Verification and validation, in engineering or quality management systems, it is the act of reviewing, inspecting or testing, in order to establish and document that a product, service or system meets regulatory or technical standards.
In the quality management context, 'verification' refers to the process of evaluating and confirming that products, processes, or systems meet specified requirements. It involves assessing whether the desired outcomes have been achieved and ensuring that the quality standards and expectations are met. Verification plays a crucial role in quality management as it helps identify deviations, defects, or non-compliance, allowing for corrective actions to be taken. Here are some examples of 'verification' in the quality management context:
1. Product verification: In manufacturing, product verification involves checking whether a finished product meets the specified quality standards and requirements. This may include conducting inspections, measurements, and functional tests to verify the product's dimensions, functionality, performance, and reliability. For example, in automotive manufacturing, vehicles undergo extensive verification processes to ensure they meet safety standards, emission regulations, and performance criteria.
2. Process verification: Process verification focuses on assessing the effectiveness and compliance of manufacturing or operational processes. It aims to verify that the processes are capable of consistently producing products that meet quality standards. This can involve monitoring key process parameters, conducting process audits, and analyzing process data to ensure process stability and adherence to defined specifications. For instance, in the pharmaceutical industry, process verification is essential to ensure that drug manufacturing processes comply with regulatory guidelines and produce safe and effective medications.
3. Document verification: Document verification involves reviewing and validating documentation and records to ensure accuracy, completeness, and compliance with established procedures and standards. This includes verifying that all required documents are present, properly filled out, and maintained in a controlled manner. Examples of document verification in quality management include reviewing manufacturing instructions, test reports, calibration records, and quality control documentation.
4. Supplier verification: When working with external suppliers, verifying their capabilities and adherence to quality standards is crucial. Supplier verification involves evaluating suppliers based on criteria such as quality management systems, certifications, performance history, and compliance with applicable regulations. This ensures that the materials or components supplied by the suppliers meet the required quality specifications. Supplier audits, quality agreements, and ongoing performance monitoring are common practices in supplier verification.
5. System verification: System verification refers to the evaluation of entire systems or integrated processes to ensure they function as intended and meet quality requirements. This can include software systems, management systems, or complex manufacturing systems. System verification involves conducting tests, simulations, and validations to verify the system's functionality, reliability, and compliance with regulatory requirements. For example, in the aerospace industry, system verification is crucial to ensuring the safety and reliability of aircraft systems and components.
Similar concepts and activities related to 'verification' in the quality management context include:
- Validation: Validation is the process of establishing documented evidence that a system or process, when operated under specified conditions, consistently produces results that meet predetermined requirements. It focuses on confirming the suitability, accuracy, and reliability of a system or process to achieve the intended outcomes. Validation often involves conducting tests, experiments, or simulations to ensure that the system or process performs as expected.
- Audit: Auditing is a systematic and independent examination of processes, procedures, and records to determine their conformity with predetermined requirements, standards, or regulations. Audits can be conducted internally by an organization's own audit team or externally by independent third-party auditors. The purpose of audits is to identify non-conformities, assess compliance, and recommend improvements. Auditing ensures that quality management systems are effective, processes are well-controlled, and corrective actions are implemented when necessary.
- Inspections: Inspections involve visual examinations, measurements, or tests performed on products, materials, or processes to assess their compliance with specified requirements. Inspections are typically conducted at various stages of production or during product acceptance to identify defects, deviations, or non-compliance. Inspections can be performed by quality inspectors, customer representatives, or regulatory authorities.
- Review: Review processes involve the examination and assessment of documents, procedures, or systems to ensure their adequacy, accuracy, and compliance with requirements. Reviews can be conducted by individuals or teams with the objective of identifying improvements, identifying risks, or validating compliance. Reviews can encompass document reviews, design reviews, process reviews, or system reviews.
In summary, 'verification' in the quality management context refers to the process of evaluating and confirming that products, processes, or systems meet specified requirements. It involves activities such as product verification, process verification, document verification, supplier verification, and system verification. Similar concepts include validation, audit, inspections, and reviews, which are all aimed at ensuring compliance, identifying non-conformities, and improving overall quality and performance.