SKTB4133: Quality Management in Biomanufacturing (2022-2023-II)

Internal Audit

What is Internal Audit?

A systematic examination of facilities, equipment, personnel, training, procedures, record keeping, data validation, data management, and reporting aspects of a system    

TO      

determine whether QA/QC and technical activities are being conducted as planned and these activities will effectively achieve quality objectives.

Ref: •ISO 19011:2018, item 3.1 (Guidelines for Auditing Management Systems)

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Audit Methodology

  1. Evidence-based approach
  2. Process-based approach
  3. Risk-based approach

How to use these approaches ? Attend the scheduled classes…

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Audit Flow

Attributes of an internal auditor:

Speak clearly & simply
Look at the person
Rephrase the question if necessary
Ask the right person
Be impartiality
Be unemotional
Give praise if deserved
Smile & relax
Please send email / whatapp (chualeesuan@utm.my) to me for additional attributes that you think the auditor shall equip with

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