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Quality Assurance General Concept

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This document provides an overview of quality assurance concepts, including definitions, types of audits, audit reporting, principles of quality audit programs, product audits, and sampling for product audits. It defines quality assurance as the total arrangements to ensure pharmaceutical products are suitable for their intended use. It describes internal, external, and regulatory audits. Audit reports should document findings, recommendations, and corrective actions. Product audits evaluate product quality and compliance to determine fitness for use, while sampling determines sample sizes for auditing mass produced products.

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A Presentation On Quality Assurance General Concept By Mr. Krushnakant K. Wable
Contents- Definition Quality Audit Audit Reporting Principles of Quality Audit Programme Product Audit Sampling for Product Audit Reporting the Results of Product Audit References 2
Definition of Quality Assurance by WHO: "Quality Assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangement made with the object of ensuring that pharmaceutical products are of the quality required for their intended use, Quality Assurance therefore incorporates GMP and other factors, including those outside the scope of this guide, such as product design and development". 3
4 Definition of quality assurance by M.C.C. South africa: "Quality assurance is the sum total of organized arrangement made with the objective of ensuring that medicines are of the quality required for their intended use. It is thus a wide ranging concept, covers all matters affecting quality. It is the sum total of the organised arrangement made with object of ensuring the medicinal products are of quality required for their ultimate use".
5 What Is An Quality Audit ? an audit is a tool used to check, assess, analyse or verify to determine compliance and or an opportunity for improvement. Audits are tools to help an organisation review its processes, outcomes and activities. The outcome of an audit may result in any one or more of the following: A verification of compliance or non-compliance with a pre-determined criteria (e.G. Standard, procedure, regulation, etc) Evaluation of effectiveness of process/activity being audited Areas identified requiring improvement Non-compliances highlighted for corrective action.
6 Types of Audit : 1. Internal Audit : Also called as operational audit. This audit is taken by an organization to provide assurance over the effectiveness of internal control & fascillate objective of organization. Internal audit is performed by employee of organization to oppose the external audit. 2. External Audit : Also known as financial audit. The external auditor is independent of organization. This audit is taken for separation of ownership and control in large companies in which stakeholder nominates directors to run the affairs of company on their behalf.
7 3. Regulatory authority audit: It is public authority or government agencies responsible for autonomous authority over some area of human activity. Regulatory authorities are setup to maintain standards and safety to oversee use of public goods. There are different regulatory authorities like TGA, WHO, FDA, etc.
8 Audit Reporting: Audit results should documented in reports. Auditors and activity audited should agree in advanced on distribution audit reports. Audit Report include following items: Executive summary Purpose and scope of audits Details of audit plan Standards, checklist or other reference documents used during audit Recommendations for improvement opportunities Recommendation for corrective actions implemented by line management Distribution list of audit reports
9 Summarizing Audit Data: 1. Reports of each discrepancy to secure corrective action. 2. Reports of overall status subject matter under review.
Principles Of Quality Audit Programme: Five principles are essential for successful quality audit programme. 1. An uncompromising emphasis on conclusion based on facts. 2. An attitude is part of auditor provide assurance to management and useful service to line manager to manage their departments. 3. Opportunity for improvement including good ideas. 4. Addressing the human relation issue discussed. 5. Competence of auditor.
11 Product audit: A product audit is an independent evaluation of products quality to determine its fitness for use and conformance to specifications. Purpose of product audit: To estimate quality delivered to customer. To evaluate effectiveness of product. To provide information about improvement in effectiveness of product Ideally in product audit actual service performance is compared with users need.
12 Scope of Product Audit: To measure customers reactions. By the focused audit, concentrate on the specific area of product, which needs to studied. As random samples was selected for sampling so real status of qualities easily identified.
13 Sampling For Products Audit: For product manufactured by mass production, sample size for product audit can often determined by conventional statistical methods. In contrast product manufactured in large units in small quantity, the conventional statistical sampling is costly. In such case the sample size seems small from probability point of view.
14 Reporting the results of product audit: Results of product audit appeared in the form of presence or absence of defects, failure etc. Rating of quality is then prepared based on audit results. Product audit programme often use seriousness classification of defects such as critical, major, minor. A manufacturer of consumers product classifies defect in product audit as visual, performance and predict service cost. Audit can also summarize to show effectiveness of previous inspection activities.
15 References: M.A.Potdar, Pharmaceutical Quality Assurance, Nirali Prakashan;5.1- 5.58,(dec 2007). Frank M Gryna , Richard Chua , Joseph Defeo ; Jurans Quality Planning & Analysis for Enterprise quality ; 5th Ed. ;Pg no : 526-544 .
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Quality Assurance General Concept

