21 CFR 820 QSR Quality Management System documentation
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)
Interestingly, how are we going to start our quality manual without knowing what regulations or standards this manual is for? The quality policy defines it. The policy specifies what regulations or standards, a business wants to comply with. If you like this idea, your 21 CFR 820 QMS will contain five levels as in the following list:
21 CFR 820 Policy – level 1
Quality Manual – level 2
21 CFR 820 Procedures – level 3
Work Instructions – level 4
Records – level 5
Naming your QSR documents
Companies use various approaches to titling their manuals, procedures, instructions, etc. For example, one of my customers titled their documentation management procedure as “Documentation Management – Document Control Standard Operating Procedure.” This very descriptive title does define the document, but does not appear to be efficient.
Regulated industries, including medical device manufacturers, are known for calling the 2nd-level documents “Standard Operating Procedures” or SOPs. Do these companies have “Non-standard Operating Procedures”, so these long titles differentiate them? Since a short name identifies a document, I really cannot justify long names for documents. I preach 21 CFR 820 management system optimization and reduction of waste in all elements of management systems. I invite you too not to make things more difficult than they have to be to deliver the message.
Document No’s for your 21 CFR 820 Management System
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:
A company had some 75 employees. They had two part number formats: one for procedures, another for drawings. Procedures used AA-NNN number format. Drawings were numbered as NNNNN-NNN. One of the drawings had a number 00011-003. Assemblers simplified the system and called it “Eleven.”
Is it acceptable to have long and difficult-to-read and remember QMS document numbers? Yes, of course! Is it practical? I do not believe so! In the example above, the procedure number, without the tab, contained six digits. This means that the system was prepared to handle almost one million document or part numbers. The company had approximately 150 QMS documents and probably would never go beyond 250. If nothing else, just reading these numbers with four sequential zeros in the front may give one a headache. Surprisingly, this is not the worst case. The business that won my “The Worst P/N” Grand Prize assigned twelve (!) digits to their part numbers in the alphanumeric format.
If you are designing or constructing a top-end X-ray machine, a jet fighter or a satellite, you will need millions of parts and procedures, so a long part number format would be needed and will make business sense. Otherwise, save yourself the trouble of writing all those zeros and make your 21 CFR 820 QSR numbering system practical. One of my customers, who won my “The Best Part Number” Grand Prize, numbered their 21 CFR 820 quality management system documents as 401, 402, 403, and so on. Short and sweet!
Part Number designators
So far we explored opportunities for improvements in the area of document titles and numbers. Yet, there is another issue with part numbers. Many companies relate a document number to a document type. For example, 45-nnn indicates a procedure, 56-nnn indicates a drawing, POP-nnn indicates a Production Operating Procedure, etc. My experience with a few businesses that used part number designation approaches showed that “no designation” systems are more practical. Several QMSs that used designation I have worked with have failed. Some time ago, one of my clients mentioned that they ran out of range in their document numbering format.
That 21 CFR 820 documentation system allowed for assigning materials through a two-digit designator within the part number. When the system was designed a few years ago, needing more than 99 materials was not considered possible. Unfortunately, company’s needs changed over time, and just a few years later, the quality management system needed more than 99 materials causing the existing part number format to fail.
To get around this issue, there is a simple solution – a “no designation” system. Document numbers in such systems are simply assigned unique numbers. Areas of use, materials, suppliers, and other attributes are not reflected in part numbers. Moving in this direction, you can simplify your system even more. I worked with a company that did not use document No’s at all. That documentation system used just document names followed by their revision numbers, like Process Validation Protocol AB.
If you are developing your 21 CFR 820 quality management system, and want to avoid common mistakes, check out our 21 CFR 820 Quality Assurance consulting page.
Mark Kaganov :: Aug.31.2009 :: Uncategorized :: No Comments »
