Introduction When an organization gets "no non-conformity" in an audit, it's often seen as a sign of a perfect system. But is that really true? The answer is simple: No, having zero non-conformities does not always mean the organization has a good system. Let's look at the real reasons behind this. Reasons for "No Non-Conformity Hiding Information from the Auditor The most common reason for getting no non-conformity is that information gets hidden from the auditor. This doesn't happen by accident — it's usually because of some kind of pressure. - Management pressure: Many times, the auditee faces strong pressure from management to not have any non-conformities in the report. - Department targets: Sometimes departments get specific targets like "no non-conformities during the audit," which can encourage hiding real issues. Auditing Issues It's not just about what's happening inside the organization. Sometimes the fault is with the audit i...

When auditing processes that involve physical activities—such as production, inspection, or stores management—it's best to use a three-stage approach that starts and ends with document review. Stage 1: Initial Document Review Begin by reviewing all relevant documents. This helps you understand the overall requirements and expectations of the process Stage 2: Site Visit and Interviews After the initial document review, conduct interviews with staff and perform a site visit. This allows you to verify whether actual practices align with documented procedures. Stage 3: Final Document Review End with another document review to cross-check your findings. Why This Approach Works: This three-stage method gives internal auditors two valuable verification opportunities: 1. After the first document review, you can verify on-site whether documented procedures are being followed 2. After the site visit, you can verify in the final document review whether what you observed matches the documented...

  What are Quality Objectives? Quality objectives are specific, measurable, achievable, relevant, and time-bound (SMART) goals that an organization sets to improve its QMS performance. These objectives should be aligned with the organization's overall goals and should be relevant to the customer's requirements and expectations. Why are Quality Objectives important? Quality objectives play a vital role in an organization's QMS as they provide a roadmap for achieving the desired results. By setting quality objectives, an organization can: Focus on continual improvement: Quality objectives help organizations focus on improving their QMS performance and achieving their overall goals. Align with customer requirements: Quality objectives should be relevant to the customer's requirements and expectations, which ensures that the organization is delivering products and services that meet customer needs. Measure performance: Quality objectives should be measurable, which helps or...

  Quality control  is a crucial aspect of any business, especially in  manufacturing , where product defects can be costly. To ensure that products are manufactured to meet customer expectations, businesses must have effective  quality control  measures in place. One tool that can assist in enhancing  quality control  is the  process capability index  (Cp Cpk). Process capability is the ability of a  manufacturing  process to consistently produce products that meet customer requirements. Cp Cpk is a statistical tool used to measure process capability and determine if a process is capable of producing products within predetermined tolerance limits. By utilizing Cp Cpk, businesses can pinpoint areas for improvement and drive  process improvement , ultimately leading to increased efficiency and profitability. In this article, we will explore the  process capability index  (Cp Cpk) and how it can be effectively used to en...

  What: The PPM approach compares total defects to the total sample size and normalizes the data to a standard rate in order to evaluate a process = ( defective units / total sample size ) x 100 Where: The overall sample size is equal to the sum of the defective and passed units. A defective unit is one that doesn't match the requirements. How: Is a process being evaluated using ppm or %? What is superior? Rule of thumb: Defect rate greater than 2% or 20,000ppm: This gives all floor operators a better means of communication. It is preferable to display flaws as a percentage in these cases since it is simpler to grasp. 30% Defective = 300,000ppm Defective. Use a ppm to assess and explain the process when the fault rate is less than 3% or 30,000 ppm. This offers a more effective instrument for progress. Since this encourages improvement at lower quality levels, it is preferable to display flaws in these circumstances as a ppm.

 Part per million (PPM) methodology is a proven approach designed for the  manufacturing industry  to streamline processes, increase productivity, efficiency, and overall business performance.  PPM methodology  involves identifying and measuring defects in products or processes, then implementing corrective actions to reduce their occurrence and ensure continuous improvement. The  manufacturing industry  is consistently evolving, becoming more competitive, and demanding higher quality products.  PPM methodology  offers manufacturers a competitive edge by identifying and eliminating defects, reducing waste, improving customer satisfaction, and enhancing product quality. It ensures that products meet industry standards, comply with regulations, and exceed customer expectations. Effective implementation of  PPM methodology  requires an understanding of measurements and analysis of parts per million. By setting ppm targets and conductin...

 What Poka-Yoke devices and procedures are very effective in breaking cause chains. Poka-Yoke is a process that gives a structure for designing a failure mode out of a product or process. They frequently consist of straightforward, low-cost tools that either stop errors from happening or identify problems that have already happened. Why Make it simpler to find the mistakes that do happen. Make it possible to "undo" errors so that they can be corrected. Make mistakes more challenging or impossible to make. When The requirement for worker vigilance (manual operations) Positioning errors can happen. A change is necessary. SPC is inefficient or difficult to implement. Attributes are crucial, not measures. Both employee turnover and training costs are significant. Mixed model production takes place. When clients make errors, they criticize the service provider. Particular reasons recur. Field malfunctions are very expensive. How To distinguish between errors that lead to flaws and...

