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Quality Control
- 1. Course Title: QUALITY CONTROL Course Code: CHM-404 Semmester: 4th E
- 2. QUALITY ASSURANCE/QUALITY CONTROL Quality assurance (QA) Part of quality management focused on providing confidence that quality requirements will be fulfilled. Quality control (QC) Part of quality management focused on fulfilling quality requirements.
- 3. QUALITY ASSURANCE/QUALITY CONTROL Quality assurance and quality control activities are interrelated. QC is a subset of the QA activities
- 4. QUALITY ASSURANCE/QUALITY CONTROL Quality assurance/ Quality control tools Control charts
- 5. QUALITY ASSURANCE/QUALITY CONTROL Quality assurance/ Quality control tools Documenting and archiving All activities performed by the laboratory dealing with quality assurance should be documented in written form. Electronic records Electronic validation will need to be done to document data integrity, backup and recovery, archiving and restoring, and how electronic signatures are used.
- 6. QUALITY ASSURANCE/QUALITY CONTROL Quality assurance/ Quality control tools Electronic signatures Electronic signature technologies include identification codes (usernames, passwords) or more sophisticated biometric systems (based on measurement of physical features such as palm prints, fingerprints).
- 7. QUALITY ASSURANCE/QUALITY CONTROL Quality assurance/ Quality control tools Validation Validation determines the suitability of an analysis for providing the sought-for information and can apply to samples, to methodologies, and to data.
- 8. QUALITY ASSURANCE/QUALITY CONTROL Quality assurance/ Quality control tools Labortary accreditation Accreditation is a procedure by which an authoritative body gives formal recognition that the laboratory is competent to carry out specific tasks.
- 9. QUALITY ASSURANCE/QUALITY CONTROL Difference between quality assurance (QA)/ quality control(QC) Proactive (QA) / Reactive (QC) QA aims to prevent defects before they occur through process design. QC is reactive and exists to identify defects after they have happened.
- 10. QUALITY ASSURANCE/QUALITY CONTROL Process (QA) /Product (QC) QA is process-oriented, and it focuses on preventing quality issues. QC is product-oriented and focused on identifying quality issues in manufactured products. System (QA) / Parts (QC) Quality assurance control systems are the methods and procedures which are used to safeguard quality standards. Quality control systems measure parts, including the outputs of the system.
- 11. QUALITY ASSURANCE/QUALITY CONTROL Creation (QA) /Verification (QC) The result of QA activities is a roadmap for creating high-quality products. QC involves verification of products post-manufacture and before distribution, or confirming safety and efficacy. Entire Team (QA) /Dedicated Personnel (QC) Every member of QA team is responsible for QA activities by following SOPs.QC is generally the responsibility of certain personnel within the organization.
- 12. QUALITY ASSURANCE/QUALITY CONTROL Prevention (QA) /Detection (QC) The purpose of QA is to prevent defects from entering into the solution in the first place. QC is a reactive means by which quality is gauged and monitored.
- 13. REFERENCE BOOKS Harris, B. C. and W.H. Harris. 2010. Quantitative Chemical Analysis. 8th Edition. Freeman and Company New York. Christian, G.D. 2006. Analytical Chemistry. Sixth edition, John Wiley and Sons, New York. Skoog, D. A. and D.M. West 2005. Fundamentals of Analytical Chemistry. Hot Reinehart Inc., London. Kealey, D and P.J.Haines, 2002. Analytical Chemistry, Bios Scientific Publishers Limited, Oxford, UK. Sharma, B. K. 2004. Instrumental methods of chemical analysis, In; Introduction to Analytical chemistry: Goel Publishing House Meerut, 23th Edition. Reilley, C. 1993. Laboratory Manual of Analytical Chemistry. Allyn & Bacon, London.
