QMS Audit Process June 2015

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Page 1: QMS Audit Process June 2015




Page 2: QMS Audit Process June 2015

Presenter’s Name


AuditingWhat is an audit?

Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled

Why audit?Requirement of ISO 9001:2008Monitor and measure the management system

Measurement for adequacy / gap Measurement for performance

Promote continuous improvement of the management system

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Principles relating to auditors:

Ethical conduct Fair presentationDue professional care

Principles relating to audit:

IndependenceEvidence-based approach

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•Identifies improvement opportunities•Continuous improvement if performed regularly•achieves planned results and yields continual improvement of processes.

Verifies conformity to requirements

Provides a measurement of effectiveness of the management system to top management


Increases awareness and understandingReduces risk of management system failure

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Types of Audits Registration / Certification: The initial audit to get an

organization's system certified

Surveillance : ongoing periodic review of an organization's quality management system, by a third party registrar

Product: often referred to as a quality audit -- is an inspection of a final product before delivering it to a supplier or a customer

• Customer contract Audit: ensures that the agreement is being executed in accordance with the intent of all parties to the contract

Gap assessment / Pre-assessment: comparison of actual performance with potential or desired performance

Combined audit / joint audit: of a firm/country by two different entities simultaneously having some common interests.

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PDCA (Plan-Do-Check-Act)



The Plan-do-Check-Act (PDCA) methodology applies to all processes

•Deploy and conform with plan


•Analyze/review•Decide/change•Improve effectiveness

•Measure and monitor for conformity and effectiveness

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Process Auditing “Turtle Diagram”

With what?Resources With who?


What results?Performanceindicators


InputsFrom Whom/Where

How done?Methods/Documentation

Process(specific value-added activities)

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Process Auditing Example

With what?• Order processing


With who?• Customers•Competent sales and processing staff

What results?• Order processing

time• Number or orders• Value of orders• Contract accuracy

OutputsProduction/Service Delivery

Inputs• Customer requirements• Sales staff

How done?• IT system• Processing system• Terms and conditions• Contract review procedure


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Elements of Quality Management System Audit

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Typical Audit Activities

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Typical Audit Activities




Initiating the Audit


Conducting Document Review

Preparing for On-site Activities

Conducting for On-site Activities

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Typical Audit Activities




Preparing & Reviewing Audit Report


Distributing Audit Report

Corrective Actions Report

Conducting Audit Follow-up

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Initiating the audit includes:

Appointing the audit team leaderDefining audit objectives, scope, criteriaDetermining feasibility of the auditSelecting the audit teamEstablishing initial contact with the auditee


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Selecting the Audit TeamFor Team size and competence, consider:

Audit objectives, scope, criteria, and durationWhether audit is combined or jointCompetence of team to meet objectivesStatutory, regulatory, contractual and accreditation/certification requirementsIndependence of the team

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Auditor CompetencePersonal Attributes







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2. Conducting Document Review

A review of documentation includes:Should be conducted prior to on-site audit activities unless deferring review is not detrimental to the effectiveness of the audit

May include relevant QMS documents, records, and previous audit reports

May include a preliminary site visit


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3. Preparing on-site Audit Activities

One Approach is to:oIdentify audit scope and process(es) within scopeoIdentify applicable factors (inputs, outputs, measures, resources, etc.)oUse these points and other requirements

(ISO 9001-2008, system documentation, etc.) to:Plan what to look atPlan what to look for (audit evidence)

• Prepare checklist

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Audit checklist structure:

Process/Activity Audited:

Requirement Source Evidence Notes

ISO 9001:2008Clause # or other


What to “look at”

What to“look for”


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4. Conducting on-site Audit Activities

Conduct opening meeting

Communicate during the audit

Explain roles and responsibilities of participants

Collect and verify information

Generate audit findings

Prepare audit conclusions

Conduct closing meeting

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Opening Meeting

Hold opening meeting with auditee top management and those responsible for processes audited

Meeting may be informalChaired by team leaderAudit team presentPurpose is to confirm all prior arrangements

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Sources of


Collect by

appropriate sampling

& verification

Evaluate against

audit criteria

Collecting and Verifying Information

Audit Conclusions

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Auditing Process Collect information relevant to:

Audit objectives, scope, and criteria interfaces between functions, activities and processes

Collect audit evidence by appropriate sampling and verify and record it

Be aware on sampling limitations, if acting on the audit conclusion Use only information that is verifiable as audit evidence

Interview: Personnel that manage, perform, and verify activities Also ensure they are responsible for the activity being audited Listen carefully to responses

Observe: Identity, status, condition, processes, equipment, activities,

environment, and people

Auditing Techniques

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During Interview…….. Show interest Be tactful and polite Show patience and understanding Remember to say please and thank you Ask the right person Don`t say you understand when you do not Put auditee at ease Ask short questions and listen Reflect right attitude, tone of voice, body

language, and facial expressions Smile and show eye contact Avoid interruptions Avoid insulting and arrogant remarks Give praise when appropriate

Empower Teams

Respect Individuals

Maintain Agility

Own Decisions

Maintain Agility

Enjoy Work

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Questioning TechniquesOpen question

Using why, who, what, where, when, or how gets more than a yes or no answer

Expansive question Further elaborates the current point

Opinion question Asks opinion about current point

Non-verbal Uses body language, for example: raise eye-brow to elicit further

informationAVOID (or minimum) Repetitive question

Repeats back response in form of a question Hypothetical question

Uses what if, suppose that, etc. Closed questions as they draw answers in yes or no

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5. Preparing & Reviewing the Audit Report

• Audit focus must be on conformity and effectiveness, NOT on

finding nonconformities

• The auditee must be given the benefit of any doubt where there

is insufficient audit evidence

• Evaluate audit evidence against audit criteria to generate audit


• Indicate if findings are conformities, nonconformities or

opportunities for improvement

• Meet (audit team) to review findings

• Specify (with supporting evidence) or summarize conformity by

location, function, or processes, as required by audit plan

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Nonconformity Non-fulfillment of a specified requirement:

Not doing it Partially doing it Doing it the wrong way

Specified requirement: Conditions of the customer contract Quality standard (ISO 9001:2008) Quality management system Statutory or regulatory requirements

Nonconformity (Minor)

Failure to comply with a requirement which (based on judgment and experience) is not likely to result in QMS failureExamples:

A two month lapse in the internal audit program A training record not available No actions taken to improve system based on previous

result findings

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6. Distributing Audit Report

• Issue within agreed time period

• If delayed, provide reasons and agree on new issue date

• Report must be dated, reviewed, and approved as per procedures

• Distribute to recipients designated by audit client

• Report is property of audit client

• Recipients and audit team must respect the confidentiality of the report

• Maintain confidentiality of audit documents, information, and report

• Notify audit client and auditee ASAP if disclosure of audit information is required

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7. Corrective Action Report

1. Audit conclusions may require corrective, preventive, or

improvement actions

2. Auditee receives the nonconformity report

3. Auditee decides and carries out these actions within agreed


4. Auditee prepares a corrective action plan

5. Auditee submits the plan to auditors

6. Auditors evaluate and approve the plan

7. Auditee implements the approved corrective action plan

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8. Conducting Audit Followups

1. Auditor verifies the implementation and effectiveness

2. Audit team number should verify completion and effectiveness

of actions taken

3. This verification may be part of a subsequent audit

4. Records of all actions taken by auditor and auditee

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Thank you