Internal audits and corrective actions

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Is there a procedure in place for conducting internal audits? Does it include frequency of audit, elements to be audited, and who is responsible for the audit and follow-up of corrective actions? Does the internal audit cover all aspects of the establishment and its operations including:

  • Export documentation
  • Good Manufacturing Practices
  • Preventative maintenance
  • Transport
  • Training
  • Trade Descriptions

Is there a procedure for documenting corrective actions where monitoring, verification, internal audit, or an audit undertaken by a third party identifies non-compliance? Does the procedure include actions to:

  • Investigate the cause of the non-compliance
  • Address the non-compliance
  • Determine the timeframe for action
  • Prevent recurrence
  • Assess effectiveness
  • Allocate responsibility for management and action
  • Escalate when corrective action is not done within the allocated timeframe
  • Does the system cover corrective action requests resulting from external audits (e.g., state regulator, third party)?

For the relevant legislative references in the Export Control (Milk and Milk Products) Rules 2021, please refer to the department’s, Approved Arrangement Checklist.

Your site’s procedures should reflect current practices and conducting an internal audit provides you with an opportunity to verify that your documented procedures correspond with actual practices. It allows an organisation to take a step back and review the whole process by examining key areas to ensure current practices are acceptable and reflect your documented procedures.

Often regulatory and customer requirements change over time, and whilst your operations may have been modified to meet these new requirements to ensure compliance and customer satisfaction, you may not have had the opportunity to update your documented procedures to reflect the recent updates.  An internal audit enables you to review these changes and any new requirements and then update your procedures accordingly.

Your site’s internal audit procedure should capture key attributes including:

  • How often will an audit take place?
  • Which areas will be covered during an audit?
  • Who is authorised to conduct an audit?
  • How will non-conformances or areas of concern be reported and rectified?
  • Who is responsible for assessing corrective actions and
  • Nominate an alternate responsible person, in the absence of the main responsible person.

Any non-conformances identified, either through an internal audit or during an external third-party audit, must be documented and addressed using a corrective actions procedure. The procedure must categorise the level of non-conformance, such as critical vs non-critical, and identify the corresponding corrective action documentation to be used for the investigation of non-conformances.

The corrective actions request (CAR) form must include:

  • A root cause investigation which has led to the non-conformance,
  • Determine corrective actions and preventative actions to address the non-conformance,
  • Clear determined timelines for implementation,
  • An escalation process for when corrective actions are not actioned within the stipulated timeline,
  • Evidence of corrective actions,
  • Methodology to assess the effectiveness of the implemented actions in preventing similar non-conformances from re-occurring, and
  • Management responsibility and closeout of the non-conformance.

Consider the below points when documenting your Internal audits and corrective actions program.

  • A schedule or plan to ensure all elements and manufacturing areas are reviewed and audited regularly.
  • The allocation of resources (internal auditors) to conduct audits regularly and their rotation to remove the effects of complacency.
  • A review process to update your current internal audit checklists to reflect new requirements.
  • A competent method for conducting root cause investigations.
  • A classification process to determine low risk and high-risk non-conformances along with consideration for when a corrective actions documentation would be filled.
  • A process to review past root cause analysis (RCA) and implemented corrective actions for their effectiveness.
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Self Assessment

How much do you know about Internal audits corrective actions?

Take this short assessment to find out.

Question 1

Steven is the QA coordinator of a dairy processing plant and is conducting a review of the internal audit schedule for the following year.

In order to be export compliant, which areas of the facility and procedures should Steven include in the internal audit schedule for the following year?

Question 2

Steven has identified 22 procedures and corresponding areas that must be reviewed and is considering updating his internal audit schedule to have one target area and element reviewed per calendar month.

As Steven has 22 areas to review, and only 12 calendar months in a year, in order to be export compliant, is Steven correct to target one internal audit per month?