際際滷

際際滷Share a Scribd company logo

Good Manufacturing Practices QA Presentation M02A1.pdf

Jennifer Alinsunurin
Jennifer Alinsunurin

good manufacturing practices

1 of 39
Download to read offline
January 2006 Quality Management and GMP
January 2006 Quality Management Objectives To understand key issues in quality assurance / good manufacturing practices / quality control To understand specific requirements on quality management and quality assurance including: Organization Procedures, processes and resources. To develop actions to resolve your current problems.
January 2006 Quality Management Quality relationships Quality Management Quality Assurance GMP Production and Quality Control
January 2006 Quality Management What is Quality Management? The aspect of management function that determines and implements the quality policy The overall intention and direction regarding quality, as formally expressed and authorized by top management
January 2006 Quality Management Quality Management The basic elements are: An appropriate infrastructure or quality system encompassing the organization structure, procedures, processes and resources The systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for Quality The totality of these actions is termed
January 2006 Quality Management Quality Management Quality assurance is a management tool QA, GMP and Quality Control are interrelated aspects of Quality Management
January 2006 Quality Management An effective QA System : Production and control operations are defined Responsibilities are defined In job descriptions In procedures and WI Provides end to end solutions
January 2006 Quality Management An effective QA System Controls are established and performed in WIP, FG, bulk, calibration and validation Correct processing and checking of the finished product Products are sold/supplied only after review by the authorized person Complying with production and QC requirements Proper storage, distribution and handling
January 2006 Quality Management An effective QA System Procedures for self-inspection and/or quality audits Reporting, investigation and recording of deviations System for change control/approval Regular evaluation of product quality to verify consistency and continued improvement
January 2006 Quality Management Quality Assurance Manufacturer is responsible for the quality of the product Fit for intended use Comply with customer specifications Regards safety commitment of management and staff
January 2006 Quality Management Quality Assurance Requires a comprehensively designed and well implemented QA system Fully documented, and effectiveness monitored Competent personnel, sufficient premises, equipment and facilities
January 2006 Quality Management Good Manufacturing Practices (GMP) That part of QA that ensures that products are consistently produced and controlled Quality standards Customer specification
January 2006 Quality Management Basic Requirements for GMP I Clearly defined and systematically reviewed processes Qualification and validation is performed Appropriate resources are provided: Qualified and trained personnel Premises, space, equipment and services Materials, containers and labels Procedures, storage and transport in-process control
January 2006 Quality Management Basic Requirements for GMP I Clear, written instructions and procedures Trained operators Records of actions, deviations and investigations Records for manufacture and distribution Proper storage and distribution Systems for complaints and recalls
January 2006 Common Issues Quality Management procedures not documented Limited resources Lack of qualified people Processes not properly validated SOPs are poorly executed and/or has intense gap Quality Management
January 2006 Common Issues More consideration to cost than quality Substandard materials deliberately purchased Technical staff not involved in purchasing No commitment to training Quality Management
January 2006 QUALITY ASSURANCE Definition Of Quality Assurance As per American National Standard (ANSI/ASQC A8402- 1994), quality control refers to all the planned and systematic activities implemented within the quality system, and demonstrated as needed, to provide adequate confidence that an entity will fulfill requirements for quality. American Society for Quality (ASQ) defines assurance of quality as the planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled. From the above definition of quality control, we can say that quality guarantee or assurance is the set of procedures developed and activities done before the product or service is manufactured or delivered to assure of good quality to the customers. This is a proactive approach. Source www.totalqualityassuranceservices.com
January 2006 All About Quality Control Definition Of Quality Control Juran says Quality control is a universal managerial process for conducting operations so as to provide stability to prevent adverse change and to maintain the status quo. As per American Society for Quality, quality control is the observation techniques and activities used to fulfill requirements for quality. From the above two definitions, we can say that quality control is the set of activities performed to ensure that the products or services meet the requirements as defined during the earlier process for assurance of quality. These activities are done during the manufacturing process and once the product is manufactured.
