Quality Management Systems Quiz

Course Information

• 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: 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 ISO 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 proficiency testing programmes: Confidentiality
• Advantages of accreditation

Quality

• Definition: Fitness for use, customer satisfaction, doing things right the first time, zero defects, a degree of excellence, superiority in kind
• Basic elements: Quality Management, Quality Control, Quality Assurance
• Quality Management: Implementing and carrying out quality policy
• Quality Control: Techniques and activities to monitor and improve conformance to specifications
• Quality Assurance: Planned and systematic actions to assure product or service satisfaction

Quality System

• Establishing, documenting, and maintaining a quality system: Quality manual, system procedures, quality planning
• Quality Assurance: Ensuring quality requirements are met (part of quality management)
• Internal quality audits: Establishing and maintaining documented procedures for internal quality audits to verify quality activities and results

Quality Management System (QMS)

• Formalized system for documenting processes, procedures, and responsibilities to achieve quality policies and objectives
• Benefits: Meeting customer requirements, improving repeat business, meeting regulatory demands, efficient resource use, increasing room for growth, reducing waste, preventing errors and mistakes, potentially lowering costs, aiding in training identification, and setting organisational direction

Elements and Requirements of a QMS

• 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

• Process of creating a project and determining essential factors to ensure project meets high standards
• Document or several documents specifying quality standards, practices, resources, and specifications
• Sequence of relevant activities for a specific product, service, project, or contract

Forensic Science Laboratory Quality System

• Establishing an effective QMS appropriate to the volume and type of forensic science activities
• QMS policies and procedures adhering to accreditation requirements
• Documented procedures for controlling all documents and information related to the quality system
• Documents such as manuals, workbooks, worksheets, charts, posters, notices, memorandums, drawings, plans, software and standard operating procedures

Quality Control

• Monitoring analytical performance using appropriate quality control procedures
• Using reference collections, certified reference materials, internally generated reference materials, independent checks with other analysts/examiners, statistical tables, positive and negative controls, control charts, replicate testing, and alternative methods
• Including spiked samples, standard additions, and internal standards
• Documented quality control procedures

Quality Policy (Central Forensic Science Laboratory)

• Quality services for scientific examination and analysis of evidence
• Accurate, relevant, and reliable analyses and examinations, timely
• Objective interpretations and reports free of internal and external influences
• Clear, objective, balanced, and readily understood reports and testimonies
• Periodic upgrading of personnel skills and expertise

Laboratory Policies and Practices

• Conformance to ISO/IEC 17025:2005, General Requirements
• Conformance to NABL 113: 2008 standards by following accreditation requirements
• Adherence to the laboratory's code of professional ethics
• Continuous improvement of quality management system effectiveness through data analysis, corrective actions, preventive measures, and management review

Inspection and Testing

• Establish and maintain documented procedures for verifying products meet specifications
• Non-specific inspection: Manufacturers' processes for verifying product compliance
• Specific inspection: Pre-delivery inspection to verify produced goods comply with specifications
• Certificates of inspection: Based on technical specifications, order regulations, or inspection unit's technical rules

Inspection and Test Records

• Maintain records demonstrating product inspection and, if appropriate, testing
• Records should clearly indicate whether a product passed or failed inspections/tests
• Records must adhere to defined approval criteria
• Procedures for controlling nonconforming products should apply if a product fails testing

Materials / Equipment's

• Inspection and witness by personnel or an assigned third party

Handling, Storage, Packaging, Preservation, Delivery of Materials

• Suppliers must establish and maintain documented procedures for all material processes: handling, storage, packaging, preservation, and delivery of products
• ISO 9000-2 guidance for a supplier’s system
• Handling methods to prevent damage/deterioration
• Designated storage areas, with stipulated receipt/dispatch protocols

Packaging, Preservation, and Delivery

• Controls over packing, packaging and marking processes (materials used)
• Appropriate preservation and segregation methods
• Delivery protection and extension to destination (contractually defined)
• Records of activities and results for QMS compliance verification

Importance of Records

• Records are essential for verification, validation, monitoring, and testing to facilitate improvements and management reviews

Reasons for Records

• Protecting service users and staff, ensuring continuity of care, showcasing work transparency, providing permanent care records, and improving accountability

Record Keeping

• Provides an audit trail
• Helps to create a detailed picture of needs for service users
• Demonstrates service quality and person-centred care.
• Evidence for court and reviews

Control of Quality Records

• Documented procedures for identification, collection, indexing, access, and filing quality records
• Records demonstrate adherence to specified requirements

Documents and their Locations

• Various document titles and their corresponding departments/locations

Minimum Records for Maintenance

• Record distribution of quality manuals and related documents
• Organizational document details, issue dates, identification numbers
• Modifications and amendments to issued documents
• Subcontractor assessment records, customer product information, and process capability studies

Records related to Process Control

• Observation and decisions for processes
• Corrective actions for process control
• Preventive maintenance of equipment and rework of products
• Records related to customer complaints and warranty claims
• Preventive actions taken and documented
• Personnel qualifications and training documentation
• Major nonconformities and corrective actions

Training Laboratory Accreditation

• Use of ISO, a non-governmental organization, to set international quality standards
• Meeting customer requirements is one of the company reasons to seek ISO 9001 certification

Increase Customer Satisfaction

• Produce quality products that meet customer expectations
• Document, understand, and communicate company processes, using business metrics
• Encouraging employee professionalism and morale
• Improve the consistency of operations
• Management, employee focus, defined quality objectives, and metrics within the QMS
• Improve efficiency, reduce waste, and save money
• Quality recognition from worldwide standards organisation

ISO 9000 Standard

• International standards for quality management and quality assurance to ensure required systems documentation is in place
• Ensuring companies meet customer requirements, regulatory standards, and continual improvement by documenting quality systems effectively.

