Quality Assurance in Auditing

Dear IT Auditors, What Quality Evidence Looks Like in IT Audits Strong evidence separates credible audit results from weak conclusions. Quality evidence gives you confidence in your findings and gives leadership confidence in your assurance work. Auditors who master evidence collection improve accuracy, speed, and audit value. 📌 Evidence Must Be Complete Gather everything you need to support each test step. Screenshots, logs, approval records, access lists, configuration files, reports, and workflow outputs must cover the full control activity. Partial evidence creates uncertainty and weakens audit opinions. 📌 Evidence Must Be Accurate Check that timestamps, system names, request numbers, and user IDs match the sample you selected. Mismatched information happens often and leads to flawed conclusions. Make sure the evidence ties directly to the item being tested. 📌 Evidence Must Be Original Pull evidence from the source system. Export it yourself when possible. Relying on manually prepared documents increases the risk of errors or manipulation. 📌 Evidence Must Be Timely Audit evidence should align with the period under review. The evidence date should prove the control worked at the right time. Incorrect timing is one of the most common issues in failed tests. 📌 Evidence Must Be Clear Reviewers should be able to understand what they are looking at without needing explanations from the control owner. Label screenshots and highlight relevant fields. Remove clutter so the evidence supports the narrative cleanly. 📌 Evidence Must Be Secure Audit teams handle sensitive data. Store evidence in secure audit folders. Protect access and adhere to retention requirements to minimize the risk of exposure. 📌 Evidence Must Be Reproducible Another auditor should reach the same conclusion with the same evidence. Reproducibility builds trust in the audit process. Quality evidence strengthens findings and reduces disagreements with control owners. It proves the control worked or failed without doubt and improves reliability across the entire audit cycle. #ITAudit #CyberVerge #AuditEvidence #InternalAudit #GRC #RiskManagement #ITControls #Assurance #AuditLeadership #ControlTesting #TechGovernance

Don't be just a checklist auditor. This goes primarily for Quality but could cover other compliance related functions. It is vital that an auditor be curious, and have a strategic mindset that looks beyond just compliance verification from a generic checklist, built by themselves or not. Auditing isn't just ticking boxes, or asking yes or no questions, but identifying risks, offering insights, and driving continuous improvement. While checklists can ensure consistency and cover minimum requirements, relying solely on them will cause you to miss the bigger picture. Significant risks or opportunities for improvement aren't always on a checklist. Relying on a rigid list can hinder critical thinking and professional skepticism, which are important in effective auditing. Using the same checklist repeatedly, means the auditee could fail to adapt to evolving risks and priorities, limiting value. Getting past the checklist allows a different mindset and expands skills and knowledge. Listening and learning from auditees allows collaboration. Build rapport. Have conversations. Walk the operation. Collaborate. Be curiosity, look around and ask. Why is a process done a certain way, what could happen if a step is skipped, and who makes the final decisions? This can uncover risks, gaps and process weaknesses. The primary goal is to leave the function or business with insights that help them improve, grow, and have confidence in their systems, not just a bunch of nonconformities. A great auditor understands the purpose behind the standards and regulations, using common sense. To truly be value-added, an auditor needs to customize the checklist. A generic checklist is a starting point, not an end goal. Change the checklist with each audit by adding new things to look at, learning from past misses/mistakes, and ask what you can do to assist with a potential issue. Conduct a thorough document review before any on-site audit/review to understand the organization's specific role, past issues they've had, and their processes. This ensures time on-site time is effective and focused. Encourage an environment where identifying gaps and nonconformances are seen as an opportunity for improvement, not a failing. This will build trust and lead to more honest and transparent communication. Getting Quality into the workforce's mindset will make a better outcome through the environment long term. Stay curious.