January 2006 All About Quality Control Definition Quality control is a failure detection system that uses a testing technique to identify errors or flaws in products and tests the end products at specified intervals. The main issue of using this system is that if the products are not subject to tests at regular intervals, the cost of tests will outweigh the benefits to the company. Processes Quality control and assurance feature entirely different tasks. The processes of quality control involve calibration, sampling and documenting reviews. Who Does The Job Quality control tasks are usually carried out by experts who are directly involved with the design, research or manufacture of a product. A quality monitoring professional just has to report to his department no further.
January 2006 Difference Between Quality Control and Assurance Assurance of quality is a set of preventive activities, which are focused on processes whereas quality control is a detection activity, which is focused on detecting the defects once the product is manufactured. Assurance defines the standards to be followed in order to meet the customer requirements whereas quality control ensures that these defined standards are followed at every step. This is done by conducting various tests and checks. Based on these tests and checks, the quality control prepares regular reports that act as an input to the assurance of quality department which then reviews the same and decides on the corrective and preventive actions required in the processes.
January 2006 Difference Between Quality Control and Assurance Despite the differences in the definition of quality assurance and quality control, these terms are often used interchangeably. But whatever you term it as, the importance of both cannot be undermined. Quality guarantee department develops all the planning processes and procedures that try to make sure that the products manufactured by the organization or the service delivered by the organizations will always be of good quality. Despite all these, some process parameters cannot be controlled and here is where quality control comes into picture. They check the products or services for the defects that happen due to these parameters and hence help quality control in achieving the overall objective of providing a defect-free product or service to the customers. So whether you call it assurance or control, quality is the goal.
January 2006 Direct comparison QC QA P P Focused on : C with S D S activity C P & P objective P R reports
January 2006 AUDIT Quality assurance audit is performed in order to ensure that the systems are in place and being followed religiously to provide good quality to the customers. It also highlights the need for any improvement in the systems in order to consistently deliver good quality products or services. The audits are also performed to make sure that the organization is following the legal and regulatory requirements. Some audits are conducted by internal auditors whereas some are performed by external ones.
January 2006 Distinguishing Quality Control From Assurance It is very necessary to treat quality control activities as different from the tasks of assurance of quality due to the following reasons A product that is subject to regular quality control checks will not be entirely successful if the assurance processes that monitor the tests are not efficient. Another important fact is that QC and QA tasks must not be assigned to the same person. Since the activities of quality monitoring maintains a smooth progress of quality control functions, delegating these two jobs to one person will result in a conflict of interest. It is often found that while some companies concentrate more on quality control, others focus mainly on assurance of quality. For efficient running and quality products, both these processes must be subject to proper evaluation and management.
January 2006 Distinguishing Quality Control From Assurance Most people use the two terms quality control and quality assurance synonymously to refer to the same concept. While on the face of it, it sounds okay but in effect, this is an incorrect tendency that points at an inadequate understanding of quality management systems and processes. Here is the explanation of the two quality processes, their differences and the importance of understanding these differences.
January 2006 Types of Quality Assurance Audit System Audit - The organization has various systems which when put together make a whole system. A system audit is an audit performed on any of these systems. Any non-conformity during a system audit is critical, since if the system itself is wrong, the output is likely to be wrong. Product or Service Audit - The product or service audit is performed on the product or service to find out if the product or service meets the requirements of the customers and the standards set by the organization. There are various stages at which this can be performed. It could be during the process of product manufacturing, after the product has been manufactured, or even after the product is packed and ready to be delivered to the customer. The nonconformities found during this quality assurance audit are taken very seriously, since all these nonconformities are equivalent to customer complaints.
