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What are the most effective ways to handle unfavorable quality audit results?

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Quality audits and reviews are essential for ensuring that laboratory processes, procedures, and standards are compliant, consistent, and reliable. However, they can also reveal gaps, errors, and risks that need to be addressed promptly and effectively. How can you handle unfavorable quality audit results without compromising your laboratory's performance, reputation, and morale? Here are some tips to help you manage this challenging situation.

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Marcello Couto
Andre Dytz

Executive C-Level / Board Member / Advisor / Management Thinker
Jose Paul Meleth

Founder & Managing Director at FEROCITER TECHNOLOGIES (OPC) Pvt Ltd.| Author| Inventor| Speaker| Sustainability|…

1 Accept the findings

The first step to handle unfavorable quality audit results is to accept the findings as constructive feedback, not as criticism or blame. Resist the urge to deny, justify, or ignore the issues that the auditors have identified. Instead, acknowledge them openly and respectfully, and thank the auditors for their valuable input. This will show that you are committed to quality improvement and willing to learn from your mistakes.

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Marcello Couto
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Uma auditoria é uma avalia??o imparcial baseada em evidências e se há uma n?o conformidade, esta deve ser encarada como uma mera oportunidade de que algo pode - e deve - ser melhorado. Em hipótese alguma a falha é da pessoa, o foco deve ser sempre no sistema. Ent?o deixe o orgulho de lado e m?os à obra!

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Andre Dytz

Executive C-Level / Board Member / Advisor / Management Thinker
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As pessoas s?o vítimas de processos erráticos, burocráticos, paralelos e ultrapassados. Tais atributos n?o geram os resultados esperados, bem como acabam sendo desconsiderados pelos funcionários, os quais procuram alternativas para a consecu??o de suas atividades. Um auditor com a devida expertise e independência irá identificar isto. O que fazer? Mudar os processos e, preferencialmente, convidando as equipes a fazê-lo, considerando sempre o direcionamento estratégico e o compliance em sua máxima dimens?o.

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Jose Paul Meleth

Founder & Managing Director at FEROCITER TECHNOLOGIES (OPC) Pvt Ltd.| Author| Inventor| Speaker| Sustainability| Circular Economy| Biomimicry| Ex Director - PRIMUS GLOVES Pvt Ltd | Isolator/RABS gloves | Pharma Gloves
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First of all, I don't think there could be an "unfavorable quality audit" findings/result! All audit findings are good enough as it could go a long way to improve your system, and help you make a better product. A proper root cause analysis, and a time bound corrective and preventive action could avert recurrence of the problem. This when properly communicated to the auditor(s) could be very effective. The real "unfavorable quality audit result" comes in when the auditor is biased, or when his knowledge is limited, (especially when auditing technical areas, where his expertise is limited), in such case you have to put your foot down, and refute/contest

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2 Analyze the root causes

The next step is to analyze the root causes of the unfavorable quality audit results. This means going beyond the symptoms and finding out why and how the problems occurred. You can use various tools and methods, such as the 5 Whys, fishbone diagrams, or Pareto charts, to help you identify the underlying factors that contributed to the quality issues. By doing this, you can avoid repeating the same errors and focus on addressing the most critical and impactful causes.

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Nicole Baldridge

President at Baldridge Consulting, LLC
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Once we’ve determined the findings are going to stand, assessing them for a root cause is critical. Nothing is ever perfect. You might not agree with the findings, but if you approach with an open mind to improving the processes and policies you have I promise you will find a root cause to the issue raised. Be open to the results. You’ll be surprised how much growth can come from working through “bad audit findings”.

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3 Develop an action plan

Once you have analyzed the root causes, you need to develop an action plan to correct the problems and prevent them from happening again. Your action plan should include specific, measurable, achievable, realistic, and timely (SMART) goals, as well as clear roles and responsibilities, resources, and timelines. You should also consult with your staff, stakeholders, and auditors to ensure that your action plan is aligned with the quality standards and expectations, and that everyone is on board with the proposed solutions.

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4 Implement and monitor the plan

The next step is to implement and monitor the action plan. This means putting the solutions into practice and tracking their progress and outcomes. You should use appropriate indicators and tools, such as checklists, dashboards, or audits, to measure the effectiveness of your actions and evaluate their impact on the quality issues. You should also communicate regularly with your staff, stakeholders, and auditors to update them on the status of the plan and solicit their feedback and suggestions.

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5 Review and improve the plan

The final step is to review and improve the plan. This means assessing the results of your actions and identifying any gaps, challenges, or opportunities for further improvement. You should compare the actual outcomes with the expected goals and analyze the reasons for any discrepancies. You should also document the lessons learned and best practices from the process and share them with your staff, stakeholders, and auditors. You should then revise and update your plan accordingly and continue to monitor and improve it until you achieve satisfactory quality audit results.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Robert W.

Quality Assurance Auditor
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It will always depend on the individual circumstances, but the best teams I've worked with took any negative findings and found an opportunity. Often, the problem identified is one that's been there for too long, with too many work-arounds in place to account for it. Use the attention and support findings can bring to the processes' advantage.

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What are the most effective ways to handle unfavorable quality audit results?

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1 Accept the findings

2 Analyze the root causes

3 Develop an action plan

4 Implement and monitor the plan

5 Review and improve the plan

6 Here’s what else to consider

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