SOP on Quality Audits

SOP on Quality Audits
1.0 Purpose: The objective of this SOP is to describe the method of auditing department in order to ensure compliance with regulations and guidelines, as well as internal standards and policies.
2.0 Scope: This SOP applies to all audits conducted by the Quality Assurance Manager.
3.0 Responsibility: 
3.1 It is the responsibility of the Quality Assurance Manager to inspect departments at least annually to ensure compliance with FDA regulations and guidelines, as well as internal standards and policies. It is also Quality Assurance Manager Responsibility to document each auditing event.
3.2 It is the responsibility of each department to provide access by Quality Assurance Manager. Each department is also responsible for responding in writing within 30 days to Quality Assurance recommendations for action to be taken.
4.0 Materials and Equipment: Audit records
5.0 Procedure:
5.1 Preparation for Audit – 
5.1.1 Review the last internal audit. Note the citations and comments so that these can be evaluated during the audit.
5.1.2 Contact the department for a work schedule and agree on meeting dates.
     
5.2   Audit
5.2.1 The audit is to take place during normal working hours.
5.2.2 The audit work is done in cooperation with department personnel.
5.2.3 The audit is carried out using the approved checklist.
5.2.4 The Quality Assurance auditors, after the audit write up a report of the findings on the department. These comments are classified as follows – 
a. Critical – a problem that directly affects the product.
b. Major – a problem that may affect the product.
c. Minor – an issue that does not directly affect the product.
5.2.5 The auditors hold a meeting with the department personnel to discuss the findings and agree on improvements to be made.
5.2.6 The department respond to the findings with the improvements to be made and their expected completion dates.
5.2.7 The auditors follow up on the issue to ensure that they are being resolved and that compliance has improved. A follow-up report is prepared.
5.2.8 The Quality Assurance Manager maintains all the records of audit.
5.3. Frequency of Audit – Quality Assurance will audit for each department at least once in a year. Unannounced audits may occur at any time by the regulatory authorities.

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