January 2006 Types of Quality Assurance Audit Department Audit - As the name suggests, the department audit is performed with a focus on a given department. The scope of the audit covers all the activities performed, all the procedures followed and all the systems available in the department. This audit highlights the areas for improvement in that department. Process Audit - Various processes are critical for the smooth running of an organization. All the activities from order inquiry to delivery of products follow a defined process in any organization. Hence, an audit of such processes is performed to identify the areas for improvement. Process audit also covers the audit of some special manufacturing processes that are critical for the quality of the end product. These processes may be in-house or at the suppliers place, the one to whom that process has been outsourced to.
January 2006 Types of Quality Assurance Audit Conformance Audit - The external parties normally perform this QA audit. It is a form of third party audit where the auditing party evaluates if the organization does meet the requirements as are supposed to by the systems. This could also be for any kind of system certifications that organizations wish to apply for. The certificate-awarding agency also conducts the conformance audit periodically to make sure that the organization is meeting the certification requirements. Compliance Audit - Compliance audit is performed by regulatory agencies to confirm if the organization is meeting the legal and regulatory requirements. In case of any non-conformity, a re-audit may be required. The purpose of the re-audit is to ensure the effectiveness of the corrective actions taken. The output of the audit is an audit report that is circulated to all the concerned people. The purpose of any type of QA audit is not to find mistakes, but to find the areas for improvements. If it is taken by the auditor and the audited party in this spirit, the organization can be sure that it is on the path to improvement and will be able to consistently meet all customers, system, legal or regulatory requirements.
January 2006 Responsibilities Defining quality policies and interacting with the production manager also falls under quality assurance job description . This is to ensure that the existing standards of production are satisfactory and follow safety regulations. A quality manager checks the past records of production to review if the existing standards will continue to bring in more customers. In many companies, teams of quality professionals are authorized to inspect products that are fresh out of the production line. Such an inspection is to ensure the required quality standards are met The Basic Responsibilities Handled By A Quality Manager Involve To review business statistics. To determine and document any areas that may need improvement. Inspecting and sampling the entire manufacturing process is another part of quality assurance job description . To review the current policies and improvise plans to improve upon the existing quality standards. To review and analyze the effectiveness of the modifications made. To ensure that all procedures within the company conform to health and safety regulations, financial policies and legislation such as equal opportunity. To educate the sales and marketing departments regarding the specific requirements of clients.
January 2006 The Quality Department Quality Department undoubtedly plays a key role in the success of a company. They mostly carry out support functions in the production and manufacturing sectors. Very often, taking charge of productions processes and quality systems is also a part of this job description. General Skills Required - quality managers & engineers must ideally possess qualities like Effective communication and report writing skills. Good negotiation skills with customer-oriented attitude. Excellent analytical abilities to grasp the key points from complicated details. Good leadership capabilities to lead projects to successful completion. Basic knowledge of applicable software to infer statistical data. Familiarity with the tools, concepts and methodologies of quality management. QA jobs obviously vary as every company deals with a different product. However, the general concept remains the same. For candidates, with an eye for detail and a desire for continuous improvement, who satisfy the job description, this career can be an immensely satisfying one.
January 2006 Quality Assurance Report A well-written quality assurance report are very important to implement total quality systems in the organization. With increasing competition and stricter government regulations, quality systems have become an integral part of the organizations. One of the most important steps in implementing quality systems is conducting audits. Audits give a clear picture of how the quality systems are implemented in the organization, to what extent they are being followed and how effective they are in improving the quality of the products and services. An audit or inspection report conveys the results of the audit to the concerned people in the organization and at times to the top management as well. Based on the audit report, various strategic decisions are taken regarding product quality, wastage, execution time of orders & customer requirements & etc. Quality report is one of the most important report in the organization since it acts as a feedback and triggers corrective and preventive action.
January 2006 Quality Assurance Report Few points that should be adhered to while making QA report or audit report. Easy To Understand Language - The report should be well written in simple language. This not only enables the concerned people to understand the content of the report but also results in effective communication, better decision making, and proper implementation Abstract - The first step is to give brief summary of the audit report. It should be clear and concise. The audit reports are circulated to heads of various departments, top management, engineers, and the supervisors on the shop floor. A summary gives idea of what is there in the full report and hence when a person reads the summary, he/she can decide whether they want to go through the entire content of the audit report or not. This saves the precious time of the employees.
