How to develop a corrective and preventive action plan (CAPA)

NHP Bulletin 6, September 27, 2024, from the Health Products Compliance Directorate

On this page

• What are CAPAs and why they're important
• The CAPA process
• Health Canada's role
• Contact us

What are CAPAs and why they're important

CAPAs are comprehensive corrective and preventive actions. They include immediate, corrective and preventive actions, which are defined as follows:

• Immediate action is action taken to immediately correct or contain an issue. This type of action is reactive and generally does not fully address the issue, which means the problem will likely remain.
• Corrective action is action taken to eliminate the cause of the issue that has been detected.
• Preventive action is action taken to prevent the issue from ever happening again.

Regulated parties, such as manufacturers, importers, packagers and labellers, are required to develop comprehensive CAPAs to address the following:

• good manufacturing practices (GMP) deficiencies or
• issues (known as non-conformities) with natural health products

Learn more about your regulatory responsibilities in the Good Manufacturing Practices guidance document.

How an issue or deficiency is identified

A deficiency or issue may be identified in a number of ways, for example:

• company personnel:
  • an operator may notice that a standard operating procedure (SOP) is not being followed
  • the quality assurance person may notice that a batch record is not complete
• a testing laboratory:
  • out-of-specification test results may be found for raw materials or finished products
• consumers:
  • complaints about a defective product
• Health Canada:
  • site licence applications or renewals and GMP inspections of natural health products
• other sources:
  • inspection by another regulatory authority
  • self-inspection
  • investigation of identified issues

The CAPA process

Companies that have an effective process in place are better able to identify, correct and prevent an issue or a deficiency. An effective CAPA process also supports ongoing and long-term GMP and quality assurance requirements.

There are 8 key steps in the CAPA process:

1. Document and record the issue.
2. Put together a team to investigate.
3. Contain the issue.
4. Identify the cause.
5. Assess the impact.
6. Take appropriate action.
7. Monitor the plan's effectiveness.
8. Close the plan.

Step 1. Document and record the issue

Document the issue and how you addressed it. Your standard operating procedure or work instruction should outline what you need to do. There should be a controlled form to document your issue as part of your quality system.

Step 2. Put together a team to investigate

Assemble a team made up of the appropriate personnel (such as quality assurance, quality control, manufacturing personnel) to investigate the issue.

Step 3. Contain the issue

Contain and correct the issue as soon as possible. This may involve putting regular processes on hold or quarantining a product lot or piece of equipment while the issue is being investigated.

High-risk issues require immediate correction to mitigate risks. You may need to introduce short-term measures while long-term measures are being implemented.

Step 4. Identify the cause

You must identify the underlying cause of the issue to determine the actions that must be taken to ensure the issue doesn't happen again.

Use an appropriate methodology (or combination of methods) to help you identify the cause, such as the:

• 5 whys analysis
• Fishbone diagram
• Pareto analysis

Step 5. Assess the impact

An impact assessment will help you:

• ensure the entire issue has been analyzed
• identify what went or may go wrong, the likelihood of the issue happening again and the severity of the consequences

Use categories to describe the level of impact (critical, major or minor, or high, medium or low) and outline these in your documentation. Be as detailed as possible.

When you conduct an impact assessment, you should consider if the:

• same or similar issues could apply to other products
• safety, quality or efficacy of marketed lots of natural health products or other products may be impacted
  • revisit previous product batches or lots that could be affected
  • identify related trends
• data and information that were used to arrive at previous decisions are reliable
• level of control (such as over other products, internal processes, systems or suppliers) is adequate

You must also consider what possible actions should be taken to mitigate or eliminate the identified risks and gaps.

Step 6. Take appropriate action

The level of action you take to address the findings of the impact assessment should be in proportion to the risk and complexity of the issue.

If you identify actions as corrective or preventive, it's easier to demonstrate that your CAPA plan has addressed an issue to the fullest extent. This is why in-depth investigations into the cause of an issue and analyses of the impact of an issue are critical to a CAPA plan.

