Common Questions during IQA

I've been doing alot of presentation on how to conduct IQA, sometimes old habit die hard, I tend to be technical with the jargons, so since my posting is derived from my presentation, I hope I can enlighten you with the audit methods.

When you come to the place to audit, introduce yourself and inform your auditee the reasons for the visit. DO not intimidate your auditee, auditee suppose to assist the auditee and not find faults on the audit site. (You should have with you, Quality Questionnaires and Quality plan)

Here's are more example on questions you may ask during your audit?

1. Do you know what is the company quality policy? (make sure the policy is visually display)
   
2. Do you know how to operate this machine? Can you show me how to conduct quality check/test?
3. Where's the quality tools? (check if the tools have proper identification, calibrated & easy to access)
4. Where is the SOP? (Check if the SOP has validation, updated and easy to understand)
5. Do you go through any training? (check his training records to verify)
6. Where are your checklist?
   
7. How often do you check the item?
8. If you are on day off, who take over your job as operator/QC checker?
9. Who is the QMR?(we need to ensure quality is communicated throughout the organisation, from top down)
   
10. other relevant questions.

Remember to cross reference with records or other employee to verify the answer.
Once the audit is done, thank the auditee and do share some improvement activities for the site too.

How to Evaluate IQA Findings?

Evaluation of results/Audit Findings

Categorization of Non-Conformance: this is to allow an organization to priorities its correction and prevention efforts in an effective manner.

Major non-conformance

• An element of the standard is not addressed. (e.g. No manual, no policy, no significant procedure manual)
• An activity, which is in direct contravention of standard.
• An activity, which is in direct contravention of a procedure and could have significant effect on product and service quality.

Minor Non-conformance

• An isolated incident of a non-conformance with a system or procedural requirement with no direct consequential effect on product/service quality.
• Trends of minor non-conformance could lead to major non-conformance if more than 3 incidents of the same deficiency are encountered.

Observation

• Comments on the quality system with a view to improvement.

What do you do during audit?

Documentation : Checklist

Six steps for developing process checklists

Step 1: Consider the overall business goals.

Step 2: Review the core process(es) and required outcomes

Step 3: Review of any documentation relevant to outcomes.

Step 4: Establish process issues critical to outcomes

Step 5: Prioritize the points.

Step 6: Prepare the checklist

The Audit Visit:

The Auditors will normally visit the Auditees on their 'home territory'.

The Auditors should be:

• Clear on the aims of the audit
• Clear on the Scope/boundaries of the audit
• Polite at all times
• Courteous
• Confident
• Well prepared
• Thorough

The Audit Visit: Stage I Audit

• Will look at the process as presented by the Auditees and whether or not:
• the Auditees follow the process as presented
• the Auditees understand the process as presented
• the Auditees recognize the process as presented
• the Auditees find that it works

• Where there is no documentation the Auditors should ask for an oral account of the procedure(s) that are followed for the particular process being audited. In such cases the audit report will include a strong recommendation that the procedures are documented.

• If there are 'Service Standards' connected to the process or function they should be uncovered, but not imposed if there are none to begin with.

The Audit Visit: Stage II or Follow-Up Audit

• It is expected that, by this stage, the process has been documented, so the audit will look to see if the process is being followed as stated by the staff that use it.
• The audit will also look for continual re-evaluation of the working practice and procedures and any improvement necessary. In addition the Audit will ensure that all staff involved with the process have understood and incorporated any changes made.
• The ability of the staff to reflect on their work should be aided by the independent and unprejudiced nature of Internal Quality Audit.
• Auditors when making their visit should take into consideration the Company’s Plan where that plan contains targets pertinent to the process being audited.

Conducting audit:
Audit techniques/communication

• 7% Verbal

What was said

• 38% Vocal

How it was said; pitch, rhythm, enthusiasm

• 55% Non-verbal

Body language, gestures, culture, personalities, space and setting, word meanings, emphasis and punctuation

Non-Verbal Actions

• Positive Non-Verbal Actions
• Leaning Forward
• Eye contact
• Facing the person
• Relaxed posture
• Negative Non-Verbal Actions
• Leaning away
• Avoiding eye contact
• Standing above or behind auditee’s (confrontation)
• Standing/sitting too close
• Sitting on auditee’s work bench
• Carrying clipboards
• Loud emotive tones
• Threatening gesture
• Pointing directly at auditee’s

What else???

• Effective listening
• Hearing is not listening
• Aids to effective listening
• Use attentive body language
• Learn to use your thinking time wisely
• Become an observer (control your mouth)
• Listen with open mind
• Listen all the why through (don’t make assumption)
• Effective Observation
• Observation must be substantiated with objective evidence.