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Basic Process Auditing

Presented by:
Ron Villones
Lean Six Sigma/Account Management
Quality
Version 1.0

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In details

Duration: 6 hours
Part 1: Classroom Training
Part 2: Application

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Terms and definitions

Process is defined in as "a set of interrelated or interacting


activities that transforms inputs into outputs."

Audit is a systematic, independent and documented process for


obtaining audit evidence [records, statements of fact or other information
which are relevant and verifiable] and evaluating it objectively to
determine the extent to which the audit criteria [set of policies,
procedures or requirements] are fulfilled.
Auditee an organization (or part of an organization) that is being
audited. Organizations can include companies, corporations,
enterprises, firms, charities, associations, and institutions.
Organizations can be either incorporated or unincorporated and can
be privately or publicly owned.
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Terms and definitions

Auditor a person who carries out audits.Auditorscollect


evidencein order to evaluate how well audit criteriaare being met.

Audit Programme set of one or more audits planned for a


specific time frame and directed towards a specific purpose.

Audit Evidence are records, statement of fact or other


information which are relevant to the audit criteria and verifiable.

Audit Criteria set of policies, policies, or requirements

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Terms and definitions

Audit Findings results of evaluation of the collected evidence


against audit criteria. Note: Audit findings can indicate either
conformity, non conformity, or opportunities for
improvement
Requirement need or expectation that is stated, generally implied or
obligatory. Expression in the content of a document conveying criteria to
be fulfilled if compliance with the document is to be claimed and from
which no deviation is permitted.
Generally implied means that is custom or common practice for the
organization, its customers, and other interested parties that the need
or expectation under consideration is implied.
Conformity fulfillment of a requirement. Synonymous to
Conformance.
Nonconformity non-fulfillment of a requirement related to an
intended or specified use.
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Terms and definitions

Audit Conclusion outcome of an audit provided by an audit


team after consideration of the audit objectives and all audit
findings
Audit Team one or more auditors conducting an audit,
supported if needed by technical experts. Note: One auditor of the audit
team is appointed as audit team leader.
Technical Experts person who provides specific knowledge
or expertise to the audit team. Note: Specific knowledge or expertise
relates to the organization, the process or activity to be audited, language or
culture. A technical expert does not act as an auditor in the audit team.

Audit Plan description of the activities and arrangements for


an audit.
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Terms and definitions

Audit Scope extent and boundaries of audit. Generally includes a


description of the physical locations, organizational units, activities and
processes as well as the time period covered.

Objective Evidence data supporting the existence of verity of


something. Note: Objective evidence may be obtained through
observation, measurement, test, or other means.

Inspection conformity evaluation by observation, judgement


accompanied as appropriate by measurement, testing or gauging.

Test determination of one or more characteristics according to a


procedure.

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Terms and definitions

Preventive Action action to eliminate the cause of potential


nonconformity or other desirable potential situation.

Corrective Action action to eliminate the cause of a


detected nonconformity or other undesirable situation.

Correction is a first aid action that protects the


customer from the problem until we define the root
cause and implement permanent corrective
actions.

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Principles of Auditing

Auditing is characterized by reliance on a number of principles. These


principles should help to make the audit an effective and reliable tool
in support of management policies and controls by providing
information on which an organization can act in order to improve its
performance.
Adherence to these principles is a prerequisite for providing audit
conclusions that are relevant an sufficient and for enabling the
auditors, working independently from one another, to reach similar
conclusions in similar circumstances.

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Principles of Auditing

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Principles of Auditing

PRESENTATiON

the obligation to report truthfully and accurately

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Principles of Auditing

the application of diligence and judgement in auditing

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Principles of Auditing

Independence
The basis for the impartiality of
the audit and objectivity of the
audit conclusion.

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Principles of Auditing

-BASED APPROACH

Audit evidence should be verifiable.


Appropriate sampling should be
applied.

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Principles of Auditing

Confidentiality

Security of information.
Auditors should exercise discretion in
the use and protection of information
acquired in the course of their duties.
Proper handling of sensitive or
confidential information

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Process Audit

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Process Audit

audit of a process against agreed on requirements. It involves


verification by evaluation of an operation or method against
predetermined instructions or standards. It measures conformance
to these standards and the effectiveness of the instructions.
examines the resources (equipment, materials and people) used to
transform the inputs into outputs, the environment, the methods
(procedures and instructions) followed and the measures collected
to determine process performance.
checks the adequacy and effectiveness of the process controls
established by procedures, work instructions, flowcharts, training
and process specifications.
is an evaluation of the sequential steps and interactions of a process
within
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Managing an Audit Programme

An organization needing to conduct audits should establish am audit


program that contributes to the determination of the effectiveness of the
auditees management system. Priority should be given to allocating the
audit programme resources to audit those matters of significance within
the management system.
The audit programme should include information and resources necessary
to organize and conduct its audit effectively and efficiently within the
specified time frames and can also include the following:

Objectives for the audit Audit methods


Extent/number/types/duration/ Selection of audit team
location/schedule Resources
Audit program procedures Process for handling confidentiality,
Audit criteria information security, health and
safety, etc.
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Managing an Audit Programme (PDCA Apporoach)

Elements of the Plan Do Check Act cycle:

Plan establish the objectives and processes necessary


to deliver the objectives.
Do realize your plan. Putting words into action.
Check monitor and measure the process and the
products according to the plan, policies, objectives and
requirements. Review and report the results.
Act the output of the results take measure and activities
or improving the performance. Take actions to continually
improve processes performance.

