Medicinal Cannabis Risk Management Methodologies

An important part of keeping your medicinal Cannabis facility compliant to its GACP or GMP certification, is to carefully and thoroughly manage risks through the implementation of effective and custom-designed risk assessment and management through a validated risk management methodology. This article discusses compliant and regulated risk management methodologies appropriate for medicinal Cannabis facilities.

What is risk?

A risk is the occurrence of an anomaly or event that impacts on the quality and safety of the product, whether finished or unfinished. A big risk in medical Cannabis facilities is the presence of contaminants such as pests, dirt, mold or particles that can lead to rot, disease or health concerns. Seeing as the requirements for a GACP or GMP facility falls squarely within the pharmaceutical realm, the management of these and other risks is essential to the facility’s operations.

Risk Management Terminology

Here are some important terminology to note in risk management methodologies:

  • Detection: The act of identifying the risk before it causes damage
  • Likelihood: The statistical probability of occurrence of a certain risk
  • Risk: The possible occurrence of damage
  • Risk analysis: Using available information to analyse the likelihood and probability or the possible risk
  • Risk assessment: A comprehensive process consisting of analysing and evaluating the risk
  • Risk control: Measurement and evaluation off a risk to ultimately decide how risks can be reduced and maintained within defined limits
  • Safety: Ensuring that measures are in place to safeguard employees against negative events
  • Severity: The possible seriousness of the result of a risk occurrence

Risk Management Methodologies for Medicinal Cannabis

There are various risk management methodologies available that would comply to the requirements of a GACP or GMP facility. We briefly discuss each risk management methodology and indicate each potential area of use within medicinal Cannabis.

Failure Mode Effects Analysis (FMEA)

FMEA is a powerful tool to summarize the important modes of failure, the factors leading to such failures and the possible and likely effects of those failures. It facilitates the evaluation of potential failure modes for processes, including its possible effect on product performance. Failure modes are established and after the risk has been evaluated, risk reduction is used to contain, reduce, control or eliminate the potential failures. In order to apply this risk management methodology effectively, you’ll need a thorough understanding of the product and its processes, because FMEA entails the methodical break down and analysis of complex processes into manageable and controllable steps.

In a medicinal Cannabis facility, FMEA can be applied from a general overview of risk factors and control activities, but is best used in a GMP facility where manufacturing takes place, seeing as it focuses on equipment and facility effectiveness. The result of applying the FMEA risk management methodology is an output used as basis for design or further analysis, or to restructure resource usage throughout the operation.

Fault Tree Analysis (FTA)

The FTA risk management methodology focuses on functionality failures in products or processes. Using hierarchical graphic drawings of possible failure factors and analysis of each failure configuration, in conjunction with determining possible causes (including human error), failure factors are identified and classified as primary and sub-factors. The results of the FTA is represented in the form of a tree of fault modes, each level in the tree identifying combinations of fault modes. Understandably, facilitating a FTA requires a clear understanding of processes, equipment and hardware in order to identify all possible functionality failures.

FTA can be applied throughout GACP and GMP facilities – in a GACP facility where only cultivation and bulk packaging takes place, the FTA risk management methodology can be applied to environmental controls throughout the cultivation processes and up to storage of medicinal Cannabis flower. In a GMP facility, all equipment used in the manufacturing process will be subject to FTA – extractors, freeze driers, scales, packaging and labelling equipment, to name a few.

Hazard Analysis and Critical Control Points (HACCP)

HACCP is a structured approach, applying technical and scientific principles to effectively analyse, evaluate, prevent and control identified risks. It assures product quality, reliability and safety in a systemic, proactive and preventive manner. HACCP consists of seven steps:

  1. Perform a hazard analysis for each step of each process and identify preventive measures.
  2. Determine Critical Control Points (a step in the process where a check needs to be performed before the process is continued)
  3. Establish Critical Limits (criteria for checks performed in 2.)
  4. Establish a system to monitor Critical Control Points
  5. Complete a Corrective Action process if monitoring indicates lack of control of a Critical Control Point
  6. Design a verification system to ensure your HACCP system is working effectively
  7. Establish a record-keeping system, proving the effectiveness of your HACCP system.

HACCP is specifically effective in identifying physical, chemical and biological hazards and the risks associated with those hazards. Hazards of those types could be present at any stage in the medicinal Cannabis process, whether cultivation or manufacturing. Therefore HACCP is highly recommended for both GACP and GMP facilities, as it assists with methodical and comprehensive process design.

Hazard Operability Analysis (HAZOP)

HAZOP focuses on deviations as primary risk and identifies hazards through the use of “guide words” such as “no”, “more than”, “other than”, etc. to determine relevant parameters to help identify potential deviations from designed processes. It is not focused around potential failures or other risks, therefore it is often used in conjunction with another risk management methodology. HAZOP is usually designed by a team of people with expertise in the design of processes or products and its application.

HAZOP is specifically fruitful in GMP facilities where manufacturing of medicinal Cannabis products take place, although it could also be useful in GACP facilities. It focuses on manufacturing processes which includes outsourced production (such as a GACP facility supplying raw flower into the GMP facility), upstream suppliers (such as packaging material for medicinal Cannabis products), equipment, facilities and process safety hazards. The output is similar to that of HACCP – a list of critical operations for risk management that facilitates regular monitoring or critical control points throughout the manufacturing process.

Preliminary Hazard Analysis (PHA)

PHA is an analysis tool based on prior knowledge or experience of a potential failure or hazard, to identify future hazards and their probability of occurrence. There are four steps to facilitating PHA:

  1. Identify the possibility of the risk event taking place
  2. A qualitative evaluation of the extent of possible damage should the risk event take place
  3. Relative ranking of the hazard through evaluation of severity combined with likelihood of occurrence
  4. Identification of possible remedial measures.

PHA is not a comprehensive risk management methodology and is typically used during the initial design of a GACP or GMP facility, seeing as it focuses on preliminary risk identification. It focuses on all processes in the life cycle of the facility’s operations, including product, process and facility design and is a good precursor to a more comprehensive risk management methodology.

The type of risk management methodology you choose to use will largely depend on the experience and expertise of your Quality Control Manager and Responsible Pharmacist. It is not uncommon to use a combination of the above risk management methodologies to ensure comprehensive cover of all potential risks. If you require assistance with designing an appropriate risk management methodology for your medicinal Cannabis facility, get in contact today to let us assist.

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