Editor's Notes
- QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services meet consumer expectations. Quality assurance is process oriented and focuses on defect prevention, while quality control is product oriented and focuses on defect identification.[1] Quality assurance and quality control are two aspects of quality management. While some quality assurance and quality control activities are interrelated, the two are defined differently. Typically, QA activities and responsibilities cover virtually all of the quality system in one fashion or another, while QC is a subset of the QA activities. Quality Assurance Quality assurance can be defined as "part of quality management focused on providing confidence that quality requirements will be fulfilled." The confidence provided by quality assurance is twofold—internally to management and externally to customers, government agencies, regulators, certifiers, and third parties. An alternate definition is "all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality." Quality Control Quality control can be defined as "part of quality management focused on fulfilling quality requirements." While quality assurance relates to how a process is performed or how a product is made, quality control is more the inspection aspect of quality management. An alternate definition is "the operational techniques and activities used to fulfill requirements for quality." https://en.wikipedia.org/wiki/QA/QC
- Quality assurance and quality control are two aspects of quality management. While some quality assurance and quality control activities are interrelated, the two are defined differently. Typically, QA activities and responsibilities cover virtually all of the quality system in one fashion or another, while QC is a subset of the QA activities. Also, elements in the quality system might not be specifically covered by QA/QC activities and responsibilities but may involve QA and QC. https://asq.org/quality-resources/quality-assurance-vs-controls
- The laboratory should maintain a continuing quality control chart for each method. A reference material of known analyte content is blindly and randomly run each day, or preferably with each batch of samples. If measured values fall outside prescribed standard deviation limits, then you should check for some systematic error such as reagent deterioration or instrument drift (needs recalibration). Analytical chemistry by GD CHristian
- This is a tedious and time-consuming, but critical, part of quality assurance. All activities performed by the laboratory dealing with quality assurance should be documented in written form. This includes recording the chain of custody of the sample, the calibration and performance of instruments, standard operating procedures, original measurement data, results, and reports. Documents should be traced to individuals, meaning they should be signed and dated by the individual creating or responsible for them. Electronic validation will need to be done to document data integrity, backup and recovery, archiving and restoring, and how electronic signatures are used. A validated system must be for the life cycle of the software. If it is changed or updated, the data must be transferable. One problem is that electronic records are comprised of databases, which are dynamic, that is, the content changes as new information is added. Worse, data can be changed or deleted, with no evidence and in a manner that destroys the original data. System access must be limited to authorized individuals. There must be regular system checks. There must be time- and date-stamped audit trails. If changes are made in the database, the audit trail must show who made the changes, when, what the old and new values are, and why the data were modified Analytical chemistry by GD CHristian
- Access to the system must be limited to authorized persons. The type of security will depend on whether the system is open or closed. Electronic signature technologies include identification codes (usernames, passwords) or more sophisticated biometric systems (based on measurement of physical features such as palm prints, fingerprints, or iris or retinal pattern scanners). The latter is expensive and less likely to be implemented, especially for multiple users. User names must be unique and never reassigned. Passwords should be unique and changed periodically
- Another form of external evaluation is laboratory accreditation by a formal organization or government agency. This is generally voluntary but may be required for laboratories dealing with regulatory measurements. Accreditation is a procedure by which an authoritative body gives formal recognition that the laboratory is competent to carry out specific tasks. The accreditation procedure may take the form of qualitative inspection of the laboratory operations, to verify that good laboratory practice policies are followed, that is, proper documentation and record keeping, validation, proficiency testing, and the like. Or it may include measurement of submitted reference materials. In any event, certification will involve periodic laboratory audits, which may be unannounced. Validation determines the suitability of an analysis for providing the sought-for information and can apply to samples, to methodologies, and to data. Validation is often done by the analyst, but it can also be done by supervisory personnel. Validation of samples is often used to accept samples as members of the population being studied, to admit samples for measurement, to establish the authenticity of samples, and to allow for resampling if necessary. I
- Another form of external evaluation is laboratory accreditation by a formal organization or government agency. This is generally voluntary but may be required for laboratories dealing with regulatory measurements. Accreditation is a procedure by which an authoritative body gives formal recognition that the laboratory is competent to carry out specific tasks. The accreditation procedure may take the form of qualitative inspection of the laboratory operations, to verify that good laboratory practice policies are followed, that is, proper documentation and record keeping, validation, proficiency testing, and the like. Or it may include measurement of submitted reference materials. In any event, certification will involve periodic laboratory audits, which may be unannounced. Validation determines the suitability of an analysis for providing the sought-for information and can apply to samples, to methodologies, and to data. Validation is often done by the analyst, but it can also be done by supervisory personnel. Validation of samples is often used to accept samples as members of the population being studied, to admit samples for measurement, to establish the authenticity of samples, and to allow for resampling if necessary. I
- Effective quality assurance is proactive. It aims to prevent defects before they occur through process design. QC is reactive and exists to identify defects after they have happened. QA involves the design of processes, such as documenting standard operating procedures (SOPs). A safe, effective product should be the result every time processes are followed. QC involves the testing of products to ensure they meet standards for safety and efficacy. If QC testing uncovers quality issues, it should result in reactive steps to prevent an unsafe product from being shipped and distributed. Ideally, QC issues should also spark a QA review. Non-conforming test results should result in corrective and preventive action (CAPA) investigation to determine the root cause of quality issues and update processes to prevent the problem from happening in the future.
