What are the most common quality audit mistakes to avoid?

Yes, it is necessary to define clear objectives before start of audit: Objectives could be just, adherence to QMS or specific related to any major quality issue or improvement of QMS in any specific area etc. Accordingly audit checklist should be prepared

Transparency is fundamental in auditing. The auditee should be well-informed about the expectations regarding preparation & presentation in the audit process. The atmosphere in the room plays a significant role in determining how openly the auditee will be. Therefore, it's crucial for the auditor to create a positive & welcoming tone. It's equally important for the auditor to explain the rationale behind the questions. Often, the topics being discussed may be unfamiliar to the auditee, clarifying the purpose of gathering specific information is essential. In many cases, the auditee can contribute to facilitating the audit process. It's the auditor's task to guide the auditee in understanding what is expected from the management.

Keep it simple. Remember audit is a fact finding exercise and not fault finding. An auditor and auditee too should always remember this.

One thing I've found helpful is to always begin a quality audit with clear and specific objectives. Without a well-defined purpose, it's easy to lose direction and waste resources on irrelevant or redundant tasks. By establishing these objectives based on the organization's quality policies, goals, and stakeholder expectations, you not only create a roadmap for the audit but also ensure that everyone involved understands its purpose and significance. This proactive approach sets the stage for a more focused, efficient, and ultimately valuable audit process.

Audit Objectives may be - Check on Product as well as Process against Documented Organizational Requirements , as well as Based on Needs and expectation from common experience , while Auditing Positive Mind set must be there both on Auditor as well Auditee. Audit Must not be used for Pointing Individual but on System gaps be it in process or product or even in behavioral aspect such as communications. Scope of Improvement both in product and process ,identification of risk areas should be objective of Audit . Audit may also be used to develop a quality culture and empower auditee by making him realize importance of his role. Many organization have culture of documenting only Responsibility and not the authority , audit may point this gap.

Define team roles and responsibilities clearly. Allocate sufficient resources - auditors, tools, budget. Don't cut corners on planning. Start audits only when fully ready. Continuously monitor progress during audits. Adjust plans if required. Carefully review processes, risks and audit criteria. Clearly define your audit objectives, scope, timeline and methodology upfront.

“Proper planning & preparation prevent poor performance “one of the popular quotes on planning is self-explanatory. Audits shall be planned with proper preparation to avoid any mistake or poor performance. Planning covers -communication with the interested parties, analyzing risks for non-achievement of plan and accordingly take necessary actions. Careful review of organizations context, Importance & complexity of processes, lessons from the past can be key inputs while preparing audit plan. The definition of audit is - systematic, independent & documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. It's important to ensure the systematic approach.

- Always start with a preliminary consultation. This way you can exchange up front what you expect from each other. - Use as a starting point trust instead of suspicion - Define the scope/goal of the audit up front and share this with you audit client

Totally agree that planning is an essential element of the audit. When visiting an external organisation it is necessary to enquire in advance about any security protocols. This will help to save valuable time for example, by sending the documents (such as passport copy or picture) in advance for any pass that might be required or carry the same documents when arriving at the facility. As most audits are time bound, sharing an audit agenda will allow the auditee to suggest any changes in advance. Making a plan for each day of the audit along with approximate timelines can ensure that an audit progresses smoothly. If there are any last minute changes, they can be easily accommodated based on the prepared schedule. Plan well and be prepared.

Conducting audits without a well-defined plan or checklist is a mistake. It is recommended to develop a comprehensive audit plan, including objectives, scope, criteria, and a checklist to guide the audit process.

One thing that often gets missed for internal audits is the requirement to "audit the audit". There should be documented evidence that the audit has been reviewed for completeness and conformance to procedure and that the process for closing audit findings is being followed. Easily documented on form.

