This document establishes procedures for mechanical integrity inspections at OGX Petróleo e Gás Participações S.A. facilities. It outlines responsibilities, planning requirements, and quality assurance to ensure equipment is properly inspected, tested, repaired and maintained. Inspections and testing must be carried out according to documented plans and procedures, and results must be systematically recorded.
1) The Validation Master Plan (VMP) is a comprehensive document describing the validation requirements and plan for a pharmaceutical production facility. It was prepared by Vishal H. Parikh for his professor Ms. Krupa Thula.
2) The VMP includes details on qualification protocols, personnel responsibilities, schedules, documentation requirements, and change control procedures to ensure the facility and processes are appropriately validated.
3) The VMP development process involves identifying regulatory standards and developing protocols for installation, operational, and performance qualification to test facility and equipment operations. The VMP then guides ongoing validation activities and system changes.
This document provides information on various qualification documents used in pharmaceutical industries, including:
- User Requirement Specification (URS) which documents the end user requirements and functionality.
- Design Qualification (DQ) which verifies that the design will meet the requirements in the URS.
- Installation Qualification (IQ) which verifies proper installation.
- Operational Qualification (OQ) which tests the operation of the equipment.
- Performance Qualification (PQ) which verifies the equipment can perform as intended based on approved processes and specifications.
Guidance and requirements for each qualification type are defined. Supporting documents required for each are also listed.
Equipment qualification of medical deviceNahri Musyrif
The document defines key terms related to qualification and validation such as qualification, validation, commissioning, and calibration. It discusses classifying systems based on their impact on product quality and determining appropriate qualification approaches. Risk assessments are an important part of qualification and should be conducted according to GMP guidelines. Design, installation, operational, and performance qualifications are described as the key qualification steps. The importance of maintaining qualification status over the lifecycle is also covered.
This document provides a qualification protocol for bag sealing equipment. It outlines responsibilities for authoring, executing, reviewing, and approving qualification tests. The protocol scope is to establish evidence that the bag sealer is properly installed and operating according to requirements. It describes the bag sealer, lists test plans to verify installation and operation, and defines acceptance criteria. Responsibilities for personnel involved in authoring, executing, reviewing and approving the qualification tests are also defined.
This document is a mechanical integrity audit checklist provided by Inspectioneering LLC to evaluate mechanical integrity programs. The checklist covers topics such as MI program management, process safety management equipment, written MI procedures, MI training programs, inspection and testing procedures, deficiencies and repairs, and quality assurance programs. The checklist contains over 100 questions to help users audit their mechanical integrity programs and ensure compliance.
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
This document provides qualification procedures for an electronic balance, pH meter, and UV-visible spectrophotometer. It describes design qualification, installation qualification, and operational qualification tests. For the electronic balance, design qualification includes supplier certification. Installation qualification includes installation and operational tests using reference weights. Operational qualification includes daily measurement of reference weights. For the pH meter and spectrophotometer, design qualification includes selection criteria. Installation qualification includes installation and checks. Operational qualification includes calibration and performance verification tests using standards traceable to national references.
1) The Validation Master Plan (VMP) is a comprehensive document describing the validation requirements and plan for a pharmaceutical production facility. It was prepared by Vishal H. Parikh for his professor Ms. Krupa Thula.
2) The VMP includes details on qualification protocols, personnel responsibilities, schedules, documentation requirements, and change control procedures to ensure the facility and processes are appropriately validated.
3) The VMP development process involves identifying regulatory standards and developing protocols for installation, operational, and performance qualification to test facility and equipment operations. The VMP then guides ongoing validation activities and system changes.
This document provides information on various qualification documents used in pharmaceutical industries, including:
- User Requirement Specification (URS) which documents the end user requirements and functionality.
- Design Qualification (DQ) which verifies that the design will meet the requirements in the URS.
- Installation Qualification (IQ) which verifies proper installation.
- Operational Qualification (OQ) which tests the operation of the equipment.
- Performance Qualification (PQ) which verifies the equipment can perform as intended based on approved processes and specifications.
Guidance and requirements for each qualification type are defined. Supporting documents required for each are also listed.
Equipment qualification of medical deviceNahri Musyrif
The document defines key terms related to qualification and validation such as qualification, validation, commissioning, and calibration. It discusses classifying systems based on their impact on product quality and determining appropriate qualification approaches. Risk assessments are an important part of qualification and should be conducted according to GMP guidelines. Design, installation, operational, and performance qualifications are described as the key qualification steps. The importance of maintaining qualification status over the lifecycle is also covered.
This document provides a qualification protocol for bag sealing equipment. It outlines responsibilities for authoring, executing, reviewing, and approving qualification tests. The protocol scope is to establish evidence that the bag sealer is properly installed and operating according to requirements. It describes the bag sealer, lists test plans to verify installation and operation, and defines acceptance criteria. Responsibilities for personnel involved in authoring, executing, reviewing and approving the qualification tests are also defined.
This document is a mechanical integrity audit checklist provided by Inspectioneering LLC to evaluate mechanical integrity programs. The checklist covers topics such as MI program management, process safety management equipment, written MI procedures, MI training programs, inspection and testing procedures, deficiencies and repairs, and quality assurance programs. The checklist contains over 100 questions to help users audit their mechanical integrity programs and ensure compliance.
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
This document provides qualification procedures for an electronic balance, pH meter, and UV-visible spectrophotometer. It describes design qualification, installation qualification, and operational qualification tests. For the electronic balance, design qualification includes supplier certification. Installation qualification includes installation and operational tests using reference weights. Operational qualification includes daily measurement of reference weights. For the pH meter and spectrophotometer, design qualification includes selection criteria. Installation qualification includes installation and checks. Operational qualification includes calibration and performance verification tests using standards traceable to national references.
validation is a technique of validating the final product either starting from the raw material or within the process, its all types cover the methods of validation and sequence in the product development.
This document provides an overview of equipment qualification terminology and processes. It discusses conducting a risk assessment to determine validation requirements and maintaining qualified equipment. The key points covered include defining user requirements, performing installation qualification to verify proper installation, and operational qualification to confirm the equipment operates as intended. Maintaining qualification involves ongoing change control and periodic review.
The document discusses analytical instrument qualification, including the revision of USP chapter 1058. It describes the qualification process which involves design qualification, installation qualification, operational qualification, and performance qualification. It also covers roles and responsibilities, software validation, and change control, which are important aspects of ensuring analytical instruments are qualified and performing as intended.
This document discusses considerations for equipment qualification when purchasing, designing, or qualifying storage units. It provides definitions of key terms related to validation and equipment qualification. The document outlines regulatory requirements for validation documentation. It discusses key validation documents including validation master plans, protocols, reports, and change control systems. Challenges in validation like inadequate specifications and planning are covered. The importance of early involvement of validation personnel and good communication for validation success is emphasized.
This document outlines the components and requirements of a user requirement specification (URS) for designing new facilities and equipment. A URS ensures that user needs are clearly defined upfront and includes operating requirements, regulatory standards, and specifications that will be used in the design review process. It covers various areas like project description, regulatory requirements, environmental conditions, safety devices, utilities needs, technical specifications, cleaning requirements, performance data, controls, and calibration and maintenance plans. The URS establishes the foundation for design qualification to take place before equipment is constructed so that risks can be identified and addressed early in the design phase.
In this slide contains Introduction, overview and details of FACTORY ACCEPTANCE TEST
Presented by: P.NARESH (Department of pharmaceutical analysis).RIPER, anantapur
Analytical Instrument Qualification and System ValidationComplianceOnline
Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.
