CHAPTER-3 Product and Process Information.pdf
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The document discusses the distinction between process audits and product audits in manufacturing, highlighting that process audits evaluate the efficiency of processes during production, while product audits assess the final product's adherence to standards before delivery. It emphasizes the importance of both audit types for ensuring quality and compliance, noting that effective quality management typically requires a structured approach to both processes and products. Additionally, the document outlines the procedures for addressing non-conformance in product audits and the critical quality goals associated with process audits.
CHAPTER-3 Product and Process Information.pdf
- 1. CHAPTER-3 PRODUCT & PROCESS INFORMATION PREPARED BY DR DINESH KUMAR MEHTA MM COLLEGE OF PHARMACY, MM(DU), MULLANA
- 2. CONTENTS Process audit Product audit Quality goals Process audit vs Product Audit What is Process Audit? A process audit is an examination of results to determine whether the activities, resources and behaviour that cause them are being managed efficiently and effectively. A process audit is not simply following a trail through a department from input to output - this is a transaction audit. In contrast with rear-facing product inspections, process audits focus on how your team prepares, produces, packages and distributes those products. This approach provides a more comprehensive view of the value stream than product audits, which only sample the finished output.
- 3. Process audits look at details of manufacturing process such as: Fabrication steps Safety measures Temperature settings Pressure readings Calibration of gauges What is Product Audit The product audit is the assessment of the final product/service and its qualification for use evaluated versus the intent of the purpose of the product/service. It ensures a thorough inspection of a final product before delivery to a supplier or a customer. Product audits take place after manufacturing is complete, but before the product reaches the customer. If a product doesn’t meet standard requirements or specifications, the auditor documents the findings and logs a non-conformance. While each company will have its own procedures for addressing non-conformances, the process typically includes: Identifying the problem Containing the non-conformance Reworking or repairing the products, if possible
- 4. Disposing of nonconforming products if you can’t rework or repair them Determining the necessary counter measures for preventing recurrence Product audits can help a manufacturer improve quality, profits, customer satisfaction, and loyalty. Product and Process Audits Go Hand-in-Hand An effective manufacturing process audit program that ensures the highest level of quality requires both product and process audits. Though nearly all manufacturers conduct product audits, fewer of them have defined process audit procedures in place. Process audits are critical to quality goals that include: Standardizing processes to ensure compliance with specific requirements such as time, components, accuracy or temperature Continuously reducing risk through systematic identification and correction of process errors Monitoring key metrics for evaluating overall process performance Assessing effectiveness of process controls such as procedures, instructions and specifications Reviewing production resources, work standards and the Manufacturing environment itself
- 5. Difference between Product and Process Audits Process Audit Product Audit Auditor will concentrate on process at each stage & its relevant parameters process parameters like temperature, pressure, speed, etc. Auditor will concentrate only on output of the process & its relevant parameters.