January 2006 Quality Assurance Report Background Information - The audit report should contain all the information like the date of the audit, the name of the department where the audit was conducted, the name of the official who conducted the audit, the purpose of the audit and so on. Findings - The inspection or audit should give complete details of the findings. If any calculations are done, then those should be shown in a separate section or attached to the quality assurance report . The content of various audit reports varies based on the type of audit. Like the quality management system audit report states the observations with reference to the clauses of the standard or the department manual whereas the process audit report states the observations with reference to the code of practice defined for that process.
January 2006 Quality Assurance Report Inferences - The findings are compared with standards to check whether different quality systems are being followed properly in the organization or not. Any deviations in the system should be highlighted. Use graphics to make points clearer and explicable. The inference is a very important part of the audit report as the senior management takes the decision based on it after consulting the engineers and managers. Signatories to indicate responsibilities and authorities in the report Hard or soft copy should be completely filled-out In short, audit and QA report play an important role in the continual improvement of the organizations quality management system.
January 2006 Quality Assurance Tools Quality assurance tools are available to quality professionals to successfully accomplish their task of maintaining the quality of the organization so as to meet or exceed the expectations of the customers. These are also used by the management in the decision making process. Some of the commonly used tools are : The Why Why Analysis It is one of the methods used in analyzing various quality-related problems. The Why why analysis is used to find the root cause of the problems. As per this method, for getting to the crux of any problem, the person has to ask why five times.
January 2006 Quality Assurance Tools Example of a why-why analysis Q Why is there a shortage of material A Due to rejection during quality inspection. Q Why did it get rejected A Due to failure in meeting specifications. Q Why it did not meet the specifications A Due to a manufacturing error in the suppliers process. Q Why was there an error in the suppliers process A Due to non-clarity of work instructions. Q Why were the instructions not given clearly A Due to the verbal communication of the instructions. Hence, in this example, through the why quality assurance tools the manager has understood that the shortage of material is due to the verbal communication of the instructions.
January 2006 Quality Assurance Tools Affinity Diagram This tool is used for problem analysis. In an organization, all processes are interrelated a problem in any one area or process can affect the quality of the end product or service. To draw a conclusion from the vast pool of data, affinity diagrams are used. It uses the bottoms up approach. Teams are formed to work on the problem. All possible causes of the problem are written on separate post-it notes or cards. These are then pasted or spread over a
January 2006 Quality Assurance Tools Tree Diagram This is also known as Dendrogram. This quality assurance tools is used to divide any task or process into sub tasks to have greater in depth knowledge of the systems. Also, it is used in understanding the problems. So, the first step while using this tool is to determine the objective. Based on the objective statement, the team will write various sub statements. Each sub statement is further divided into various statements. The process usually involves three levels or it can continue till the statement cannot be further subdivided. -sub-statement 1a -statement 1 -sub-statement 1b For e.g. Objective -statement 2 -statement 3 - sub-statement 3a -sub-statement 3b -sub-statement 3c
January 2006 Quality Assurance Tools Prioritization Matrix These tools is used when there is a need to prioritize from a large number of available possibilities. It can be used for the prioritization of the tasks, work, or any other issues where there is a difference of opinions among those involved. This is an analytical method of prioritizing based on the weighted-average method. Each task or issue is assigned a weight age and then by comparison, their priority is determined. Also a method is developed for deciding the weight age for each task. This tool is also used by the top management in decision making, such as for prioritizing different projects in case of the resource crunch. Apart from these tools, there are various other industry approved and accepted tools that one can use for quality monitoring and quality control.

