Laboratory Management and Safety PDF 22FS2001 2024-25

Course Title Laboratory Management and Safety Course Code 22FS2001 Branch III B.Sc., FORENSIC SCIENCE – SEC B S...

Course Title Laboratory Management and Safety Course Code 22FS2001 Branch III B.Sc., FORENSIC SCIENCE – SEC B Semester 2024-25 (EVEN SEMESTER) Credits 3:0:0 Teaching Scheme Lecture 3 hrs/week Examination Scheme 22FS2001 – Nandhu - 201 100 Marks  Unit 2: Quality Management Introduction – Quality - Quality system – Quality plan – Inspection and testing – Test records – Control of inspection - Handling, storage, packaging, preservation and delivery of the material – Control of quality records – Internal quality audits – Quality assurance – Training Laboratory Accreditation – ISO 9000 - ISO 14000 and 17000 series of standards – Accreditation Boards – NABL guidelines for accreditation in India Proficiency testing system – Internal quality control – Inter and intra laboratory testing programmes – Designing and running the proficiency testing programmes – Confidentiality - Advantages of accreditation Quality Quality can be defined as “fitness for use,” “customer satisfaction,” “doing things right the first time,” or “zero defects “a degree of excellence” “superiority in kind”. There are three basic elements in a quality system: Quality Management Quality Control Quality Assurance Quality Management being the means of implementing and carrying out the quality policy. Quality Control being all the techniques and activities of an organization that continuously monitor and improve the conformance of products, processes or services to specifications. Quality Assurance being all the planned and systematic actions necessary to assure that a product or service will satisfy the specified requirements. ❖Quality system: To establish, document, and maintain a quality system which includes a quality manual, system procedures, and quality planning. ❖Quality Assurance: The ISO 9000 definition states that quality assurance is part of quality management focused on providing confidence that quality requirements will be fulfilled. ❖Internal quality audits: To establish and maintain documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system. Quality Management System: A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Benefits of Quality Management Systems: Implementing a quality management system affects every aspect of an organization's performance. Benefits of a documented quality management system include: ✓ Meeting the customer’s requirements, which helps to instill confidence in the organization, in turn leading to more customers, more sales, and more repeat business ✓ Meeting the organization's requirements, which ensures compliance with regulations and provision of products and services in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit ✓ Reducing waste ✓ Preventing mistakes ✓ Lowering costs ✓ Facilitating and identifying training opportunities ✓ Engaging staff ✓ Setting organization-wide direction ✓ Communicating a readiness to produce consistent results Elements and Requirements of a QMS: ❖The organization’s quality policy and quality objectives ❖Quality manual ❖Procedures, instructions, and records ❖Data management ❖Internal processes ❖Customer satisfaction from product quality ❖Improvement opportunities ❖Quality analysis ❖Quality plan is the process of creating a project and determining the essential factors to ensure that a project meets high standards. Or ❖A quality plan is a document, or several documents, that together specify quality standards, practices, resources, specifications, and the sequence of activities relevant to a particular product, service, project, or contract.  The forensic science laboratory shall establish, implement and maintain an effective quality management system appropriate to the type, range and volume of forensic science activities it undertakes. The quality system shall include policies and procedures addressing all the criteria detailed in these accreditation requirements. The forensic science laboratory shall establish and maintain documented procedures to control all documents and information that relate to its quality system. Documents include manuals, work books, work sheets, charts, posters, notices, memoranda, drawings, plans software, Standard Operating Procedures etc. Documents maintained in computerised systems must also be considered. Quality Control ❖ Analytical performance must be monitored by using quality control procedures appropriate to the type and frequency of the testing undertaken. The range of quality control activities available to laboratories includes the use of: Reference collections Certified reference materials Internally generated reference materials Independent checks by other analysts/examiners Statistical tables Positive and negative controls Control charts Replicate testing Alternative methods Spiked samples, standard additions and internal standards ❖ Quality control procedures must be documented. QUALITY POLICY (Central Forensic Science Laboratory) The Central Forensic Science Laboratory, Hyderabad strives hard in providing quality services in the Scientific Examination/Analysis of the evidencial material referred by the Central and State Law Enforcement Agencies and supports the process of Criminal Justice System in India. The performance of forensic analyses and examinations that are accurate, relevant reliable through, timely and meets the need of the customer. Interpretation of analytical results objectively and free of internal and external influence. The presentation of the results of analyses and examination in reports and testimonies that are clear, objective, balanced and easily understood by its customers The upgrading of the skills and expertise of its personnel is periodic ✓ The conformance of laboratory polices and practices to ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratory and NABL 113: 2008, ✓ Specific Guidelines for Accreditation of Forensic Science Laboratory. ✓ Adherence to the Laboratory’s code of professional ethics ✓ Continual improvement of the effectiveness of its management system through the use of this quality policy, quality objectives, audit results analysis of data, corrective and preventive actions and management review.  