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Why “No Non-Conformity” Doesn’t Always Mean a Good System

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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...

Best Practice for Auditing Physical Processes

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...

Quality Objectives as per ISO 9001:2015 - Clause 6.2

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  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...

Cp Cpk: Enhancing Quality Control in Your Business

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  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...

ppm Methodology

  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.

PPM Methodology: Streamlining Manufacturing Processes for Operational Excellence

 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...

Poka Yoke

 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...