Internal Auditing of the - elsmar.com Internal Auditor Training.pdf · OF MATERIAL REVIEW OF...

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Original Release, (Mo/Yr)

Internal Auditing of theQuality Management

System

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Part 1:Introduction to ISO 9001

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Why Standardize?

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The Origins of ISO 9001

ISO 9001:2000

“ISO 9K2K”

BS9000(1971)

ISO 9001:1987

ISO 9001:1994

Virtually identical Minor changes

BS5179(1974)

BS5750(1979)

MIL-Q-9858(1959)

NATO AQAP-1(1968)

ISO 9001:2008

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The ISO 9001 Document Set• Published as a set of THREE documents:

– ISO 9000:2000 “Fundamentals & Vocabulary”– ISO 9001:2008 “Quality Management System Requirements”– ISO 9004:2000 “Guidelines for Performance Improvement”

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Process Approach• ISO 9001:2008 requires the Company

adopt the “process approach” to its management activities.

• “The application of a system of processes within an organization,together with the identification and interactions of these processes, and their management, can be referred to as the ‘process approach.’” --- ISO 9001:2008 clause 0.2.

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The ISO 9001: 1987/1994 Method

• LINEAR• Assumes the Company’s operations are

comprised of a sequential, linear set of operations, managed in tandem.

• Example:

• Receipt of Customer order Create traveler manufacture product inspection delivery

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The ISO 9001:2008 Method

• Everything has inputs and outputs, making it a “process.”• Those inputs may not appear on a linear graph, as they may

not always come from a previous process.• Outputs may then be used by multiple subsequent

processes.

PROCESS

INPUTS OUTPUT

PROCESS

PROCESS

PROCESSCopy

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Nested Processes

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Example of a Nested Process

Production

OUTPUTPROCESSES

INPUT PROCESSES

MATERIALPRODUCTION

PROCUREMENT & VALIDATIONOF MATERIAL

REVIEW OFCUSTOMERREQUIREMENTS

SHIPPING

QUALITY DATA REVIEW

DEFECTIVE MATERIAL

Prep Load Material

Program machine Finishing

Typical manufacturing process

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Benefits of the Process Approach

• Shows a more accurate picture of a Company’s operations than the “life cycle” or linear model.

• Everyone knows where they fit in the Company’s scheme.• As a result, may reveal built-in problems immediately. Examples:

– Points out built-in inefficiencies– Points out redundancies– Enables companies to review areas for growth or cutback and

predicts areas affected of such changes• Each process has its inputs and outputs (internal Customers)

clearly defined• Enables management to set goals and objectives by process,

instead of global ones that don’t address sourceCopy

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Process ≠ Procedure• Not every process needs a procedure.

For example, “sorting files” may be a process but do you need a procedure on how to sort?

• Where ISO calls for “defining” a process, this may not always require a “procedure.”

• Sometimes “defining” is a simple sentence in the Quality Manual or a box on a flowchart, not an entire procedure.

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What is AS9100• The AS9100 standard adds some

additional AEROSPACE-SPECIFIC requirements onto the ISO 9001 standard.

• AS9100 was created by the Americas Aerospace Quality Group (AAQG), and is published by SAE.

• Through International Aerospace Quality Group (IAQG), the it is now recognized worldwide.Co

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AS9100 = ISO 9001 Plus

• AS9100 simply adds boldface requirements to the text of ISO 9001.

ISO 9001 language

AS9100 addendum

“quality” changed to conformity

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Origins of AS9100

AS9000:1998

ISO9001

AS9100:1999

AS9100 Rev A2000

Section 2:ISO 9001:1994Requirements

Section 1:ISO 9001:2008Requirements

AS9100 Rev. B2003

ISO 9001:2000 only

Current version

Not widely adopted

AS9100 Rev. C2009

ISO 9001:2008

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OASIS• On-line Aerospace Supplier Information System

– Lists AS9100 companies– Includes a score from previous audit(s)– Does not divulge nonconformity details– Viewable by registrars, potential buyers

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All Politics is Local…Sort of

ISO develops and publishes standards

International Accreditation Forum: Governs standards for accrediting bodies

ANSI represents US within ISO.

Registrar Accreditation Board accredits US registrars; certifies registrar’s auditors

Registrar audits companies for compliance, issues

certificates

Registrar

ANSI

RAB

IAF

ISO

Registrant

Uni

ted

Stat

es

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Part 2:Auditing

to ISO 9001 & AS9100

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There is an Auditing Standard

• ISO 19011 provides guidance on auditing itself.