This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.
The course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.
For More Info:
http://www.complianceonline.com/analytical-instrument-qualification-and-system-validation-seminar-training-80113SEM-prdsm?channel=slideshare
The document discusses the components of equipment qualification for processing equipment, which include design qualification, installation qualification, operational qualification, performance qualification, and re-qualification. Design qualification establishes specifications and requirements for equipment. Installation qualification documents delivery, installation, and startup. Operational qualification verifies equipment functions as described. Performance qualification confirms equipment operates correctly and consistently for its intended use. Re-qualification is required if any critical changes are made.
This document discusses the qualification of equipment used in the production of artemisinin-based combined medicines. It covers the objectives, principles, and stages of equipment qualification, including design qualification, installation qualification, operational qualification, and performance qualification. The stages of qualification ensure that equipment is suitable for its intended uses and capable of consistently meeting specifications. Qualification applies to all production and quality control equipment and must demonstrate acceptable performance under worst-case conditions. Periodic requalification is necessary to confirm continued suitability of equipment for its uses.
The document discusses concepts and terminology related to qualification and validation of equipment and systems. It defines qualification as proving that premises, systems and equipment are properly installed and work correctly. Validation is defined as proving that processes, procedures or methods consistently lead to expected results. The document provides definitions and descriptions of key terms in validation including validation master plan, user requirement specification, functional specification, design specification, factory acceptance testing, site acceptance testing, design qualification, installation qualification, operational qualification, process/performance qualification, protocols, reports, and types of validation.
The document discusses several auxiliary facility programs that are important components of a GMP quality system, including pest control, cleaning programs, drawing control, engineering change control, spare parts management, lubricant control, and qualification of maintenance technicians and outside contractors. It emphasizes that written procedures and documentation are required for these programs to ensure facilities and equipment are properly maintained and calibrated.
The document discusses approaches to equipment qualification for pharmaceutical manufacturing using a lifecycle approach. It outlines key points including that equipment qualification should not be a one-time event but rather consider design, demonstration, and ongoing monitoring stages. It compares traditional IQ/OQ/PQ approaches to the ASTM E2500 standard and recommends following a consistent documentation hierarchy and using model document outlines for validation projects.
This document outlines the commissioning process for a building project. It defines key terms related to commissioning and describes the commissioning plan, schedule, and responsibilities. Commissioning aims to verify that building systems and assemblies meet design intent and operational needs. It involves testing and documenting that equipment is installed properly and performs as required. The commissioning process is led by a Commissioning Authority and involves cooperation across design, construction, and facility management teams.
Self-inspections of key GMP processes are to be conducted semi-annually according to a schedule set by the quality management team. Inspections results are recorded on logs which are signed, dated, and saved in a shared folder for review by the quality team. The team then considers any recommendations and records approved changes and corrective actions on the logs along with required timeframes for completion.
This document provides guidance on interpreting ISO/IEC 17020 for inspection bodies seeking accreditation. It was produced by the Asia Pacific Laboratory Accreditation Cooperation (APLAC) Technical Committee. The guidance clarifies requirements around scope of accreditation, independence, quality systems, personnel, facilities, equipment, and records. It is intended to help inspection bodies understand what will be examined during accreditation assessments.
This document discusses the importance and requirements of qualification for pharmaceutical equipment. Qualification ensures equipment is properly installed and functions as intended to maintain quality standards. It involves documented verification that equipment meets design specifications and user requirements through various stages from design to operation. Key segments of qualification discussed include users requirement specification, design qualification, factory acceptance testing, installation qualification, operational qualification, and performance qualification.
Qualification and validation activities were taking place during Quality Week from November 14-19, 2016. Qualification proves that systems and equipment work correctly, while validation proves procedures lead to expected results. There are various types of qualification including design (DQ), installation (IQ), operational (OQ), and performance (PQ) qualification. Validation can be prospective, retrospective, or concurrent. Analyst qualification requires a minimum of two analysts to run tests in triplicate to demonstrate accuracy of 98-102%. Uncertainty encompasses variability that could be reasonably attributed to measurement results and includes components evaluated statistically or from experience.
This document discusses computer system validation and 21 CFR Part 11 requirements for electronic records and signatures. It provides definitions of key terms from Part 11 such as electronic record, electronic signature, closed system and open system. It also summarizes the controls required by Part 11 for closed and open systems, including validation, audit trails, limiting access, documentation controls and more. The purpose is to ensure electronic records and signatures are trustworthy and equivalent to paper records.
009 what are the systems validation protocol methods at atl 05 28-2015atlmarketing
If your product must meet the requirements of FDA cGMP, 21 CFR 210, 211, 820, ISO-9000, ISO-13485, or MDD/93/42/EEC (for the CE Mark), there are three very critical elements you must have to be in regulatory compliance. First, you must have a sound and strong Quality Management System (QMS). This is an expression of WHAT you do (your quality policies and structure). Second, you must have reliable Standard Operating Procedures (SOP’s). These are expressions of HOW YOU DO THINGS.
Missing in the above two items is an expression of HOW WELL YOU DO WHAT YOU DO? This is where you must establish your “Systems Validation Protocol” (SVP). Your SVP is an expression of how well your system is working (for example, this can be expressed in overall product conformance percentage or in defects per million for your various products). The SVP is a living and continuous document based on your quality records. The ATL White Paper “What Are The Systems Validation Protocol Methods At ATL?” is our attempt to share with you a sound approach to Systems Validation and the various protocols that you can use.
This document provides revised guidance on qualification and validation for facilities, equipment, utilities, processes, and computer systems used in the manufacture of medicinal products. Key changes include incorporating a quality risk management approach, emphasizing the need for prospective validation over retrospective validation, and aligning with other international guidelines. The guidance outlines principles and provides details on qualification stages, documentation requirements, process validation approaches, and ongoing verification.
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATIONManikant Prasad Shah
This document discusses validation, which is the process of establishing documented evidence that a system will consistently produce a product meeting its quality standards. It defines validation according to WHO and FDA and outlines the merits and scope of validation. It also discusses validation concepts like the validation master plan, V model, qualification processes for design, installation, operation and equipment, change control, and WHO guidelines for equipment validation. The types of validation covered are prospective, concurrent, retrospective and revalidation.
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.
validation is a technique of validating the final product either starting from the raw material or within the process, its all types cover the methods of validation and sequence in the product development.
This document provides an overview of equipment qualification terminology and processes. It discusses conducting a risk assessment to determine validation requirements and maintaining qualified equipment. The key points covered include defining user requirements, performing installation qualification to verify proper installation, and operational qualification to confirm the equipment operates as intended. Maintaining qualification involves ongoing change control and periodic review.
The document discusses analytical instrument qualification, including the revision of USP chapter 1058. It describes the qualification process which involves design qualification, installation qualification, operational qualification, and performance qualification. It also covers roles and responsibilities, software validation, and change control, which are important aspects of ensuring analytical instruments are qualified and performing as intended.
This document discusses considerations for equipment qualification when purchasing, designing, or qualifying storage units. It provides definitions of key terms related to validation and equipment qualification. The document outlines regulatory requirements for validation documentation. It discusses key validation documents including validation master plans, protocols, reports, and change control systems. Challenges in validation like inadequate specifications and planning are covered. The importance of early involvement of validation personnel and good communication for validation success is emphasized.