(1) Describe the audit methods (Interviewing auditee, verification of documented information, observing process through Facility visit /Remote techniques). (2) Describe audit criteria (standards, documented information) (3) Document the criteria for deciding the category of findings: (a) conformity, non -conformity. (b) strengths & Opportunity for improvements (3) Provide guidance on how to deal with- extraordinary situations, conflicts, reporting of unresolved issues & risks. (4) Provide guidelines on how to draw samples, appropriate documentation of the audit evidence and retaining supporting documents where deviations observed, ensuring confidentiality, and timely reporting of findings to the auditee management.

Attention to detail is extremely important in preparing for an audit. Anticipating what the audit will cover and having relevant documents or certifications readily available can make the process go much smoother. Know your audience and no matter how far the auditor digs don’t lose your cool. Do not wing an answer, if it will take time to get the requested information say so. Credibility is completely lost if you get caught providing information which is false or misleading. Always act with professionalism and integrity, the auditors will recognize that and appreciate your competence and cooperation.

Audits are not a punishment but rather a way to assess where your management system stands against the standards and your own objectives. It’s not the first nor the last audit so should be taken as such. A business which designs its QMS around the business and correct interpretation of the standards lives by what it designs. There should be no need for a lot of preparation if everyone in the business follows the defined system, beyond some refresher activities around where the records, SOPs and policies are. When the QMS is significantly detached from the daily operations of the business then certainly there’s a lot of preparation necessary to avoid any surprises and non- conformities.

As part of audit preparation, a critical component entails comprehending the status of the previous year's audit, particularly with regard to any outstanding actions. Regrettably, there have been instances where auditors have overlooked this crucial step, either during the preparatory phase or even during the audit itself. For newly appointed auditors, in particular, familiarizing oneself with the pertinent auditing standards prior to commencing the audit proves highly advantageous. Regardless of an auditor's level of experience, thorough preparation is an indispensable step, but it assumes even greater significance for those who are new to the role.

Audit is not a fault finding exercise but fact based approach. Auditors should refrain from giving suggestions unless specifically requested by audtee.

In my career, i have come across instances where Auditors ask questions which are out of the scope of Audit. In such situations, i respectfully communicated and reiterated the limitations/ scope of the Audit and requested Auditor to stick to the agreed scope. I have noticed that when Auditees respectfully communicates and raise his concerns, Auditors will be alerted and the focus is again brought to the scope of Audit.

Subjectivity would defeat the purpose of any audit. Findings have to be based on evidence found (or lack thereof). In case some evidence is missing, a good auditor should specify that the evidence wasn't shown during the audit, without assuming that the evidence doesn't exist. Objectivity also helps you deliver consistent results through different audits.

Audit evidence can be internal or external. External evidence, like third-party confirmations or industry reports, is usually more reliable than internal evidence. However, internal evidence can be reliable if the organization has strong internal controls. When gathering audit evidence, auditors consider factors like: The risk of material misstatement, The materiality of the item, The client's system of internal control, and Whether tests of control have revealed operating weaknesses.

Personal biases, conflicts of interest, or unprofessional behavior are examples of biased or unprofessional audit conduct. This behavior, whether intentional or unintentional, can undermine audit objectivity, lead to inaccurate assessments, harm relationships with auditees, erode trust in the process, and stymie organizational improvement efforts. Organizations should provide training, promote auditor independence, establish clear guidelines, encourage feedback, and review audit findings on a regular basis to ensure fairness and effectiveness in the audit process.

I think audit sample size is very important & critical. To validate system compliance it is necessary to collect enough evidence to evaluate system implementation. Insufficient sample size for any audit evidence may lead to wrong conclusion.

1. Lack of Planning 2. Inadequate Documentation 3. Bias or Conflict of Interest 4. Inadequate Audit Scope 5. Insufficient Sampling 6. Noncompliance with Audit Standards 7. Lack of Communication 8. Inadequate Follow-up 9. Overlooking Root Causes 10. Inadequate Auditor Training

Auditors have many ways to collect evidence but they should focus on how to collect the objective evidence which based on data and based on the standard requirements only not on the Auditor insights and point of view. Auditor can collect objective evidence during the audit by reviewing ptocedures, records , interviewing people and observation during site tour.

