Client Corrective Action (CAPA) Submission Guide

How to complete and submit corrective actions within the 30‑day allocation.

1. Purpose of this guide

This guide explains how clients must complete and submit Corrective Actions (CAPA) following an Apex Global Quality audit. It is designed to ensure:

• Clarity: You understand exactly what is required in your response.
• Consistency: Responses are aligned with the applicable standard and audit expectations.
• Timeliness: Nonconformities (NCs) are closed within the agreed timeframe.
• Continuity: Certification can continue without disruption.

This guide applies to all clients receiving Major or Minor Mandatory Actions.

2. Understanding nonconformity grading

2.1 Major Mandatory Action

A Major is issued when:

• There is an absence or significant failure to implement a requirement of the applicable standard; or
• Available objective evidence raises significant doubt about the management system’s ability to achieve its intended outcomes.

A Major requires immediate containment, root cause analysis, corrective action, and evidence of implementation and effectiveness.

2.2 Minor Mandatory Action

A Minor is issued when:

• A weakness, omission, or isolated failure is identified; and
• It could escalate to a Major if not addressed.

Each Minor should be considered for potential improvement and included in a corrective action programme where appropriate.

3. Submission requirements and deadlines

3.1 Timeframes

• Minor nonconformities: CAPA must be submitted within 30 days of the audit report date.
• Major nonconformities: CAPA and implementation may be allowed up to 90 days, and may require a special visit depending on severity.

3.2 Submission method

• Email is the current preferred method of submission and delivery.
• Send your CAPA directly to your Lead Assessor using the email address provided in your audit report or communication.

3.3 File and folder structure

For ease of review, each nonconformity must be submitted in its own folder. For example:

NC01/
    Correction.pdf
    Root-Cause.pdf
    Corrective-Action-Plan.pdf
    Evidence/
        Training-Records.pdf
        Revised-SOP.pdf
        Photos/

NC02/
    Correction.pdf
    Root-Cause.pdf
    Corrective-Action-Plan.pdf
    Evidence/

Submissions that do not clearly separate NCs may be returned for re‑formatting.

4. Components of a complete CAPA

A complete CAPA for each NC must include:

• Correction (including containment and extent assessment)
• Root cause analysis
• Corrective action (to address the root cause)
• Verification of effectiveness (VoE)
• Supporting evidence for all of the above

4.1 Correction (containment and immediate action)

Definition (ISO 9000:2015): Action to eliminate a detected nonconformity.

Your correction must:

• Be written in the past tense (the action has already been implemented).
• Show that the nonconforming product/service is no longer being produced or offered.
• Include an assessment of extent (where else did this occur?).
• Describe containment measures (what was stopped, quarantined, or removed).
• Address whether similar occurrences were corrected (systemic correction).

Example: “Micrometer #123 was taken out of use and calibrated on dd‑mm‑yy. Micrometer #456 and Caliper #789 were also missing a calibration label; they were taken out of use and calibrated on dd‑mm‑yy.”

4.2 Root cause analysis

Definition: The underlying cause of a problem which, if adequately addressed, will prevent recurrence.

Your root cause must:

• Not simply restate the finding or direct cause.
• Not use superficial statements such as “training error”, “operator error”, or “human error”.
• Be detailed enough that no further “why?” questions remain (5 Why principle).
• Be developed using a recognised method such as:
  • 5 Why analysis
  • Ishikawa (Fishbone) diagram
  • Is / Is Not analysis

Example: “The calibration process does not adequately define provisions for entering new devices into the recall system.”

4.3 Corrective action

Definition: Action to eliminate the cause of a detected nonconformity and prevent recurrence.

Your corrective action must:

• Directly address the identified root cause.
• Include what will change, who is responsible, and by when.
• Describe what evidence will demonstrate implementation.
• Address all root causes if more than one is identified.

Example: “The calibration process was revised to include provisions for adding new devices into the recall system, and relevant personnel were trained on the new process.”

4.4 Verification of effectiveness (VoE)

Definition: Evidence that the corrective action has prevented recurrence and is effective over time.

Your VoE plan must:

• Define a timeline for verification.
• Assign responsibilities for checking effectiveness.
• Specify what evidence will be reviewed (e.g. records, audits, interviews).
• Demonstrate sustained compliance, not just a one‑off fix.

Example: “Evidence collected shows the internal audit programme is issued and approved before the beginning of the new year, and internal audits are scheduled and completed as per the programme. Personnel responsible for the programme understand the process and their responsibilities.”

5. Supporting evidence

Each CAPA submission must include objective evidence to support:

• The correction and containment actions taken.
• The implementation of corrective actions.
• The verification of effectiveness.

Examples of acceptable evidence include:

• Revised procedures, SOPs, work instructions, or forms.
• Training records and attendance sheets.
• Photographs of corrected conditions.
• Screenshots of updated systems or software.
• Updated logs, registers, or calibration records.
• Internal audit reports or checklists.
• Meeting minutes or action logs.
• Risk assessments or change control records.

Important: Lack of evidence, or evidence that does not clearly relate to the NC and CAPA, may result in rejection of the response, escalation to a Major, or suspension of certification.

6. How your CAPA fits into the audit execution flow

Your CAPA submission is a key part of the certification process. In simplified form:

• Audit conducted and nonconformities raised.
• Client receives NCs and 30‑day (Minor) / 90‑day (Major) allocation.
• Client prepares and submits CAPA via email, with NC‑specific folders.
• Lead Assessor reviews CAPA and evidence (accepts or rejects).
• Where required, special visits or follow‑up activities are conducted (especially for Majors).
• Technical review and certification decision are made.

If CAPA is not acceptable, it will be returned with comments and must be resubmitted within the original timeframe unless otherwise agreed.

7. Common reasons CAPA is rejected

• Root cause is superficial (e.g. “training error”, “operator error”, “human error”).
• Correction is written in future tense (not yet implemented).
• No evidence submitted, or evidence is incomplete.
• Evidence does not match the described corrective action.
• Corrective action does not address the identified root cause.
• No verification of effectiveness plan is provided.
• Multiple NCs are mixed together with no clear separation.
• Responsibilities and dates are missing or unclear.

8. How to submit your CAPA by email

When you are ready to submit your CAPA:

• Address your email to your Lead Assessor.
• Use a clear subject line, for example:
  CAPA Submission – [Company Name] – [Audit Date]
• Attach your NC‑specific folders (zipped if necessary).

We recommend including a simple summary table in the body of the email:

9. Client responsibilities

• Submit complete CAPA responses within the required timeframe.
• Maintain copies of all CAPA submissions and evidence for future audits.
• Ensure all corrective actions are implemented and effective before the next audit.
• For Major nonconformities, ensure actions are implemented and effectiveness verified before certificate expiry.

10. Apex Global Quality support

Apex Global Quality can clarify nonconformity wording, expectations for root cause analysis, and the type of evidence required. We can guide you on how to structure your CAPA, but the development and implementation of actions remain your responsibility.

If you have questions about your CAPA, please contact your Lead Assessor in the first instance.