So, You Got the QC Job – What Now? The interview prep worked, and you landed the job—congratulations! But getting the job is just the beginning. Now, we need to set you up for success, and that’s where I come in. Here are five things you need to do during your onboarding to set yourself on the right path. 1. Request the Company Organogram & Communication Procedure You need to know who’s who in the company. QA is linked to everyone—procurement, production, engineering. Understanding who reports to whom will make your job easier. But don’t just look at the organogram. Request the communication procedure and matrix. -Who speaks to whom? -Who communicates what issues? -Who escalates problems when things don’t get done? Don’t make the rookie mistake of sending an email to the wrong person and then having to recall it. 2. Get the Flow Diagrams & HACCP Studies You need to understand the process—all of it. Request the flow diagrams and HACCP studies for every line you’ll be working on. Audit the process. (Yes, you’re new, but that actually makes you the perfect auditor.) Walk through each step and compare it to the flow diagram. Check what hazards are identified and how they’re controlled. -Know your controls -Who is responsible for each control? -Who is accountable? -What is your role? 3. Learn the History – Read Past Issues History helps you make informed decisions. Start with: -Customer complaints -Internal & external audit findings -Past non-conformances Go through them and ask yourself: -What was the issue? -What corrective actions were taken? -What was the root cause? This is the level of understanding that will set you apart. (Warning: This will take time, sometimes in your own spare time, but it’s worth it.) 4. Walk the Line – Be Present on the Floor Be visible. Let people know you are there. Don’t assume things are fine. When the cat is away, the rats will play. If you’re a QC ask your manager if you have the authority to stop the line. (And yes, in some places, they won’t allow it—be careful of such places.) Exercise your authority: If conditions are unhygienic, stop the line. If people aren’t wearing full PPE, don’t let them in the plant. People will try to take advantage of a new QA person. Don’t be a pushover. 5. Learn the Product Specs & Quality Parameters You need to know what "good" looks like at every stage. Request: Raw material specifications (at receiving) Work-in-progress (WIP) product specifications Final product specifications When you know the specs, you don’t have to rely on production’s opinion. (Let’s be honest—sometimes, their views can be biased.) If your company doesn’t have clear visual specs, this is your chance to stand out. Start taking photos of materials and products at different stages. Document quality parameters and present it as a project. This will not only help you but also improve the system for everyone Final Advice: Question Everything in Your First 6 Months

🔍 Auditors Don’t Just Check Numbers — They Protect Trust. Behind every clean audit opinion lies a disciplined, methodical process that safeguards the integrity of financial reporting. 🛡️ Auditors are guardians of confidence in business. Through rigorous evidence gathering, they ensure transparency, accountability, and accuracy in financial statements. Here’s how assurance is built, one step at a time: ✅ 1. Inquiry – Ask. Listen. Understand. Engage with management and staff to gain insight into how controls are designed and actually function. ✅ 2. Inspection – Look beyond the paperwork. Examine documents, records, contracts, and physical assets to confirm accuracy and existence. ✅ 3. Observation – Watch it happen. Observe processes in real-time to ensure they align with documented procedures. ✅ 4. Recalculation – Crunch the numbers again. Test the mathematical accuracy of calculations to validate reported figures. ✅ 5. Reperformance – Trust, but verify. Independently perform controls to assess whether they operate effectively. ✅ 6. Analytical Procedures – Connect the dots. Use ratios, trends, and comparisons to identify anomalies or areas that warrant deeper investigation. 💡 7. Risk Assessment – Start smart. Every audit begins with identifying and understanding where misstatements are most likely to occur. 💡 8. Professional Skepticism – Think critically. Auditors approach evidence with a questioning mind — assuming nothing, verifying everything. 💡 9. Documentation – Leave a trail. Every conclusion is backed by clear, sufficient, and appropriate audit evidence. 💡 10. Continuous Learning – Stay sharp. Auditing standards evolve — and so do the businesses we audit. Staying updated is non-negotiable. 🔐 Auditing is not just a compliance task — it's a cornerstone of corporate trust. Through these procedures, auditors don't just check the books — they help businesses build credibility with investors, regulators, and the public. #Audit #Assurance #FinancialReporting #Trust #CorporateGovernance #InternalControls #Transparency #AuditingStandards #RiskManagement #LinkedInFinance

