How To Build An Audit Agenda

Every ISO and GxP certified organization must undergo audits, whether internal (1^st party audits) or external (2^nd and 3^rd party audits). These audits are critical to the certification process and the submission of marketing authorizations for medicinal products (Article 8 of EU-Directive 2001/83/EC) and help the organization identify risks, issues, and improvement opportunities.

Sometimes, if we lack direction and clear objectives, the planning of an audit can become a tedious and useless tool. However, planning an audit correctly, whether as an internal auditor or a third-party auditor, will provide you with enormous advantages. In this article, we will explain why it is so and how to use the audit plan to your benefit.

The First Steps To Successful Audit Plan Execution

To build a successful audit agenda, it is necessary first to follow four critical steps:

#1 – Communicate with the auditee

Before planning an audit, it is crucial to communicate with the auditee. First, confirm the agreement with the auditee regarding the feasibility of the audit and the extent of the disclosures, and the treatment of confidential information.

Take the necessary steps to collect information to understand the operations and prepare audit activities and applicable audit documents.

#2 – Define the audit type, and its objectives

Types of audits can vary from organization to organization; therefore, each approach might differ.

These audits can be:

Certification/ Regulatory audits;
Supplier audits;
Internal audits;
Data integrity audits.

After defining the type of audit, it is essentialto establish the objectives, scope, and audit criteria. Remember that an audit is but a way to sample the quality management system of an organization to test its effectiveness and compliance. To do this, you should consider multiple factors, such as:

The organization profile and background (location, activities performed, size)
Audits history (nonconformities, deviations, audit observations)
Nature of material or service; product development stage.
Regulatory oversight and certifications (applicable policies, statutory and regulatory requirements, management system requirements)
Risks and opportunities, (contamination, safety, environmental)
Recalls and complaints

#3 – Define methods and tools on the Audit Agenda

Based on the type of audit, select and determine the methods for effectively and efficiently performing the audit, depending on the defined objectives, scope, and criteria of the audit. They can be conducted on-site, remotely, or as a combination.

If you use a remote audit method, have a backup plan in case of technology failure. The auditor and the auditee parties should agree on the backup communication plan in advance, which should take place before the audit.

#4 – Know and select your audit team

You should select your audit team by considering the competencies needed to achieve the audit objectives. Auditors, even internal ones, must be impartial and knowledgeable. In a GXP environment, auditors must have only the product’s quality and the patient’s well-being in mind.

A good auditor should also have the perfect mix between a flexible and a goal-oriented personality while maintaining the balance between being spontaneous, open-minded, assertive, and regimented. To help you select your audit team, you can use the assistance of Work Style Assessment (WSA) Tools. Using WSA tools to choose an audit team can be crucial to ease the entire audit process and the interactions with the auditee.

The Audit Agenda

Once these critical steps are covered, we can start building the perfect audit agenda which adapts to the audit necessities (verify compliance) and add measurable value to the auditee.

The scale and content of the audit agenda can differ between external and internal audit and initial and subsequent audits. Therefore, you need to have a flexible agenda that can adapt to changes as audit activities progress.

The audit agenda should be presented to the auditee before the audit date. Any issues with the audit plan should be resolved with the audit team leader, the auditee(s), and the individuals (if necessary) managing the audit program.

Keeping up with the Audit Agenda and adapting on the fly

During an audit, the most common causes of deviation from the audit agenda are the following:

Lack of audit objectives and direction;
Lack of communication and misunderstandings between the audit team and the auditee;
Unplanned events that hinder the planned audit activities, e.g., machinery failures;
The intentional or unintentional actions of the auditee divert the auditor’s attention.

Therefore, the key to keeping up with the agenda should be found in the “opening meeting,” as it is where auditors must review the schedule with the auditee and where they verify that all planned audit activities can be performed, audit checklist can be reviewed, questions can be answered, and uncertainties resolved.

An auditor must always remain focused on the audit objectives and keep track of the agenda. However, when challenges and setbacks arise during an audit, the audit team’s flexibility and spontaneity play a considerable role in the ability to come up with solutions to allow the audit flow to continue.

As seen previously, effective audit planning can help the team devote appropriate attention, time, and resources to critical audit areas. It also helps reduce misunderstandings regarding the audit work and establish backup plans.

How Qualifyze can help

Instead of assigning audit tasks to your employees, having experienced external auditors in the processes you or your supplier have can provide you with a more comprehensive audit report. In addition, you’ll have a clearer idea about the audited process in less time. Qualifyze can help you on that point by reducing your audit burden and saving you a considerable amount of time and resources but not having to accommodate new audits on a one-on-one basis which will most likely cover the same products.