Once the rules and procedures have been written down in the company Bible, they must be rigorously followed. Unlike the holy book, however, the text can be revised. The policies are not set in stone, but there is a process for making changes that must be followed.

If you agree with this premise and are able to train your staff to understand the critical nature of having a strong and comprehensive quality system manual and SOPs, it would go a long way toward avoiding problems and ensuring compliance with FDA QSR/cGMP and ISO13485.

When setting up a quality system or writing SOPs, it is important to understand what you are trying to achieve based on the criticality of your operations and device(s). If you take a commonsense approach and look at what is necessary to maintain control of your operations, then add in the extra requirements to ensure compliance, you will have a well-documented system that can be controlled and maintained with a minimum of paperwork. Drafting SOPs that are too restrictive and hard to follow or document is asking for trouble.

Maintaining compliance with FDA regulations and ISO standards does not require long, drawn-out SOPs; only SOPs that make sense, are appropriate, meet the regulatory requirements, and can be documented. Casting a critical eye on all of this can save you time, aggravation, and regulatory problems.

The 10 Commandments of SOPs

1. First, determine what SOPs are necessary
2. If possible, have the employee responsible for the SOPs draft them
3. Make sure the SOPs are understandable
4. Make sure the SOPs match the procedure
5. Keep the SOPs succinct where possible
6. Train the staff to the SOPs
7. Audit the SOPs to make sure they are being implemented correctly
8. When making changes to the document, make sure that it has the correct revision
9. Remove all out of date SOPs, including ones in employee desks
10. If your SOP has written notes, it is not a good SOP.

Alan P. Schwartz of mdi Consultants Inc. has been providing strategic planning on FDA regulatory compliance issues since 1978. Prior to joining mdi, Schwartz was a supervisor of field operations for FDA. He has been an invited speaker on FDA policy and issues both in the United States and internationally. His insight and understanding of FDA regulatory strategy, preparing replies to FDA 483 and Warning Letters, and acting as a third party certification body under FDA approval has provided companies with some very novel approaches to dealing with their regulatory problems and ensuring full compliance. For more information about mdi Consultants, view its listing in the online Consultants Directory.