This document outlines quality control procedures for a laboratory and production facility. It defines key terms related to quality control and management. It establishes objectives to strictly adhere to requirements and specifications. It lists quality control activities to inspection and testing of materials, processes, equipment and records. Finally, it provides a master list of quality control records to be maintained, including test reports, non-conformance reports, audit reports and more. The document provides a framework to ensure consistent and compliant work that meets quality standards.
This document outlines the documentation requirements for laboratories to be compliant with ISO/IEC-17025:2017. It lists the key clauses of the standard and whether each technical requirement is procedures (P), documented (R) or implemented (O). Some of the main requirements covered include having documented procedures for impartiality, confidentiality, handling complaints and nonconforming work. Laboratories must also document their organizational structure, personnel requirements, equipment management and methods validation. Technical records must contain sufficient information to enable repetition of tests and monitoring is required to ensure validity of results.
A Risk-Based Approach for Investigating Environmental Monitoring ExcursionsRobert Westney
This document outlines a risk-based approach for investigating environmental monitoring excursions. It discusses elements of an investigation plan, key investigation points, root cause analysis, corrective actions, and assessing the impact on facilities and products. A risk-based approach considers the probability and severity of harm to determine appropriate corrective actions. Investigations should identify root causes and prevent recurrence by modifying procedures, training, or equipment. The potential impact on facilities and products is assessed based on historical data trends and control of manufacturing processes.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
The document defines a master formula record as specifying starting materials, quantities, packaging materials, and processing instructions to produce a finished product batch. It outlines the requirements for a master formula record including: (1) product name and reference code, composition, strength, and batch size; (2) processing location and equipment; (3) starting materials and quantities; (4) expected final yield and intermediate yields; and (5) detailed processing, storage, and packaging instructions. International guidelines from WHO, EU, PIC, Canada, and USA provide further requirements for master formula record contents.
This document provides instructions for reporting, investigating, and handling deviations from standard operating procedures and processes. It defines deviations as planned or unplanned and categorizes them based on their severity and impact on product quality. The procedure outlines the process for reporting deviations, investigating the root cause, implementing corrective and preventive actions, evaluating their effectiveness, and trending analysis. Quality assurance is responsible for approving deviation reports and deciding if batches can be released.
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
Presentation: Cleaning and Contamination Control: A regulatory perspectiveTGA Australia
The document discusses regulatory perspectives on cleaning and contamination control from an inspector of the Therapeutic Goods Administration in Australia. It covers current GMP requirements, future GMP developments, observed good practices in contamination control, and common deficiencies found in inspections. Some key points include that contamination control strategies should be risk-based and rely on quality risk management principles. Inspections often find deficiencies in assessing intrinsic hazards of products and processes, in the design of facilities and equipment to control contamination risks, and in validation of cleaning processes.
Second Party Audit and External Third Party AuditShantanuThakre3
Second Party Audit:- Second-party audit is when a company performs an audit of a supplier to ensure that they are meeting the requirements specified in the contract.
External Third Party Audit:-
A third-party audit occurs when a company has decided that they want to create a Quality Management System (QMS) that conforms to a standard set of requirements, such as ISO 9001 and hire an independent auditing company to perform an audit to verify that the company has succeeded in meeting these standards.
This document outlines the documentation requirements for laboratories to be compliant with ISO/IEC-17025:2017. It lists the key clauses of the standard and whether each technical requirement is procedures (P), documented (R) or implemented (O). Some of the main requirements covered include having documented procedures for impartiality, confidentiality, handling complaints and nonconforming work. Laboratories must also document their organizational structure, personnel requirements, equipment management and methods validation. Technical records must contain sufficient information to enable repetition of tests and monitoring is required to ensure validity of results.
A Risk-Based Approach for Investigating Environmental Monitoring ExcursionsRobert Westney
This document outlines a risk-based approach for investigating environmental monitoring excursions. It discusses elements of an investigation plan, key investigation points, root cause analysis, corrective actions, and assessing the impact on facilities and products. A risk-based approach considers the probability and severity of harm to determine appropriate corrective actions. Investigations should identify root causes and prevent recurrence by modifying procedures, training, or equipment. The potential impact on facilities and products is assessed based on historical data trends and control of manufacturing processes.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
The document defines a master formula record as specifying starting materials, quantities, packaging materials, and processing instructions to produce a finished product batch. It outlines the requirements for a master formula record including: (1) product name and reference code, composition, strength, and batch size; (2) processing location and equipment; (3) starting materials and quantities; (4) expected final yield and intermediate yields; and (5) detailed processing, storage, and packaging instructions. International guidelines from WHO, EU, PIC, Canada, and USA provide further requirements for master formula record contents.
This document provides instructions for reporting, investigating, and handling deviations from standard operating procedures and processes. It defines deviations as planned or unplanned and categorizes them based on their severity and impact on product quality. The procedure outlines the process for reporting deviations, investigating the root cause, implementing corrective and preventive actions, evaluating their effectiveness, and trending analysis. Quality assurance is responsible for approving deviation reports and deciding if batches can be released.
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
Presentation: Cleaning and Contamination Control: A regulatory perspectiveTGA Australia
The document discusses regulatory perspectives on cleaning and contamination control from an inspector of the Therapeutic Goods Administration in Australia. It covers current GMP requirements, future GMP developments, observed good practices in contamination control, and common deficiencies found in inspections. Some key points include that contamination control strategies should be risk-based and rely on quality risk management principles. Inspections often find deficiencies in assessing intrinsic hazards of products and processes, in the design of facilities and equipment to control contamination risks, and in validation of cleaning processes.
Second Party Audit and External Third Party AuditShantanuThakre3
Second Party Audit:- Second-party audit is when a company performs an audit of a supplier to ensure that they are meeting the requirements specified in the contract.
External Third Party Audit:-
A third-party audit occurs when a company has decided that they want to create a Quality Management System (QMS) that conforms to a standard set of requirements, such as ISO 9001 and hire an independent auditing company to perform an audit to verify that the company has succeeded in meeting these standards.
This document discusses calibration and qualification. It begins by defining calibration as comparing a measurement system or device of unknown accuracy to a standard of known accuracy. The objectives of calibration are to check accuracy, determine traceability, and provide confidence that results meet specifications. Calibration is important to detect drift over time and ensure measurements remain reliable. Qualification establishes that equipment is suitable for its intended use and performs properly. It includes design qualification to define specifications, installation qualification to confirm proper installation, operational qualification to demonstrate functional specifications are met, and performance qualification to establish consistent performance.
