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:
Quality Manual, Procedures, Instructions, and Records
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:
21 CFR 820 Policy - level 1
Manual - level 2
21 CFR 820 Procedures - level 3
Work Instructions - level 4
QMS Records - level 5
Document titles for your 21 CFR 820 QMS
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."
This tendency to use long titles and document identifiers like "Standard Operating Procedure" most likely comes from regulated industries. Even though I could not find a requirement for such long titles, many companies still use these apparently outdated and inefficient conventions. If a short name sufficiently describes a document, let's use it. I suggest streamlining all elements of management systems. Consider this and do not make your system more complicated than it can be.
21 CFR 820 QMS document numbers
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 developing or optimizing your 21 CFR 820 quality management system, consider a simple rule: "The shorter - the better". If you are constructing a hydro electric plant or building an aircraft carrier, you will need millions of parts. To number this kind of inventory, one will definitely need long numbers. If not, think optimization. Once I audited a 21 CFR 820-compliant start-up that numbered their documents 103. 104, 105, etc. They deserve applauds!
Use of designators in Part Numbers
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.
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.
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.
Quality Manual, Procedures, Instructions, and Records
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:
21 CFR 820 Policy - level 1
Manual - level 2
21 CFR 820 Procedures - level 3
Work Instructions - level 4
QMS Records - level 5
Document titles for your 21 CFR 820 QMS
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."
This tendency to use long titles and document identifiers like "Standard Operating Procedure" most likely comes from regulated industries. Even though I could not find a requirement for such long titles, many companies still use these apparently outdated and inefficient conventions. If a short name sufficiently describes a document, let's use it. I suggest streamlining all elements of management systems. Consider this and do not make your system more complicated than it can be.
21 CFR 820 QMS document numbers
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 developing or optimizing your 21 CFR 820 quality management system, consider a simple rule: "The shorter - the better". If you are constructing a hydro electric plant or building an aircraft carrier, you will need millions of parts. To number this kind of inventory, one will definitely need long numbers. If not, think optimization. Once I audited a 21 CFR 820-compliant start-up that numbered their documents 103. 104, 105, etc. They deserve applauds!
Use of designators in Part Numbers
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.
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.
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.
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