• The internal auditing program has been built on these requirements, with some added necessities.

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The Auditing Process• Despite weaknesses in 19011 – which

treats auditing as a “program” instead of a “process” – registrars nonetheless have properly interpreted ISO 9001 as requiring auditing to be conducted both:

• AGAINST processes• AS a process Co

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The Basic Audit Process

• Like all processes, auditing converts inputs into outputs

AUDITINGPROCESS

REQUIREMENTS

EVIDENCE Requirements are compared against

evidence.

FINDINGS

INPUTS OUTPUTSCopy

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Typical Audit Inputs

• Requirements:– ISO 9001/AS9100 requirements– Customer requirements– Industry requirements– Company requirements– Statutory or regulatory requirements

• Evidence:– Objective evidence only

Typically documented, but not always

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Typical Audit Outputs• Audit findings

– Reports of noncompliances– Corrective Action Requests (NCRs)– Preventive Action Requests (NCRs)– Documented “opportunities for improvement”– Compliments– Document change requests

• Audit reports

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Structure of the Audit

• Develop Audit Plan• Compare Requirements vs. Documentation• Compare Actual Practice vs. Requirements • Record findings• Submit audit report for review• Request corrective action• Review overall auditing trends (by management)

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Current Processes

• Calibration (7.6)• Configuration management (7.3.7)• Contract review (7.2.2)• Control of nonconforming product (8.3)• Control of documents (4.2.3)• Control of production and service (7.5.1)• Control of records (4.2.4)• Corrective and preventive actions (8.5.2, 8.5.3)• Design development (7.3.4)• Internal audit (8.2.2)• Management Review (5.6)• Purchasing (7.4)• Receiving (7.4.3)• Responsibility and authority (5.5)• Shipping (7.2.1, 7.5.1, 7.5.5)• Training (6.2.2)

Currently, there are 16 processes in use.

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Each Process Gets Audited

• Receiving• Management• Purchasing

Each process...

... Gets at least one audit

• AUDIT OF• Receiving• AUDIT OF• Management• AUDIT OF• Purchasing

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The Internal Audit Schedule

• The Quality Manager will develop and maintain a schedule of audits for each year.

• The audits are scheduled according to importance, need, and other factors.

• A process with a lot of audit findings may be audited more frequently if necessary

• One audit per process per year is the minimum.

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(Auditing)2

• Even “Internal Auditing” is a process that must be audited itself.

• When an auditor does the audit of the Internal Audit process itself, they must be sure not to audit their own audit reports.

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Getting Assigned• The Quality Manager will assign an Auditor

for each audit.• Each audit covers only one process.• If a process is particularly complicated, an

audit team may be assigned.• When a team is assigned, one member is the

Lead Auditor.

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Lead Auditor

• The Lead Auditor has the final say on audit findings and makes final decisions regarding the audit.

• They also responsible for making any corrections to the final audit report if such problems are found by the Quality Manager.

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Part 3:In-Depth Look

at A9100 Rev. C

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ClausesAS9100 / ISO 9001:2008 is comprised of Nine “Clauses” each of which is subdivided into any number of sub-clauses.

Clauses 0 through 3 are introductory, and not auditable (i.e., they do not contain requirements for registration or for implementation.)

Clauses 4 through 8 however ARE auditable and contain the requirements of ISO 9001 and AS9100.

Thoroughly review changes in ISO 9001:2008 and AS9100C as part of this orientation.

Also, consider the affects that changes in ISO 9001:2008 have on the business operation.

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Introductory Clauses• 0.0: Introduction•• Outlines the intent of ISO 9001, the process approach, and

some important limitations on its application. For example: “It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.” (Clause 0.1.)

• The next three are self-explanatory:– 1.0: Scope– 2.0: Normative Reference– 3.0: Terms & DefinitionsCo

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Clause 4: Quality Management System

• This first auditable clause sets out the basic rules for developing the ISO 9001 compliant “QMS”

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4.1 General Requirements• Possibly the most important Clause within the entire

standard, it’s generic name belies its impact. Here it requires that the Company to:

• Determine its processes (Has the Company determined it’s processes?)

• Define their interaction and sequence (Has the Company defined the interaction?)