ISO/IEC 17025 outlines the requirements for laboratories to demonstrate competence and generate reliable test and calibration results. It covers management requirements like documentation, audits, and reviews as well as technical requirements for personnel, methods, equipment, measurement traceability and reporting. The standard requires laboratories to have a quality management system in place to ensure consistent, valid results and provide traceable measurements that can be compared internationally through an unbroken chain of calibrations.
This document discusses quality control principles for pharmaceutical testing laboratories. It covers 10 key principles: test facility organization and personnel; quality assurance programs; facilities; apparatus, materials and reagents; test systems; routine controls; standard operating procedures; protocols; reporting of study results; and storage and retention of records. For each principle, responsibilities of management, study directors, and other personnel are outlined.
المواصفة القياسية المصرية 7136 لسنة 2010 flash_hero
This document is the Egyptian General Organization for Standardization and Quality's standard number 7136/2010 which sets maximum limits for certain food contaminants. It adopts the limits from the European Directive 1881/2006 and replaces the following Egyptian standards: maximum limits for aflatoxins in food, ochratoxin A in food, iron, copper, zinc in food, lead in food, cadmium in food, mercury in food, and methylmercury in fish. The standard was approved on June 21, 2010.
Use of control charts in laboratory as per ISO 17025:2017Rahul Gupta
This document discusses the use of control charts in laboratories to monitor testing processes and ensure validity of test results. It provides examples of different types of control charts, including mean charts, range charts, recovery control charts, and duplicate sample charts. Control charts can be used to detect changes in testing processes, monitor equipment performance, compare testing methods, and evaluate different analysts. Trend analysis of control charts allows labs to determine if a process is in or out of statistical control. Control charts are a powerful tool for internal quality control in testing laboratories.
The document summarizes the key changes and structure of ISO/IEC 17025:2017 compared to the 2005 version. Major changes include an expanded scope to include sampling and a process-based approach. It adopts a new high level structure with common clauses across standards. Key requirements include impartiality, confidentiality, personnel competence, facilities, equipment calibration, metrological traceability, and management of externally provided products and services. The standard aims to ensure laboratories consistently operate at a high level of technical competence and quality.
This document provides an overview of ISO standards including ISO 9001 and ISO 14001. It discusses:
- The history and present scenario of ISO as an independent international standardization body with 162 member countries.
- The benefits of ISO standards in ensuring safety, reliability and quality for businesses and access to new markets.
- An overview of the key requirements of ISO 9001:2008 for quality management systems and ISO 14001 for environmental management systems.
- Updates and changes in ISO 9001:2015 and ISO 14001:2015 including greater emphasis on risk-based thinking and the Plan-Do-Check-Act cycle.
This document discusses Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It begins with an overview of why GMP is important for ensuring consistent quality and safety of medicines. It then outlines the key principles of GMP, including requirements for facilities, equipment, documentation, personnel, sanitation, and quality control. The document provides details on specific GMP requirements for premises, materials, production areas, equipment, packaging, batch records, and quality assurance systems. It also discusses self-inspection and quality auditing.
The document discusses the International Organization for Standardization (ISO). It provides information on ISO's history, structure, members, standards development process, and strategy. Additionally, it discusses implementation of ISO standards in Pakistan, including examples of Pakistani companies that have obtained ISO certifications and the certification bodies operating in Pakistan. The key points are: ISO was established in 1946 and has 163 member countries; it develops standards through technical committees using a six-stage process; the most commonly used ISO standards are ISO 9001, 14001, and 18001; and obtaining ISO certification can improve a company's performance and reputation.
Step-wise implementation of Good laboratory practices(GLP)Mohamed Minas
The implementation of the OECD Principles of Good Laboratory Practice (GLP) represents a significant challenge to novice organizations. The aim of the document is to provide a
sequential framework for GLP implementation. Although there are many ways to achieve
GLP compliance, the steps recommended here are based upon the practical experience of scientists who have already implemented GLP.
The document discusses contamination and personal hygiene in the pharmaceutical industry. It identifies several potential sources of contamination including personnel, buildings and facilities, equipment, materials, manufacturing processes, and HVAC systems. Poor hygiene practices by personnel such as lack of training and cleanliness can lead to microbiological contamination. Maintaining good hygiene practices such as hand washing, using dedicated protective clothing and hair coverings, and restricting street shoes in manufacturing areas are important to prevent contamination and ensure product quality. Regular health checks and hygiene training of personnel are also recommended.
Decreto 22912 - Atendimento Integração Inversa e Classes EspeciaisCarlos Junior
Este decreto regulamenta a lei que dispõe sobre atendimento especializado a alunos portadores de deficiência na educação básica no Distrito Federal. O decreto define as formas de atendimento especializado como classes especiais, classes de integração inversa, salas de recursos materiais e salas de apoio. Além disso, estabelece que o atendimento deve ser oferecido a partir da educação infantil e ser realizado por equipe multidisciplinar.
The document discusses the requirements of ISO/IEC 17025 for testing and calibration laboratories. Some key points:
1) It covers the competency requirements for laboratories to perform both testing/analysis and instrument calibration using standards, non-standards, and laboratory-developed methods.
2) Laboratories must have qualified personnel, validated methods, traceable standards, documented quality management systems, and procedures for audits, management reviews, corrective actions and control of records.
3) The standard addresses technical and administrative operations including method development, subcontracting, purchasing, customer complaints, nonconforming work, and management commitment to meet requirements.
The document provides information about the International Organization for Standardization (ISO) and two of its most widely implemented standards: ISO 9001 and ISO 17025. ISO is the world's largest developer of voluntary international standards, with over 20,000 standards covering almost all industries. ISO 9001 helps organizations implement quality management systems, while ISO 17025 provides requirements for competence and impartiality of testing and calibration laboratories. Both standards have been implemented by over a million organizations globally and facilitate international acceptance of certifications.
Quality management systems are important for companies to meet customer needs and expectations. Key aspects of quality management include quality assurance to ensure products meet performance and reliability standards, and quality control which implements quality policies and procedures. Major international quality standards include ISO 9001, while FDA regulations like 21 CFR parts 210, 211, and 212 provide guidelines for pharmaceutical Good Manufacturing Practices. An effective quality management system focuses on parameters like performance, efficiency, effectiveness and user satisfaction to deliver high quality products.
Control of component, containers and closuresJamia Hamdard
The document discusses current good manufacturing practices (CGMP) regulations for control of components, containers, and closures according to the FDA. It outlines the subparts of Schedule M which provide GMP guidelines, including requirements for testing, approving, and rejecting components and ensuring clean, approved materials are used and stored properly. The document also discusses production and process control procedures to ensure quality and prevent contamination during manufacturing.