Inspection and Testing To establish and maintain documented procedures for inspection and testing activities to in order to verify that the specified requirements for the product are met. Nonspecific Inspection: Inspected by the manufacturer, according with their own standards to check whether the products resulting from same production process correctly answer order specifications. The inspection has to be performed necessarily on the products delivered. Specific Inspection: Inspected before delivery, on products will deliver or inspection units disposed for delivery to check that products comply with the order specifications. Certificate of Inspection: Document based on the inspection and testing performed in accordance with the technical specifications of the order or in the regulations or technical rules that apply. Testing shall be done on supplied products or products of an inspection unit, which form part of the supplied products. The inspection unit should be defined in the product standard, the official regulations, in applicable technical rules or the order  There are certain quality parameters which cannot be visually measured or identified and those things can be measured or evaluated using certain instruments or equipment’s. This process is called as testing. Inspection and Test Records. Developer shall establish and maintain records that provide evidence that the product has been inspected and, as applicable, tested. These records shall show clearly whether the product has passed or failed the inspections and, as applicable, tests according to defined approval criteria. Where the product fails to pass any inspection and, as applicable, test, the procedures for the control of nonconforming product shall apply. Quality Inspection is an activity of checking, measuring, or testing one or more product or service characteristics and comparing the results with the specific requirements to confirm compliance. An efficient inspection process standardizes quality, eliminates paper documents, and increases efficiencies on the floor. ❖ Materials / Equipment’s (as applicable) will be inspected / witnessed by qualified personnel or by the third party inspectors deputed by the PM at manufacturer point of origin as per the contract requirement. ❖ The inspection and testing activities are conducted as indicated in the Inspection and Test Plans (ITP’s). Necessary co-ordination will be done with PM Representative. ❖ The forensic science laboratory shall establish a system that will ensure that all records required by its quality system are maintained.  Handling, storage, packaging, preservation and delivery of the material "The supplier shall establish and maintain documented procedures for handling, storage, packaging, preservation and delivery of product.“ ISO 9000-2 Guidance "The supplier's system for handling, storage, packaging, preservation and delivery of materials should provide proper planning, control and documentation. This includes in-process materials and finished product.“ Handling: The supplier shall provide methods of handling product that prevent damage or deterioration.“ Storage: The supplier shall use designated storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery. Appropriate methods for authorizing receipt to and dispatch from such areas shall be stipulated. Packaging: The supplier shall control packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements. Preservation: The supplier shall apply appropriate methods for preservation and segregation of product when the product is under the suppliers' control. Delivery: The supplier shall arrange for the protection of the quality of product after final inspection and test. Where contractually specified, this protection shall be extended to include delivery to destination. Record: Document stating results achieved or providing evidence of activities performed in order to show compliance with requirements and effective operation of the QMS. Important of Records: Records are an essential element of a QMS and are required for verification, validation, monitoring, inspection and testing of activities in order to facilitate continual improvement of the QMS. They serve as evidence for audits and management reviews. Control of quality records: To establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records. Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system. Document Title Department / Location Document Title Department / Location Document Title Department / Location The minimum records that need to be maintained. The ISO certification is more important for every business Startups. In a manufacturing enterprise, the following additional records have to be kept to demonstrate that an effective quality system is being operated. Records of the distribution of the quality manual, quality plan and related documents. Details of documents available in the organization, dates of issue, identification numbers. Modifications and amendments to documents issued. Records of assessments of subcontractors and their performance review. List of products supplied by customers for specific orders. Records of process capability studies. ✓ Records of observation and consequent decisions