More Related Content

Good Manufacturing Practices QA Presentation M02A1.pdf

  • 2. January 2006 Quality Management Objectives To understand key issues in quality assurance / good manufacturing practices / quality control To understand specific requirements on quality management and quality assurance including: Organization Procedures, processes and resources. To develop actions to resolve your current problems.
  • 3. January 2006 Quality Management Quality relationships Quality Management Quality Assurance GMP Production and Quality Control
  • 4. January 2006 Quality Management What is Quality Management? The aspect of management function that determines and implements the quality policy The overall intention and direction regarding quality, as formally expressed and authorized by top management
  • 5. January 2006 Quality Management Quality Management The basic elements are: An appropriate infrastructure or quality system encompassing the organization structure, procedures, processes and resources The systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for Quality The totality of these actions is termed
  • 6. January 2006 Quality Management Quality Management Quality assurance is a management tool QA, GMP and Quality Control are interrelated aspects of Quality Management
  • 7. January 2006 Quality Management An effective QA System : Production and control operations are defined Responsibilities are defined In job descriptions In procedures and WI Provides end to end solutions
  • 8. January 2006 Quality Management An effective QA System Controls are established and performed in WIP, FG, bulk, calibration and validation Correct processing and checking of the finished product Products are sold/supplied only after review by the authorized person Complying with production and QC requirements Proper storage, distribution and handling
  • 9. January 2006 Quality Management An effective QA System Procedures for self-inspection and/or quality audits Reporting, investigation and recording of deviations System for change control/approval Regular evaluation of product quality to verify consistency and continued improvement
  • 10. January 2006 Quality Management Quality Assurance Manufacturer is responsible for the quality of the product Fit for intended use Comply with customer specifications Regards safety commitment of management and staff
  • 11. January 2006 Quality Management Quality Assurance Requires a comprehensively designed and well implemented QA system Fully documented, and effectiveness monitored Competent personnel, sufficient premises, equipment and facilities
  • 12. January 2006 Quality Management Good Manufacturing Practices (GMP) That part of QA that ensures that products are consistently produced and controlled Quality standards Customer specification
  • 13. January 2006 Quality Management Basic Requirements for GMP I Clearly defined and systematically reviewed processes Qualification and validation is performed Appropriate resources are provided: Qualified and trained personnel Premises, space, equipment and services Materials, containers and labels Procedures, storage and transport in-process control
  • 14. January 2006 Quality Management Basic Requirements for GMP I Clear, written instructions and procedures Trained operators Records of actions, deviations and investigations Records for manufacture and distribution Proper storage and distribution Systems for complaints and recalls
  • 15. January 2006 Common Issues Quality Management procedures not documented Limited resources Lack of qualified people Processes not properly validated SOPs are poorly executed and/or has intense gap Quality Management
  • 16. January 2006 Common Issues More consideration to cost than quality Substandard materials deliberately purchased Technical staff not involved in purchasing No commitment to training Quality Management
  • 17. January 2006 QUALITY ASSURANCE Definition Of Quality Assurance As per American National Standard (ANSI/ASQC A8402- 1994), quality control refers to all the planned and systematic activities implemented within the quality system, and demonstrated as needed, to provide adequate confidence that an entity will fulfill requirements for quality. American Society for Quality (ASQ) defines assurance of quality as the planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled. From the above definition of quality control, we can say that quality guarantee or assurance is the set of procedures developed and activities done before the product or service is manufactured or delivered to assure of good quality to the customers. This is a proactive approach. Source www.totalqualityassuranceservices.com
  • 18. January 2006 All About Quality Control Definition Of Quality Control Juran says Quality control is a universal managerial process for conducting operations so as to provide stability to prevent adverse change and to maintain the status quo. As per American Society for Quality, quality control is the observation techniques and activities used to fulfill requirements for quality. From the above two definitions, we can say that quality control is the set of activities performed to ensure that the products or services meet the requirements as defined during the earlier process for assurance of quality. These activities are done during the manufacturing process and once the product is manufactured.
