SOPs: What happened to say what you do and do what you say?

 Document control is still one of the most commons areas of non-conformance in audits and inspections. Analysis of these non-conformances identifies the failure is most often the result of non-compliance to the procedure, rather than noncompliance to the regulation or standard. Let’s look at some of the practices in industry that contribute to these types of issues.

Sometimes, SOPs are written very explicitly in an attempt to error proof them for the employee. As employees become familiar with the process, they don’t always have the written document open in front of them when performing the specific process. This opens opportunities to omit steps or small details that were included in the procedure, but are not truly critical to the completion of the process.

Clarity of the procedure is a delicate balance in the amount and type of detail provided in the instructions. There are some processes where explicit detail is necessary to assure the quality of the end product. Here are a couple of examples:

· Mix 30 minutes at 37 degrees C. – Is 30 minutes critical? What happens if it mixes 35 minutes? Or 25 minutes? What if the temperature goes to 38 degrees?

· Product must sit in staging for up to 48 hours – can the product be released to the marketplace if it sits 50 hours? 72 hours?

· Adjust pH to 7.2 – what is the impact on the product if you overshoot the pH adjustment? Can you adjust further without ruining the product?

· Turn screw 2 ½ times – what happens if you turn the screw 3 times? Or only 2 times?

While these examples may seem extreme, they demonstrate the importance of clarity in the SOP. Product and process validation should determine the criticality and impact of specifics, such as the examples on the end product. Tolerances should be established (37 +/- 2; stage 48-72 hours) where appropriate to allow adequate flexibility and prevent potential manufacturing deviations and non-conformances. If a measurement or action is Critical To Quality (CTQ) for the end product or process, this should be documented in the SOP.

There are many approaches you can take when writing SOPs for usability. Remember, the auditor is looking for compliance from two perspectives:

· To regulations or standards
· To your own processes

Suggestions for success:

· Keep it simple. Make it easy for the employee to be compliant
· Too much detail (not critical to the quality of the end product) creates potential for error and nonconformance
· Make it clear if steps must be performed in sequence
· Consider the use of flow charts over lots of words
· Validate the SOP

About the Author

B. Christine Park is a quality systems consultant with expertise in the implementation and remediation of sustainable and regulatory compliant quality systems. She has led the successful implementation of quality systems in large
corporations, as well as small startup companies. Her industry experience and background supports compliant yet practical, pragmatic quality systems. She can be contacted at 678-480-5411 and cpark928@mindspring.com

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Posted By Glenn Melvin (800+)
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