What does quality mean when it comes to SOC 2 audit firms? This is how I think about it. Firm Quality -Leadership understands how to balance commercial considerations without sacrificing quality. -Leadership promotes quality from the top down. -Employees trust leadership to make decisions that don't override the quality of the work performed. -Threats to firm's independence are considered before accepting new audit clients. -The firm has implemented a system f quality management that ensures the firm and its personnel meet professional standards and conduct engagements accordingly. Audit Quality -Appropriate fees are charged to ensure that audit quality can be maintained. -Auditors have the necessary competency and experience to perform the audit sufficiently. -Auditors are provided with a sufficient amount of time to complete audits and are not overscheduled leading to burn out. -The audit is appropriately scoped and planned. -Auditors understands the evidence required to appropriately conclude on the design and operating effectiveness of controls. -Auditors understand how to appropriately test the operating effectiveness of controls. -Less experienced auditors are appropriately supervised. -Auditors are encouraged to exercise professional skepticism and challenge clients when evidence is not sufficient. -The firm's professional judgment is not impaired due to undue influence from the client or third parties. Report Quality -Reports are aesthetically pleasing. -Reports do not contain grammar mistakes. -Reports include accurate and complete information about the system description and controls. -Reports include the information required by professional standards and do not omit key information. Service Quality -Expectations for the audit are communicated to the client upfront and there are open lines of communication between auditors and the client. -Invoices are accurate and the client is not surprised by when invoices are sent or the amount. -Auditors act professionally throughout the engagement. -Auditors communicate efficiently and respond to questions timely. -Evidence request lists are provided to clients to ensure they have sufficient time to gather the evidence prior to the start of the audit. -Auditors are cognizant of the client's time and work efficiently to mitigate the risk of the client feeling "audit fatigue". -Auditors are not stuck in their ways and are willing to leverage technology as part of the audit. -Testing is completed within a reasonable amount of time without undue delay. -Reports are drafted and finalized in a timely manner once all evidence has been provided and accepted. Quality leads to trust. Without quality, there is no trust.

The United States spends over $1 trillion a year on construction. Schools. Hospitals. Universities. Stadiums. Housing. But almost nobody is checking whether it was built right. Here's what a quality audit reveals that a punch list never will: We build at an extraordinary scale in this country. The investment in infrastructure is one of the great reflections of American ambition. Every new school is a bet on the next generation. Every hospital is a commitment to a community. Every university building is a promise that knowledge matters. That investment deserves protection. But here's the problem most owners don't see until it's too late: The construction industry has a quality control gap that almost nobody talks about. At the end of a project, there's a punch list. The contractor walks the building with the owner. They note cosmetic issues. A paint scratch here. A missing outlet cover there. A door that sticks. The punch list gets completed. Everyone shakes hands. The owner takes occupancy. And the real problems (the ones you can't see) go undetected. Systemic design failures. Building envelope deficiencies. Code non-conformance. Improper installation of waterproofing, flashing, drainage systems. Structural shortcuts that won't show up for two or three years. A punch list was never designed to catch any of this. A quality audit is. A quality audit evaluates the property system by system. It questions facilities directors and maintenance staff. It examines contract documents, construction records, warranties, inspection reports, test results, and design plans. The output is a detailed audit report: detected issues, potentially liable parties, and the owner's options for maximizing repair, maintenance, and financial recovery. An action plan. Not a checklist. Here's the part that keeps me up at night: Statutes of limitations start running from the moment construction is complete. Not from when you discover the problem. From when the building was finished. Most owners don't initiate an audit until problems become visible — excessive energy bills, water stains, cracks, mold. But by then, years of the recovery window may have already passed. Some owners have started conducting quality audits in intervals across the first few years after construction. Not waiting for visible problems. Getting ahead of them. The integrity of what we build matters. Not just for the balance sheet. For the people who learn in those schools, heal in those hospitals, and live in those buildings. A quality audit is how owners take control of their investment. From the moment a problem is suspected, the clock is ticking. Don't wait.