affecting process control. ✓ Records of corrective action taken to keep processes under control and results obtained. ✓ Records of preventive maintenance of process equipment. ✓ Records of deviations and concessions, reworked products and repaired work. ✓ Records of Records of customer complaints and warranty claims. ✓ Records of preventive actions taken and results obtained. ✓ Details of qualifications & training of personnel engaged in functions affecting quality. ✓ Records of major nonconformities noted during the servicing operation and corrective actions. ✓ Records of statistical techniques used. Training Laboratory Accreditation ISO (International Organization for Standardization) is an independent, non-governmental international organization with a membership of 169 national standards bodies. International standards ensure that the products and services you use daily are safe, reliable, and of high quality. ISO need, Why? Meet customer requirements: Many companies seek ISO 9001 certification solely to satisfy the requirement of one customer. Get more revenue and business from new customers: Once you earn your ISO 9001 certification, you can advertise your quality certification and respond to requests for quotes (RFQ) from companies that make ISO 9001 certification a requirement. Improve company and product quality: A QMS standard is all about quality so, of course, one result of adopting a QMS should be an improved level of quality for the entire organization, meaning every process and every product.  Increase customer satisfaction with your products: Quality means that whatever you produce will work as your customers expect Describe, understand and communicate your company processes: The ISO 9001 QMS standard requires that you identify and describe your processes using business metrics, the purpose of which is to better manage and control your business processes. Develop a professional culture and better employee morale: Implementing an ISO 9001 QMS can empower employees. Improve the consistency of your operations: Reducing the variation in your processes is the very definition of consistency. Focus management and employees: This column defined quality objectives, metrics and procedures used within an ISO 9001 QMS. Improve efficiency, reduce waste and save money Achieve international quality recognition: ISO 9001 is a worldwide standard administered by the International Organization for Standardization (ISO) based in Switzerland. ISO 9000 series of standards ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system. ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and achieve continual improvement. Customer focus Understand the needs of existing and future customers Align organizational objectives with customer needs and expectations Meet customer requirements Measure customer satisfaction Manage customer relationships Aim to exceed customer expectations Learn more about the customer experience and customer satisfaction Leadership Establish a vision and direction for the organization Set challenging goals Model organizational values Establish trust Equip and empower employees Recognize employee contributions Learn more about leadership Engagement of people Ensure that people’s abilities are used and valued Make people accountable Enable participation in continual improvement Evaluate individual performance Enable learning and knowledge sharing Enable open discussion of problems and constraints Learn more about employee involvement Process approach Manage activities as processes Measure the capability of activities Identify linkages between activities Prioritize improvement opportunities Deploy resources effectively Learn more about a process view of work and see process analysis tools Improvement Improve organizational performance and capabilities Align improvement activities Empower people to make improvements Measure improvement consistently Celebrate improvements Learn more about approaches to continual improvement Evidence-based decision making Ensure the accessibility of accurate and reliable data Use appropriate methods to analyze data Make decisions based on analysis Balance data analysis with practical experience See tools for decision making Relationship management Identify and select suppliers to manage costs, optimize resources, and create value Establish relationships considering both the short and long term Share expertise, resources, information, and plans with partners Collaborate on improvement and development activities Recognize supplier successes Learn more about supplier quality and see resources related to managing the supply chain ISO 14000 series of standards ISO 14000 is defined as a series of international environmental management standards (EMS), guides, and technical reports. The standards specify requirements for establishing an environmental management policy, implementing programs to meet objectives, determining environmental impacts of products or services, planning environmental objectives, conducting corrective action and management review. ISO 14000 EMS- General Guidelines on Principles, Systems and Supporting Techniques ISO 14001 EMS- Specification with Guidance for Use ISO 14004 EMS - General Guidelines on Systems, Principles and Supporting Techniques ISO 14010 EA- General Principles of Environmental Auditing ISO 14011 EA- Auditing of Environmental Management Systems ISO 14012 EA- Qualification Criteria for Environmental Auditors ISO 14013 Management of Environmental Audit Programs ISO 14014 Initial Reviews ISO 14015 Environmental Site Assessments ISO 14020 EL- Basic Principles of Environmental Labeling ISO 14021 EL- Self Declaration- Environmental Claims- Terms and Definitions ISO 14022 EL- Symbols ISO 14023 EL- Testing