled tags and I really have a very difficult time in updating them... can anyone provide me a suggestion on how to organize the documents well and update the list religiously? Any techniques? :thanks:
 
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Wes Bucey

Prophet of Profit
#2
Whoa!!!

Why are you updating ANY of these documents?
What is the process for creation and approval of a new version of an existing document?
You are probably confusing
  • "general documents" (plans or instructions)
  • forms (blank documents on which you enter data from an activity)
  • records (documents which contain data from an activity)
General documents and forms may be updated (revised) from time to time as circumstances change. Organizations should have a procedure to periodically review documents to see if they need to be modified, or replaced. Keeping track of these changes to assure only the most recent, valid version is used is called Configuration Management. There are lots of resources on conducting Configuration Management.

Records are the history of an activity (inspection, maintenance, shipment, complaints, etc.) and are required to be maintained UNCHANGED for a period of time to be determined by government regulation, customer contract, or organization whim (depending on which takes precedence.) Records can be paper or electronic. A FORM is only a convenient template for entering the data to make a record. A FORM can be paper or an electronic screen on a computer.

If you have a FORM which has data added to it as more activity takes place (running tally of machine maintenance?), the FORM is updated with new data, but the record (already entered data) in never changed or "updated" - new data added creates a new record.
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#4
189 records is certainly a lot...you know, I've never counted how many we have at my company...well, that can be saved for a rainy day. :)

If the list is truly changing that much - items like record location, disposition methds, etc. - I see two possible options....
  1. Train your document authors to update the records list. This is what I have done. When they realize that a change to the process will result in a change to the record (for whatever reason), the document author is responsible for ensuring that the list of quality records is updated. Easier on me...and they learn to take ownership of their own material and processes. ...OR...
    [*]Set a realistic review period. As part of your record control process, you could indicate "The list of quality records will be reviewed by XXX, not less than twice a year to ensure that the information contained in the list is current and valid. Any discprepancies will be discussed with the holder of the quality record prior to the list being modified." Of course, you will then need to figure out how to demonstrate that you are reviewing the list at the frequency you select.
 
M

M Greenaway

#5
I would suggest you rationalise what you actually consider to be a 'quality record' - 189 seems an awful lot. ISO9001 mandates some areas where quality records are a must, the rest is really up to you.
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#6
M Greenaway said:
I would suggest you rationalise what you actually consider to be a 'quality record' - 189 seems an awful lot. ISO9001 mandates some areas where quality records are a must, the rest is really up to you.
You're right in that the standard indicates where records are a must, but some companies prefer having a system that goes beyond the requirements of ISO 9001. Unfortunately, they attempt to pursue this before having an adequate grasp on how to address the minimum requirements....not the most effective approach to take.

I'm a big advocate of Business Management Systems....not just Quality Management Systems. However, I can fully appreciate the need to meet the requirements first before expanding the system.
 
#7
There is also the question of the format of the records list. Placing it in a normal procedure is not a good idea imo. That ensures that you will have a perpetually obsolete procedure to deal with. One of many much easier ways is to keep the list as a separate database and refer to it in the procedure.

/Claes
 
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