Follow
1.0 OBJECTIVE
To establish a procedure for selection, evaluation and subsequent appointment of personnel for conducting quality audits on QM-System and vendors.
2.0 SCOPE
This SOP shall be applicable for the auditors for the QM-System as well as vendor auditing.
3.0 ASSOCIATED DOCUMENTS
Not applicable.
4.0 RESPONSIBILITY/ACCOUNTABILITY
4.1 Head of Quality/Sr. Manager, Quality shall be responsible and accountable for selection, evaluation and subsequent appointment of Auditors.
5.0 ABBREVIATIONS AND DEFINITIONS
Not applicable.
6.0 PRECAUTIONS /SPECIAL INSTRUCTIONS
Not applicable.
7.0 PROCEDURE
7.1 Selection of Auditors
Auditors for Internal Quality Audits/Self Inspection
7.1.1 BPL maintains a team of auditors to perform the planned audits in scheduled time. To do so, new auditors are appointed from time to time. Head of Quality/Sr. Manager, Quality shall select Officers from different departments to undergo training and evaluation.
7.1.2 Before selecting auditors the Head of Quality/Sr. Manager, Quality shall consider following points.
Auditors shall be selected from different department to enable audit of one department being done by officers of other department.
The officer who has been selected must be, B3 or above grade Officer and having minimum 2 years working experience in Pharmaceutical Industry.
Auditors for Vendor Audit
7.1.3 The Head of Quality/Sr. Manager, Quality shall designate external qualified auditors or in-house experienced auditor (minimum five years) to conduct vendor audit.
7.2 Training for Auditors
7.2.1 The Head of Quality/Sr. Manager, Quality shall select trainer, usually auditors who are already auditing, to conduct training for selected candidates and also set the schedule, outline and content of the training.
7.2.2 Curriculum of Training
The training curriculum shall cover following topics :
Basics of QM-System
Understanding the requirements
Overview on quality objectives, quality manual and SOP
Fundamentals and Procedure for Audit
Objectives of quality audit
Principles for auditors
Course of audit interview
Standardization of questions
Conversation techniques
Authorities and responsibilities
Implementation Audit
Understanding audit-focus, which is set by Head of Quality/Sr. Manager, Quality
Preparation of checklist
Report writing procedure and submission of report
Evaluation of the proposed corrective measures
7.3 Evaluation of Knowledge and Performance of Trainees
7.3.1 Each trainee shall conduct an audit as leader on pre-select SOP in front of trainer. Trainer shall evaluate the performance as auditor in different aspects i.e., preparation of checklist, report submission, communication skill etc. and rate in quantitative term in record sheet.
7.3.2 After filling-in the training record of individual trainee, trainer shall forward it to the Head of Quality/Sr. Manager, Quality.
7.4 Final Interview and Recommendation
7.4.1 The Head of Quality/Sr. Manager, Quality shall take interview of each trainee and judge the suitability on the basis of performance in earlier events (those are recorded in the same).
7.4.2 If the candidate gets more than 50% marks in average, then he/she is recommended by Head of Quality/Sr. Manager, Quality to conduct audit along with the existing Auditors.
7.4.3 The selected candidate has to conduct three audits before he is appointed by the Head of Quality/Sr. Manager, Quality as Auditor.
7.4.4 The existing auditors shall be given training from time to time on updated information.
