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We’ve all seen headlines or heard rumors about products being seized or returned because of pesticide and mold contamination or other issues. When issues like this arise, they cost the producer money. The cost is not only in the form of regulatory fines and lost product. It also extends to the reputation of the brand. Products that gain attention for being contaminated or of poor quality result in decreased sales from thrifty consumers moving to an alternative brand they know they can trust.

The cost of poor Quality

Poor quality also affects the bottom line of businesses in more direct ways. Without defined procedures in place and data to demonstrate those procedures were followed, operators have no solid ability to maintain oversight. Lack of oversight during production means issues are not identified until the final product is tested if the product is tested at all.

What is Quality and the Benefits of CAPA?

Quality has increasingly become a strong focus for public health officials, regulators and companies operating in the cannabis industry. Quality control requirements, such as Good Manufacturing Practices (GMP), ensure products are consistently produced through controlled processes according to quality standards. GMP is designed to minimize risks throughout the process before testing.

An important part of effective quality management is Corrective and Preventive Action (CAPA). As the cannabis industry advances and evolves, there will be a continued emphasis on product quality and regulatory compliance as a means to ensure public health and safety. An auditor’s gauge of quality and compliance is through an organization’s management and resolution of quality issues. Establishing processes and procedures to address and correct quality issues from cultivation to sale of the product is critical for the sustainability of cannabis businesses and the industry as a whole.

The CAPA Process

Corrective Action and Preventive Action (CAPA), is a documented process for identifying and correcting existing and potential issues that may impact product quality.

The CAPA process involves four (4) basic steps:
1. Define the issue
2. Assess impact/risk
3. Investigate the cause of the issue
4. Correct the issue

Every quality issue should be defined, investigated, and corrected. Thus, CAPA-related activities should occur in every process. The objective of CAPA is to prevent recurrence and/or avoid the occurrence of quality issues. The ability to identify and respond to improvement opportunities before issues become systemic or before issues are a risk to consumer health and safety is vital to maintaining compliance, achieving consumer expectations, managing cost, and minimizing loss.

The extent of the investigation into the cause of a quality issue is determined by the initial impact assessment and the level of risk identified. Implemented actions may include the following:

Correction: Immediate action to eliminate a detected issue. Corrections are typically one-time fixes. Corrections are also known as remedial or containment actions. Corrective Action: Action to eliminate the causes of a detected issue or other undesirable condition. The corrective action should eliminate the recurrence of the issue.
Preventive Action: Action taken to eliminate the cause of a potential problem or other undesirable condition. Preventive action should prevent the occurrence of a potential issue.

Proactive vs. Reactive

Ideally, companies should operate in a way that prevents issues from happening. However, the reality is that most companies don’t realize a problem exists until something undesirable happens. This may include failed inspections, unacceptable test results or a forced recall. These scenarios may result in lost revenue or a loss of a business’ operating license. Being proactive by monitoring operations through quality management practices and implementation of CAPA principles at the first sign of suspected trouble, greatly reduces or eliminates the risk of issues occurring.

Define the issue (and Scope)

A successful CAPA investigation begins with a clearly defined and documented problem description and scope. The problem description should answer the who, what, when, where, and scope (magnitude) of the issue. Who identified the issue? What is the issue? When did the issue occur? Where did the issue occur? What is the magnitude or scope of the issue? The magnitude or scope should identify if the issue is seen in other product batches, is isolated to specific equipment, or may only occur on certain days of the week.

The following is an example of a clearly defined problem description:
On 06/12/2017 (WHEN) the Quality Control laboratory (WHO and WHERE) identified a trend of mold results (WHAT) for testing conducted from 06/01/2017 through 06/10/2017 for Product Code 98456, Batches 1234, 5678, and 9101. (SCOPE/MAGNITUDE)

Assess Impact/Risk

Defining the scope of an issue includes an evaluation of risk. Evaluating the level of risk upon identification of the issue determines the depth of the investigation required and what actions may be necessary to correct the issue.
In the example given above a risk evaluation and a trend analysis of all similar products and all additional batches from the affected Product Code should have been conducted immediately when the issue was identified. Identifying potential product impact up front minimizes the likelihood of detecting additional failures on other product batches at a later date. Early detection allows for immediate correction and the avoidance of batch destruction and subsequent lost revenue.

Investigate the cause of the issue

Root Cause Analysis (RCA) is the most widely used approach for problem-solving. RCA is often used to determine the root cause during the execution of a CAPA investigation. The use of investigational tools while utilizing RCA facilitates the accurate identification of the root cause(s) and any other contributing factors of an issue.

An example of an RCA tool is an IS-IS NOT analysis. IS-IS NOT works by making you deliberately think about the problem and in particular the boundaries of what it is or is not. In the above example, one could determine what processes are in scope and which ones are not (i.e. sanitization practices), what days of the week the mold failures occur and which days they do not occur, or were batches that failed tested by the same technician, various technicians, or possibly a new technician. Scoping the boundaries of the issue allows for more concise identification of root cause.

Correct the issue

Once root cause has been determined an action plan should be established and documented. The plan should be reviewed and approved to ensure all root causes identified have an associated action.

The plan should include a description of how the action(s) will be tested before it is implemented to ensure there is no negative impact on any process or product. Details of how the action(s) is implemented (when and by whom) and the justification for implementation should be provided and documented.

If the mold testing issue is linked to a new testing technician not following the documented procedure, the technician should be retrained. The technician should be assessed on their understanding and execution of the test method prior to being allowed to again test product for release. Product testing results for that technician should be monitored for a period of time to determine adherence to procedure.

Evaluate/Monitor Effectiveness

An effectiveness plan, based on a statistical evaluation, verifies resolution of the quality issue by the implemented action(s). Data is collected and measured over an appropriate period of time to determine if the actions were truly effective. Effectiveness does not necessarily mean the “elimination” of the issue, but that a statistical improvement was demonstrated. If the established effectiveness criteria does not pass, the CAPA should return to the investigation phase.

An appropriate effectiveness evaluation for the mold failures would be to determine what the actual failure rate was at the time the issue was identified. Once all corrective actions are implemented testing results could be monitored for a period of time (i.e. six months). Effectiveness is met if that data demonstrates a 98% conformance rate (no greater than 2% of the product batched fail for mold). The ability of the effectiveness to meet the established acceptance criteria verifies that the corrective actions implemented addressed the root causes identified and are effective.

Dissemination

Dissemination occurs once effectiveness passes the established criteria and root cause has been determined. Communication on findings identified during the CAPA investigation informs all those directly involved and responsible to ensure the issue does not happen again.

For more information on how to effectively implement CAPA processes and procedures into your business please contact MP Consulting, LLC; www.contactmpconsulting.com

This article was written in collaboration with Jeremy Applen, he is the Vice Chairman of the ASTM International Cannabis Committee, D37.

References:
Food and Drug Administration (FDA), Quality System Inspection Technique (QSIT) Guide, August 1999
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices, Jon Speer, October 27, 2017
American Society for Quality (ASQ), Cost of Quality (COQ)

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