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Managing an Audit Programme (PDCA Apporoach)

Consider the following:


Management priorities
Commercial and other business intentions
Characteristics of processes, products and projects,
and any changes to them
Management system requirements
Legal and contractual requirements and other
Establishing requirements
Need for supplier evaluation
the audit Needs and expectations of interested parties,
programme including customers
objectives Auditees level of performance
Risk to auditee
Result of previous audit
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Managing an Audit Programme (PDCA Apporoach)

Example of audit programme objectives:


To contribute to the improvement of a
management systems and its performance.
To fulfill external requirements
To verify conformity with contractual requirements
To obtain and maintain confidence in the
Establishing capability of a supplier
the audit To determine the effectiveness
programme
To evaluate the compatibility and alignment of
objectives
management systems objectives with the system
policies and the overall organizational objectives

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Managing an Audit Programme (PDCA Apporoach)

Roles and responsibilities of the person managing


the audit program
Competence of the person managing the audit
programme
Establishing the extent of the audit programme
Identifying and evaluating audit programme risks
Establishing Establish procedures for the audit programme
the audit
Identifying audit programme resources
programme

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Managing an Audit Programme (PDCA Apporoach)

Define the objectives, scope and criteria for an


individual audit
Select audit methodology
Select audit team member competence and
evaluation of auditors
Assign responsibility for an individual audit to the
Implement the audit team leader performing an audit
audit
Manage the outcome of audit programme
programme
Manage and maintain audit programme records

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Managing an Audit Programme (PDCA Apporoach)

Activities and actions to consider:


Evaluate conformity with audit programmes,
schedules and audit objectives
Evaluate the performance of the audit team
members
Evaluate the ability of the audit teams to implement
Monitor the
audit plan
audit
programme Evaluate feedback from top management, auditees,
auditor and other interested parties

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Managing an Audit Programme (PDCA Apporoach)

Activities and actions to consider:


Results and trends from audit programme monitoring
Conformity with audit programme procedures
Evolving needs and expectations of interested
parties
Review and Audit records
improve audit Alternative or new auditing methods
programme Effectiveness of the measures to address the risks
associated with the audit programme
Confidentiality and information security issues
relating to the audit programme
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Typical Audit Activities

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Typical Audit Activities

When an audit is initiated, the responsibility for conducting the audit


remains with the assigned audit team leader until the audit is completed.

- Establish communications with auditees representative


- Confirm the authority to conduct the audit
- Provide information on audit objectives, scope, methods and audit
team composition, including technical experts
- Request access to relevant documents and records for planning
purposes
- Determine applicable legal and contractual requirements and other
requirements
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Typical Audit Activities

- Confirm the extent of the disclosure and treatment of confidential


information
- Make arrangements for the audit including scheduling the audit
dates
- Determine any location-specific requirements for access, security,
health and safety
- Agree on the attendance of observers and the need for the guides
for the audit team
- Determine any areas of interest or concern to the auditee in relation
to the specific audit
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Typical Audit Activities

Preparing audit activities include:


Performing document review
Preparing the audit plan (Audit objectives, scope, criteria, location,
audit methodology, roles and responsibilities of the audit team
member, allocation of resources, consider follow-up actions from
previous audit)
Assigning work to the audit team
Preparing work documents (checklists, audit sampling plans, forms
for recording information such as supporting evidence, audit findings
and records of meetings.
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Typical Audit Activities

Audit activities are normally conducted in a defined sequence as


indicated above. The sequence may be varied to suit the circumstances
of specific audits:
Opening meeting
Performing document review while conducting the audit
Communicating during the audit
Assigning roles and responsibilities if guides and observers
Collecting and verifying information
Generating audit findings
Preparing audit conclusions
Conducting the closing meeting
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Typical Audit Activities

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6


Initiating Audit Preparing The Conducting The Preparing and Completing the Audit Follow-up
Audit activities Audit Activities distributing the Audit
audit report

Opening meeting
The purpose of the opening meeting is to confirm the following:
Audit team
Audit scope
Audit criteria
Audit plan
Outline the conduct of the audit
Explain non-conformity reporting
Guide for each auditor
Private facilities
Closing meeting schedule
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Typical Audit Activities

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6


Initiating Audit Preparing The Conducting The Preparing and Completing the Audit Follow-up
Audit activities Audit Activities distributing the Audit
audit report