and Verification Methodologies ISO 14024 EL- Practitioner Programs- Guiding principles, practices and certification procedures of multiple criteria (type1) ISO 14031 Environmental Performance Evaluation ISO 14040 LCA- General Principles and Practices ISO 14041 LCA- Goal and Definition/Scope and Inventory Assessment ISO 14042 LCA- Impact Assessment ISO 14043 LCA- Improvement Assessment ISO 14050 Terms and Definitions ISO 14060 Guide for the Inclusion of Environmental Aspects in Product Standards ISO technical committee ISO/TC207, Environmental management, is responsible for developing and maintaining the ISO 14000 family of standards. ISO/TC 207 has relationships with over 30 international organizations that serve as liaison members to the technical committee. These organizations include the following : ❖ Sierra Club ❖ United Nations Environment Programme ❖ Asian Productivity Organization ❖ World Business Council for Sustainable ❖ Confederation of European Paper Industries Development ❖ European Commission ❖ World Health Organization ❖ Environmental Defense Fund ❖ World Resources Institute ❖ Global Ecolabelling Network ❖ World Trade Organization. ❖ International Aluminium Institute ❖ International Chamber of Commerce ❖ International Institute for Sustainable Development ❖ International Iron and Steel Institute ❖ Organisation for Economic Co-operation and Development  Published documents and on going work of ISO/TC 207 address the following areas (Scope): Environmental management systems Environmental auditing and related environmental investigations Environmental performance evaluation Environmental labelling Life cycle assessment Environmental communication Environmental aspects of product design and development Environmental aspects in product standards Terms and definitions Greenhouse gas management and related activities Measuring the carbon footprint of products.  NABL guidelines for accreditation in India Guidelines for Forensic Science Laboratory Assessment Laboratory Accreditation activities are administered under the direction of the Board for National Accreditation Board for Testing and Calibration Laboratories (NABL), by involving Technical Committees and Evaluation Panels as the recommending bodies. NABL system is based on the ISO/ IEC 17011 for Accreditation Bodies, ISO/ IEC 17025:2005 “General Requirements for the Competence of Testing and Calibration Laboratories” for laboratories. Scope of Accreditation Forensic Science refers to examination of crime scene, recovery of evidence, laboratory examination, interpretation of findings and presentation of the conclusions reached for investigation and intelligence purpose. The scope of accreditation of NABL is applicable to the following disciplines/areas of activity in the Forensic Science Laboratories 1. Chemistry 8. Questioned Documents 2. Toxicology 9. DNA Finger Printing 3. Biology 10. Forensic Psychology 4. Serology 11. Fingerprints 5. Explosives 12. Narcotics 6. Physics 13. Forensic Electronic Investigation 7. Ballistics 14. Crime Scene Investigation Quality Policy Statement: The laboratory shall identify the policies and objectives to be achieved by implementing the management system as per the requirements of ISO / IEC 17025:2005. Organization and Management: The FS laboratory shall clearly define and document the type and extent of the forensic science services it provides. Management must ensure that, the laboratory will not engage in any activities that might diminish trust in its competence, impartiality, judgement or operational integrity. The laboratory must define and document, in the form of job descriptions and organizational charts, the responsibility, authority and interrelation of all personnel who manage or perform work affecting the quality of the forensic science services.  Maintenance of the laboratory's Quality Manual, Monitoring of laboratory practices to verify continuing compliance with policies and procedures Evaluation of instrument calibration and maintenance of records, Periodic assessment of the adequacy of report review activities, Ensuring the validation of new technical procedures, Investigation of technical problems, proposal of remedial actions and verification of their implementation Administration of proficiency testing and evaluation of results, Selection, training and evaluation of internal auditors, Scheduling and coordination of quality system audits, Maintenance of training records of laboratory personnel, Training recommendations to improve the quality of laboratory staff, Proposal of corrections and improvements to the quality system Quality Management System- forensic science laboratory ❖ The forensic science laboratory shall establish, implement and maintain an effective quality management system appropriate to the type, range and volume of forensic science activities it undertakes. ❖ All elements of the laboratory's quality system shall be documented. ❖ The forensic science laboratory shall establish and maintain documented procedures to control all documents and information that relate to its quality system. ❖ The forensic science laboratory shall establish a system that will ensure that all records required by its quality system are maintained. ❖ All data and observations and any other analytical or administrative records which support conclusions must be generated and kept by the laboratory. (Records of case related conversations, evidence receipts, description of evidence, packaging, seals, test(s) conducted, standards and controls used, diagrams, print outs, autoradiographs, photographs, observations and results of examinations)  PERSONNEL Technical Management of Forensic Science laboratories must have relevant scientific qualifications and appropriate