Quality assurance in the pharmaceutical industryfatboysec
This document discusses quality assurance in the pharmaceutical industry. It states that research, development, production and distribution must comply with global and local rules to ensure medicines are pure, safe and effective. Pharmaceutical companies must satisfy directives from the FDA and EMA regarding GMP, GLP, GCP and GDP. Ordina provides quality assurance services including validation and documentation of processes, training, audit services, and optimization of quality management systems. Ordina experts are knowledgeable in relevant legislation and methodologies to design validation approaches focused on critical quality attributes.
Nessreen Maher Elkhabeeri Farahat is seeking a new office manager position. She has over 15 years of experience as an office manager for Cairo Contracting Company, where she was responsible for administrative and management tasks, supervising office staff, coordination and planning, filing, and maintaining a good working environment. Prior to that, she worked as an accountant for The International Company for Trading. She has a bachelor's degree in accounting from Ain Shams University and excellent English language skills.
This document discusses calibration and qualification. It begins by defining calibration as comparing a measurement system or device of unknown accuracy to a standard of known accuracy. The objectives of calibration are to check accuracy, determine traceability, and provide confidence that results meet specifications. Calibration is important to detect drift over time and ensure measurements remain reliable. Qualification establishes that equipment is suitable for its intended use and performs properly. It includes design qualification to define specifications, installation qualification to confirm proper installation, operational qualification to demonstrate functional specifications are met, and performance qualification to establish consistent performance.
ISO/IEC 17025 outlines the requirements for laboratories to demonstrate competence and generate reliable test and calibration results. It covers management requirements like documentation, audits, and reviews as well as technical requirements for personnel, methods, equipment, measurement traceability and reporting. The standard requires laboratories to have a quality management system in place to ensure consistent, valid results and provide traceable measurements that can be compared internationally through an unbroken chain of calibrations.
This document discusses quality control principles for pharmaceutical testing laboratories. It covers 10 key principles: test facility organization and personnel; quality assurance programs; facilities; apparatus, materials and reagents; test systems; routine controls; standard operating procedures; protocols; reporting of study results; and storage and retention of records. For each principle, responsibilities of management, study directors, and other personnel are outlined.
المواصفة القياسية المصرية 7136 لسنة 2010 flash_hero
This document is the Egyptian General Organization for Standardization and Quality's standard number 7136/2010 which sets maximum limits for certain food contaminants. It adopts the limits from the European Directive 1881/2006 and replaces the following Egyptian standards: maximum limits for aflatoxins in food, ochratoxin A in food, iron, copper, zinc in food, lead in food, cadmium in food, mercury in food, and methylmercury in fish. The standard was approved on June 21, 2010.
Use of control charts in laboratory as per ISO 17025:2017Rahul Gupta
This document discusses the use of control charts in laboratories to monitor testing processes and ensure validity of test results. It provides examples of different types of control charts, including mean charts, range charts, recovery control charts, and duplicate sample charts. Control charts can be used to detect changes in testing processes, monitor equipment performance, compare testing methods, and evaluate different analysts. Trend analysis of control charts allows labs to determine if a process is in or out of statistical control. Control charts are a powerful tool for internal quality control in testing laboratories.
The document summarizes the key changes and structure of ISO/IEC 17025:2017 compared to the 2005 version. Major changes include an expanded scope to include sampling and a process-based approach. It adopts a new high level structure with common clauses across standards. Key requirements include impartiality, confidentiality, personnel competence, facilities, equipment calibration, metrological traceability, and management of externally provided products and services. The standard aims to ensure laboratories consistently operate at a high level of technical competence and quality.
This document provides an overview of ISO standards including ISO 9001 and ISO 14001. It discusses:
- The history and present scenario of ISO as an independent international standardization body with 162 member countries.
- The benefits of ISO standards in ensuring safety, reliability and quality for businesses and access to new markets.
- An overview of the key requirements of ISO 9001:2008 for quality management systems and ISO 14001 for environmental management systems.
- Updates and changes in ISO 9001:2015 and ISO 14001:2015 including greater emphasis on risk-based thinking and the Plan-Do-Check-Act cycle.
This document discusses Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It begins with an overview of why GMP is important for ensuring consistent quality and safety of medicines. It then outlines the key principles of GMP, including requirements for facilities, equipment, documentation, personnel, sanitation, and quality control. The document provides details on specific GMP requirements for premises, materials, production areas, equipment, packaging, batch records, and quality assurance systems. It also discusses self-inspection and quality auditing.
The document discusses the International Organization for Standardization (ISO). It provides information on ISO's history, structure, members, standards development process, and strategy. Additionally, it discusses implementation of ISO standards in Pakistan, including examples of Pakistani companies that have obtained ISO certifications and the certification bodies operating in Pakistan. The key points are: ISO was established in 1946 and has 163 member countries; it develops standards through technical committees using a six-stage process; the most commonly used ISO standards are ISO 9001, 14001, and 18001; and obtaining ISO certification can improve a company's performance and reputation.
Step-wise implementation of Good laboratory practices(GLP)Mohamed Minas
The implementation of the OECD Principles of Good Laboratory Practice (GLP) represents a significant challenge to novice organizations. The aim of the document is to provide a
sequential framework for GLP implementation. Although there are many ways to achieve
GLP compliance, the steps recommended here are based upon the practical experience of scientists who have already implemented GLP.
The document discusses contamination and personal hygiene in the pharmaceutical industry. It identifies several potential sources of contamination including personnel, buildings and facilities, equipment, materials, manufacturing processes, and HVAC systems. Poor hygiene practices by personnel such as lack of training and cleanliness can lead to microbiological contamination. Maintaining good hygiene practices such as hand washing, using dedicated protective clothing and hair coverings, and restricting street shoes in manufacturing areas are important to prevent contamination and ensure product quality. Regular health checks and hygiene training of personnel are also recommended.
Decreto 22912 - Atendimento Integração Inversa e Classes EspeciaisCarlos Junior
Este decreto regulamenta a lei que dispõe sobre atendimento especializado a alunos portadores de deficiência na educação básica no Distrito Federal. O decreto define as formas de atendimento especializado como classes especiais, classes de integração inversa, salas de recursos materiais e salas de apoio. Além disso, estabelece que o atendimento deve ser oferecido a partir da educação infantil e ser realizado por equipe multidisciplinar.
