What are Classified as Quality Records?

quality records

I was confuse on how to clasify a quality records. Is it what you mention in a procedure or instruction? Or is it only those quality related records?

As we all know all records contains an evidence of activities done. My question is how can I differentiate a quality record from non-quality record?

And may I ask if the Document Control Center is the responsible or in-charge for those in-active records of each department for safe keeping? And what will be the consequences if I transfered the responsiblity for those record in each department, and those only related to the quality will be keep in DCC.

[This message has been edited by lv (edited 03 December 1999).]
Elsmar Forum Sponsor
1- Both assumtions are correct;
a- If you state in a procedure a certain record is required then you need to maintain it.
b- The only quality records that are required to be maintained are those that are specifically stated by reference in the standard e.g., "records are to be .... (see 4.16)

2- This is a tough one and there are many different opinions. Refer to the definition of a quality record in the Glossary of the QSRM and the second paragraph in 4.16.
Key phrases:
- conformance to specified requirements
- effective operation of the quality system
- pertinent quality records from the subcontractor.

3- It doesn't make any difference who keeps the records as long as they are maintained in accordance with 4.16.
Develop a matrix;list the records on one side ,the eight requirements across the top fill in the blanks and you are done.

I know this might sound too simplistic but it is effective and it will at least get you started.

Kevin Mader

One of THE Original Covers!
Staff member

Generally speaking (IMHO), Quality Records are maintained by those who create the records. For example, Production Records are maintained in the Production Office. The Production Clerk maintains these records by product name perhaps. In another area, Calibration records are maintained by the Metrology Lab. These records are filed by equipment number perhaps. The point being, records are maintained in different fashions by different people. Retention is also their responsibility. In the case of Production records, these items are created in bulk (several records on a daily basis). The periodicity of Calibration produces fewer records. How much space is there to store these items in the Production office or the calibration lab? What are the retention periods for these records? If space is an issue, records should be stored elsewhere (hopefully readily retrievable). In our organization, we have a records room where "spill over" records are kept prior to being shipped to an off-site storage facility.

What is a Quality Record? A few are clearly indicated in the ISO standards. In addition, those record that you or your organization feels is important to demonstrating conformance to you Quality Program should be considered. Determine which these are. Ask your self if the record under consideration helps the organization to improve the system, process, or product/service (i.e. records of rework identify the top problems by cost and frequency to generate Corrective Action, validation or verification documents of a design process record vital results and offers data for analysis and process improvement).

Retention of working documents is probably not advisable in that it may be a waste of effort and space (i.e. a form that is used to record information that is later updated (on a daily basis) to a database). An example: Material handlers use a Stock Transfer sheet to record stock movements in a warehouse during the day but later updated to an Inventory Database by a Clerk at night (who only retains these sheets for a week in case of obvious problems). In my opinion, keeping the documents a week is a waste of effort. I often notice that these sheets pile up for a month (messy, messy, messy). Still, the record keeper feels more comfortable this way.

I hope this helps.

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