forensic experience. The Laboratory Director is defined as the person with direct operational control of the laboratory. He/she must have a minimum of M.Sc. degree. However, it is desirable to have PhD degree and additional qualifications in management and administration with sufficient experience. Training and Development: A training programme must be established and documented for each functional area of the laboratory. Evidence Management: The forensic science laboratory must have a documented evidence control system. The control system is effectively designed when it ensures and documents the integrity of physical evidence. A chain of custody record (eg. Signature, date, time, description of evidence) must be maintained which provides a comprehensive history of each evidence transfer, over which the laboratory has control. Methods and Procedures: Test methods and procedures used must be accepted in the field or supported by data gathered and recorded in a scientific manner. Standards and reagents used should be of satisfactory quality Documentation: Test methods and related procedures (e.g. sample procurement) must be documented and readily available to the analysts/examiners. Method Validation: All technical procedures used by a forensic science laboratory must be fully validated before using them for casework. ❖ Methods may be validated by comparison with other established methods using certified reference materials Quality Assurance: Analytical performance must be monitored by using quality control procedures appropriate to the type and frequency of the testing undertaken. Case Record Review: The laboratory must have documented its policies and procedures for the technical and administrative reviews of case records. Court Testimony Monitoring: The laboratory must have and follow a documented procedure whereby the testimony of each examiner is monitored atleast once in a year. Instruments and Equipment: Instruments/equipment must be maintained in proper working order. Maintenance procedures must be documented. Records must be kept of all maintenance, servicing and repairs. ❖ Instruments/ equipments must be properly calibrated. Security: Access to the operational area of the laboratory must be controllable and limited. NABL guidelines for accreditation in India Proficiency testing system ISO/IEC 17043:2010 specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. Proficiency testing involves the use of inter-laboratory comparisons for the determination of laboratory performance Proficiency testing: Valuation of participant performance against pre-established criteria by means of inter-laboratory comparisons. For the purposes of this International Standard, the term “proficiency testing” is taken in its widest sense a) Quantitative scheme — where the objective is to quantify one or more measurands (the quantity intended to be measured) of the proficiency test item b) Qualitative scheme — where the objective is to identify or describe one or more characteristics of the proficiency test item c) Sequential scheme — where one or more proficiency test items are distributed sequentially for testing or measurement and returned to the proficiency testing provider at intervals; d) Simultaneous scheme — where proficiency test items are distributed for concurrent testing or measurement within a defined time period e) Single occasion exercise — where proficiency test items are provided on a single occasion f) Continuous scheme — where proficiency test items are provided at regular intervals g) Sampling — where samples are taken for subsequent analysis h) Data transformation and interpretation — where sets of data or other information are furnished and the information is processed to provide an interpretation (or other outcome). i) Proficiency test item sample, product, artefact, reference material, piece of equipment, measurement standard, data set or other information used for proficiency testing Inter and intra laboratory testing programmes Intra laboratory Comparisons: An intra laboratory comparison is conducted when several analysts or technicians within an organization perform testing or calibrations on the same or similar artefact, using the same method, under specified, controlled conditions. The data resulting from this activity shall be analyzed for statistical validity A proficiency testing program (or interlaboratory comparison or round robin test): interlaboratory comparison organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions Three different objectives can be pursued: ✓ Validate a test method and determine the uncertainty of results ✓ Determine the characteristics of a product intended for be used as a reference material ✓ Assess the reliability of the test results of the participating laboratories. ❖ It focuses on ensuring that the test produces consistent and reliable results when conducted within the same laboratory over time. ❖ Inter-laboratory validation, on the other hand, involves the evaluation of the performance of a test across multiple laboratories. Confidentiality: Normally, it is policy of most programs to maintain confidentiality of the identity of individual participants. The identity of participants should only be known to the minimum number of people involved in coordinating a program, and this should extend to any subsequent remedial advice or action applied to a laboratory exhibiting poor performance. Advantages of accreditation: International recognition Access to Global market Time and money efficient Enhanced customer confidence and satisfaction Robust Quality Management System Continual improvements Better operational control Assurance of accurate and reliable results Cost Reduction Prevent loss due to defects Contd. In 22FS2001 - 301