The document discusses the requirements of ISO/IEC 17025 for testing and calibration laboratories. Some key points:
1) It covers the competency requirements for laboratories to perform both testing/analysis and instrument calibration using standards, non-standards, and laboratory-developed methods.
2) Laboratories must have qualified personnel, validated methods, traceable standards, documented quality management systems, and procedures for audits, management reviews, corrective actions and control of records.
3) The standard addresses technical and administrative operations including method development, subcontracting, purchasing, customer complaints, nonconforming work, and management commitment to meet requirements.
The document provides information about the International Organization for Standardization (ISO) and two of its most widely implemented standards: ISO 9001 and ISO 17025. ISO is the world's largest developer of voluntary international standards, with over 20,000 standards covering almost all industries. ISO 9001 helps organizations implement quality management systems, while ISO 17025 provides requirements for competence and impartiality of testing and calibration laboratories. Both standards have been implemented by over a million organizations globally and facilitate international acceptance of certifications.
Quality management systems are important for companies to meet customer needs and expectations. Key aspects of quality management include quality assurance to ensure products meet performance and reliability standards, and quality control which implements quality policies and procedures. Major international quality standards include ISO 9001, while FDA regulations like 21 CFR parts 210, 211, and 212 provide guidelines for pharmaceutical Good Manufacturing Practices. An effective quality management system focuses on parameters like performance, efficiency, effectiveness and user satisfaction to deliver high quality products.
Control of component, containers and closuresJamia Hamdard
The document discusses current good manufacturing practices (CGMP) regulations for control of components, containers, and closures according to the FDA. It outlines the subparts of Schedule M which provide GMP guidelines, including requirements for testing, approving, and rejecting components and ensuring clean, approved materials are used and stored properly. The document also discusses production and process control procedures to ensure quality and prevent contamination during manufacturing.
Quality assurance in the pharmaceutical industryfatboysec
This document discusses quality assurance in the pharmaceutical industry. It states that research, development, production and distribution must comply with global and local rules to ensure medicines are pure, safe and effective. Pharmaceutical companies must satisfy directives from the FDA and EMA regarding GMP, GLP, GCP and GDP. Ordina provides quality assurance services including validation and documentation of processes, training, audit services, and optimization of quality management systems. Ordina experts are knowledgeable in relevant legislation and methodologies to design validation approaches focused on critical quality attributes.
Nessreen Maher Elkhabeeri Farahat is seeking a new office manager position. She has over 15 years of experience as an office manager for Cairo Contracting Company, where she was responsible for administrative and management tasks, supervising office staff, coordination and planning, filing, and maintaining a good working environment. Prior to that, she worked as an accountant for The International Company for Trading. She has a bachelor's degree in accounting from Ain Shams University and excellent English language skills.
Moderne backends mit dem aktor programmiermodellDamir Dobric
The document discusses modern backend architectures using Service Fabric and the actor model. It begins with an overview of traditional multitier architectures and their scaling limitations. The document then introduces the scaling cube approach of scaling horizontally, functionally, and by data partitioning. It describes how Service Fabric supports scaling across all three dimensions. The remainder of the document focuses on the actor model, defining actors as asynchronous and stateful/stateless primitives. It discusses how actors are deployed and activated in Service Fabric and covers key concepts like state persistence, messaging, and location transparency provided by the actor runtime.
Students will be assigned to groups of about 14 for activities. They will stay in cabins with either all boys or all girls, along with chaperones. Students should pack clothes for outdoor activities, a sleeping bag, toiletries, and a water bottle. The camp will include activities like horseback riding, rock climbing, hiking, and nature lessons. Lunch on the first day should be packed, and meals will be provided in the dining hall for the rest of the trip.
La carrera de color más divertida ahora a tu alcance en cualquier ciudad, lleva el color y la diversión en un evento inolvidable informes y ventas: support@thecolorvibe.mx con copia a humcarrillo@gmail.com
This document appears to be a track listing for an album titled "Foundations" by artist Kate Nash. The track listing includes 12 songs: Play, Foundations, Mouthwash, Dickhead, Birds, We Get On, Mariella, Shit Song, Pumpkin Soup, Skeleton Song, Nicest Thing, and Merry Happy. The album is labeled as a special edition of Kate Nash's Foundations album.
Satonda Island offers the opportunity to develop a high-end eco-resort. The 535 hectare island is home to rare living stromatolites in Crater Lake, fruit bats, deer, and monkeys. It has pristine beaches and diving locations. PT RIA SO MILA PANTAI INDAH manages Satonda Island and holds the necessary permits to develop 49 hectares for a resort, with plans including landscaping, staffing, and small villas. Satonda Island offers activities like diving and hiking in a unique pre-Cambrian environment that could reveal secrets of early life.
PowerPoint-presentatie die Fanny Matheusen, onderzoekster bij CIMIC, toelichtte tijdens de reflectiedag 'Divers sociaal-cultureel werk(t)?' van Socius (8 november 2010).
The document discusses the changing business model of social housing providers. It notes that assumptions about rented products, funding models, and rent increases are changing. As a result, providers' business models and financing are becoming more complex, incorporating factors like asset sales, new development, and diversification. The regulator seeks to understand how providers are managing risks in this shifting environment and ensure boards have the capacity to do so, but does not determine business strategies or risk appetite. The role is to assess compliance with regulatory standards and work with providers to remedy issues when concerns arise.
PIC USB Starter kit is a simple and easy platform for newbies. The board features an PIC18F2550 and all of its Pinouts. Just plug the device with your PC or Laptop and load hex file to the on board PIC18F2550.The Pinouts Lets you connect the chip with external components like LEDs,buzzers etc.
Accessories:1)USB Cable
2)User Manual DVD
This document discusses validation, including definitions, purposes, types, and processes. It provides details on:
1. Validation is the process of proving that any procedure, process, equipment, or system achieves expected results. It involves establishing evidence that quality requirements are fulfilled.
2. Validation is important for new processes and equipment, changes to existing processes/equipment, and where product testing alone cannot ensure quality. It occurs in three phases: pre-validation qualification, process validation, and validation maintenance.
3. A validation master plan is a comprehensive document that describes validation requirements for a facility and provides a validation plan. It covers qualifications, personnel, schedules, and documentation for the validation process.
This quality manual outlines the quality management system used by ABC Co., Ltd. to manage the quality of its products, which include medicines and cosmetics. It describes the organization structure, manufacturing facility, quality system procedures, and quality programs for design and change control, purchasing, material traceability, process validation, inspection and testing, calibration, non-conforming product handling, and quality records maintenance. The manual provides a high-level overview of ABC's quality system to ensure its products comply with requirements and are manufactured according to appropriate standards.