• Determine criteria and methods for control• Ensure resources are available for each process• Monitor, analyze and/or measure those processes• Employ corrective and preventive action to improve

the processes

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4.2 Documentation Requirements• 4.2.1 General • Defines the minimum documentation required for ISO

9001 compliance.– Does the company maintain the required procedures?

– 4.2.3 Document control procedure– 4.2.4 Record control procedure – 8.2.2 Internal audit procedure – 8.3 Control of nonconforming product procedure – 8.5.2 Corrective action procedure

– 8.5.3 Preventive action procedure, etc.

– Are Quality objectives and Quality policy defined?– Other documents to support QMS.Co

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• Does the Company maintain the required records?

– Management Review Minutes 5.6.1– Training records 6.2.2– Records needed to provide evidence that the realization processes and

resulting product meet requirements 7.1.d– Contract review records 7.2.2– Design inputs records 7.3.2– Design review records 7.3.4– Design verification records 7.3.5– Design validation records 7.3.6– Design change records 7.3.7– Supplier evaluation records 7.4.1– Traceability records (if required) 7.5.3– Records of loss, damage or nonconforming CSP 7.5.4– Calibration records 7.6– Records of release authority of inspected product 8.2.4– Corrective action records 8.5.2.e– Preventive action records 8.5.3.d

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4.2.2 Quality Manual

– Defines the requirements of the Quality Manual.

– Has the Company defined scope & exclusions– Required procedures or reference to them.

(Also mentioned in 4.2.1)– Description of process interaction.

(Also mentioned in 4.1)

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4.2.3 Document Control Sets rules for control of documents.• Does the Company have a procedure that

defines?– Are documents approved prior to release?– Review and Update; re-approve– Are changes identified (example: history table)– Is the current revision identified?– Ensure documents are available, legible and

identifiable.– Obsolete documents identified and controlled– External documents are identified and

controlled

* Required Procedure

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4.2.4 Record Control• Sets rules for control of records.• Records provide evidence of conformity to

requirements.• 16 required records; any other records used within the

QMS. • Records must be legible (no white out, changes must

be identified)• Records must be readily identifiable & retrievable

(records must be presented during the audit)• Is there a documented procedure that defines controls

for:– Identification Storage Protection Retrieval Retention time– Disposition


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Clause 5:Management Responsibility

• This Clause defines the minimum requirements for Management in order to maintain compliance to ISO 9001.

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5.1 Management Commitment

• Management shall provide evidence of it’s commitment to development, implementation and continual improvement of the quality system

• Not an idle requirement, audits must confirm ongoing management commitment.

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5.1 Management Commitment

• Does management communicate the importance of meeting Customer, regulatory & statutory requirements?

• Has management established a quality policy?• Has management established quality

objectives?• Has management conducted formal

management reviews?• Has management ensured the availability of

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5.2 Customer Focus

• Requires a general awareness of Customer requirements throughout the Company.

• Some companies elect to use this as a way of promoting the concept of internal Customers, which is acceptable.

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5.3 Quality Policy

• Sets forth the requirements for the Company Quality Policy, including:– Must include a statement of continual

improvement– Must act as a “framework” for quality

objectives.– Is communicated and understood within

the Company– Is reviewed for continued suitability

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5.4 Planning• 5.4.1 Quality objectives

– Objectives must be established for processes and product.

– Quality objectives must be measured and consistent with quality policy.

• Example: Quality policy says”…provide products on time…”

– Company must show measurement for on time delivery through a quality objective.

• 5.4.2 QMS planning– Sets some minimum requirements for overall

planning of the QMS... but very minimal.

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5.5 Responsibility, Authority & Communication

• 5.5.1 Responsibility & Authority– Company must define both– “Authority” now emphasized

• 5.5.2 Management Representative– A member of the Company’s management must

be assigned to spearhead and represent the QMS. They must:

• Promote awareness• Report to managementCo

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5.5 Responsibility, Authority & Communication

• 5.5.3 Internal Communication– Requires processes be established for

internal communication, especially for communicating the “effectiveness of the QMS” throughout the Company.

– Employees throughout the Companyshould be aware of the QMS and its current standing (quality objectives data, status of registration, etc).

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5.6 Management Review• Sets forth the minimum agenda and other requirements

for periodic review of the QMS by top management.– results of audits,– Customer feedback,– process performance and product conformity,– status of preventive and corrective actions,– follow-up actions from previous management reviews,– changes that could affect the quality management system, and– recommendations for improvement.

• Management review meeting minutes must be maintained.

• If quality objectives or other goals are not met, action should be taken to meet goal.

