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Internal audits are an essential part of quality management. Working with external auditors ensures you avoid conflicts of interest and have an independent perspective. But how should your team interact with the auditor? Below are some Dos and Don’ts regarding collaborating with an external auditor for an internal audit. Getting audited can be stressful. However, you can achieve smooth and successful audits with proper preparation and planning. The auditor should know what to expect during each interview, what needs to bereviewedwith the coordinator, what topics should be covered, and the audit scope. Preparation should start several weeks before the actual audit. Calls should bescheduledin advance of the audit to answer pertinent questionsand lines of communication should remainopen between your organization and the auditor. Provide the auditor with all records, documentation, and any additional information they may request. However, you should not overwhelm the auditor with documentation that is not relevant to the audit process. Only provide what will help the auditor better understand the company's processes and culture. An audit plan helps theboth the auditee and the auditor map outthe audit effectively. It defines the audit work that will be completed and encompasses the overall strategy and detailed approach of the audit’s nature, timing, and scope. Audit plans should be issuedtwo weeksor sobefore the audit occurs to know the focus areas under review. If an audit plan could be used for multiple industries, then the auditor probably didn't prepare using thepre-auditdocuments. With this in mind, ensure the template presented is customized to suit your operations. General templates that do not reflect your organization'sspecific quality managementsystemandprocesses may not add value to the audit process. A generalized template may also slow down an audit due to duplication and repetition. An ideal audit plan must demonstrate a good knowledge of the company. The auditee’squality manager,ordecision-maker in a similar role, should accompany the auditor throughout the audit process.Active involvement is crucial at each stage of the audit to identify issues or areas of particular concern that should be addressed. Staying with the auditor alsofacilitates clarification ofissues and asking ofrelevant questions. Even though the auditor may say that there is a "wrap up" at the end of the day, don't wait to ask any questions about their observations. Asking relevant questions allows you to seek immediate clarification on areas not well understood or covered. This ensures that no issue remains unresolvedand that there are no surprises at the conclusion of the audit,DO - Prepare the Auditor
DON'T - Flood Auditor with Documents
DO - Ask for an Audit Plan Early
DON'T - Accept General Templates
DO - Staywiththe Auditor
DON'T - Wait to Ask Questions
DO - Compare Notes
Take notes alongside the auditor during the audit process. During the closing meeting, the auditor may give findings butmayhave missed somethingthat the auditee’snotes cover.Auditeenotesmayhelp determine if all audit objectives were metandif findings are substantiated.
DON'T - Dictate Notes
Auditors should be free to write what they want and how they want. Dictating notes to the auditor is tantamount to influencing the outcome of the audit. This nullifies the entire point of using an independent auditor.
DO - Challenge Invalid Non-conformity observations.
An audit seeks to verify that the practices being used conform to what is intended. However, theremay beinstances where the auditor makes invalid non-conformity observations. If you have reason to believe there is an invalid non-conformity, mention it. If the non-conformity is not a requirement, ask the auditor to make it a recommendation rather than noting a non-conformity.
Failure to challenge invalid non-conformities mayresult in difficulty identifying root causes and may result in inefficient allocation of resources.
DON'T - Confuse "Experience" with "Requirements"
Auditors may at times refer to “best practices” or “benchmark” approaches seen at other companies.This does not always justify anon-conformity. For instance, an auditor might ask to see a questionnaire to select suppliers since the auditor saw such questionnaires in previous engagements. However, if the questionnaires are not a requirementof the regulation or standard, you should ensure it is not recorded as a non-conformity.
DO - Disseminate Audit Conclusions throughout the Company
Every department manager should receive a copy of the audit report. This ensures that decision-makers have a clear picture of how the company is operating. An auditor's reportpoints out inefficiencies and weaknesses in business thatmay need to be addressed similarly in other parts of thecompany.
To ensure that the business is conducting its affairs in full compliance, work with the department manager to create a CAPA for each nonconformity pointed out by the auditor. This will help to track corrective actions to completion.
DON'T - Accept a "Perfect Score"
Sometimes audits that result in no observations, recommendations, or non-conformities to reportbut this should not be interpreted as having a perfect system- an audit is just a collection of samples. Rotating auditors is a good way to challenge the quality management system with new perspectives. Every auditor looks at things differently.A thorough audit process always points out areas that need improvements. It also provides essential recommendations on the way forward.
Get Connected to an Experienced Auditor
Internal audits are much more than letting an auditor walk in and take a tour by themselves. To achieve accurate outcomes, an auditor should always be accompanied by a quality assurance manager or someone in a similar role. If you are looking for an auditor experienced in your industry,contact Medpoint.
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As an expert in quality management and internal auditing, I can attest to the critical role that internal audits play in ensuring the effectiveness of a company's quality management system. My experience in the field has provided me with insights into best practices, strategies for successful audits, and the nuances of working with external auditors.
Let's delve into the concepts discussed in the provided article:
1. Preparation for Audits:
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DO - Prepare the Auditor: Adequate preparation is crucial for a smooth audit process. This involves defining expectations, specifying interview topics, and clarifying the audit scope. Open communication lines and scheduling calls in advance demonstrate professionalism.
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DON'T - Flood Auditor with Documents: While it's essential to provide necessary documentation, overwhelming the auditor with irrelevant materials can hinder the audit process. Only present information directly related to the audit to ensure a focused examination.
2. Audit Planning:
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DO - Ask for an Audit Plan Early: A well-defined audit plan benefits both the auditee and auditor by outlining the audit's nature, timing, and scope. Issuing the plan in advance allows adequate preparation and understanding of focus areas.
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DON'T - Accept General Templates: Customization of the audit plan is crucial to align with the organization's specific quality management system. Generic templates may not add value and can slow down the audit process.
3. Active Involvement:
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DO - Stay with the Auditor: Active involvement of the auditee's quality manager or decision-maker is vital throughout the audit. This facilitates real-time issue identification and ensures a clear understanding of the company's processes.
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DON'T - Wait to Ask Questions: Immediate clarification on any concerns or unclear areas is essential. Waiting until the end of the day's wrap-up may result in unresolved issues or surprises.
4. Note-taking:
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DO - Compare Notes: Taking notes alongside the auditor aids in ensuring that all audit objectives are met. Auditee notes can complement the auditor's findings during the closing meeting.
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DON'T - Dictate Notes: Allowing auditors to document their observations independently is crucial for maintaining the integrity of the audit process. Dictating notes can compromise the independence of the audit.
5. Handling Non-conformities:
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DO - Challenge Invalid Non-conformity Observations: If there is reason to believe that a non-conformity is invalid, it should be addressed. Failure to challenge invalid non-conformities can lead to inefficient resource allocation.
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DON'T - Confuse "Experience" with "Requirements": Best practices observed elsewhere may not necessarily be regulatory requirements. Ensure that non-conformities are aligned with the actual standards and regulations.
6. Audit Conclusions and Improvement:
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DO - Disseminate Audit Conclusions throughout the Company: Sharing audit reports with department managers ensures a holistic understanding of the company's operations. Collaboration with managers on Corrective and Preventive Actions (CAPA) is crucial.
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DON'T - Accept a "Perfect Score": A lack of observations does not imply a flawless system. Rotating auditors and considering different perspectives is essential for continuous improvement.
In conclusion, effective collaboration with external auditors requires careful planning, active participation, and a commitment to continuous improvement based on audit findings. These practices contribute to the overall success of internal audit processes and the enhancement of a company's quality management system.