Clear and concise communication of findings and recommendations of the auditor to auditees is crucial for the audit's effectiveness!

I follow a principle: "A picture is worth a thousand words." It's a highly effective form of audit evidence, especially when combined with references. If you have official permission, using your mobile phone is convenient for this in internal audits. It's especially useful for addressing non-conformances. When auditing external companies, you can request auditees to take photos for reference, aiding in non-conformance reporting and sharing best practices. Often, companies only recognize their best practices when highlighted by an external auditor due to their unique perspectives and exposure.

Lack of documented evidences of non conformance points or observations. Missing positive points. Discrepancies between positive & negative observations as sometimes un professional auditors reporting negative points in one paragraph proceeding reporting the same point as a positive point.

Ineffective audit reporting diminishes the value and impact of the entire audit process. When findings are poorly communicated, key stakeholders might struggle to grasp the significance or urgency of the issues presented. A report lacking clarity, structure, or actionable recommendations can lead to misunderstandings, or worse, inaction. Such ineffectiveness can result in critical issues persisting, undermining the goal of continual improvement. Additionally, a weak report can erode confidence in the audit team's competence, jeopardizing future engagements. For an audit to drive change and enhance operations, clear, concise, and compelling reporting is essential.

Often, auditors inadvertently overlook the positive aspects discovered during audits, missing an opportunity to boost employee morale and engagement. However, it's vital to maintain the objectivity established during audit preparation. Auditors' primary goal is to assess conformance with requirements, not to pinpoint system flaws. A well-crafted audit report can also showcase the strengths of the Quality System being audited, followed by areas for improvement. Precision and clarity are essential in reporting, ensuring auditees are not caught off guard. Only information agreed upon with auditees during the audit should be included in the report.

Important to capture both positive practice observed as well as findings that require addressing. When it comes to reporting, the sooner it can be done the better

Quality Audits Learning; ? Schedule audits; Auditors has to submit agenda in advance ? For cause audits; Triggers through complaints and reported failures ? Pre Approval; Before starting of commercial manufacturing ? GMP; On periodic to assess the compliance of commercial products ? Surveillance; Surprise inspection with out information Audit means review of system compliance ????????

Conscious Auditing The problem with new age auditors is that they interpret system per book. And rate inconsistencies as Major or Minor NC without looking thro the severity of the issue. The severity will differ from industry to industry. For instance, a NG product mix up in Fastner Mfg has low severity when compared to similar mix up in Food Mfg. So, it is imperative that Auditor has domain knowledge of the industry that is being audited

Get to know the auditee business.? Before starting the audit, take some time to learn about the auditee's business, operations, and risks. This will help you to better understand the auditee's environment and to identify potential audit areas. Use risk-based auditing.? Risk-based auditing is a process of focusing the audit on the areas where there is the highest risk of material misstatement. This approach helps to make the audit more efficient and effective. Communicate with the auditee. ?Auditors should communicate with the auditee throughout the audit process. This will help to ensure that the auditee understands the audit findings and that the auditor has all of the information they need to complete the audit.

Good auditors are focused on finding examples of compliance in key processes or systems in the organizations they are auditing. Unskilled auditors are only looking for flaws. The purpose of the audit is to improve the condition of the system. So even though audit results could lead to a major finding, the best approach is always to look for examples of systemic compliance of requirements.

Listen! A great quality auditor needs good hearing. Or rather a highly developed ability to listen. On what an auditee says, but above all – what is not said. The concept of "active listening" is the most important ingredient for a successful audit. The auditor needs to pick up and understand what the auditee wants to convey to the auditor. But also go deeper into areas where the auditee does not illustrate and explain sufficiently. It is a balancing act, and the auditor needs to be alert throughout the audit. So, the saying "talking is silver, silence is gold" should be every auditor’s motto.