  • 19. January 2006 All About Quality Control Definition Quality control is a failure detection system that uses a testing technique to identify errors or flaws in products and tests the end products at specified intervals. The main issue of using this system is that if the products are not subject to tests at regular intervals, the cost of tests will outweigh the benefits to the company. Processes Quality control and assurance feature entirely different tasks. The processes of quality control involve calibration, sampling and documenting reviews. Who Does The Job Quality control tasks are usually carried out by experts who are directly involved with the design, research or manufacture of a product. A quality monitoring professional just has to report to his department no further.
  • 20. January 2006 Difference Between Quality Control and Assurance Assurance of quality is a set of preventive activities, which are focused on processes whereas quality control is a detection activity, which is focused on detecting the defects once the product is manufactured. Assurance defines the standards to be followed in order to meet the customer requirements whereas quality control ensures that these defined standards are followed at every step. This is done by conducting various tests and checks. Based on these tests and checks, the quality control prepares regular reports that act as an input to the assurance of quality department which then reviews the same and decides on the corrective and preventive actions required in the processes.
  • 21. January 2006 Difference Between Quality Control and Assurance Despite the differences in the definition of quality assurance and quality control, these terms are often used interchangeably. But whatever you term it as, the importance of both cannot be undermined. Quality guarantee department develops all the planning processes and procedures that try to make sure that the products manufactured by the organization or the service delivered by the organizations will always be of good quality. Despite all these, some process parameters cannot be controlled and here is where quality control comes into picture. They check the products or services for the defects that happen due to these parameters and hence help quality control in achieving the overall objective of providing a defect-free product or service to the customers. So whether you call it assurance or control, quality is the goal.
  • 22. January 2006 Direct comparison QC QA P P Focused on : C with S D S activity C P & P objective P R reports
  • 23. January 2006 AUDIT Quality assurance audit is performed in order to ensure that the systems are in place and being followed religiously to provide good quality to the customers. It also highlights the need for any improvement in the systems in order to consistently deliver good quality products or services. The audits are also performed to make sure that the organization is following the legal and regulatory requirements. Some audits are conducted by internal auditors whereas some are performed by external ones.
  • 24. January 2006 Distinguishing Quality Control From Assurance It is very necessary to treat quality control activities as different from the tasks of assurance of quality due to the following reasons A product that is subject to regular quality control checks will not be entirely successful if the assurance processes that monitor the tests are not efficient. Another important fact is that QC and QA tasks must not be assigned to the same person. Since the activities of quality monitoring maintains a smooth progress of quality control functions, delegating these two jobs to one person will result in a conflict of interest. It is often found that while some companies concentrate more on quality control, others focus mainly on assurance of quality. For efficient running and quality products, both these processes must be subject to proper evaluation and management.
  • 25. January 2006 Distinguishing Quality Control From Assurance Most people use the two terms quality control and quality assurance synonymously to refer to the same concept. While on the face of it, it sounds okay but in effect, this is an incorrect tendency that points at an inadequate understanding of quality management systems and processes. Here is the explanation of the two quality processes, their differences and the importance of understanding these differences.
  • 26. January 2006 Types of Quality Assurance Audit System Audit - The organization has various systems which when put together make a whole system. A system audit is an audit performed on any of these systems. Any non-conformity during a system audit is critical, since if the system itself is wrong, the output is likely to be wrong. Product or Service Audit - The product or service audit is performed on the product or service to find out if the product or service meets the requirements of the customers and the standards set by the organization. There are various stages at which this can be performed. It could be during the process of product manufacturing, after the product has been manufactured, or even after the product is packed and ready to be delivered to the customer. The nonconformities found during this quality assurance audit are taken very seriously, since all these nonconformities are equivalent to customer complaints.