This document provides an overview of pharmaceutical validation and calibration processes. It discusses the objectives of validation which include reducing regulatory risks and defects. The scope of validation covers analytical, facilities, manufacturing, product design, cleaning, instrumentation, utilities, materials and equipment. A validation master plan outlines the validation strategy and includes qualification methods, personnel responsibilities, schedules, documentation and change control. Similarly, a calibration master plan ensures equipment is routinely calibrated against reference standards to ensure proper performance and measurement traceability.
1. The document discusses pharmaceutical validation including calibration and validation master plans. It defines validation and calibration, outlines their objectives and importance.
2. It describes the scope and methods of validation including process, analytical, equipment and cleaning validation. It also discusses the merits of validation in ensuring consistency and reducing risks.
3. The document provides details on validation master plans including contents such as introduction, methodology, personnel, schedules, documentation etc. It also discusses calibration master plans, the need for periodic calibration of instruments and maintaining calibration records.
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
The document discusses pharmaceutical validation, including its history, purpose, and key aspects. It provides definitions for validation, describing it as demonstrating and documenting that a process will consistently produce the expected results. The summary is as follows:
Validation aims to ensure quality is built into pharmaceutical systems and processes at every step. It includes qualification of equipment and facilities. Key parts of validation include process design, qualification, and continued verification to maintain process control. Validation is required by regulations and improves quality, efficiency and compliance for the pharmaceutical industry.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Quality assurance and quality control are important concepts in pharmaceutical manufacturing. Quality assurance refers to planned and systematic activities that ensure quality in processes, while quality control refers to activities that ensure quality in products. Some key differences are that quality assurance focuses on preventing defects through proper processes, while quality control identifies defects in finished products. Total quality management aims to produce perfect products through quality measures at every stage of production and requires team effort across an organization.
documentation in pharmaceutical industry ppt.pptxashokgorja8
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
documentation in pharmaceutical industry ppt.pptxashokgorja8
The document discusses documentation requirements in the pharmaceutical industry. It defines documentation and explains that documentation is an integral part of good manufacturing practices (GMP). It describes the objectives of documentation such as defining specifications and procedures. It provides details about types of documentation required by GMP such as master formula records, batch manufacturing records, distribution records, specifications, and quality auditing. The document emphasizes that comprehensive documentation is necessary to ensure product quality and traceability in the pharmaceutical industry.
The document discusses validation in the pharmaceutical industry. It defines validation according to regulatory bodies as establishing evidence that a process will consistently produce a product meeting its quality standards. Validation master plans outline the principles and programs for qualifying facilities, processes, analytical methods, and computer systems. The main types of validation are prospective, concurrent, and retrospective. Key aspects of validation covered include process validation, cleaning validation, and analytical method validation. Validation aims to demonstrate processes and methods are fit for their intended purposes.
Quality assurance aims to ensure that pharmaceutical products meet quality standards by building quality into every stage of design, development, and manufacturing. It involves planned and documented activities like process validation, quality audits, and staff training to verify that products satisfy quality requirements. Quality control is the part of GMP concerned with testing and release of materials and products to ensure they meet specifications before release or use. Together, quality assurance and quality control comprise a quality system that helps deliver pharmaceuticals free of contamination and suitable for their intended use.
This document provides an overview of process validation according to FDA guidance. It defines process validation as collecting data from process design through commercial production to establish that a process is capable of consistently delivering quality products. The guidance outlines a lifecycle approach with three stages: process design, process qualification, and continued process verification. Process design defines the commercial process based on development knowledge. Process qualification evaluates the design and determines if the process is reproducible. Continued process verification ensures the process remains controlled during routine production. Critical quality attributes and critical process parameters are identified, and control strategies are established.
This document discusses quality control and inspection. It defines quality as fitness for use and outlines why quality control is important to ensure consistent product quality given variability in manufacturing processes. Quality control involves planned actions to measure product characteristics against requirements. Inspections occur at various stages of production like pre-production, in-process, and final inspection to check for defects. Statistical tools like control charts and acceptance sampling are used to objectively evaluate quality.
The document discusses various aspects of validation in the pharmaceutical industry. It begins with introducing validation and its importance in assuring quality of pharmaceutical products. It then covers topics such as validation planning, documentation, validation master plan, types of validation including process, cleaning and equipment validation. The document also discusses ICH and WHO guidelines for validation. It highlights the need, merits and demerits of validation as well as who performs validation activities. Finally, it provides an overview of prospective, retrospective and concurrent validation approaches.
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The document discusses pharmaceutical validation, including definitions, types, and elements of validation. It provides definitions of validation from WHO, FDA, and ICH. The main types of validation discussed are process validation (prospective, concurrent, retrospective), analytical method validation, equipment validation (design qualification, installation qualification, operational qualification, performance qualification), and revalidation. The key elements of validation discussed are specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, and robustness. Validation is presented as an important part of ensuring consistent and quality pharmaceutical production.
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Lab&production quality controll manual
1. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
CONTROLLER (HUMPHREY MUIRURI MUHIU)
Page 1 of 15
DOCUMENT TITLE
LABORATORY AND PRODUCTION QUALITY
CONTROL MANUAL
DOCUMENT NO(DCN); 01-001-00
SIGNITORIES AND AUTHORIZATION TO BE IMPLEMENTED
Rev,No: Date: Title: Prepared By: Checked by: Approved by:
00 19-Mar-15 Lab &Production
Quality Control
Humphrey
2. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
CONTROLLER (HUMPHREY MUIRURI MUHIU)
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TABLE OF CONTENT
1.0TERMS & DEFINATION................................................................................................. 3
2.0GENERAL..................................................................................................................... 4
2.1QUALITY OBJECTIVES & POLICY. .................................................................................. 4
2.2SCOPE & PURPOSE ...................................................................................................... 4
2.3MASTER LIST OF QC RECORDS ..................................................................................... 5
3.0CONTROL OF MATERIAL & STORAGE ........................................................................... 7
3.1MATERIAL MANAGEMENT........................................................................................... 8
3.2MATERIAL TRACEBALITY.............................................................................................. 8
3.3PROCEDURE FOR PMI.................................................................................................. 9
3.4ACCEPTANCE & REJECTION.......................................................................................... 9
3.5DOCUMENTATION RESULT ........................................................................................ 10
4.0TESTING PROGRAMME.............................................................................................. 10
4.1CALIBRATION,MEASURING & TESTING EQUIPMENT................................................... 10
4.2NON-CONFIMANCE REPORT ...................................................................................... 11
4.3IDENTIFICATION AND SEGREGATION ......................................................................... 11
4.4DETERMINATION OF DEPOSITION.............................................................................. 11
5.0PRODUCTION AT GLANCE NON-CONFIRMANCE ......................................................... 12
5.1CONTROLLING NON-CONFIRMANCE .......................................................................... 12
6.0LAB/PRODUCTIONQUALITY AUDIT .......................................................................... 12
6.1SCOPE....................................................................................................................... 12
6.2PROCEDURES ............................................................................................................ 13
6.3QC DOCUMENTATION ............................................................................................... 13
3. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
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1. TERMS& DEFINITIONS.