For example, if an issue could impact a product, your CAPA plan may include:

• changes to the manufacturing process, such as:
  • equipment modifications
  • new cleaning process for equipment
• a recall of impacted batches or lots distributed in Canada
  • for more information about recalls, refer to the Drug and natural health products recall guide

In the CAPA plan, you will need to record the timeline for implementing corrective and preventive actions, taking into account the resources (time, personnel, materials) used.

It's important to set reasonable timelines for implementing actions. You should justify if extra time is needed, including documenting any interim measures taken until the full CAPA plan is implemented.

Investing time and effort to prepare and implement a CAPA plan may also result in operational improvements.

Step 7. Monitor the plan's effectiveness

After you have taken action to correct the issue, you should monitor how effective your CAPA plan was. Answering the following questions will be helpful:

• Did the immediate corrections and other actions taken address the underlying issues and their root causes?
• Did employees complete the relevant training?
• Did the corrections and actions taken result in any negative consequences and, if so, how will these be addressed?

If the CAPA plan was not effective, you may need to go through steps 1 to 7 again to determine what went wrong and make any necessary changes.

Note: It's not acceptable to continue to operate under conditions that may adversely impact the quality of natural health products or the safety of consumers.

Step 8. Close the plan

Before the quality assurance person approves and closes the CAPA plan, you should:

• ensure the deficiency or issue is fully corrected and prevented
• consolidate the records (including outcomes) and documents for each step of the process

You can use this information to create or modify your standard operating procedures.

Records should include the following information:

• a description of the immediate corrections taken
• the results of the root cause and impact analyses
• a description and the date that CAPAs were implemented
• the effectiveness of the actions taken
• the date the plan was closed

Records concerning a batch or lot of a natural health product should be maintained for 1 year after that product has expired.

Avoid:

• using vague information such as general timelines for implementation (for example, "from now on", "in the future" or "to be determined") or
• submitting updated written standard operating procedures as a CAPA plan, with no additional explanation as to how or why the procedure was updated

Health Canada's role

Inspection and site licensing process

We may inspect sites conducting licensable activities to assess their compliance with the applicable regulatory requirements under the Natural Health Products Regulations. After an inspection, companies are issued an inspection exit notice. This notice includes the inspection rating (compliant or non-compliant) and any observations identified during the inspection. The notice and accompanying cover letter indicate the date that the company must provide a written CAPA plan to address any issues identified during the inspection.

During the site licensing process, we may issue a notice that describes any observations identified during the review. The notice:

• provides an opportunity to prepare a CAPA plan in response
• indicates the date that a written response must be provided

CAPA plan assessment

During the inspection or site licensing process, we review only a sample of the natural health products processed by a company. Our observations describe a specific situation seen or identified.

Your CAPA plan must address the underlying issues related to the observation made. It must not be limited to the specific product or example identified in the inspection exit notice. For example, if an inspector identifies an issue with a specific product lot, you must consider the impact of that issue on other lots and products that could be affected.

A CAPA plan is mandatory, as it's an important part of the inspection and licensing process. We review a CAPA plan to ensure it mitigates the risk posed by the observations we made.

A CAPA plan may be under way and not fully completed when you submit a written response to us. You must, however, provide the plan by the due date and have clear target dates for completing it.

Include in your plan a summary of the steps completed, along with a description of:

• immediate corrections taken, with dates
• preliminary or completed root cause investigations and impact analysis conclusions
• plans for ongoing investigations, impact analysis and target dates
• CAPAs that were taken, with dates completed for each observation
• planned CAPAs and target completion dates for each observation

We may ask for documented evidence to demonstrate and support the actions taken. Documented evidence could be in the form of photographs, repair bills or updated standard operating procedures, for example.

If a target completion date extends over a prolonged period, you should explain why. It's important that your target dates are reasonable or account for the actual time needed to complete the required work.

Target completion dates confirmed to Health Canada that must be extended due to unforeseen circumstances should be managed through quality management processes. You should include:

• a rationale as to why commitments and target dates can't be met
• an updated action plan to address the issues, including revised target dates
• interim control measures put in place to mitigate risk, with date of implementation

Contact us

For questions about GMP inspections for natural health products, email us at hpcrm.nhpinspection-inspectionpsn.cpsgr@hc-sc.gc.ca.

For questions about site licensing, email us at hpcd.nhp.sl-dcps.psn.le@hc-sc.gc.ca.