This document outlines the components and requirements of a user requirement specification (URS) for designing new facilities and equipment. A URS ensures that user needs are clearly defined upfront and includes operating requirements, regulatory standards, and specifications that will be used in the design review process. It covers various areas like project description, regulatory requirements, environmental conditions, safety devices, utilities needs, technical specifications, cleaning requirements, performance data, controls, and calibration and maintenance plans. The URS establishes the foundation for design qualification to take place before equipment is constructed so that risks can be identified and addressed early in the design phase.
In this slide contains Introduction, overview and details of FACTORY ACCEPTANCE TEST
Presented by: P.NARESH (Department of pharmaceutical analysis).RIPER, anantapur
Analytical Instrument Qualification and System ValidationComplianceOnline
Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.
This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.
The course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.
For More Info:
http://www.complianceonline.com/analytical-instrument-qualification-and-system-validation-seminar-training-80113SEM-prdsm?channel=slideshare
The document discusses the components of equipment qualification for processing equipment, which include design qualification, installation qualification, operational qualification, performance qualification, and re-qualification. Design qualification establishes specifications and requirements for equipment. Installation qualification documents delivery, installation, and startup. Operational qualification verifies equipment functions as described. Performance qualification confirms equipment operates correctly and consistently for its intended use. Re-qualification is required if any critical changes are made.
This document discusses the qualification of equipment used in the production of artemisinin-based combined medicines. It covers the objectives, principles, and stages of equipment qualification, including design qualification, installation qualification, operational qualification, and performance qualification. The stages of qualification ensure that equipment is suitable for its intended uses and capable of consistently meeting specifications. Qualification applies to all production and quality control equipment and must demonstrate acceptable performance under worst-case conditions. Periodic requalification is necessary to confirm continued suitability of equipment for its uses.
The document discusses concepts and terminology related to qualification and validation of equipment and systems. It defines qualification as proving that premises, systems and equipment are properly installed and work correctly. Validation is defined as proving that processes, procedures or methods consistently lead to expected results. The document provides definitions and descriptions of key terms in validation including validation master plan, user requirement specification, functional specification, design specification, factory acceptance testing, site acceptance testing, design qualification, installation qualification, operational qualification, process/performance qualification, protocols, reports, and types of validation.
The document discusses several auxiliary facility programs that are important components of a GMP quality system, including pest control, cleaning programs, drawing control, engineering change control, spare parts management, lubricant control, and qualification of maintenance technicians and outside contractors. It emphasizes that written procedures and documentation are required for these programs to ensure facilities and equipment are properly maintained and calibrated.
The document discusses approaches to equipment qualification for pharmaceutical manufacturing using a lifecycle approach. It outlines key points including that equipment qualification should not be a one-time event but rather consider design, demonstration, and ongoing monitoring stages. It compares traditional IQ/OQ/PQ approaches to the ASTM E2500 standard and recommends following a consistent documentation hierarchy and using model document outlines for validation projects.
This document outlines the commissioning process for a building project. It defines key terms related to commissioning and describes the commissioning plan, schedule, and responsibilities. Commissioning aims to verify that building systems and assemblies meet design intent and operational needs. It involves testing and documenting that equipment is installed properly and performs as required. The commissioning process is led by a Commissioning Authority and involves cooperation across design, construction, and facility management teams.
Self-inspections of key GMP processes are to be conducted semi-annually according to a schedule set by the quality management team. Inspections results are recorded on logs which are signed, dated, and saved in a shared folder for review by the quality team. The team then considers any recommendations and records approved changes and corrective actions on the logs along with required timeframes for completion.
This document provides guidance on interpreting ISO/IEC 17020 for inspection bodies seeking accreditation. It was produced by the Asia Pacific Laboratory Accreditation Cooperation (APLAC) Technical Committee. The guidance clarifies requirements around scope of accreditation, independence, quality systems, personnel, facilities, equipment, and records. It is intended to help inspection bodies understand what will be examined during accreditation assessments.
This document discusses the importance and requirements of qualification for pharmaceutical equipment. Qualification ensures equipment is properly installed and functions as intended to maintain quality standards. It involves documented verification that equipment meets design specifications and user requirements through various stages from design to operation. Key segments of qualification discussed include users requirement specification, design qualification, factory acceptance testing, installation qualification, operational qualification, and performance qualification.
Qualification and validation activities were taking place during Quality Week from November 14-19, 2016. Qualification proves that systems and equipment work correctly, while validation proves procedures lead to expected results. There are various types of qualification including design (DQ), installation (IQ), operational (OQ), and performance (PQ) qualification. Validation can be prospective, retrospective, or concurrent. Analyst qualification requires a minimum of two analysts to run tests in triplicate to demonstrate accuracy of 98-102%. Uncertainty encompasses variability that could be reasonably attributed to measurement results and includes components evaluated statistically or from experience.
This document discusses computer system validation and 21 CFR Part 11 requirements for electronic records and signatures. It provides definitions of key terms from Part 11 such as electronic record, electronic signature, closed system and open system. It also summarizes the controls required by Part 11 for closed and open systems, including validation, audit trails, limiting access, documentation controls and more. The purpose is to ensure electronic records and signatures are trustworthy and equivalent to paper records.
009 what are the systems validation protocol methods at atl 05 28-2015atlmarketing
If your product must meet the requirements of FDA cGMP, 21 CFR 210, 211, 820, ISO-9000, ISO-13485, or MDD/93/42/EEC (for the CE Mark), there are three very critical elements you must have to be in regulatory compliance. First, you must have a sound and strong Quality Management System (QMS). This is an expression of WHAT you do (your quality policies and structure). Second, you must have reliable Standard Operating Procedures (SOP’s). These are expressions of HOW YOU DO THINGS.
Missing in the above two items is an expression of HOW WELL YOU DO WHAT YOU DO? This is where you must establish your “Systems Validation Protocol” (SVP). Your SVP is an expression of how well your system is working (for example, this can be expressed in overall product conformance percentage or in defects per million for your various products). The SVP is a living and continuous document based on your quality records. The ATL White Paper “What Are The Systems Validation Protocol Methods At ATL?” is our attempt to share with you a sound approach to Systems Validation and the various protocols that you can use.
This document provides revised guidance on qualification and validation for facilities, equipment, utilities, processes, and computer systems used in the manufacture of medicinal products. Key changes include incorporating a quality risk management approach, emphasizing the need for prospective validation over retrospective validation, and aligning with other international guidelines. The guidance outlines principles and provides details on qualification stages, documentation requirements, process validation approaches, and ongoing verification.
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATIONManikant Prasad Shah
This document discusses validation, which is the process of establishing documented evidence that a system will consistently produce a product meeting its quality standards. It defines validation according to WHO and FDA and outlines the merits and scope of validation. It also discusses validation concepts like the validation master plan, V model, qualification processes for design, installation, operation and equipment, change control, and WHO guidelines for equipment validation. The types of validation covered are prospective, concurrent, retrospective and revalidation.
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.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines key terms like process validation, cleaning validation, and maximum allowable carryover. It describes the importance of validation in assuring quality and reducing costs. The document outlines the various stages of validation including process design, qualification, and continuous verification. It emphasizes that validation is an ongoing process to demonstrate consistency. Key aspects that must be addressed in a validation program are also summarized such as personnel training, change control procedures, and documentation.
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.
Quality management Policy in PharmaceuticalPinki Devi
Quality management Policy is a set of the rule that is helpful to produce quality product at manufacturing site. 1. Background
The following document provides general considerations with respect to
Quality Assurance and Quality Management Systems and an overview of
the Audit procedures in place.
2. Responsibilities.
QA, QC, QMS and audit are the responsibility of the director of the
biorepository and its management committee.