The purpose of this quality plan and supporting procedures with the following
definitions, which, in some instances, clarify those, contained Quality Management and
Quality Assurance shall apply.
Quality The totality and characteristics of product or
service that bear on its ability to satisfy
stated or implied needs & requirements.
Quality Management The aspect of the overall management
functions that determines and implements
the quality policy.
Quality Assurances All those planned and systematic activities
and functions necessary to provide adequate
confidence that a product or service shall
satisfy given requirements for quality.
Quality Control The techniques and activities that
demonstrate compliance with specified
requirements. This includes inspection,
testing, etc.
Project Quality Plan A document derived from the quality
management system, modified as necessary
to accommodate particular requirements.
QC Inspection & Test Plan A Key documents which supports the project
quality plan and lists in a logical sequence
key activities such as contract review,
engineering, procurement etc. it identifies
individual activities controlling procedures
/standards verifying documentation,
inspection and test requirements etc.
Quality Audit A systematic and independent examination
to determine whether quality activities and
related results comply with planned and / or
documented arrangements and whether
these arrangements are implemented and
effective in achieving stated objectives.
4. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
CONTROLLER (HUMPHREY MUIRURI MUHIU)
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2. GENERAL
The program is made to ensure that the quality of work is maintained as per the
Institution/companies, specifications and applicable local standards and codes.
2.1 QUALITY OBJECTIVE & POLICY
It is the policy of QC and Laboratory technician to provide a consistent level of
work performance that meets or exceeds the quality standards set forth in this
manual. Quality is herein defines as conforming to the requirements and
specifications cited within this manual in all matters of chemical analysis and
material control.
With regard to this job opportunity, the program set forth in this manual
becomes a mandatory, specific analysis of enforcing the policy of QA and
Laboratory Technician on this Institution.
The quality control program is established to ascertain that all chemical
analysisis performed in complete conformance with the approved
chemicalexperiments and all applicable standards and requirements.
The overall responsibility to maintain the quality program from quality control
manager and his delegated QA Supervisors. Their direct responsibility is to
ensure that all requirements for this institution together with the integral quality
program are strictly adhered to. The QA Department is authorized to stop any
work activity until compliance with manual is achieved.
The Quality Control Manager in his exercise of all functions controlling quality
of chemical products, test procedures, and the materials used, shall not be
overruled by any Manager.
QC and Lab Technician shall cooperate and coordinate in all matters related
to the Quality Control program, and all personnel directly involved in his Job
Description shall be continuously kept informed of Institution and companies
requirements as work progress.
2.2 SCOPE & PURPOSE.
This plan is provided for quality control procedure at the laboratory and
production line, to be applied on the activities, which will be implemented. The
purpose of Quality control program is to ensure the following basic objectives:
1. All the works adheres strictly to all requirements of the project and
governing agencies where the work is being performed.
2. To maintain QC procedure to ensure that works performed being
complied with the institution/companies requirements and the
specification.
5. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
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3. To prevent deficiencies through pre-production quality control
coordination.
4. To detect, correct and take preventive action for deficiencies in a
timely manner.
5. To maintain an auditable record of all tests, inspection, procedure,
non-compliance and corrections, and other pertinent data as required.
6. To verify compliance companies QC procedures, including those QC
procedures of sub-institutions and suppliers.
7. To provide basis for measuring QC and Laboratory performance for
input company resource database.
The plan covers as a minimum the quality control at the laboratory and
provides the following activities.
Laboratory Document Control
Laboratory and storage Material Control
Laboratory and production process Inspection and Testing Control
Inspection, measuring and equipment control
Laboratory and production process Nonconformance Control
Laboratory and production process Quality Audit Control
Quality Record Control.
2.3 MASTER LIST OF QC RECORDS:
Record of all inspection and tests shall be maintained sequentially and by work categories. All
tests including but not limited to the following shall be controlled and properly documented
(Materials, chemicals products).
Record of daily/ weekly QC reports.
A record of all vendors and technical approvals lab/production correctively by submittal number
and index.
A file of correct and governing Institution/Companies plan and specifications, variation orders,
chemical experiments and technical standards issued for Production. A documents control
clerk on Production line will log and track the latest governing data and chemical process, and
ensure proper issuance of the same.
QA/QC inspection forms.
Institution/Companies materials receiving report file.
Record of properly logged non-conformance reports.
A separate set of production plans for noting changes for subsequent incorporation on the as
product reproducible.
6. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
CONTROLLER (HUMPHREY MUIRURI MUHIU)
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Approved QA/QC inspection report.
Approved QA/QC checklist.
Record of properly logged approved method statements
Record of properly logged approved production process inspection & test plan
Record of properly logged approved material & data sheet
Record of properly logged approved Technical Queries
Record of properly logged approved Third party test reports
Record of properly logged approved test packages
Deficiency log book
Record of properly logged material inspection report
Record of properly logged internal audit report
Record of weekly internal QC meetings
Record of properly logged As-production output
Record of properly logged interoffice Memo
Record of properly logged QC personnel’s CVs
Approved organization chart with name & contact numbers
Approved flow chart for inspection procedure
Approved flow chart for NCR procedure
Record of properly logged Daily QC report
Record of properly logged Punchlist
Record of properly logged list of inspection & test equipments
Record of properly logged internal work release note
Record of properly logged list of distribution of production methodology
Lab/productiondesign changes / deviations. (RFIs)
7. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
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Approved vendor list
Copy of original scope of work
Copy of Companies and institution specifications/ requirements
QC Daily Reports.
The QC supervisor may prepare a daily report (if asked by CLIENT) at the end of each working
day containing all inspections and testing made including any work discrepancy, material NCR,
problem or obstruction encountered during inspection, change in production methodology due
to practical difficulties or any reason due to which the inspection was delayed or could not be
performed .
