Risk Management: Not Just For Product Safety Anymore!

A
strong risk management program is one of the cornerstones for an effective quality management system. Does your risk management program extend deep enough into the processes to benefit your organization? Three main areas where risk management can be of great benefit are product safety, process control and
project management.

The ISO 14971:2007 Medical devices – Application of risk management to medical devices document defines requirements to manage risks of the device, as applicable to the patient, operator, other persons/equipment and
environment. Additionally, there is a Global Harmonization Task Force (GHTF) Guidance Study Group 3 SG3/N15R8 Implementation of risk management principles and activities within a Quality Management System. This
guidance applies general principles of quality systems for manufacturers of medical devices, and does not address financial or other business risks.
  
Product risk management should be applied throughout the entire product
lifecycle to identify and address product safety issues. The guidance
identifies four basic stages for applying risk management:

·     Determine what levels of risk would be acceptable for the device

·     Complete the risk analysis

·     Compare estimated risks to the acceptability criteria

·     Identify risk control and monitoring activities

I would add one more stage – validate the effectiveness of the controls that were put in place to mitigate risks. This validation is more than just confirming that the mitigation or control was implemented. It should demonstrate the control has eliminated the potential risk, or reduced it to an acceptable level.

The second area where risk management is important is the manufacturing process design and validation. The same stages and process you use for product safety can be used to identify the Critical To Quality (CTQ) steps in the
manufacturing process. This activity should be a joint process between the development team and manufacturing. The developers have designed the product and should understand what steps in the manufacturing process are critical to producing a high quality product. Working hand in hand with the manufacturing
team, they can identify the process steps and/or critical reagents/ingredients/components for the product. Then the potential failures can be identified with appropriate mitigations determined and built into the process.

The third area (and probably the one often overlooked in risk management) is overall project risk.

EXAMPLE

Let’s use the example of a new facility to manufacture a reagent currently being manufactured. The business plan is to manufacture material in both facilities. A risk assessment and plan should be developed and managed
throughout the life of the project, focusing on any differences or commonalities. For example:

·     The mixing tanks are the same at both facilities (manufacturer, material, size). This would be a minimum risk to the end product because they are the same.

·     The mixing blade is smaller in the new facility tanks than in the original facility. This could create a difference in how the end product performs. Therefore, a FMEA (or other tool) should be used to analyze
the differences. Validation of the product should demonstrate that the product manufactured at both facilities can be used interchangeably.

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
a href="http://www.enkap.com/profiles/blogs/cpark928@mindspring.com">http://www.enkap.com/profiles/blogs/cpark928@mindspring.com>


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