3. Quality Assurance (QA)
This term describes an integrated system of management activities
involving planning, implementation, documentation, assessment, and
improvement to ensure that a process, or item, is of the type and
quality needed for the project. The QA systems in place will be covered
in general by ‘standard operating procedures’ (SOP) and will be made up
of the following essential components:
Title – Each SOP should be given a unique name which captures
the essence of the practice described.
Number – Each SOP should be given a unique number that can
be used for easy reference. The numbering system should
include the revision number for the practice so that the most
recent version can be easily identified.
Date – The date the procedure is to be reviewed as well as the
date of the most recent version. The date format should be
based on the ddmmyyyy system where d represents day, m
represents month and y represents year.
Protective Wear – Protective equipment that should be worn by
staff when performing the procedure described.
Equipment – A list of the equipment needed to perform the
procedure.
Supplies – All materials and supplies should be recorded.
Step-by-Step Guidance – The procedure should be written in
specific detail to ensure that the procedure can be repeated in a
reproducible fashion to include the order of steps that should be
followed, the times allowed for each step (as needed) and the
temperatures at which the steps are performed.
All SOPs before implementation or after revision will be approved by the
management committee before implementation. Previous versions of all
documentation will be stored electronically, with only the current
versions available in the biorepository file.
All SOPs will be reviewed on an annual basis by the management
committee.
QA & QM procedures
Document Reference:
Page 3 of 3
4. QUALITY MANAGEMENT SYSTEM (QMS)
The QMS describes the biorepository’s commitment to quality and
approaches for ensuring that the requirements of the QA program are
met.
Security
The facility is in a secure, locked area with limited access.
Records are maintained of all access to the facility, detailing name,
date & time and reason for entry.
Training
Personnel should be trained in all procedures and successful
completion of such training is documented with evidence of updates
as required, on a periodic basis.
Equipment. for more details you may visit https://pharmaguddu.com/
Presentation Workshop Beograd Octobar2012Miodrag Huber
1. The document outlines the legal framework and certification scheme for entities in charge of maintenance (ECM) and maintenance workshops according to the Railway Safety Directive and other regulations.
2. It establishes requirements for ECM and maintenance workshop certification systems regarding management functions, maintenance delivery functions, and risk assessment.
3. Certification provides evidence that an ECM has established a maintenance system to ensure the safe operation of any freight wagon it maintains and is carried out by a national accreditation body according to European standards.
This document outlines IGO's standards for operations integrity, design, construction, and commissioning. It discusses engineering practices and specifications, process safety, new plant and equipment, maintenance, inspections, testing, design, construction, and commissioning. The key points are:
1. It sets minimum standards for maintaining asset integrity and preventing unplanned releases.
2. Engineering specifications must meet legislation, IGO standards, and other relevant standards.
3. Process safety objectives and KPIs are used to measure performance, which is reported regularly.
4. Risk assessments must be conducted for new plants, equipment, and processes.
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.
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.
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.
It is the documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected result.
It is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
This document describes the procedures for performing a SAFE Audit of electrical equipment. The audit involves a visual inspection, individual equipment inspection with equipment isolated, and a final report. The scope of work includes gathering equipment details, assessing conditions, and assisting the client in developing a maintenance strategy. The audit procedures include identifying important assets, assessing their condition and importance, optionally devising a risk management plan, and implementing the risk management plan.
This document provides guidance on process validation for medical device manufacturers. It discusses the purpose and scope of process validation, definitions of key terms, and when processes should be validated versus verified. It describes the three phases of validation: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Guidelines are provided for developing validation protocols, conducting validations, and maintaining validated states. Statistical tools that can be used in validation are also summarized. The overall intent is to help manufacturers understand quality system requirements and apply principles of process validation.
Validation ( process validation, TT from R&D to pilot plant)RushikeshPalkar1
The document discusses process validation in the pharmaceutical industry. It begins by defining process validation as establishing evidence through documentation that a process is capable of consistently producing a product meeting predetermined specifications and quality attributes. It then describes the three stages of process validation: process design, process qualification, and continued process verification. The document provides details about each stage and emphasizes that process validation is important for assuring pharmaceutical product quality since end product testing alone is not sufficient. It concludes by stating that if each step of production is validated, the final product quality can be assured.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification protocols for equipment operational performance and process validation protocols to demonstrate processes consistently meet requirements. The VMP is a living document that is updated with changes to facilities, equipment, or processes.
Similar to Pg og sms 018 procedimento de integridade mecânica eng (20)
Navigating the world of forex trading can be challenging, especially for beginners. To help you make an informed decision, we have comprehensively compared the best forex brokers in India for 2024. This article, reviewed by Top Forex Brokers Review, will cover featured award winners, the best forex brokers, featured offers, the best copy trading platforms, the best forex brokers for beginners, the best MetaTrader brokers, and recently updated reviews. We will focus on FP Markets, Black Bull, EightCap, IC Markets, and Octa.
Digital Marketing with a Focus on Sustainabilitysssourabhsharma
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
IMPACT Silver is a pure silver zinc producer with over $260 million in revenue since 2008 and a large 100% owned 210km Mexico land package - 2024 catalysts includes new 14% grade zinc Plomosas mine and 20,000m of fully funded exploration drilling.
The Steadfast and Reliable Bull: Taurus Zodiac Signmy Pandit
Explore the steadfast and reliable nature of the Taurus Zodiac Sign. Discover the personality traits, key dates, and horoscope insights that define the determined and practical Taurus, and learn how their grounded nature makes them the anchor of the zodiac.
Brian Fitzsimmons on the Business Strategy and Content Flywheel of Barstool S...Neil Horowitz
On episode 272 of the Digital and Social Media Sports Podcast, Neil chatted with Brian Fitzsimmons, Director of Licensing and Business Development for Barstool Sports.
What follows is a collection of snippets from the podcast. To hear the full interview and more, check out the podcast on all podcast platforms and at www.dsmsports.net
Discover innovative uses of Revit in urban planning and design, enhancing city landscapes with advanced architectural solutions. Understand how architectural firms are using Revit to transform how processes and outcomes within urban planning and design fields look. They are supplementing work and putting in value through speed and imagination that the architects and planners are placing into composing progressive urban areas that are not only colorful but also pragmatic.
4 Benefits of Partnering with an OnlyFans Agency for Content Creators.pdfonlyfansmanagedau
In the competitive world of content creation, standing out and maximising revenue on platforms like OnlyFans can be challenging. This is where partnering with an OnlyFans agency can make a significant difference. Here are five key benefits for content creators considering this option:
The Genesis of BriansClub.cm Famous Dark WEb PlatformSabaaSudozai
BriansClub.cm, a famous platform on the dark web, has become one of the most infamous carding marketplaces, specializing in the sale of stolen credit card data.
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
Introduction
The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
Presentation by Herman Kienhuis (Curiosity VC) on Investing in AI for ABS Alu...Herman Kienhuis
Presentation by Herman Kienhuis (Curiosity VC) on developments in AI, the venture capital investment landscape and Curiosity VC's approach to investing, at the alumni event of Amsterdam Business School (University of Amsterdam) on June 13, 2024 in Amsterdam.
The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...APCO
The Radar reflects input from APCO’s teams located around the world. It distils a host of interconnected events and trends into insights to inform operational and strategic decisions. Issues covered in this edition include:
Storytelling is an incredibly valuable tool to share data and information. To get the most impact from stories there are a number of key ingredients. These are based on science and human nature. Using these elements in a story you can deliver information impactfully, ensure action and drive change.