Location of inspections, highlighted nature of deficiencies observed and corrective actions
taken shall be submitted with this report.
The QC supervisor shall consolidate the above reports for submission to the head companies
Authority.
QC/QA manager shall prepare weekly QC report and submit to the head office during weekly
QC meeting. The report shall consist of material submittal, approval & procurement status, QC
documents (like TQ, proposed methodology, specific method statement, etc.) submittal &
approval status and inspections done during last week.
Distribution and Review.
1. Documents Distribution log shall be prepared and maintained by DC to control the
document distribution.
3.0 Control Of Material and Storage.
All material delivered to the Lab/Companies store will be inspected and checked by QC
Inspectors to ensure that materials are not damaged or defective and in conformity with the
material approval, purchase order and packing lists. If discrepancies are found will be reported
to the Procurement Manager, who in turn will notify the vendor concerned for corrective
measures or replacement
Materials found acceptable shall be stored in a manner suited for the particular type of
material, or in accordance with the manufacturer and or supplier’s recommendations. The QC
Inspector will ensure proper storage of materials.
The QC and warehouse staff shall implement the following storage guidelines.
• Stocked items shall be suitably protected from damage by spacers or load
distribution supports and shall be safely arranged. No metal works or materials
shall be stored directly on the ground. Materials shall be properly stored so that
8. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
CONTROLLER (HUMPHREY MUIRURI MUHIU)
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they are not subjected to excessive stresses, and that protective coatings and
finishes are not damaged.
• All materials stored outside that may deteriorate or may be damaged as a result
of direct exposure to weather shall be adequately covered or protected as
recommended by the manufacturer
3.1Material management: The following material management plan shall be
applicable at the store, only in case, if the material supply is in the employer’s scope:
1. Issue of material and equipment authorized personnel:Company
representative shall submit a list of authorized personnel to request and sign for
the receipt of company/owner furnished materials.
2. Issue via electronic system: On project where client Material Manager System
or other company approved material management system is utilized; the issue of
material and equipment shall be requested by companies’ procurement manager
and issue via picking tickets generated by the system.
3. Issue of tagged material/equipment: Tagged materialand equipment, not on a
bill of material, will be requested by companies via a lab/production material
request (FMR) with the following information:
• Companies name, the required, and the authorized person receiving the
material or equipment must be indicated.
• The completed FMR will be presented to company's lab/production
material management group who will review, verify and generating a
picking ticket.
3.2Material traceability:
Material traceability shall be maintained in such a way that one can easily trace an
individual component back to the material certificate that represents it and able to
identify the installed location of any component of the material represented by the
material certificate through the use of traceability reference mentioned on the
component, cross referencing documentation or database, and the certificate.
QC Inspector will check and verify the identification / tags on the materials in
comparison with the list on the certified materials test reports or mill certificates. They
shall perform visual and dimensional inspection and prepare incoming material reports.
Comments shall be marked on the material items and shall be tractability of materials to
be used.
All material traceability activities shall be carried out in accordance with the guidelines as
given in production process conforming to the product specifications.
The following major points shall be kept in mind while maintaining the traceability
system:
1. Formaterial consisting of numerous parts with possibly many different types and
grades of material it is important that only the correct material are connected
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together in a system thereby allowing full material traceability to an original
material certificate of every component part.
• Surface preparation of components: the surface of the component
subjected to the test shall be free from grease, oil, paint and oxides. The
surface preparation shall be performed with a portable grinding machine or
any suitable equipment and the surface should represent the original surface
of the component
• Verification of testing instrument: Verification shall be performed at the
production line once daily by using standards reference samples before
commencing the actual testing or as and when required during the day.
2. Alloy material should be alloy verified prior to delivery to the store using PMI
process that makes an on the spot checking analysis. PMI testing may be done,
through a qualified and approved testing agency in accordance with the project
specifications, if QM (Quality Manager)asks to do so.
3.3Procedure for PMI:
The following procedure to carry out positive material identification ( PMI) which
is based on assumption to identify alloying elements in metal without destroying
the material by X-Ray fluorescence technique using XRF ALLOY ANALYSER
Model XLt 898 , make NITON shall be adopted :
• Surface preparation of components: the surface of the component
subjected to the test shall be free from grease, oil, paint and oxides. The
surface preparation shall be performed with a portable grinding machine or
any suitable equipment and the surface should represent the original surface
of the component
• Performed at lab/production line once daily by using standards reference
samples before commencing the actual testing or as and when required
during the day.
Material should be color coded to indicate the type and the fact that certification has
been checked and identity verified by performing PMI.
All the piping components should be ready marked and tagged with the purchase order,
item number, item code, heat numbering in accordance with the project requirements by
the vendor, prior to supply to the production line
All the material shall be inspected, including verification of material certificate and for
correct marking upon the receipt by the company.
Make sure that the cast/heat number, as marked by the manufacturer, provides
traceability back to the relevant material certificate that has to be stored by the recipient
at the store.
10. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
CONTROLLER (HUMPHREY MUIRURI MUHIU)
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3.4Acceptance & rejection: All results within +/- 10 % of the requirements of
the relevant material specification shall be considered acceptable and the considerable
deviation of alloying elements / or absence of alloying elements with respect to the
required material specification shall be considered non acceptable. A detailed chemical
analysis may be performed in a laboratory for the materials having a very nominal
deviation of alloying elements from the acceptable limits, as a referee method, before
rejecting the material. In such cases a final decision to accept and or reject is left to the
client and their consultant. All rejected materials are identified and kept separately.
3.5Documentation of Results: A detailed report shall be made in a prescribed
format having all relevant data of the material tested.
4.0 TESTING PROGRAMME
4.1CALIBRATION, MEASURING&TESTING EQUIPMENT.
Following criteria for the selection of inspection, measuring and testing equipment will be
observed.
Criteria 1- Selection of Inspection, Measuring and Test Equipment
IMTE will have manufacturer’s stated accuracy (and precision, where applicable) that
exceeds the company’s procedures, inspection, measurement and/or testing tolerance(s).
IMTE will have durability, stability and appropriate measurement ranges consistent with
the intended use(s).
Calibration standards that will be required for the initial and subsequent calibrations will be
identified when selecting IMTE. Such calibration standards will be requisitioned or the
services of a calibration facility with the calibration standards will be under surveillance.
Criteria 2 – Procuring Calibration Services.
Following guidelines shall be adhered to for preparing a purchase order for calibration
procedures used.
