Having a robust and repeatable quality control and risk management process throughout a product’s lifecycle is crucial. The race to a COVID-19 vaccine has shown us how quickly bioprocessing is changing, and staying prepared can help you face unknown variables.

With shrinking timelines and rapid developments becoming more prevalent, we have crafted a set of best practices to help you assess your facility’s bioprocessing quality risk management program.

Solid QRM is critical at all phases of operations, from initial development to discontinuation. We follow the guidance set by ICH Q9 on QRM to ensure consistency in risk management decision-making.

How QRM is Beneficial in the Regulatory, Inspection, and Assessment Phases

ICH Q9 outlines a key set of benefits on how a robust QRM program can influence your work:

  1. Improves resource allocation for inspection planning, frequency, and assessing the inspection’s intensity.
  2. Evaluates the significance of quality defects, potential recalls, and findings from previous assessments.
  3. Determines when there should be post-inspection follow-ups.
  4. Evaluates industry information.
  5. Evaluates proposed variations or changes and their potential impacts.
  6. Identifies risks that need to be communicated between inspectors and assessors to understand risk controls and if those controls need to be adjusted.

Best Practices for Establishing or Refining a QRM Process

QRM should include repeatable processes designed to coordinate, facilitate, and improve decision-making related to risk. Any QRM planning process should consist of these four steps:

  1. Define the problem and risk question, including pertinent assumptions identifying if the risk might happen.
  2. Assemble background information and data on the potential hazard, harm, or human health impact relevant to the risk assessment.
  3. Identify a leader or risk owner and if additional resources are needed.
  4. Specify a timeline, deliverables, and appropriate level of decision-making for the risk management process.

Principles of QRM

QRM helps to provide a rationale to understand risk and mitigate it through the appropriate channels. The principles of QRM are outlined below according to Quality Risk Management and Industry Case Studies.

  1. Compliance with applicable laws is an absolute requirement.
  2. Risk gets managed when it is identified, assessed, considered for further mitigation, and communicated.
  3. All quality risk evaluations must comply with scientific and process-specific knowledge and ultimately be linked primarily to the patient’s protection.
  4. Effective risk management requires a sufficient understanding of the business, the potential impact of the risk, and ownership of any risk management assessment results.
  5. Risk assessment must consider the probability of an adverse event in combination with the severity of that event.
  6. It is not necessary or appropriate to always use a formal risk management process (e.g., standardized tools); the use of informal risk management processes (e.g., empirical assessment) is acceptable for areas of less complexity and lower potential risk.
  7. The level of documentation of the risk management process to render an appropriate risk assessment should be commensurate with the risk level.

Consistency is Key

Remember that QRM is a continual, risk-centric, quality-focused exercise that happens throughout a product’s lifecycle. Regulatory bodies all over the world have embraced QRM and integrate it into their processes.

Regular assessment of your program is essential, and it never hurts to get an outside perspective about how your current plan is performing.