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Clause 6:Resource Management

• ISO 9001 requires certain resources, and that management ensure the provision and control of those resources.

(Within the Company’s means, of course.)

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6.1 Provision of Resources

• Requires resources:– to implement and maintain the QMS and

continually improve its effectiveness– to enhance Customer satisfaction by meeting

Customer requirements.

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6.2 Human Resources• Requires management of human

resources• Includes all the requirements for a

Company training program– competence for personnel– provide training – evaluate training effectiveness– personnel are aware quality system including quality

objectives– maintain appropriate records of education, training,

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6.3 Infrastructure

• Requires infrastructure be managed.• “Infrastructure” includes:

– buildings, workspace & utilities,– process equipment & software– supporting services (transportation,

communication, internet, intranet, etc.)

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6.4 Work Environment

• Requires management of the work environment so that quality is not impaired

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Clause 7:Product Realization

• Sub-clauses within Clause 7 may be excluded from the scope of the Company’s QMS, if not applicable to the business.

• This clause presents most of the “production” related requirements.

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7.1 Planning of Product Realization

• Requires that production planning include definition of:– quality objectives and requirements – processes, documents, and resources – required verification, validation, monitoring, inspection and test

activities specific to the product and the criteria for product acceptance;

– Records

• These requirements may not be written in a single document but may be implemented throughout the Company. An auditor may have to find evidence of each.Co

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New and Relocated Requirements• 7.1.1 Project Management• New requirement for planning and managing product realization in a

structured and controlled way.• 7.1.2 Risk Management• New requirement of implementation of a risk management process

applicable to the projects & products; responsibility, criteria,mitigation & acceptance.

• 7.1.3 Configuration Management• Moved from clause 4.3 to clause 7.1 and added details on the

different activities to be covered.• 7.1.4 Control of Work Transfer• Moved from clause 7.5 (Production) to clause 7.1 to add emphasis

on having a process for planning and control of transfer activities.

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7.1.3 Configuration Management

• Company must define and implement a configuration management process that is applicable to the product.– Method of configuration management must be

defined.

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7.2 Customer Related Processes– 7.2.1 Determination of requirements

• Company must determine requirements including delivery and post delivery activities.

• Requirements not stated by Customer, but necessary.• Statutory, regulatory or other requirements

– 7.2.2 Review of requirements • Company must review requirements prior to commitment to supply

product.• Company must ensure that:

– Product requirements are defined– Requirements differing from those previously expressed are

resolved.– The company can meet the defined requirements

• Records of the review and actions arising must be maintained.

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7.2.3 Customer Communication• Customer communication

– ISO 9001 now requires there be formal “arrangements” for handling Customer communications, including but not limited tocomplaints

– Company must maintain effective communication for:

• Product information• Enquiries, contracts order handling• Customer feedbackCo

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7.3 Design & Development• Defines all the requirements for activities

related to the design and/or development of product or services.

• Design planning: plan the steps of design, manage communication, define responsibility and authority.

• Design Input: functional, performance, regulatory, statutory and other requirements defined. Records are required.

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Design and Development

• Design output: outputs to meet input requirements, contain acceptance criteria, and information for purchasing and servicing.

• Design review: evaluate design to meet requirements, identify problems, propose solutions, and records maintained.

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Design and Development

• Design verification: ensuring the resulting design (drawing, code, etc.) addresses all requirements. Records must be maintained.

• Design validation: ensuring the resulting product meets the original requirements. Records must be maintained.

• (“Testing from the user’s standpoint.”)• Design changes must be controlled.

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7.4 Purchasing

• Defines the minimum requirements for:– Evaluating suppliers and subcontractors– Defining scope of approval– Purchasing goods and services– Defining information on purchase orders– Defining aerospace specific requirements on

POs– Verifying received goods or services.

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7.5 Production & Service Provision

• Defines a variety of requirements to be carried out during typical production or servicing.– 7.5.1: Control of Production & Service Provision:

activities shall be done under controlled conditions• the availability of information that describes the characteristics of the

product,• the availability of work instructions, as necessary,• the use of suitable equipment,• the availability and use of monitoring and measuring devices,• the implementation of monitoring and measurement, and• the implementation of release, delivery and post-delivery activities.

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Special processes

– 7.5.2 Validation of Processes for Production and Service Provision: such processes must be validated before implementation

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• 7.5.3 Identification & Traceability: product must be properly identified throughout the production life cycle

• 7.5.4 Customer Property: the use of any property belonging to the Customer ---including materials or equipment and intellectual property must be controlled.