  • 1. A Presentation On Quality Assurance General Concept By Mr. Krushnakant K. Wable
  • 2. Contents- Definition Quality Audit Audit Reporting Principles of Quality Audit Programme Product Audit Sampling for Product Audit Reporting the Results of Product Audit References 2
  • 3. Definition of Quality Assurance by WHO: "Quality Assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangement made with the object of ensuring that pharmaceutical products are of the quality required for their intended use, Quality Assurance therefore incorporates GMP and other factors, including those outside the scope of this guide, such as product design and development". 3
  • 4. 4 Definition of quality assurance by M.C.C. South africa: "Quality assurance is the sum total of organized arrangement made with the objective of ensuring that medicines are of the quality required for their intended use. It is thus a wide ranging concept, covers all matters affecting quality. It is the sum total of the organised arrangement made with object of ensuring the medicinal products are of quality required for their ultimate use".
  • 5. 5 What Is An Quality Audit ? an audit is a tool used to check, assess, analyse or verify to determine compliance and or an opportunity for improvement. Audits are tools to help an organisation review its processes, outcomes and activities. The outcome of an audit may result in any one or more of the following: A verification of compliance or non-compliance with a pre-determined criteria (e.G. Standard, procedure, regulation, etc) Evaluation of effectiveness of process/activity being audited Areas identified requiring improvement Non-compliances highlighted for corrective action.
  • 6. 6 Types of Audit : 1. Internal Audit : Also called as operational audit. This audit is taken by an organization to provide assurance over the effectiveness of internal control & fascillate objective of organization. Internal audit is performed by employee of organization to oppose the external audit. 2. External Audit : Also known as financial audit. The external auditor is independent of organization. This audit is taken for separation of ownership and control in large companies in which stakeholder nominates directors to run the affairs of company on their behalf.
  • 7. 7 3. Regulatory authority audit: It is public authority or government agencies responsible for autonomous authority over some area of human activity. Regulatory authorities are setup to maintain standards and safety to oversee use of public goods. There are different regulatory authorities like TGA, WHO, FDA, etc.
  • 8. 8 Audit Reporting: Audit results should documented in reports. Auditors and activity audited should agree in advanced on distribution audit reports. Audit Report include following items: Executive summary Purpose and scope of audits Details of audit plan Standards, checklist or other reference documents used during audit Recommendations for improvement opportunities Recommendation for corrective actions implemented by line management Distribution list of audit reports
  • 9. 9 Summarizing Audit Data: 1. Reports of each discrepancy to secure corrective action. 2. Reports of overall status subject matter under review.
  • 10. Principles Of Quality Audit Programme: Five principles are essential for successful quality audit programme. 1. An uncompromising emphasis on conclusion based on facts. 2. An attitude is part of auditor provide assurance to management and useful service to line manager to manage their departments. 3. Opportunity for improvement including good ideas. 4. Addressing the human relation issue discussed. 5. Competence of auditor.
  • 11. 11 Product audit: A product audit is an independent evaluation of products quality to determine its fitness for use and conformance to specifications. Purpose of product audit: To estimate quality delivered to customer. To evaluate effectiveness of product. To provide information about improvement in effectiveness of product Ideally in product audit actual service performance is compared with users need.
  • 12. 12 Scope of Product Audit: To measure customers reactions. By the focused audit, concentrate on the specific area of product, which needs to studied. As random samples was selected for sampling so real status of qualities easily identified.
  • 13. 13 Sampling For Products Audit: For product manufactured by mass production, sample size for product audit can often determined by conventional statistical methods. In contrast product manufactured in large units in small quantity, the conventional statistical sampling is costly. In such case the sample size seems small from probability point of view.
  • 14. 14 Reporting the results of product audit: Results of product audit appeared in the form of presence or absence of defects, failure etc. Rating of quality is then prepared based on audit results. Product audit programme often use seriousness classification of defects such as critical, major, minor. A manufacturer of consumers product classifies defect in product audit as visual, performance and predict service cost. Audit can also summarize to show effectiveness of previous inspection activities.
  • 15. 15 References: M.A.Potdar, Pharmaceutical Quality Assurance, Nirali Prakashan;5.1- 5.58,(dec 2007). Frank M Gryna , Richard Chua , Joseph Defeo ; Jurans Quality Planning & Analysis for Enterprise quality ; 5th Ed. ;Pg no : 526-544 .