Relationship Management

• Identifying and selecting suppliers to optimize resources and create value
• Establishing short- and long-term relationships
• Sharing expertise, resources, information, and plans with partners
• Collaborating on improvements
• Recognizing supplier successes

ISO 14000 Series of Standards

• International environmental management standards that establish and implement various environmental management plans
• Includes general guidelines on principles, systems, and supporting techniques

ISO 14015 to 14060 Standards

• Includes: Environmental Site Assessments, Basic Principles of Environmental Labeling, Self-Declaration, Environmental Claims, Terms and Definitions, Symbols, Testing and Verification Methodologies, Practitioner Programs, Environmental Performance Evaluation, Life Cycle Assessments, Impact Assessments, and more.

ISO Technical Committee

• Establishing and maintaining the ISO 14000 family of standards.

Published Documents and Ongoing Work of ISO/TC 207

• Environmental Management Systems
• Environmental Auditing and Investigations
• Environmental performance evaluation
• Environmental labelling, life cycle assessment
• Environmental communication
• Environmental aspects of product design and development
• Environmental aspects of products and standards
• Greenhouse gas management and related activities, measuring carbon footprint

NABL Guidelines for Accreditation

• Overseen by the Board for National Accreditation (NABL), working with Technical Committees and Evaluation Panels
• Based on ISO/IEC guidelines and requirements for testing, calibration, and proficiency testing
• Scope of accreditation includes specific forensic science disciplines

Scope of Accreditation (NABL)

• Specific forensic science disciplines are accredited, including Chemistry, Toxicology, Biology, Serology, Explosives, Physics, Ballistics, Questioned Documents, DNA Fingerprinting, Forensic Psychology, Fingerprints, Narcotics, Forensics, and Crime Scene Investigation.

Quality Policy Statement (Forensic Science Laboratory)

• Determining policies and objectives and implementing the management system accordingly (ISO/IEC 17025:2005)

Organization and Management

• Clearly defining and documenting the type and extent of forensic services
• Ensuring management operates to maintain competence, impartiality, judgment, and operational integrity
• Establishing job descriptions and organizational charts for clear responsibility, authority, and interrelation of personnel

Maintenance of the Laboratory Quality Manual, and other activities

• Maintaining and monitoring the laboratory's quality manual and policies and procedures
• Evaluation of instrument calibration and record maintenance
• Periodic assessment of report review activities
• Validating new technical procedures
• Implementing proficiency testing and evaluating its results
• Selecting, training, and evaluating internal auditors
• Scheduling and coordinating quality system audits for personnel
• Recommending improvements, and corrections.

Quality Management System (Forensic Science Laboratory)

• Establishing, implementing, and maintaining an effective quality management system relevant to scope
• Documenting all elements of quality system
• Documented procedures for controlling all documents and information related to the quality system
• Establishing a system to maintain required records
• Generating, maintaining, and keeping all related data, observations, and administrative records (case records, evidence receipts, examinations, etc.)

Personnel

• Defining laboratory director qualifications (M.Sc. minimum, preferably PhD) and relevant experience
• Establishing and documenting training programs for all functional areas
• Establishing evidence control system ensuring integrity of physical evidence (chain of custody record)
• Validating test methods, using established methods and validated standards and reagents
• Monitoring and maintaining instruments/equipment, providing maintenance and repair record keeping
• Controlling access to the laboratory operation area

Documentation, Method Validation, Quality Assurance, Case Review

• Documenting procedures e.g., sample procurement
• Validating technical procedures
• Monitoring analytical performance and using suitable quality control procedures
• Procedures and methods for technical and administrative reviews of case records

Court Testimony Monitoring

• Procedure ensuring testimony monitoring at least annually

Instruments and Equipment

• Procedures for maintaining instruments, documenting records, servicing and repairs, calibrations.

Security

• Controlling and limiting laboratory operational area access

NABL Guidelines for Accreditation- Proficiency Testing

• ISO/IEC 17043 guidelines: specifies requirements for competence for providers of proficiency testing schemes and development/operation of those schemes
• Proficiency testing definition: using inter-laboratory comparisons for determining laboratory performance; criteria are pre-established
• Different Proficiency Testing Schemes

Proficiency Testing Schemes

• Quantitative scheme: Objective to quantify a measure
• Qualitative scheme: Identifying or describing characteristics
• Sequential scheme: Distributions and returns of test items over time
• Simultaneous scheme: Distribution and testing of items in a specific time period; or a single occasion exercise over a single period
• Continuous scheme: Items distributed regularly over a defined period
• Sampling: Procedures for providing samples for testing
• Data transformation and interpretation: Procedures to process data and interpretations
• Proficiency test item examples include (but are not limited to) samples, products, artifacts, standards, data sets.

Inter and Intra Laboratory Testing

• Intra laboratory comparison procedures: Multiple analysts test the same or similar items under controlled conditions, analysed for validity
• Proficiency testing procedures: Establishing and evaluating test performance across multiple laboratories using inter-laboratory comparisons, with pre-established criteria

Confidentiality

• Confidentiality policy to maintain privacy of individual participants
• Restrictions on identifying individuals involved in subsequent remedial action of poor performers

Advantages of Accreditation

• International recognition
• Access to global market
• Time and money efficiency
• Confidence and customer satisfaction
• Robust and improved quality management system
• Continual improvements
• Better operational control
• Assurance of accurate and reliable results
• Cost reduction
• Reduce loss due to defects