A. Limits of permissible error.
B. Calibration standards used (including serial number and certificates)
C. Details of any maintenance, servicing, adjustment, repairs or modifications carried out
D. Identification of person responsible for the correctness of the information provided.
E. Identification of person responsible for the correctness of the information provided.
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CONTROLLER (HUMPHREY MUIRURI MUHIU)
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The calibration supplier shall seal using a unique temper-resistant system, all adjustment
access points after calibration, where practical. The system used shall provide visual
evidence of tampering.
4.2Nonconformance Report.
1. When QC detects any nonconforming condition of any equipment or materials, that do not
conform to specified requirements at inspection or during chemical Mixing or in production
line whatsoever will be automatically subjected to NCR and reported immediately,
2. QC will keep nonconforming condition as it is and immediately report to the Companies
Quality Control Department, Production management and supplier.
3. When a nonconformance is reported, QC Department at large will check and identify the
nonconforming condition, and will approve the lab/production NCR and notice it to the
concerned department.
4.3Identification and Segregation.
1. Upon submitting the lab/production NCR, Production line Inspector will identify a
nonconforming item marking, tagging or other methods, which will not adversely affect the
end use of the items.
2. QC will segregate a lab/production nonconforming item or take other precaution to
preclude inadvertent installation, use of the items or proceeding further sequence until
proper disposition completed.
4.4Determination of Disposition.
1. QC will hold a lab/production nonconformance review meeting with procurement
department
2. QM (Quality Manager) will evaluate and provide a recommended disposition for
Production nonconforming characteristics against specified requirements to ensure that
performance, operability, maintainability, compatibility, Safety Quality and interface
conditions will be adequately maintained.
5.0 Production at Glance Non-Conformances.
QC Supervisor would initiate a NCR (Non-conformance Report) for a portion of work or
material that does not conform to the approved production methodology and specification.
This written report is submitted to Companies headthat shall ensure that appropriate
action is taken to rectify the problem.
5.1CONTROL OF NON-CONFORMANCES
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Scope
This procedure describes the methods and responsibilities for controlling non-conforming
items to prevent their inadvertent use when other control methods, inspection reports,
surveillance reports, etc are used considered inadequate. This procedure provides for the
identification, documentation, evaluation, disposition, notification, segregation, (prevention of
inadequate use), and re-inspection of these non-conformance items.
Items Requiring NCR:
Chemical Material, and laboratory items which are found not to be compliance with the
approved production methodology requirements, specification, , codes and standard shall
require the generation of Non-conformance report, when any of the following conditions
exists:
When other control methods, inspection/testing reports, and surveillance reports are
considered inadequate to initiate correction and control of the problem.
The disposition would allow its use without conformance to the design requirements
(methodology& specifications).
QC will adopt the following procedures for documentation of non-conformance.
For materials and equipment identified as non-conforming generate a Non-conformance
report to document the non-conforming item(s). The report is to be processed as follows:
Enter the date the non-conformance is documented.
Enter the name of the organization responsible for the non-conforming work.
Use these entries in the heading of the form to provide unique traceability and
identification to the nonconforming item.
Identify the work package affected by the non-conformance.
Enter a complete description of the nonconforming condition.
6.0LAB/PRODUCTION QUALITY AUDIT.
6.1 Scope
This procedure provided for control of the lab/production quality audit to be planned and
conducted during Production stage, to verify the quality activities of work.
6.2 Responsibility.
QC will be responsible for exhibiting indispensable objective documentary evidence to the
Auditor to certify the conformance of quality activities.
QC will be responsible for planning and conducting lab/productionquality audits, assigning the
auditor and reporting audit results to the Administration or head.
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An internal audit in the production line shall be performed by the QC manager, head
management and QC supervisor to verify control activities are in accordance with this
manual, production methodology and specifications. The audit includes but not limited to:
Personnel certification
Material tracing
Document control records
Test equipment calibration records
Daily reports
The frequency of scheduled internal quality audit shall be every three month and may be
changed as and when required by head depending upon the administration satisfaction to the
workers performance of implementing and maintaining required quality documentation
following all specifications and standards. Frequency and scheduling of internal audit shall be
approved by the head.
External audit/ surveillance shall be performed by the head to review documentation, action
on inspection and testing results, action on identified corrective action within required
timescale. Frequency and scheduling of external audit shall be determined by the head and
shall be notified to the production Department well in advance.
Surveillance for the production quality control as shall be performed by the head without any
advance notice to the contractor.
The QC Supervisor shall investigate corrective procedures within his terms of responsibility or
inform the QC Manager accordingly for further action. The QC Manager, production head,
and QC Supervisor shall perform a minimum of three random audits.
Random audits shall be performed any time, especially when circumstances change, such as
major change in QC program, new personnel and to verify corrective actions are properly
performed and documented.
Audit procedure shall be carried out according to checklist prepared to suit each particular
case and activity or facility to be audited. A report shall be issued on completion of each audit
giving a summary of findings and recommendations for corrective action, if necessary.
When corrective actions are recommended, the time limit for their implementations shall be
started. The activity covered shall be re-audited at the expiration of time given to rectify the
nonconformance.
6.3Procedure
The procedure is provided for control of preparation and maintenance of evidence of quality
related to the lab/production.
6.4QC Documentation
1. Production head in conjunction with QC shall define the records, required to be
required to be turned over to the head, which will be created during production
QA/QC inspection forms.
14. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
CONTROLLER (HUMPHREY MUIRURI MUHIU)
Page 14 of 15
Contract materials receiving report file.
Approved QA/QC inspection report.
Approved QA/QC checklist.
Record of properly logged approved method statements
Record of properly logged approved inspection & test plan
Record of properly logged approved material & data sheet
Record of properly logged approved Technical Queries
Record of properly logged approved Third party test reports
Record of properly logged approved test packages
Deficiency log book
Record of properly logged material inspection report
Record of properly logged internal audit report
Record of properly logged As-built drawings
Record of properly logged interoffice Memo
Record of properly logged QC personnel’s CVs
Approved organization chart with name & contact numbers
Approved flow chart for inspection procedure
Approved flow chart for NCR procedure
Record of properly logged Daily QC report
Record of properly logged Punchlist
Record of properly logged list of inspection & test equipments
Record of properly logged internal work release note
Record of properly logged list of distribution of doc/drawings
Approved copies of bar bending schedules
15. SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
CONTROLLER (HUMPHREY MUIRURI MUHIU)
Page 15 of 15
Approved vendor list
Copy of original scope of work
Copy of client specifications/ requirements