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Tastemy Pandit
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.AnnySerafinaLove
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.
Pg og sms 018 procedimento de integridade mecânica eng
1. OGX Petróleo e Gás Participações
S.A., Subsidiaries & Affiliates
MANAGEMENT PROCEDURE PG.OG.SMS.018
Title:
Mechanical Integrity
Issued on: 04/May/12 Version 01
Prepared by:
Alter Azevedo
SSO Engineer
Revised by:
Hegel Bernardes
SSO Manager
Approved by:
Reinaldo Belotti
Develop. and Production Director
Page 1 of 17
SUMMARY
The purpose of this procedure is to set up the conditions that will allow the performance of
inspections, tests, repairs and maintenance, taking into consideration the equipment
deterioration mechanisms, trying to preserve their integrity and reliability.
TABLE OF CONTENTS
1 – Objective: 3
2 – Application and Scope: 3
3 – References: 3
4 – Definitions and Acronyms: 3
5 – Responsibilities: 4
6 – Assumptions: 4
7 – Records: 6
8 – Annexes: 6
The content of this procedure must be disclosed to all employees.
Requests for clarification should be sent to the Operational Health and Safety by e-mail
addressed to alter.azevedo@ogx.com.br
2. OGX Petróleo e Gás Participações
S.A., Subsidiaries & Affiliates
MANAGEMENT PROCEDURE PG.OG.SMS.018
Title:
Mechanical Integrity
Issued on: 04/May/12 Version 01
Prepared by:
Alter Azevedo
SSO Engineer
Revised by:
Hegel Bernardes
SSO Manager
Approved by:
Reinaldo Belotti
Develop. and Production Director
Page 2 of 17
REVISION/ISSUE CONTROL
Issue Version Date Topics
Type
(I / E / A / N)
Summary of changes
2012 01 04/May/12 NA N Establishment of the procedure
REVISION RECORD CODE – TYPE OF CHANGE
Acronym Description
I Inclusion: New information was added.
E Exclusion: Information excluded from prior version.
A Change or adjustment to information existing in the previous version.
N New: Shows procedure establishment date, corresponding to document 1st version.
Additional Information: (Field for comments or guidance for next revision or specific issues related to procedure subject
matter).
3. OGX Petróleo e Gás Participações
S.A., Subsidiaries & Affiliates
MANAGEMENT PROCEDURE PG.OG.SMS.018
Title:
Mechanical Integrity
Issued on: 04/May/12 Version 01
Prepared by:
Alter Azevedo
SSO Engineer
Revised by:
Hegel Bernardes
SSO Manager
Approved by:
Reinaldo Belotti
Develop. and Production Director
Page 3 of 17
1 – Objective:
The objective of this procedure is to establish, in a planned and systematic manner, the
requirements to be applied by Operational Safety Management System (SGSO) to perform
inspections, tests, repairs and maintenance, taking into account the mechanisms of equipment
deterioration, seeking to preserve its integrity and reliability.
2 – Application and Scope:
This procedure applies to onshore and offshore facilities connected to OGX and OGX
contractors oil and natural gas drilling and production operations.
This procedure is to be implemented based on the Risk Analysis study, Critical Systems, and on
equipment construction design standards. Good operating practices are those described in the
manufacturers' manuals and in the operational procedures issued by OGX.
3 – References:
Risk Assessment Study Preparation Procedure – PG.OG.SMS.002
Critical Equipment Management Procedure – PG.OG.SMS.007
4 – Definitions and Acronyms:
4.1 - ABNT: Brazilian Association of Technical Standards.
4.2 - Rated Area: Any area with a potential risk of explosion.
4.3 - Calibration: Set of operations establishing the relationship between the values indicated by
a measuring instrument and the values established by the magnitude in the standards.
4.4 - Reliability: Refers to the situation where the equipment remains operational throughout the
design service life without detectable failure, provided that submitted to compliance
maintenance following the guidelines prescribed in the operating instructions and
manufacturer's manuals and not having been overloaded beyond the design limits.
4.5 - END – Non-Destructive Testing (NDT): Tests performed with finished or semi-finished
materials in order to detect the presence or absence of discontinuities or defects by applying the
physical principles set forth in the procedures, without changing physical, chemical, mechanical
or dimensional characteristics and without interfering with subsequent use thereof.
4.6 - EPS - Welding Procedure Specification.
4.7 - Hidden Failure: A latent system failure that is manifested when the function is required. For
the sake of prevention, proactive actions should be in place (procedures).
4.8 - Frequency: Number of times an event (impact, oscillation, contact) may occur over a given
period of time.
4. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 4 of 17
4.9 - HP - Hold Point: Inspection event, reported by the Contractor, which requires analysis,
verification or attestation by OGX inspection and without which the inspection process cannot
continue and be validated.
4.10 - Inspection: Set of coordinated activities designed to implement and document the status
of the equipment, piping, sensors, measuring instruments or system.
4.11 - Integrity: Property of equipment, piping, sensors, measuring instruments or system,
whether damaged or not, to remain operational offering an acceptable risk to safety and to
process reliability.
4.12 - Corrective Maintenance: Maintenance that includes all actions to return a failed system to
operational status or available.
4.13 - Predictive Maintenance: Maintenance based on the systematic application of analysis
techniques, employing centralized monitoring or sampling means in order to optimize Preventive
and Corrective Maintenance.
4.14 - Preventive Maintenance: Maintenance aimed to keep the system in operational status or
available by preventing the occurrence of failures. Maintenance intervals are to be defined in
the Maintenance Plan.
4.15 - Monitoring: Component intrinsic design function or performed by security interface which
guarantees the functionality of a security system when a component or a device has its function
reduced or limited, or when there is a hazard due to changes in process conditions.
4.16 - NBR: Brazilian Standard.
4.17 - NR: Guiding Rule (Labor and Employment Ministry).
4.18 - PDCA: Plan (prior to any process, activities must be planned and objectives and method
of execution must be set up), Develop (plan implementation by guiding/coaching people and
collecting data for control), Check (monitoring and evaluation of the process by employing
assessment tools and recording, correcting deviations) and Act (determination of a solution for
any deviations found thereby improving the process).
4.19 - PIT - Inspection and Test Plan: A document prepared by the Operator or the Contractor
clearly describing the steps to be taken for implementing the inspections and testings based on
a standard, code, requirements, specification, or procedure. The document must indicate
checks and inspections, HP or WP.
4.20 - Procedure: Written description of all essential parameters and precautions to be followed
for a given activity, according to the criteria established in a standard, code or specification.
4.21 - Skilled Professional: A skilled worker that can demonstrate their skills and abilities
through the application of written comprehensive examinations and documented results that will
allow an individual to engage in a specific activity.
4.22 - Reference Book: A set of documents systematically organized so as to provide an
updated memory (history) concerning a particular piece of equipment/facility.
4.23 - SNQC - National System of Qualification and Certification of Personnel.
4.24 - WP - Witness Point: Inspection event, reported by the Contractor, where Contractor
notifies OGX inspection aiming the analysis, verification or attestation of the events previously
assigned in the Inspection and Test Plan (PIT), without discontinuing the manufacturing
process.
4.25 - Qualified Professional: A worker holding legal authority to exercise engineering activities
in design, monitoring of operation, maintenance, inspection and supervision of boilers and
pressure vessels in accordance with professional regulations in force.
5. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 5 of 17
5 – Responsibilities:
5.1 - Top Management: must ensure compliance with the conditions specified in this procedure.