  What The PlanDoCheckAct (PDCA) cycle is a disciplined and systematic method for problem solving and ongoing improvement. The PDCA cycle is still followed in practise when steps for a process are outlined linearly. A prepared plan based on a product, process, problem, or change that has to be improved is referred to as a plan. b. Carry out or test the documented improvements or adjustments that have been planned (often on a small scale). c. Check - Collect and examine data to determine the impact of the modification and whether it was successful. d. Take Action - If the results are positive, implement the process improvement (and don't forget to include a standard checkup on the improvement/change), or reevaluate and attempt a different strategy by repeating the cycle with the information gathered (go back to Plan). Why Offers a methodical approach to improvement; Offers a standard framework and procedure that different groups within an organisation can use. Ensures that all stage...

 Are you looking for a way to boost efficiency and streamline decision making in your business practices? Look no further than  Pareto Analysis , also known as the  80/20 rule  or  Pareto Principle . This powerful analytical technique can help you identify the most critical issues and opportunities in your organization. By focusing on the 20% of factors that contribute to 80% of the results, you can prioritize your efforts and resources for maximum impact. Whether you work in manufacturing, service, or any other industry,  Pareto Analysis  can be applied to any process or problem. By understanding the root causes and patterns of issues, you can make informed decisions and drive continuous improvement. Key Takeaways: Pareto Analysis  is a powerful analytical technique for streamlining decision making. Also known as the  80/20 rule  or  Pareto Principle , this approach helps you identify the most critical issues and opportunities in y...

 In today's fast-paced business environment, knowledge is power. As companies strive to stay ahead of the competition, they need to leverage their organizational knowledge to drive innovation, improve processes, and enhance customer experiences. But what exactly is organizational knowledge, and how can companies build and maintain it? In this blog post, we will explore the key concepts of organizational knowledge and provide seven practical tips for unlocking its power. What is Organizational Knowledge? Organizational knowledge is the information, skills, and expertise that an organization accumulates over time through its experiences, successes, and failures. It is the collective knowledge that enables an organization to perform its functions effectively and efficiently. Organizational knowledge can be based on internal sources, such as intellectual property, lessons learned from successful projects, and improvements in processes, products, and services. It can also be based on ex...

  ISO 9001 current version and earlier version ISO 9001:2015 is the most recent version of the ISO 9001 standard, an international reference for quality management. This standard was last amended in February 2024 under Amendment 1. Major Changes from ISO 9001:2008 The ISO 9001:2015 version brought significant changes compared to its predecessor, ISO 9001:2008. The new standard introduced a high-level structure based on 10 clauses, making it easier to integrate with other standards. Understanding the ISO 9001:2015 Clauses ISO 9001:2015 is divided into 10 clauses. The first three clauses provide general information about the standard, whereas clauses 4 to 10 focus on its implementation. To learn more about each clause, please refer to the corresponding blog posts: Clause 1 to 3 Clause 4 Clau se 5 Clause 6 Clause 7 Clause  8 Clau se 9 Clau se 10 Process Approach (PDCA) The ISO 9001 standard relies on a smart approach called PDCA, which stands for Plan-Do-Check-Act. . First, you P...

  ISO 9001 Internal Audits Overview ISO 9001 Internal Audits is a requirement of ISO 9001:2015 standard as per clause 9.2. These audits are used to assess the effectiveness of an organization's quality management system, identify areas for improvement, and meet the requirements of ISO 9001:2015 Standards. In this article, we'll provide you with a comprehensive guide to plan, conduct and complete the ISO 9001 Internal Audits process. Preparation for ISO 9001 Internal Audits Before conducting an ISO 9001:2015 Internal Audit, it's essential to prepare effectively. The preparation process involves several steps, Establish Audit Objectives Start by determining the scope of your audit and what specific areas you want to assess. This will help you define your audit objectives and ensure that you conduct a thorough and comprehensive audit. Determine the Audit Criteria Audit criteria refer to the standards and regulations against which you'll assess your quality management syste...

  Clause 10 of ISO 9001:2015 , also known as " Improvement ," focuses on enhancing the quality management system (QMS) of an organization. It demands organizations to identify opportunities for improvement and implement necessary changes in the system. It includes two subsections: 10.2 on non-conformity and corrective action , which requires organizations to take action to eliminate the cause of non-conformities in order to prevent recurrence; and ' Root cause analysis ', which is a method used to identify the root cause of detected non-conformities. Clause 10.1 - General Clause 10.1 of ISO 9001:2015 , known as "General," outlines the general expectation for organizations to determine and select opportunities for improvement and implement any necessary changes to the quality management system. This could be achieved through the use of quality policy , quality objectives , audit results , analysis of data , corrective actions, management review , and customer...

  Clause 9 of ISO 9001:2015, titled 'Performance Evaluation', sets out the requirements for monitoring, measurement, internal audit, and management review. Clause 9.1 necessitates determining what needs to be monitored and measured, the methods for doing so, and when these activities should be performed. Clause 9.2 necessitates regular internal audits by competent personnel, and the maintenance of documented information regarding the audit process. Lastly, Clause 9.3 stipulates that top management must periodically review the organization's Quality Management System to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization. Clause 9.1 - Monitoring and measurement This clause focuses on monitoring, measurement, analysis, and evaluation. It requires organizations to determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis, and evaluation, when the monitoring and mea...