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– 7.5.5 Preservation of Product: product must be preserved during the production life cycle to prevent damage. This includes controls during:

• Identification• Handling• Packaging• Storage• Protection

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7.6 Control of Monitoring & Measuring Equipment

• Equipment needed to provide evidence of conformity of product to determined requirements must be controlled, calibrated or verified.

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Clause 8:Measurement, Analysis &

Improvement• Defines the basic requirements for:

– Measuring data– Analyzing data– Using data to improve the system

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8.1 General Rules

• Sets the scope of Clause 8, meaning activities necessary...– to demonstrate conformity of the product to

requirements,– to ensure conformity of the quality

management system, and– to continually improve the effectiveness of

the quality management system.

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8.2 Monitoring & Measurement

• Defines requirements for monitoring and measuring:

• Customer Satisfaction• Internal Auditing• Processes• Product

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8.2.4 Monitoring and Measurement of Product

– Revised: Augment 8.2.4.1 and combine with 8.2.4; delete 8.2.4.2; add,"When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriateness for use (i.e. matching the sampling plan to the criticality of the product and to the process capability)".

– Validation of recognized statistical principles utilized.– Process used to determine criticality of product.

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8.2.4.2 Moved First Article Inspection

– First Article Inspection (FAI) moved to clause 7.5.1.1 and renamed.

– Production process verification "FAI" is the requirement to validate the production process's documentation and tooling and repeat the process when necessary (i.e. when engineering or manufacturing processes change). The requirement was moved from 8.2.4.2 (measurement) to 7.5.1.1 (production) because it ispart of product realization and is not intended to be a follow-on activity.

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8.3 Control of Nonconforming Product

• Defines controls for not only nonconforming product but infers that such controls should be exercised over nonconforming service as well.


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8.4 Data Analysis

• Mandates that the Company must analyze:– Customer satisfaction data– Product quality data– Data related to characteristics and trends of

processes and products including opportunities for preventive action

– Supplier performance

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8.5 Improvement• This clause mandates that the Company improve over

time, and includes requirements for:– 8.5.1 Continual Improvement– * 8.5.2 Corrective Action– * 8.5.3 Preventive Action

• Evidence of the Company not at least attempting to improve can be seen as nonconforming to 8.5.1.

* - combine procedures is acceptable

* 2 Required Procedures

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ISO/AS Clause exercise• The current revision of the NCR form is revision 6, the NCR form

found for use in the quality control area was NCR form rev. 4.• The finishing operator did not have access to the work instructions

for his area. All work instructions were on the computer in the front office and he didn’t have access to that computer.

• In the front office there were two new work instructions in use; “Job Order creation Rev 0” and “Filing Job Orders Rev 0”. There was no evidence these documents had been reviewed and approved.

• The complete list of procedures at the Company are:• Record control• Nonconforming product control• CAR/PAR

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ISO/AS Clause Answers• 4.2.3 Control of documents• Documents required by the quality management system shall be controlled.

Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

• A documented procedure shall be established (Question 4) to define the controls needed:

• a) to approve documents for adequacy prior to issue,• b) to review and update as necessary and re-approve documents,

(Question 3)• c) to ensure that changes and the current revision status of documents are

identified,• d) to ensure that relevant versions of applicable documents are

available at points of use, (Question 2)• e) to ensure that documents remain legible and readily identifiable,• f) to ensure that documents of external origin are identified and their

distribution controlled, and• g) to prevent the unintended use of obsolete documents, and to apply

suitable identification to them if they are retained for any purpose. (Question 1)

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ISO/AS Clause Exercise

• Product was shipped to finishing and then drop shipped directly to the Customer. No representative from the Company inspected the finished production prior to shipment to the Customer.

• There was no evidence of re-evaluation of vendors. Once vendors were approved, they were never reviewed again.

• The purchasing agent had the authority to approve vendors based on price and delivery but no records of how he approved them was maintained.

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ISO/AS Clause Answers• 7.4.1 Purchasing process• The organization shall ensure that purchased product

conforms to specified purchase requirements. (Question 1)The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the finalproduct.

• The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. (Question 2) Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (Question3) (see 4.2.4). Co

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Part 4:Performing the

Audit

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The Basic Audit Process

• Recall the model of our audit process:

AUDITINGPROCESS

REQUIREMENTS

EVIDENCE Requirements are compared against

evidence.