How to audit your CRO's statistical work  (without being a statistician) You don't need advanced statistical training to spot quality issues. Here's what any sponsor team can check: Documentation Completeness  Are analysis outputs clearly labeled with dates, versions, and an analysis populations? Missing or inconsistent labeling suggests poor quality control processes. Consistency Across Documents  Does the SAP contain all the objectives and endpoints laid out in the protocol?  Do results in the demographic outputs match what you are seeing in the sugroup analyses outputs (same number of men and women, same distributions of race and ethnicity? Discrepancies often indicate errors and inaccuracies. Clarity of Results  Can you understand what the analysis shows without statistical training? If tables and figures aren't intuitive, question whether they're correct. Timeline Adherence  Are deliverables consistently late or rushed? Quality statistical work requires adequate time for review and verification. Responsiveness to Questions  How quickly and thoroughly does your statistician address concerns? Defensive responses or inability to explain methods in plain language are warning signs. Trust your instincts. If something feels off, ask for clarification. The best statisticians welcome questions and can explain complex analyses in understandable terms. Happy Quality Assurance, Happy Saturday.

🔍 Navigating FDA Audit Readiness: A Leader’s Perspective on Quality Improvement in GMP Manufacturing In the high-stakes world of GMP manufacturing, FDA audit readiness isn’t just a checkpoint—it’s a mindset. As a leader with 10+ years of experience in designing, developing, and running cGMP operations, I’ve learned that a robust Quality Improvement Plan (QIP) is the foundation for sustained compliance and operational excellence. Here’s how I approach it: 1️⃣ Start with a Gap Assessment A successful QIP begins with a thorough gap analysis. This means assessing processes, documentation, training, and facility operations to identify vulnerabilities. Leverage internal audits, mock inspections, and historical data to uncover compliance gaps before the FDA does. 2️⃣ Focus on Risk-Based Prioritization With finite resources and timelines, prioritize based on criticality to patient safety, product quality, and data integrity. Address high-risk areas first, such as deviations, CAPAs, and sterility assurance in aseptic environments. 3️⃣ Empower Cross-Functional Teams Quality improvement isn’t a siloed effort. Engage MSAT, QA/QC, manufacturing, and regulatory teams early. Cross-functional collaboration fosters a culture of ownership and accountability while ensuring seamless implementation of quality initiatives. 4️⃣ Invest in Training and Culture Compliance thrives on people. Regular GMP training, tailored to roles, and fostering a culture where employees are encouraged to report and resolve issues without fear are pivotal to audit readiness. 5️⃣ Leverage Digital Tools Modern challenges call for modern solutions. Implement digital quality management systems (QMS) to track deviations, CAPAs, change controls, and document updates efficiently. Digital tools improve traceability and reduce human error. 6️⃣ Emphasize Continuous Monitoring Audit readiness isn’t an event—it’s a process. Develop KPIs to monitor quality metrics like deviation closure timelines, training compliance, and on-time batch releases. These data-driven insights inform proactive decision-making. 7️⃣ Simulate Audit Scenarios Prepare your teams through mock FDA inspections. This not only identifies weak points in your processes but also builds confidence and composure among employees during real audits. 🔑 Key Takeaway: A well-crafted and executed Quality Improvement Plan isn’t just about passing audits—it’s about delivering safe, effective therapies to patients. Let’s ensure our facilities are always audit-ready and patient-focused! 📢 How do you ensure audit readiness at your facility? Let’s share insights and learn from each other! #FDAAuditReadiness #GMPManufacturing #QualityImprovement #BiomanufacturingLeadership #OperationalExcellence

