Quality-Risk Management

Manufacturing shutdowns, while necessary for employee rest and operational resets, introduce risks to product quality when operations resume. Equipment may malfunction, materials may degrade, and returning employees may require workflow recalibration. Post-shutdown QC testing is critical to identify and address these risks, ensuring smooth production and high-quality … [Read more...] about Ensuring Quality Control Testing After Manufacturing Shutdowns: Best Practices and Tips

Costco recently faced a significant recall of its Kirkland Signature butter due to the absence of a milk allergen warning on the label, despite milk being a key ingredient. This incident highlights the potential dangers of overlooking small but crucial quality management details, especially for allergens like milk, which is one of the “Big Eight” common food allergens. While no … [Read more...] about Crisis Averted: Mastering the Recall Management Process

CAPA (Corrective and Preventive Action) is a core element of ISO 9001:2015’s quality management framework, aimed at addressing quality issues and preventing their recurrence or occurrence. Corrective actions react to existing problems by identifying and eliminating root causes, while preventive actions proactively mitigate potential nonconformities. ISO 9001 emphasizes that … [Read more...] about CAPA Requirements in ISO 9001:2015

ISO 9001 certification is a significant milestone but not a panacea. Effective use of ISO 9001 involves adapting the system to organizational needs, addressing systemic issues, and avoiding pitfalls like ignoring procedures, clinging to outdated processes, or mis-applying the system. Companies must treat ISO 9001 as a dynamic framework to improve over time, focusing on learning … [Read more...] about When ISO 9001 Fails and Upgrading Your ISO Internal Audit Process

Lean and Six Sigma principles provide structured approaches to improving processes, reducing inefficiencies, and ensuring product and service quality. IDEXX, an organization with a diverse global customer base, illustrates the value of these methodologies, leveraging them to achieve significant growth and innovation. Central to this success is the focus on risk assessment and … [Read more...] about A Fresh Approach to Risk Assessment & FMEA

Mazars highlights the importance of a well-defined internal control system in maintaining organizational objectives, financial integrity, and law compliance. Effective internal controls, which encompass financial and operational processes, provide reasonable assurance that an organization operates efficiently, produces accurate reports, and complies with regulations. The COSO … [Read more...] about How to Assess an Organizations’ Internal Control Using a Risk-Based Approach

While this story is more from a financial/safety compliance/risk perspective, it still underscores the complexities of managing compliance, safety, and risk, especially in highly regulated industries. It discusses a recent example from Tesla’s Fremont facility illustrates the ongoing challenges: regulatory bodies ordered Tesla to address frequent toxic emissions, showing how … [Read more...] about Compliance, risk, audit, and the business

In the context of Industry 4.0, Failure Mode and Effects Analysis (FMEA) is adapting to address the increased complexity of manufacturing processes. Traditionally, FMEA assessed potential failure modes by analyzing severity, occurrence, and detection, which produced a Risk Priority Number (RPN) to guide risk mitigation efforts. However, this approach has limitations in modern … [Read more...] about FMEA in the Age of Industry 4.0

Supply Chain Risk Management (SCRM) is essential for businesses to secure operations and mitigate risks, especially in an era of increased disruptions. By identifying and assessing supply chain risks, companies can avoid costly disruptions, such as those seen in the semiconductor shortage or the Suez Canal incident. SCRM helps ensure compliance with legal and ethical standards … [Read more...] about Supply Chain Risk Management 101: Everything You’ll Ever Need to Know

In metrology, decision rules are crucial in ensuring that measurement results are accurate and reliable, determining whether products conform to specified standards. This process involves three key pillars: measurement uncertainty, metrological traceability, and decision rules. Measurement uncertainty accounts for the inherent doubt in any measurement, and it must be rigorously … [Read more...] about Decision Rule Guidance for Metrology and Measurement Risk

Governance, Risk, and Compliance (GRC) is an essential operational strategy organizations use to manage governance, enterprise risk, and regulatory compliance efforts. Developed by the Open Compliance and Ethics Group (OCEG) in 2002, GRC aims to achieve “Principled Performance” by aligning a company's activities with its business goals. It encompasses three core principles: … [Read more...] about What is GRC: A Guide to Leveraging GRC for Effective ESG Strategy

Failure mode and effects analysis (FMEA) is a risk assessment tool developed in the 1960s by the aerospace industry. It is intended to identify and prevent potential failures in systems, processes, designs, or services before they reach the customer. It is extensively applied across various sectors, including automotive, aerospace, nuclear, and electronics. The primary … [Read more...] about A Systematic Literature Review of Failure Mode and Effect Analysis (FMEA) Implementation in Industries

The Pipes and Puddles framework aims to decentralize standards from a central authority to individual process owners, facilitating continuous improvement and reducing the total cost of quality. Traditional centralized standards create a burden of chore tasks that hinder improvement efforts. This new framework integrates Lean principles, the PDCA cycle, and risk analysis, … [Read more...] about Risk Management In Manufacturing Processes To Reduce The Total Cost Of Quality

Traditional inventory management primarily addresses the uncertainty of demand, but the uncertainty in the supply, mainly due to defective products, is equally crucial. Including defective products introduces variability in supply chains, affecting order quantities and leading to overstock or shortages. This paper formulates a supply chain model incorporating defective products … [Read more...] about Impact of uncertainty ascribed to defective products on supply chains

This 36-page primer on Root cause analysis (RCA) from audit software supplier EASE covers this essential method in quality management. RCA is used to diagnose the fundamental reason for faults or problems. Five common RCA methods are Pareto Charts, The 5 Whys, Fishbone Diagrams, Scatter Plots, and Failure Mode and Effects Analysis (FMEA). This structured approach helps identify … [Read more...] about Root Cause Analysis 101

Adoption of Quality 4.0 (Q4.0) in organizations is challenging. Identifying the critical failure factors (CFFs) can lead to more effective implementation of Q4.0 initiatives. Researchers used a qualitative research methodology involving in-depth interviews with quality managers and executives to help establish the CFFs associated with Q4.0. This approach enriches the existing … [Read more...] about Critical failure factors for Quality 4.0: an exploratory qualitative study

In the dynamic manufacturing landscape, change control is a crucial mechanism to effectively manage innovations and mitigate associated risks. Recognized for its importance across industries, change control is pivotal in regulated sectors like pharmaceuticals, medical devices, and food and beverage manufacturing. This systematic approach ensures that any alterations in … [Read more...] about Why Change Control is Important: Tips for Manufacturers

(Note: Whitepaper download requires the creation of a free account and log-in)This whitepaper outlines a plan for building an effective Corrective Action, Preventive Action (CAPA) process, a crucial aspect scrutinized by the Food and Drug Administration (FDA). Highlighting the frequent issuance of warning letters due to poor CAPA implementation and documentation, the paper … [Read more...] about A Fool-proof Plan for Building an Effective CAPA Process

This "Quality Progress" journal article by Lance B. Coleman Sr. emphasizes integrating risk management into auditing processes. The author argues for a shift from traditional auditing to a risk-based approach, highlighting that this method not only enhances the performance of the audit program but also contributes significantly to the organization. Key to this approach is … [Read more...] about Elevate Your Audits: Upgrade Your Conventional Audit Program With A Risk-Based Approach