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Contents:
Definition Objectives Principles of Auditing Types of Audits Audit life cycle Audit methods and techniques Role of GMP Audit in Q.A and Q.C Programmes Requirements of ISO Elements of a systematic Audit programme Audit team Reporting Audit Finding Benefits of Audit References
Quality audit means a systematic of a quality system. Quality audits are typically performed at defined intervals. Any failure in their proper implementation may be published publicly and may lead to a revocation of quality certification.
Contd.
A first party audit is an audit performed by an organisation on itself i.e. an internal audit. A second party audit is an audit performed by one organisation on its own behalf on another usually on a supplier by a customer. A third party audit is an audit by an independent organisation other than the customer on a supplier.
Principles of Auditing
The various principles of auditing are: Ethical Conduct: The foundation of Professionalism, Trust, Integrity, Confidentiality and discretion are essential to auditing. Fair Presentation: The obligation to report truthfully and accurately. Due professional care: The application of diligence and judgment in auditing. Independence: The basis for the impartiality of the audit and objectivity of the audit conclusions. Evidence based approach: The rational method for reaching reliable and reproducible audit conclusions in a systematic audit process.
c) External Audit:
This is an audit that a company performs on its own suppliers or subcontractors. Purpose of external audit: Confidence in the partnership arrangement. Ensuring that requirements are understood. Enabling reduction of in-house Q.C testing of starting materials. Reducing the risk of failure.
d) Internal Audit
This is the most Important types of audits, which requires the company to look into its own systems, procedures and activities in order to ascertain whether they are adequate and being compiled with. It provides the management with the information on whether or not their policies are being met, if the system is as efficient and as effective as it should be and whether any changes are needed. It can provide a line of communication throughout the company and be a great motivator.
1. Horizontal Auditing
It involves examination of each functional area of an organization to verify adequacy and implementation of Quality. System requirements: Used for internal system auditing and second & third party assessment when it is necessary to establish if a basic QMS has been installed and is being implemented and maintained. Each functional area is checked for conformance with quality system requirements, applicable to that area.
2. Vertical Auditing
It involves examining functional areas of an organization that are actively contributing to a specific work package or contractual requirement.
3. Random auditing
It examines the various aspects of an organizations operation as determined by the auditor and due to the need to closely examine a particular actively or generally probe the system in arandom manner.
Requirement of ISO:
Audit procedure An audit schedule that takes into consideration the audit areas status and import results of previous audits. Trained objective and impartial auditors. An audit report including audit criteria, scope and methods. Timely corrective action of deficiencies found. Records that provide evidence that corrective action was implemented and its effectiveness was verified. Results are reviewed by top management.
Checklist Format
Use checklist as GMP audit guides and report finding. Series of questions or instructions are grouped into logical order Blocks may be used to record answer and space may be provided to make comments.
Audit Team
The personnel in the audit team are selected based on their experience and knowledge. The team is required to cover many different systems and large amount of data. Composition of team will vary depending upon the nature and scope of the audit. Leader is usually a senior auditor who has extensive knowledge of the firms operations & has strong leadership qualities. Tem size depends upon: Firm size Total number of products manufactured & control systems. The audit objective
References
Y. Anjaneyulu, R. Marayya; Quality Assurance & Quality management in Pharmaceutical Industry; Pharma Book Syndicate; Page no. 209-218. http://wisqa.org/Archive2002/nov2002/i nternal%20auditing%20presentation/ppf rame.htm http://www.authorstream.com/Presenta tion/13vinay-1177733-quality-audit/
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