Episode 1: What an Internal Audit Is and Why You Should Perform Them

As part of this series we are going to examine what an internal audit is, what organizations should perform internal audits, how to properly and effectively perform an internal audit, and how to use the results of those internal audits to evaluate and improve the safety or quality management system.

An internal audit is an investigation performed by or for the organization, into the documentation and monitoring actions to determine if the program being audited is functioning as intended.

Many organizations have quality department employees on staff, and some of their responsibilities are to make sure operations were performed correctly, but there are major differences between quality checks and internal audits.

When QA or QC employees monitor a production line, check batch records or beta test software, these important and necessary inspections do not actually count as an internal audit. Similarly, the regular walkthroughs of operations we refer to as GMP, Hygiene or Sanitation inspections in our first video series, are not the same as internal audits.

QA or QC Record reviews as a part of regular operations, and visual inspections performed daily, weekly or monthly walkthroughs are part of the Quality and Safety Management System, whereas an internal audit is a separate, independent review of the system itself, including all records of those checks and walkthroughs.

Whereas inspections and walkthroughs are assessments of individual components of a system, an internal audit is a big picture assessment of the operation or system as a whole. An internal audit can be performed all at once, or it can be broken up throughout the year. Determining the frequency will depend on the time and other resources available to perform the audit or audits.

Regardless of whether the audit is performed in it’s entirety, all at once, or split into a repeated action during the year, a person or group independent of the operational actions being reviewed is required to review the paperwork or electronic records to make sure those records are the correct records, they are completed properly , and can be readily produced upon request.
Think of an internal audit as a review of the reviews, or a master verification action to give the organization a big picture view of how much control and consistency is achieved.

For operations with a small number of employees, finding a person to perform an internal audit who is not performing the operational tasks may be challenging. For example, if the organization has a Quality Assurance Manager with only one or two support staff, most likely that QA Manager is performing quality checks and is also the person tasked with performing an internal audit.

That QA Manager cannot claim to be independent when auditing the QA department itself. But don’t worry, Kellerman Consulting will show you how to address this successfully in our later episodes.

There are several reasons why an organization may perform internal audits: One is that it is a requirement as part of a certification scheme such as an ISO 9001, 14001, 18001, or a GFSI scheme such as SQF, BRCGS, FSSC 22000, PrimusGFS or IFS.

Other reasons include changes in operational personnel, establishing a culture of quality or safety and verifying the implementation of new policies and procedures.
Conversely, an organization may choose not to perform internal audits may include the difficulty to set up, time consumption, and the requirement of a specially trained person to complete the audit. .

For organizations that have not performed internal audits in the past because they have never had a customer ask for results, or because they are not subscribed to a certification program that calls for an internal audit, employees may be unaware of internal audits all together.

As we review the logistics of performing an internal audit, we will address each of these challenges to make sure this valuable tool can be put in place and used to improve operational performance.

By watching this series on Internal audits, we know that you are determined to set up or continue to improve your organization’s internal audit program and Kellerman Consulting is here to help you begin or improve your process. We will need to first discuss preparation actions for the internal audit, as well as how to follow through on gaps identified during the review of records and operations during the audit.

We have provided free downloads on the Kellerman Consulting website to assist in internal auditing, so please be sure to give our website a visit to get access to those tools, as well as to find our other episodes in our internal auditing series.

In our next episode, we will review the key pre-planning actions for an internal audit, including determining the audit schedule, the method of auditing and the timelines of the audit and presentation to management.

Thank you for watching. For free downloads to accompany this video series, visit the free training videos & resources page of our website.

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