  • 27. January 2006 Types of Quality Assurance Audit Department Audit - As the name suggests, the department audit is performed with a focus on a given department. The scope of the audit covers all the activities performed, all the procedures followed and all the systems available in the department. This audit highlights the areas for improvement in that department. Process Audit - Various processes are critical for the smooth running of an organization. All the activities from order inquiry to delivery of products follow a defined process in any organization. Hence, an audit of such processes is performed to identify the areas for improvement. Process audit also covers the audit of some special manufacturing processes that are critical for the quality of the end product. These processes may be in-house or at the suppliers place, the one to whom that process has been outsourced to.
  • 28. January 2006 Types of Quality Assurance Audit Conformance Audit - The external parties normally perform this QA audit. It is a form of third party audit where the auditing party evaluates if the organization does meet the requirements as are supposed to by the systems. This could also be for any kind of system certifications that organizations wish to apply for. The certificate-awarding agency also conducts the conformance audit periodically to make sure that the organization is meeting the certification requirements. Compliance Audit - Compliance audit is performed by regulatory agencies to confirm if the organization is meeting the legal and regulatory requirements. In case of any non-conformity, a re-audit may be required. The purpose of the re-audit is to ensure the effectiveness of the corrective actions taken. The output of the audit is an audit report that is circulated to all the concerned people. The purpose of any type of QA audit is not to find mistakes, but to find the areas for improvements. If it is taken by the auditor and the audited party in this spirit, the organization can be sure that it is on the path to improvement and will be able to consistently meet all customers, system, legal or regulatory requirements.
  • 29. January 2006 Responsibilities Defining quality policies and interacting with the production manager also falls under quality assurance job description . This is to ensure that the existing standards of production are satisfactory and follow safety regulations. A quality manager checks the past records of production to review if the existing standards will continue to bring in more customers. In many companies, teams of quality professionals are authorized to inspect products that are fresh out of the production line. Such an inspection is to ensure the required quality standards are met The Basic Responsibilities Handled By A Quality Manager Involve To review business statistics. To determine and document any areas that may need improvement. Inspecting and sampling the entire manufacturing process is another part of quality assurance job description . To review the current policies and improvise plans to improve upon the existing quality standards. To review and analyze the effectiveness of the modifications made. To ensure that all procedures within the company conform to health and safety regulations, financial policies and legislation such as equal opportunity. To educate the sales and marketing departments regarding the specific requirements of clients.
  • 30. January 2006 The Quality Department Quality Department undoubtedly plays a key role in the success of a company. They mostly carry out support functions in the production and manufacturing sectors. Very often, taking charge of productions processes and quality systems is also a part of this job description. General Skills Required - quality managers & engineers must ideally possess qualities like Effective communication and report writing skills. Good negotiation skills with customer-oriented attitude. Excellent analytical abilities to grasp the key points from complicated details. Good leadership capabilities to lead projects to successful completion. Basic knowledge of applicable software to infer statistical data. Familiarity with the tools, concepts and methodologies of quality management. QA jobs obviously vary as every company deals with a different product. However, the general concept remains the same. For candidates, with an eye for detail and a desire for continuous improvement, who satisfy the job description, this career can be an immensely satisfying one.
  • 31. January 2006 Quality Assurance Report A well-written quality assurance report are very important to implement total quality systems in the organization. With increasing competition and stricter government regulations, quality systems have become an integral part of the organizations. One of the most important steps in implementing quality systems is conducting audits. Audits give a clear picture of how the quality systems are implemented in the organization, to what extent they are being followed and how effective they are in improving the quality of the products and services. An audit or inspection report conveys the results of the audit to the concerned people in the organization and at times to the top management as well. Based on the audit report, various strategic decisions are taken regarding product quality, wastage, execution time of orders & customer requirements & etc. Quality report is one of the most important report in the organization since it acts as a feedback and triggers corrective and preventive action.
