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How Can Your Firm Use Quality Risk Management?

July 25th, 2014 by Henry Macartney

Quality Risk ManagementRegulatory compliance can be tricky, especially when it comes to your overarching quality management services. There are many guidelines, regulations and laws to understand in order to be compliant in audits and inspections.

Central to your quality management system (QMS) is quality risk management. In order for quality systems to be effective, you must include the right processes for quality risk management.

What Is Quality Risk Management?

According to the FDA, quality risk management is a general term for a process incorporating well-defined steps that promote improved decision making by shedding light on the nature of risks. In addition to identifying potential problems, quality risk management implementations also assess their severity, provide options for dealing with extant issues, seek to eliminate previously identified issues, and communicate the effects of problems for future reference.

Many of these goals also fall under the scope of quality management systems.

Instituting Quality Risk Management Procedures

It is important to implement quality risk management procedures in order to identify and manage risks. Formulating the correct procedures will allow you to mitigate risks over the entire lifecycle of your product.

Integrated with the quality risk management system are your CAPA and deviation management systems. These work in unison to identify risks, pinpoint deviations and  provide corrective or preventive actions.  Without the specific knowledge of proven and effective processes and procedures for these systems, it will be difficult to meet your compliance goals.

A Flexible-Yet-Measured Approach

The FDA notes that risk management processes must be both iterative and dynamic. In short, it's impossible to analyze quality risks successfully if you're not willing to keep up with the little details along the way. Although your approach to dealing with quality risks should ultimately be viewed in light of the potential for risk to your end consumers, you can't gloss over the intermediate stages and focus on the final result.

In order to truly understand the ultimate consequences of various risks, you have to be conversant with the potential results and interactions of unique problems. This requires a continual approach to risk analysis that allows you to evaluate estimated risks against predetermined criteria.

Classification of Risks

Risks are normally divided into three categories:

  1. Minor risk – You may continue production under certain restrictions implemented by QA.
  2. Major risk – You must stop production until the risk has been mitigated through your deviation and CAPA processes within a timeline dictated by QA.
  3. Critical risk – You must cease the activity associated with the risk until it is completely corrected.

By quantifying identified classification of risks, firms find it much easier to devote appropriate attention to the most pertinent problems.

Can Risk Be Controlled?

One of the major goals of quality risk management is risk prevention, but risk control is just as important. Something might get overlooked but risk prevention and risk control help to avoid this and provide processes to deal with any deviations that might occur.

The manner in which you respond to deviations is of significant importance to regulating authorities. By dividing your quality risk management strategies into discrete risk assessment steps, you'll be able to effectively master deviations and continue moving forward.

GxP-CC consultants can help you identify the most optimal risk-handling tactics and devise a better plan for keeping your operations running smoothly. Learn more by contacting them now.

Posted in CAPAs, Deviations, FDA Audits, FDA & European Regulations, GxP CC, Quality Management Systems, Quality Risk Management

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Henry Macartney

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