5.2 - Unit Management: Ensure the implementation of this procedure in the operational areas
under their responsibility.
5.3 - SMS Management: Support the operational areas in the implementation of this procedure,
as well as conduct periodic audits to check the implementation and any deviations.
5.4 - Maintenance Management: Perform all activities in compliance with the guidelines in this
procedure.
5.5 – Contractor: Operate and carry out this management practice.
6 – Assumptions:
6.1 – Planning
6.1.1 – Procedures
Implementation, inspection and testing procedures (operating procedures) must be prepared so
as clearly to set out the actions to be performed. The system must ensure continuous control
and updating (PDCA cycle).
The requirements of any procedures issued by contractors must be perfectly aligned with OGX's
SGSO guidelines.
Check lists – to validate the evidences that actions have been performed and attested.
Procedures must communicate the minimum qualifications of the personnel involved in tests
and inspections and in the development of specific procedures. E.g.: END and Welding
Inspectors must be SNQC-certified. EPS qualification and END procedures, Inspectors at
required level.
6.1.2 – Plans
PITs (Inspection and Test Plans) and Maintenance Plans must clearly communicate which
pieces of equipment belong to the Critical Operational Safety System. The contents of the PIT
must be aligned with Annex 3.
The following must be considered in the objective of the Inspection Plans:
• Verification of operation and process compliance with project acceptable variables.
• The inspection plan must cover potential damage mechanisms.
• Provide information about safety conditions required in the activities (work permit,
interlock, radiation protection, confined space, working at height, PPE/CPE, etc.).
• Inspection methods must be reliable aiming at:
Detection of damage mechanisms;
Inaccessible areas must be communicated and, where possible, complementary
methods/ENDs must be employed;
Frequency of inspections/tests;
Definition of performance acceptability criteria;
6. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 6 of 17
Progress tracking with results attested by qualified personnel.
• Data and results obtained through inspections will be systematically recorded in order to
enable:
Follow-up in subsequent inspections;
Guidelines for planning new inspections;
Orientation for any investigations designed to detect and eliminate the causes of
damage
Curbing the progression of the damage;
Becoming part of the record keeping system with the history of the equipment –
Reference Book.
• Results will be analyzed according to the criteria established in the procedures, allowing:
Checking/monitoring of equipment current integrity status;
Determining equipment remaining life (life cycle);
Checking serviceability by comparing the results against the records made for other
similar pieces of equipment (if possible);
Issuing reports with recommendations for better planning/implementation aiming
future inspection.
• The inspection plan must generate maintenance recommendations in order to:
Provide feedback for future inspection plans;
Monitor implementation thereof and the service time;
During plan implementation activities must be inspected and approved by the person
in charge of the maintenance or his/her agent.
Note: Inspections and tests performed on pressure vessels and boilers framed in NR-13 must
meet the requirements of this standard and be approved by a qualified professional.
6.1.3 – Asset Integrity - Equipment List:
Lists must be compiled for better control:
• List of equipment and systems belonging to the inspections and tests plan;
• List of critical process equipment based on safety and manufacturers information,
updated and available to maintenance personnel. Example of critical equipment:
pressure vessels and storage tanks;
control and pressure relief systems;
controls / interlocks / alarms / critical tools;
emergency devices, including shutdown systems;
emergency response equipment;
ventilation systems and devices;
piping and fittings in critical service;
metering/monitoring devices;
emergency communication / alarm systems;
7. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 7 of 17
key links between process and service;
lifting equipment (slings, lugs, baskets, skids, shackles, cranes, etc.).
grounding and electrical connections;
process pumps/vents/exhausts;
emergency generators;
other specific critical drilling and vessels equipment.
Notes:
1 - Any physical identification on the equipment (plate, label, punching, etc.) must be in
compliance with the Equipment List/Inspection, Testing and Maintenance Plan) for field
verification, ensuring perfect correlation (traceability) in the system.
2 – The list of facility pieces of equipment must be aligned with the information included in the
Description of the Maritime Unit (DUM) or Description of Onshore Unit (DUT).
6.2 – SGSO Quality Assurance Requirements:
SGSO requirements must be aligned with OGX SMS Management Manual such as:
• Management Commitment;
• Policies and Objectives;
• SMS Planning;
• Review;
• Internal Communication;
• Audits;
• Provision of Resources;
• Relations with Suppliers and Contractors;
• Metering and Monitoring;
• Continuous Improvement.
6.3 – Rated Areas:
Any equipment belonging to rated areas must be clearly identified in the Equipment List.
Consider the highest risk level (zone) according to the restrictions adopted in the standard.
Operation (construction and installation) thereof must be made in such a way as to prevent the
risk of ignition from sparks (static electricity or friction between moving or hot parts and other
spark sources).
It is valuable to have a specific training program in place for electrical equipment in potentially
explosive atmospheres to inform the personnel about the risks and the basic security concepts.
6.4 – Critical Systems:
Critical systems such as controllers, SDCD’s, emergency lighting, protections and
instrumentation, must operate properly even if a failure in normal power feeding system occurs,
in order to avoid situations that will worsen facility emergency shutdowns. Contingency actions,
8. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 8 of 17
where possible, must be implemented and described in the operational documents to guarantee
the required reliability.
It is relevant to consider such data as: manufacturers’ recommendations, good engineering
practices, risk analysis study, previous operation experiences and similarity of
equipment/systems.
Any critical equipment must have a reference book clearly demonstrating the history of
interventions. Such book must include, at least, the following information:
• A copy of the operating manual supplied by the manufacturer, in Portuguese;
• Technical specifications;
• Inspection, maintenance and certification program;
• Record of inspections, maintenance and certification;
• Action plan for correction of non-conformities detected during inspections, maintenance
and certification;
• Identification and signature of the technician appointed by the company.
Inspection Reports must provide at least the following information:
• Items inspected and non-conformities detected, describing those preventing the
equipment from being operated and those not interfering with operation;
• Corrective action taken for deterrent non-conformities;
• Identification of Procedure and reference standard;
• Metering devices employed;
• Identification of the Unit, equipment and system;
• Identification of inspector and inspection report;
• Review and approval by SGSO's person responsible;
• Numerical identification.
A correction schedule must be set up to address those non-conformities not preventing the
operation of the equipment and not posing any danger to health and safety, either alone or in
combination.
6.5 – Mechanical integrity review meetings:
The department is expected to convene periodic meetings to review SGSO mechanical integrity
with management, aiming to assess:
• Action Plan;
• Internal and external audits;
• Indicators employed and overall performance;
• Effectiveness of corrective and preventive actions;
• Assessment/reassessment of risk identification;
• Documents review (Procedure and records);
• SSO objectives applicable to mechanical integrity;
9. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 9 of 17
• Effectiveness of inspection, testing and maintenance processes;
• Appraisal of resources applicable to mechanical integrity (material and personnel);
• Analysis of requirements and other requirements applicable to mechanical integrity.
6.6 – Bibliographical References
ABNT NBR 14725:2009 – Chemicals;
ABNT NBR ISO 10004:2004 – Solid Wastes;
NR 10 –Electricity Installations and Services;
NR 13 – Boilers and Pressure Vessels;
ABNT NBR 14842:2003 – Criteria for Welding Inspectors;
ABNT NBR ISO 9712:2004 – END, Personnel Qualification;
6.7 – Records:
See Check lists in Annex 1.
7 – Adequacy for the Business
Not applicable.
8 – Annexes:
Annex 1 – Check List.
Annex 2 - Equipment Integrity Flowchart.
Annex 3 - Structure for an Inspection and Testing Plan.