QUALITY AUDITS – OVERVIEW 🎯 A Quality Audit is a structured and impartial review conducted to verify whether an organization’s quality practices and performance align with defined standards and expectations. It ensures compliance with: ✅ International & internal standards (ISO 9001, IATF 16949, etc.) ✅ QMS requirements ✅ Customer, legal & regulatory obligations In essence — Quality Audits validate system performance, increase reliability, and drive continual improvement. 🌍 Objectivesof a Quality Audit Verify Compliance: Ensure processes meet QMS, procedural, and regulatory requirements Evaluate Effectiveness: Check how efficiently the QMS operates Identify Gaps & Risks: Highlight nonconformities and potential process risks Drive Continual Improvement: Foster ongoing enhancement and learning Enable Data-Based Decisions: Provide management with factual performance insights 🚀 Types of Quality Audits: Internal Audit – Conducted by the organization for self-evaluation | External Audit – Performed by customers to assess suppliers | Certification Audit – Carried out by third-party bodies for standard compliance Process Audit – Focused on process effectiveness and control | Product Audit – Ensures product conformance to specifications | Supplier Audit – Evaluates supplier capability and performance | System Audit – Reviews overall QMS implementation and effectiveness | Compliance Audit – Conducted by government or regulatory authorities for legal requirements | Layered Process Audit (LPA) – Multi-level daily check to ensure process adherence and consistency ⚙️ Quality Audit Workflow Planning: Define scope, criteria, team & schedule Preparation: Review documents & develop checklists Execution: Audit processes & gather objective evidence Reporting: Record findings, classify NCs/OFIs Corrective Action: Apply root cause–based actions Follow-Up: Verify action effectiveness 💡 Benefits of Quality Audits ✔ Early detection of process shortcomings ✔ Improved customer satisfaction ✔ Enhanced process consistency & reliability ✔ Strengthened compliance with standards ✔ Increased employee ownership & awareness ✔ Foundation for continuous improvement ⚠️ Key Challenges Inconsistent audit planning and execution discipline Lack of auditor competence or independence Data overload without insight generation Weak follow-up and ineffective corrective actions Treating audits as a formality instead of a value tool 🧠 Key Takeaways 🔸 Quality audits are not about fault-finding — they’re about fact-finding and future-proofing. 🔸 The real value emerges when findings lead to measurable improvements. 🔸 A mature audit culture builds trust, transparency, and continuous excellence. 💬 What’s the biggest challenge you’ve faced in driving audit effectiveness? Share your insights below 👇 ==== Follow me Govind Tiwari,PhD for more QHSE & operational excellence insights. #QualityAudit #QHSE #ISO9001 #ContinuousImprovement #AuditingExcellence #QualityManagement

🔥 QUALITY AUDITS – The Backbone of a Strong Quality Culture! 🎯 A Quality Audit is a structured, independent evaluation to confirm that an organization’s processes, products, and systems meet defined standards such as ISO 9001, IATF 16949, customer requirements, and regulatory obligations. It ensures compliance, strengthens process reliability, and drives continual improvement across all functions. 🌍 Why Do We Perform Quality Audits? 👉 Verify compliance with QMS, procedures & legal requirements 👉 Evaluate process effectiveness and performance 👉 Identify nonconformities, risks & improvement opportunities 👉 Support data-driven decisions for management 👉 Build a culture of discipline, accountability & excellence 🚀 Types of Quality Audits (Must Know!) • Internal Audit – By the organization for self-checking • External Audit – By customers to assess capability • Certification Audit – By third-party bodies for ISO/IATF compliance • Process Audit – Checks process robustness & control • Product Audit – Ensures product meets specifications • Supplier Audit – Evaluates supplier systems & reliability • System Audit – Reviews overall QMS effectiveness • Compliance Audit – Regulatory body inspections • Layered Process Audit (LPA) – Daily cross-level checks for consistency ⚙️ Quality Audit Workflow 1️⃣ Planning – Define scope, criteria & team 2️⃣ Preparation – Review documents & build checklist 3️⃣ Execution – Observe, interview, verify evidence 4️⃣ Reporting – Classify NCs, OFIs, strengths 5️⃣ Corrective Action – Address root causes, not symptoms 6️⃣ Follow-Up – Validate the effectiveness of actions 💡 Benefits of Quality Audits ✔ Early detection of problems ✔ Improved customer satisfaction ✔ Stronger process consistency ✔ Better compliance with standards ✔ Enhanced employee awareness & ownership ✔ Foundation for continual improvement ⚠️ Common Challenges • Poor planning or inconsistent audit discipline • Lack of trained or independent auditors • Treating audits as a checkbox activity • Weak root cause analysis & ineffective corrective actions • Too much data but not enough actionable insight 🧠 Key Takeaways 🔸 Quality Audits are NOT fault-finding — they are fact-finding. 🔸 The true value lies in how findings drive measurable improvements. 🔸 Organizations that embrace audits build trust, transparency, and long-term excellence. Pic Courtesy:Govind Tiwari, PhD,CQP FCQI #QualityAudit #QualityManagement #ISO9001 #IATF16949 #ContinuousImprovement #QMS #SupplierQuality #ProcessExcellence #Manufacturing #OperationalExcellence #Compliance #InternalAudit #QualityLeadership