- QA is process-oriented, and it focuses on preventing quality issues. QC is product-oriented and focused on identifying quality issues in manufactured products. Another way to understand this distinction is actions vs. results. QA involves the actions which create the product, while QC is focused on the resulting product. Several examples of each type of activity are detailed below. System (QA) vs. Parts (QC) Quality assurance control systems are the methods and procedures which are used to safeguard quality standards. Quality control systems measure parts, including the outputs of the system. QC efforts may also be focused on parts used to create the final product, such as raw materials from a supplier. The QA system for quality management may dictate various activities to make sure inputs are consistently safe and effective, such as auditing suppliers and batch sampling raw materials.
- Creation (QA) vs. Verification (QC) The result of QA activities is a roadmap for creating high-quality products. It involves defining standards for product design, manufacture, packaging, distribution, marketing, and sales. QC involves verification of products post-manufacture and before distribution, or confirming safety and efficacy. Entire Team (QA) vs. Dedicated Personnel (QC) Quality assurance activities involve the entire team. Every member of a life sciences organization is responsible for QA activities by following SOPs. While the quality management system (QMS) is generally the responsibility of the quality unit and the leadership team, QA activities involve standards for training, documentation, and review across the workforce. QC is generally the responsibility of certain personnel within the organization whose duties include following SOPs for product testing. QC staff follow SOPs for quality control and document their findings based on standardized procedures for product testing and process validation. https://www.qualio.com/blog/quality-assurance-vs-quality-control
- Quality Assurance: a Strategy of Prevention QA is focused on planning, documenting and agreeing on a set of guidelines that are necessary to assure quality. QA planning is undertaken at the beginning of a project, and draws on both software specifications and industry or company standards. The typical outcomes of the QA planning activities are quality plans, inspection and test plans, the selection of defect tracking tools and the training of people in the selected methods and processes. The purpose of QA is to prevent defects from entering into the solution in the first place. In other words, QA is a pro-active management practice that is used to assure a stated level of quality for an IT initiative. Undertaking QA at the beginning of a project is a key tool to mitigate the risks that have been identified during the specification phases. Communication plays a pivotal role in managing project risk, and is crucial for realising effective QA. Part of any risk mitigation strategy is the clear communication of both the risks, and their associated remedies to the team or teams involved in the project. Quality Control: a Strategy of Detection Quality Control, on the other hand, includes all activities that are designed to determine the level of quality of the delivered ICT solutions. QC is a reactive means by which quality is gauged and monitored, and QC includes all operational techniques and activities used to fulfil requirements for quality. These techniques and activities are agreed with customers and/or stakeholders before project work is commenced. QC involves verification of output conformance to desired quality levels. This means that the ICT solution is checked against customer requirements, with various checks being conducted at planned points in the development lifecycle. Teams will use, amongst other techniques, structured walkthroughs, testing and code inspections to ensure that the solution meets the agreed set of requirements. https://www.dialog.com.au/open-dialog/the-difference-between-quality-assurance-and-quality-control/