The audit team leader should report the audit results in accordance with
the audit program procedures.
The audit report should provide a complete, accurate, concise and clear
record of the audit, and should include or refer to the following:

Audit objectives Auditees Audit findings and evidences


Audit scope Dates and locations where
Audit conclusions
Identification of audit client audit was conducted Statement on the degree to which
Identification of audit team Audit criteria the audit criteria have been fulfill

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Typical Audit Activities

Nonconformity notes are the formal reports


produced by the audit team of any failure of the
Requirement company to comply with the requirements against
which the audit has been carried out.
Nonconformity is defined as non-fulfilment of a
requirement.
Process Audit Internal / External Audi
1. Conformance 1. Major
2. Nonconformance 2. Minor
3. Observation 3. Observation
4. Areas for Improvement4. Areas for Improvement
Evidence Failure

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Typical Audit Activities

Nonconformity
Logic Tree

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Typical Audit Activities

During the end of every audit area or engagement, it is important to


conduct a wash-up meeting to discuss the possible non-conformances
in the process.

All gaps, questions, and dispute should be made in this process. Audit
findings should be agreed between the auditee and auditor before the
issuance of the General Process Audit Report to the management.

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Typical Audit Activities

Closing meeting is a focal point of the audit. Its main purpose are to:
Summarize the findings of the audit
Make any recommendations
Highlight and discuss any non-conformances which the team may
have found
Identify the complaint features of the companys systems or the
process in Operations
Identify the opportunities for improvement and observations
Provide the company/group with the opportunity to respond to the
team
Discuss and agree the time-scales to correct any non-conformances
BestPresentation of the General Audit Report
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Typical Audit Activities

The closing meeting also provides the team with the opportunity to:

Thank the company for the assistance provided to the team


Discuss any additional points which the company may wish to raise

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Typical Audit Activities

Follow up audit should be performed:


As a requirement of International Standard (9001)
To verify the effectiveness of the Corrective Actions taken
To check if the Corrective and Preventive Actions are continuously
being observed

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Process Audit Diagram
Environm Documentation &
People ent
Competency
Facility
Records Job Update Forms
Skills Procedures
Workplace Acknowledgement
Knowledge Standards Attendance
Training Work Instructions
Certification Guidelines
Awareness Updates

Input (Requirements; Client PROCESS


specifications; Customer Output (Service delivery; Finished
requirements) product)

System, Tools, & Measurement and


TechnologyCAROL Control Feedback count
Quality control tools Delivery rate
Feedback database Inspection criteria
Programs Completion rate
QMS Quality inspection
Tracking system IRNPD Accuracy rate
Team performance
Connectivity CSAT
Individual performance
EPP
Error rate
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Audit Tools

Clip board
Pen
Audit Checklist
Flow charts / Process
maps
Laptop / Tablets

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Auditing Techniques

Effective Auditing requires from the auditors


A friendly but formal approach
Good recording
Should have diplomacy
Good communicator
Observant and understanding

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Auditing Techniques

LANGUAGES of an organization should be understood

Executive talk money


Middle managers talk things, numbers and technology
Supervisor talk things and numbers
Operators talk about the hope pay and outside interests

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Auditing Techniques

CULTURAL DIFFERENCES
It is important to recognize that people from different cultures have
are different in a variety of ways, including:

different ways of looking at things


different ways of dressing
different ways of expressing personality/goodness/religious belief

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Auditing Techniques

AUDITING TRICK

Mainly open ended


questions which provide ASK LOOK Observe what is
happening
information

The objective
evidence positive RECORD CHECK Availability and
Conformance to the
and negative
Procedures
Awareness
Consistency
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Auditing Techniques

losed questions are interrogative

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Auditing Techniques

HOW TO INTERVIEW
Attitude of the auditor
Purpose of the interview
Types of questions open, closed, leading, antagonistic, vague

AS AN AUDITOR:
Do not display aggression
Do not point fingers
Be professional
DO not criticize anyone
Remember you are auditing the process
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Auditing Techniques

AS AN AUDITOR:
Do not display aggression
Do not point fingers
Be professional
Do not criticize anyone
Be sure of the facts (repeat questions if needed)
Make sure the auditee agrees and acknowledges the facts
Do not write out non-conformities on the spot but do make an
accurate record of what you have found.

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Auditing Techniques

REMEMBER: You are auditing the process

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Part 3 Application 1

1. Select a project to be audited


2. Prepare a detailed audit plan
3. Identify the members of the audit team
4. Prepare the checklist

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Part 3 Application 2 (Mock Audit)

1. Using the detailed audit plan, conduct an Opening Meeting

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Part 3 Application 3 (Mock Audit)

1. Conduct the Mock Audit


2. Prepare the report

Note: Audience will be the auditee

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Part 3 Application 4 (Mock Audit)

1. Conduct a closing meeting

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