Annex 4 - SGSO Document Structure Model.
Annex 5 - Diagram proposed for the cause and effect analysis of failures in operating system
critical equipment.
Annex 6 - Functional diagram for analyzing system breakdown.
10. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 10 of 17
Annex 1 – Check List
SGSO – Check List (LV)
Nº:
REV:
MECHANICAL INTEGRITY Page 1/2
REFERENCE DOCUMENT
ANP, SGSO-MN-02-REV.1 - MANUAL PARA EXECUÇÃO DE
AUDITORIAS DE VERIFICAÇÃO DA CONFORMIDADE DE SGSO
(SGSO CONFORMITY CHECKING AUDIT MANUAL.
FACILITY/LOCATION/DATE
SUPPLIER/PERSON IN CHARGE:
INSPECTION/PERSON IN
CHARGE:
CHECKING ITEMS REPORT
1 IS THERE ANY EQUIPMENT PREVENTIVE MAINTENANCE SCHEDULE IN PLACE?
2 EMPLOYEE AND CONTRACTORS ACCESS TO RISK AREAS IS CONTROLLED AND FLAGGED?
3 IS THERE ANY BOILERS AND VESSEL INSPECTION PROGRAM AS PER NR-13?
4
IS THE NR-13 PROGRAM CONSISTENT WITH THE COMPLEXITY OF THE RISK OF EQUIPMENT
AND FACILITIES?
5
HAVE BOILERS AND PRESSURE VESSELS OPERATORS BEEN GIVEN ADEQUATE TRAINING
AS PROVIDED FOR UNDER NR-13.
6
IS THERE ANY INSPECTION AND LOAD TESTING PROGRAM IN PLACE FOR LIFTING
EQUIPMENT? IS THERE ANY VISIBLE IDENTIFICATION PLATE (LABEL) COMMUNICATING THE
STATUS OF LOAD TESTS?
7
LIFTING EQUIPMENT OPERATORS AND CARRIERS HAVE BEEN GIVEN APPROPRIATE
TRAINING?
8
HAVE THE EQUIPMENT INSTALLED IN RATED AREAS BEEN IDENTIFIED IN THE INSPECTION
PROGRAM?
9
IS THERE APPROPRIATE EQUIPMENT LOCK-OUT/TAG-OUT ROUTINE IN PLACE DURING
MAINTENANCE AND INSPECTION SHUTDOWNS?
10 IS THERE A ROUTINE FOR EQUIPMENT SAFE OPERATION IN PLACE?
11
DOES CRITICAL EQUIPMENT HAVE A HISTORY OF MAINTENANCE, INSPECTION AND
TESTING (REFERENCE BOOK) AVAILABLE?
12
DOES THE ORGANIZATION SET UP AND KEEP PROCEDURES FOR WORKPLACE DESIGN,
PROCESSES, MACHINES OPERATING PROCEDURES AND INSTRUCTIONS, IN ORDER TO
ELIMINATE OR REDUCE HEALTH AND SAFETY RISK AT THE SOURCE?
13 IS THERE SPECIFIC PROCEDURE FOR WORK IN PRESSURIZED PIPELINES IN PLACE?
14
IS THERE SPECIFIC PROCEDURE FOR APR/PT PREPARATION/ISSUANCE IN PLACE? HAVE
APR/PT BEEN APPROPRIATELY ARCHIVED?
15
ARE SGSO RELATED RECORDS (REPORTS, CHECK LISTS, CERTIFICATES, ETC.) LEGIBLE,
IDENTIFIABLE, TRACEABLE AND WERE PROPERLY STORED?
16 IS THERE ANY PROCEDURE IN LACE TO DETECT NEEDED TRAINING?
SGSO – Check List (LV)
Nº:
REV:
MECHANICAL INTEGRITY Page 1/2
11. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 11 of 17
REFERENCE DOCUMENT
ANP, SGSO-MN-02-REV.1 - MANUAL PARA EXECUÇÃO DE
AUDITORIAS DE VERIFICAÇÃO DA CONFORMIDADE DE SGSO
(SGSO CONFORMITY CHECKING AUDIT MANUAL.
FACILITY/LOCATION/DATE
SUPPLIER/PERSON IN CHARGE:
INSPECTION/PERSON IN
CHARGE:
CHECKING ITEMS REPORT
1 IS THERE ANY EQUIPMENT PREVENTIVE MAINTENANCE SCHEDULE IN PLACE?
2 EMPLOYEE AND CONTRACTORS ACCESS TO RISK AREAS IS CONTROLLED AND FLAGGED?
3 IS THERE ANY BOILERS AND VESSEL INSPECTION PROGRAM AS PER NR-13?
4
IS THE NR-13 PROGRAM CONSISTENT WITH THE COMPLEXITY OF THE RISK OF EQUIPMENT
AND FACILITIES?
5
HAVE BOILERS AND PRESSURE VESSELS OPERATORS BEEN GIVEN ADEQUATE TRAINING
AS PROVIDED FOR UNDER NR-13.
6
IS THERE ANY INSPECTION AND LOAD TESTING PROGRAM IN PLACE FOR LIFTING
EQUIPMENT? IS THERE ANY VISIBLE IDENTIFICATION PLATE (LABEL) COMMUNICATING THE
STATUS OF LOAD TESTS?
7
LIFTING EQUIPMENT OPERATORS AND CARRIERS HAVE BEEN GIVEN APPROPRIATE
TRAINING?
8
HAVE THE EQUIPMENT INSTALLED IN RATED AREAS BEEN IDENTIFIED IN THE INSPECTION
PROGRAM?
9
IS THERE APPROPRIATE EQUIPMENT LOCK-OUT/TAG-OUT ROUTINE IN PLACE DURING
MAINTENANCE AND INSPECTION SHUTDOWNS?
10 IS THERE A ROUTINE FOR EQUIPMENT SAFE OPERATION IN PLACE?
11
DOES CRITICAL EQUIPMENT HAVE A HISTORY OF MAINTENANCE, INSPECTION AND
TESTING (REFERENCE BOOK) AVAILABLE?
12
DOES THE ORGANIZATION SET UP AND KEEP PROCEDURES FOR WORKPLACE DESIGN,
PROCESSES, MACHINES OPERATING PROCEDURES AND INSTRUCTIONS, IN ORDER TO
ELIMINATE OR REDUCE HEALTH AND SAFETY RISK AT THE SOURCE?
13 IS THERE SPECIFIC PROCEDURE FOR WORK IN PRESSURIZED PIPELINES IN PLACE?
14
IS THERE SPECIFIC PROCEDURE FOR APR/PT PREPARATION/ISSUANCE IN PLACE? HAVE
APR/PT BEEN APPROPRIATELY ARCHIVED?
15
ARE SGSO RELATED RECORDS (REPORTS, CHECK LISTS, CERTIFICATES, ETC.) LEGIBLE,
IDENTIFIABLE, TRACEABLE AND WERE PROPERLY STORED?
16 IS THERE ANY PROCEDURE IN LACE TO DETECT NEEDED TRAINING?
12. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 12 of 17
NOTE: REFER TO ANP MANUAL CHECKLIST (REFERENCE DOCUMENT), MANAGEMENT PRACTICE
No. 1, FOR THE INCLUSION OF OTHER VERIFICATION ITEMS.