  • 32. January 2006 Quality Assurance Report Few points that should be adhered to while making QA report or audit report. Easy To Understand Language - The report should be well written in simple language. This not only enables the concerned people to understand the content of the report but also results in effective communication, better decision making, and proper implementation Abstract - The first step is to give brief summary of the audit report. It should be clear and concise. The audit reports are circulated to heads of various departments, top management, engineers, and the supervisors on the shop floor. A summary gives idea of what is there in the full report and hence when a person reads the summary, he/she can decide whether they want to go through the entire content of the audit report or not. This saves the precious time of the employees.
  • 33. January 2006 Quality Assurance Report Background Information - The audit report should contain all the information like the date of the audit, the name of the department where the audit was conducted, the name of the official who conducted the audit, the purpose of the audit and so on. Findings - The inspection or audit should give complete details of the findings. If any calculations are done, then those should be shown in a separate section or attached to the quality assurance report . The content of various audit reports varies based on the type of audit. Like the quality management system audit report states the observations with reference to the clauses of the standard or the department manual whereas the process audit report states the observations with reference to the code of practice defined for that process.
  • 34. January 2006 Quality Assurance Report Inferences - The findings are compared with standards to check whether different quality systems are being followed properly in the organization or not. Any deviations in the system should be highlighted. Use graphics to make points clearer and explicable. The inference is a very important part of the audit report as the senior management takes the decision based on it after consulting the engineers and managers. Signatories to indicate responsibilities and authorities in the report Hard or soft copy should be completely filled-out In short, audit and QA report play an important role in the continual improvement of the organizations quality management system.
  • 35. January 2006 Quality Assurance Tools Quality assurance tools are available to quality professionals to successfully accomplish their task of maintaining the quality of the organization so as to meet or exceed the expectations of the customers. These are also used by the management in the decision making process. Some of the commonly used tools are : The Why Why Analysis It is one of the methods used in analyzing various quality-related problems. The Why why analysis is used to find the root cause of the problems. As per this method, for getting to the crux of any problem, the person has to ask why five times.
  • 36. January 2006 Quality Assurance Tools Example of a why-why analysis Q Why is there a shortage of material A Due to rejection during quality inspection. Q Why did it get rejected A Due to failure in meeting specifications. Q Why it did not meet the specifications A Due to a manufacturing error in the suppliers process. Q Why was there an error in the suppliers process A Due to non-clarity of work instructions. Q Why were the instructions not given clearly A Due to the verbal communication of the instructions. Hence, in this example, through the why quality assurance tools the manager has understood that the shortage of material is due to the verbal communication of the instructions.
  • 37. January 2006 Quality Assurance Tools Affinity Diagram This tool is used for problem analysis. In an organization, all processes are interrelated a problem in any one area or process can affect the quality of the end product or service. To draw a conclusion from the vast pool of data, affinity diagrams are used. It uses the bottoms up approach. Teams are formed to work on the problem. All possible causes of the problem are written on separate post-it notes or cards. These are then pasted or spread over a
  • 38. January 2006 Quality Assurance Tools Tree Diagram This is also known as Dendrogram. This quality assurance tools is used to divide any task or process into sub tasks to have greater in depth knowledge of the systems. Also, it is used in understanding the problems. So, the first step while using this tool is to determine the objective. Based on the objective statement, the team will write various sub statements. Each sub statement is further divided into various statements. The process usually involves three levels or it can continue till the statement cannot be further subdivided. -sub-statement 1a -statement 1 -sub-statement 1b For e.g. Objective -statement 2 -statement 3 - sub-statement 3a -sub-statement 3b -sub-statement 3c
  • 39. January 2006 Quality Assurance Tools Prioritization Matrix These tools is used when there is a need to prioritize from a large number of available possibilities. It can be used for the prioritization of the tasks, work, or any other issues where there is a difference of opinions among those involved. This is an analytical method of prioritizing based on the weighted-average method. Each task or issue is assigned a weight age and then by comparison, their priority is determined. Also a method is developed for deciding the weight age for each task. This tool is also used by the top management in decision making, such as for prioritizing different projects in case of the resource crunch. Apart from these tools, there are various other industry approved and accepted tools that one can use for quality monitoring and quality control.