What to do during Internal Audit?

What is Internal Quality Audit?

Known as 1st party audit whereby the company aim to provide a mechanism for ensuring conformity to the quality system and to assist in the ongoing improvement to the system.

What is the objectives?

1. Record the approved procedure (this protects it against the unexpected such as sudden illness)
2. Ensure the approved procedure is followed
3. Question existing procedures - has the context within which the procedure operates changed enough to make a revised procedure more effective and efficient?

What are the requirement for an audit?

• People
• Documentation
• Process

People

The internal audit should conducted by competent team and lead by skilled Internal audit Lead auditor. How to ensure this by having all the team member to attend Internal Audit Training. The lead auditor should has experience with quality assurance background, preferably has attended the Lead Quality Auditor/ Accessor course.

Characteristics and skills which are important in the auditor role:

• being a good listener
• being articulate and having good written and oral communication skills
• being confident
• paying attention to detail - but not ‘nit-picking’
• being rigorous - but not antagonistic or aggressive
• being sensitive and approachable, able to put people at ease
• being systematic
• being patient
• being courteous having a commitment to quality development

Documentation
1. ISO 9000:2000
Structural of new standard

• Clause 4 : QMS
• Clause 5 : Management Responsibility
• Clause 6 : Resource Management
• Clause 7 : Product realization
• Clause 8 : Measurement, analysis and improvement.

(Refer to Malaysian Standard : MS ISO 9001:2000)

2. Objective Evidence
Data Supporting the existence or verification of something.

Objective evidence may verify:

• That specific requirements have been fulfilled.
• That requirements for specific use/application have been fulfilled.
• Suitability, adequacy and effectiveness to achieve established goals.
• Format may include hard or softcopy documentation, forms, record, verified statements of fact, observations or other information relevant to the audit.

Process of collecting objective evidence is two stages.

Obtain Information ---->Verify Evidence

For example, when you need to check on employees competency, you can interview both the QMR and auditees. They will provide you with the information verbally. That is called "obatain information". But you need to confirm the information given to ensure it is documented and valid, therefore you need to check the employee information agains his/hers training record, you will also need to ensure the records are updated and checked (signed), the second process is called "verify evidence".

Process:

1. Identify Audit Scope
2. Select Audit team
3. Plan Initial audit meeting
4. Audit team briefing
5. Audit visit
6. Feedback from auditees during visit
7. Report to auditee for comment
8. Confirm report
9. Feedback of report from auditees

Once you have conducted all this, it should be easier to handle the internal audit.