APPRAISAL REPORT/CAPTION: S - SATISFACTORY N - NOT SATISFACTORY NA - NOT
APPLICABLE
NOTES:
SGSO – Check List (LV)
MECHANICAL INTEGRITY Page 2/2
CHECKING ITEMS REPORT
17
IS THE NEED AND EFFECTIVENESS OF TRAINING PROVIDED ASSESSED? IS THERE ANY
EVIDENCE OF SUCH ASSESSMENTS AVAILABLE? IS THERE A PROCEDURE FOR THIS
SYSTEMATIC ASSESSMENT?
18
DO CONTRACTORS HAVE RISK ASSESSMENT STUDIES IN PLACE FOR CRITICAL
PROCESSES (HAZOP, FMEA, ETC.)? IS THERE ANY EVIDENCE OF SUCH STUDIES
AVAILABLE? HAS THIS STUDY BEEN DONE BY QUALIFIED PERSON?
19
IS THE DEFINITION OF THE ASPECTS AND IMPACTS APPLICABLE TO CRITICAL SYSTEMS
ALIGNED WITH LEGAL REQUIREMENTS AND OTHER REQUIREMENTS? IS THERE ANY
EVIDENCE OF PERIODIC REVIEW OF SUCH REQUIREMENTS AVAILABLE?
20
HAVE THE FUNCTIONS, RESPONSIBILITIES AND AUTHORITIES RELATED TO MECHANICAL
INTEGRITY BEEN SET UP AND FORMALIZED IN A DOCUMENT?
21
HAS CONTRACTOR APPOINTED A MANAGEMENT REPRESENTATIVE FOR THE SGSO? WAS
THERE FORMAL COMMUNICATION?
22
DOES CONTRACTOR SET UP AND KEEP A PROCEDURE TO ENSURE THAT ALL SGSO
RELATED INFORMATION WILL BE DISCLOSED TO EMPLOYEES AND STAKEHOLDERS?
23 IS THERE ANY SGSO RELATED PERFORMANCE INDICATORS AVAILABLE?
24
IS THERE A PROCEDURE FOR PURCHASE, INSPECTION, HANDLING, AND PRESERVATION
OF CRITICAL EQUIPMENT IN PLACE? ARE INSPECTIONS RECORDED?
25
ARE CONTRACTORS PERIODICALLY ASSESSED/REASSESSED AS TO SGSO? IS THERE ANY
EVIDENCE OF SUCH ASSESSMENTS/AUDITS AVAILABLE?
26
HAVE TESTING AND METERING INSTRUMENTS BEEN CALIBRATED? HAS THE INSTRUMENT
CALIBRATION PLAN BEEN APPROVED BY THE QC?
27
IS THERE ANY SYSTEMATIC STATISTICAL EVALUATION FOR EQUIPMENT
AVAILABILITY/FITNESS RATE IN PLACE TARGETING MECHANICAL INTEGRITY? IS THERE
ANY EVIDENCE OF SUCH SYSTEMATIC APPROACHE AVAILABLE?
28
ARE DETECTED NON-CONFORMITIES GENERATING ACTION PLANS (WHAT? WHO?
WHERE? WHEN? WHY? HOW? HOW MUCH?) TO ENABLE THE IMPLEMENTATION OF THE
MITIGATING MEASURES RESULTING FROM THE INVESTIGATION/ANALYSIS PROCESS?
29
IS ANY ANALYSIS PERFORMED TO VERIFY THE EFFECTIVENESS OF THE PREVENTIVE
ACTIONS TAKEN?
30
ARE REVIEW MEETINGS CONVENED TO DISCUSS MECHANICAL INTEGRITY? ARE THE
MINUTES OF SUCH MEETINGS AVAILABLE FOR QUERY?
30
ARE REVIEW MEETINGS CONVENED TO DISCUSS MECHANICAL INTEGRITY? ARE THE
MINUTES OF SUCH MEETINGS AVAILABLE FOR QUERY?
13. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 13 of 17
Annex 2 - Equipment Integrity Flowchart.
EQUIPMENT INTEGRITY FLOWCHART
1
• DEFINITION OF INTERNAL AND ESTERNAL DAMAGE MECHANISMS AND
EVIDENCE OF CRITICAL SYSTEM IDENTIFICATION
2
• SGSO PROCEDURE AND INSPECTION AND TESTING PLAN (PIT).
3
• OPERATING CONDITIONS MONITORING AND CONTROL
4
• INSPECTION PROCEDURE
5
• MAINTENANCE AND REPAIR PROCEDURE
6
• APPLICABLE REGISTRATIONS
14. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 14 of 17
Annex 3 - Structure for an Inspection and Testing Plan
STRUCTURE FOR AN INSPECTION AND TESTING PLAN
PIT
GARANTIA DA
COMPATIBILID
ADE COM A
DOCUMENTAÇ
ÃO APLICÁVEL
INFORMAÇÕES
SOBRE OS
DISPOSITIVOS
E
EQUIPAMENTO
S APLICÁVEIS
ESPECIFICAR
OS CRITÉRIOS
DE
ACEITAÇÃO
DESCRIÇÃO
SUMÁRIA DAS
ETAPAS DO TESTE
E/OU INSPEÇÃO
COM POSSÍVEIS
INTERVENÇÕES
INDICAÇÃO DA
QUALIFICAÇÃO
DO PESSOAL
REQUERIDO
INFORMAR O
TIPO DE
DOCUMENTO
DE REGISTRO
15. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 15 of 17
Annex 4 - SGSO Document Structure Model
SGSO DOCUMENT STRUCTURE MODEL
POLÍTICA
DO SGSO
PROCEDIMENTOS DO
SISTEMA.
PROCEDIMENTOS/INSTRUÇÕES
OPERACIONAIS E PLANOS DE INSPEÇÃO,
TESTES E MANUTENÇÃO.
REGISTROS/EVIDÊNCIAS COMPROBATÓRIAS (RELATÓRIOS,
LISTAS DE VERIFICAÇÃO, CERTIFICADOS ETC)
16. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 16 of 17
Annex 5 - Diagram proposed for the cause and effect analysis of failures in operating
system critical equipment.
DIAGRAM PROPOSED FOR THE CAUSE AND EFFECT ANALYSIS OF FAILURES IN
OPERATING SYSTEM CRITICAL EQUIPMENT.
FALHA
TESTE/INSPEÇÃOMANUTENÇÃOOPERAÇÃO
PESSOALMATERIAL
CAUSA
CAUSA CAUSA
CAUSA
CAUSA
CAUSA
CAUSA
CAUSA
CAUSA
CAUSA
CAUSA
CAUSA
CAUSA
17. Management Procedure PG.OG.SMS.018 Issued on: 04/May/12
Version
02
Mechanical Integrity Procedure Page 17 of 17
Annex 6 - Functional diagram for analyzing system breakdown
FUNCTIONAL DIAGRAM FOR ANALYZING SYSTEM BREAKDOWN
------------------------------------------------------------------------------------------------------------------------------
Note: Example of failure/effects mode analysis in systems/equipment in items/components by
employing splitting levels (review). The purpose is to communicate the operating conditions
required for the system.
COMPRESSOR
MOTOR
INSTRUMENTAÇÃO
E
MONITORAMENTO
RESERVATÓRIO
DE AR E
CONEXÕES
LUBRIFICAÇÃOREFRIGERAÇÃO
VÁLVULAS DE
ALÍVIO E LEITURA
DE PRESSÃO E
SOBRECARGA
VÁLVULA DE ALÍVIO
E LEITURA DE
PRESSÃO DA ÁGUA
DE REFRIGERAÇÃO
1º NÍVEL DE ANÁLISE
2º NÍVEL DE ANÁLISE
3rd LEVEL ANALYSIS