21 CFR 820 QSR Quality Management System documentation

By: Mark Kaganov..


ISO 10013, Guidelines for Developing Quality Manuals, gives an example of a documentation structure for ISO Standards that can also be used for 21 CFR 820 quality management systems. While this document suggests using a three-level documentation structure, most organizations implement four-level structures to include quality records, as required by Subpart M -Records of 21 CFR 820 Quality System Regulation. A typical four-level documentation structure includes:
QSR Manual (1), Operating Procedures (2), Works Instructions (3), and Quality Records (4)
While auditing systems like the one above, I always asked clients about the position of their quality policy in this structure. If you start from a quality manual, how would you know what regulation(s) or standard(s) this manual should cover? The quality policy defines it and therefore it should be included into the structure:
Policy - level 1
QMS Manual - level 2
Operating Procedures - level 3
Instructions - level 4
Quality Records - level 5
Naming your QSR documents
As you may have noticed, the titles of the documents in the structure above are quite short. Various medical device manufacturers use different conventions for their document titles. For example, one of my customers titled their quality manual as "Quality Management System Quality Manual."
It is a very typical convention in the medical device manufacturing and other regulated industries to call the second-level documents Standard Operating Procedures, known as SOPs. Unless one has a level called "Non-standard Operating Procedures," I really do not see a practical or economical reason for long titles like those. As long as the short title conveys document intent and leads a user to the right place, let's use it. I will promote this optimization and reduction of waste approach throughout this publication. Let's not make things more complicated than they practically need to be.
Numbering your 21 CFR 820 documents
In addition to tiles, document number formats very often can be optimized too. No standard requires assigning a document its number. This practice is an industry standard. Similar to part titles that we discussed above, document numbering practices often may be simplified too. Look at the example below:
Once I worked with a company compliant with 21 CFR 820 of less than 90 workers. The company manufactured fairly simple implantable devices. Their quality documentation system included a few numeration systems that depended on the type of document. One of the procedures had a number 000023-001, which they simply called "twenty three." Drawings were numbered in a format like 987-323-11-02.
Do these long numbers identify documents? Yes, they do! Are they economical? No, they are not! My customer's system allowed six digits and therefore could deal with 1,000,000 documents or part numbers. When I worked with this business, they used some 300 documents. If one plans to grow from 200 - 300 documents to a million, one has a long way to go! It is not only how many documents your QMS uses, reading these long strings with four sequential zeros gave everybody headache. Even though this example looks too complicated, The Worst Part Number format I have observed was 14-digit alphanumeric string!
I hope it is clear that when extensive part numbers are not justified, we do not have to use them. If you build helicopters or space probes, you, no doubt, will need millions of parts and therefore will need long document part numbers. If not, make your life easy and stay away from all those zeros. The most practical system I worked with used a three-digit format for their part numbers. 502, 503, 204, and so on. The system worked just fine!
Use of designators in Part Numbers
There is another opportunity for improvement of many 21 CFR 820 QMS - part number designation. Many companies relate a document type to the document type or its level. For example, WI-xxxx indicates an instruction, DR-xxxx indicates a drawing, SOP-xxxx indicates a standard operating procedure, etc. My practice with a few 21 CFR 820 compliant QMS's that used designation approaches showed that "no designation" systems are more practical. Several management systems that used designation I have worked with have failed. Not long ago, one of my clients mentioned that they ran out of range in their document numbering format.
The discussed QMS initially permitted for identifying suppliers through a two-digit identifier within the part number. While the company grew, the number of supplier increased beyond expectations and eventually the company needed more than 99 suppliers. This resulted in the document number format to not being able to support new needs.
There are good news and bad news. The bed news is that designation systems can fail. The good news is that there is another way of dealing with document numbers: no designation at all! Using such systems, you give documents or parts just sequential numbers. Going further, isn't the part title the best identifier of the part? One company I know did not use part numbers at all - their 21 CFR 820 procedures and instructions were simply identified by titles and their revision levels.

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