How to Prepare for a Quality Audit

Does anyone like audit at all? It may be a nerve wrecking situation when it came to audit.  Did anyone notice that many employees tend to take day off on audit day?  They were afraid that they will be accountable to any mistake made on audit day.  Is this true? I am surprise how this will effect other employees but with much preparation, I am sure we can address many fear or uncertainty on the audit day.  Most auditors do not look for problems rather they rather find improvement to enhance the Quality System.

Before you become a good auditee, you have to learn to know how to become a good auditor.  When I started to be involved in auditing,  I realize that documentation is a must have.  We also need to study about the process or the organization, the best way to do this is by establishing a creating a checklist.  Here's a step by step process on how to develop one with ease.

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'.  So obviously as anditee, you have a upper hands on the situation.  

During the audit, 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

There are 3 stage of audit:

The Audit Visit: Stage I Audit

Auditor 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:
When auditing, we have to consider some techniques/communication to ensure we achieve the audit objective and get as much information and objective evidence as possible.

The audit techniques are:

• 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

There are also non-verbal action which help to draw out information from auditees.  This will help auditees to feel comfortable and more confident answering your questions.

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???  

Most auditors need to acquire these skills as well:

• 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.

Once you understand how an audit works, you should be able to sit back and enjoy your day..

How to conduct Internal Quality Audit?

Plan your audit way ahead..

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 objective?

Record the approved procedure (this protects it against the unexpected such as sudden illness)
Ensure the approved procedure is followed
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 of an audit?

• People
• Documentation
• Process

1. 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.

2.Documentation:

ISO9001:2015 Structural of new standard

• Section 1: Scope

• Section 2: Normative references

• Section 3: Terms and definitions

• Section 4: Context of the organization

• Section 5: Leadership

• Section 6: Planning

• Section 7: Support

• Section 8: Operation

• Section 9: Performance evaluation

• Section 10: Continual Improvement

Objective Evidence
Data Supporting the existence or verification of something.

Documented Requirement:

• Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
• Records of training, skills, experience and qualifications (clause 7.2)
• Product/service requirements review records (clause 8.2.3.2)
• Record about design and development outputs review* (clause 8.3.2)
• Records about design and development inputs* (clause 8.3.3)
• Records of design and development controls* (clause 8.3.4)
• Records of design and development outputs *(clause 8.3.5)
• Design and development changes records* (clause 8.3.6)
• Characteristics of product to be produced and service to be provided (clause 8.5.1)
• Records about customer property (clause 8.5.3)
• Production/service provision change control records (clause 8.5.6)
• Record of conformity of product/service with acceptance criteria (clause 8.6)
• Record of nonconforming outputs (clause 8.7.2)
• Monitoring and measurement results (clause 9.1.1)
• Internal audit program (clause 9.2)
• Results of internal audits (clause 9.2)
• Results of the management review (clause 9.3)
• Results of corrective actions (clause 10.1)

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.

3. Process:

Method of conducting an Internal audit process are as follows: 

• Identify Audit Scope
• Select Audit team
• Plan Initial audit meeting
• Audit team briefing
• Audit visit
• Feedback from auditees during visit
• Report to auditee for comment
• Confirm report
• Feedback of report from auditees

Other Administration stuffs:

1. Identify quality contacts (Quality Manager, Quality Engineer, Management Representative)
2. Identify auditee (if you are not familiar with the department, be sure to contact quality contacts at relevant department for direction)
3. Schedule an audit with auditee (you could schedule  pre-audit before going on full audit)

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