FINDINGS

INPUTS OUTPUTS

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Step One: Coordinate With Your Lead

• Usually audits are conducted by a single Auditor, but if your audit has been assigned to a team, coordinate your activities with the Lead Auditor.

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Step Two: Obtain An Audit Form

• Audit forms have been developed for each process. These include instructions and guidance on conducting the audit.

• This audit report also helps an auditor in preparing for the audit itself.

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Audit Form

• The Quality Manager will provide you with the forms needed to perform the audits.

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Requirements and Processes

• Prior to starting the audit, the Auditor should review which ISO/AS clauses apply to the process being audited.

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Clauses to Remember• There are other clauses the auditor should

always be conscious of regardless of what they are auditing. – 4.2 Documentation Requirements– 6.2.2 Competence, training and awareness.– 8.3 Control of Nonconforming Product

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Other Preparations

• Review the previous audits• Review any findings (NCRs) from the last audit.• If there are any open NCRs from the last audit,

ensure you follow-up during the audit.• Notify the area or personnel of the upcoming

audit.

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Start auditing• Gather all required reference material,

audit forms, etc.• Review the reference material. Keep in

mind your objective is to do two things.– Compare Company documentation against

the ISO requirements.– Compare Company practice against

documentation and ISO requirements.

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Most important Part

• The most important step is the audit itself.

• During the audit, you are actively:• Walking around• Interviewing people• Witnessing processes• Examining product

OBTAINING EVIDENCE

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OK, Lets Review the Form

• The Internal Audit Form has been designed to guide you through the steps of an audit process.

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• Step One is the “Audit Plan”:

The Audit form

Other documents you plan to audit.Include QMS

Procedures, WI’s, QC’s, etc.

Details on the audit and the applicable clauses.

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Step Two

Give suggestions for improvement on documentation.

Three standard questions included for all processes.

Record or reference your evidence here.

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Step Three

List the source of the requirement, whether AS9100, QMS Manual

or procedure.

List the questions.

Indicate your answer

Write down your

evidence.

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Step ThreeIf you have lots of

notes to write, indicate a Notes Reference #.

Then write your notes, with the appropriate reference #, on the last page of the report.

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Step ThreeReview previous audit

findings and ensure issues were resolved.

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Step Four

The next set of questions asks you about the effectiveness of the process as a whole.

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Step FivePut new MR # here, if known.

Record your finding.

Check a finding detail.

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Step Six

Lead auditor reviews internal audit record to ensure it is

complete. Lead auditor signs and dates.

Submits the report to the Quality ManagerCo

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Step Seven

Quality Manager checks off who is sent copies of completed audit

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Finishing Up• Once the audit is done and approved as

complete, the Quality Manager will update the audit schedule and file the reports.

• As needed, these reports may be uploaded to the Company server for general publication and/or sent to specific managers.

• The Quality Manager will verify that all clauses of the standard have been audited.

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Remember the Process

• Remember to audit the effectiveness of the process, not the people– Use the Process Map as a guide– Ask Operators open-ended questions:

How do you know how to do this job? What is the first thing you do?

– Request records to verify– Record evidence

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• Interviews should be relaxed and conversational.– Take time for introductions– Ask about position and duties– Focus on understanding the process and the

Operator’s role in the process– Do not ask leading questions that expect a

specific answer

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• Avoid interviewing a Group unless there is a good reason.– Such as a project team to understand team

dynamics– Or a group of sales representatives before

they leave on assignment– When necessary, two Auditors should be

present and the Group should be less than five people

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• Corroborate facts stated and other data collected during an audit interview– Ask for information in a different way– Ask for evidence demonstrating an activity is

performed as described– Ask several people the same question– Observer the activity in question being performed– Review the evidence of other Audit team members– Review other evidence such as procedures,

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• Overcome communication problems– Rely on the Escort to correct misunderstandings– Corroborate all information– Revisit an area or raise the issue for necessary action

at the daily meeting– End the interview by asking whether the Operator is

responsible for any other activities or ask for their opinion about how well the process is performing

– Recognize and control delay tactics• Personnel unavailable; Escort always late; waiting for

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• Steering, intimidation, too busy, rambling– Randomly select Operators without being steered to

interview certain people– Sit or stand between the Escort and Operator while

facing the Operator, maintain eye contact with the Operator – the Escort fixes communication problems

– Try to sense when an Operator is too busy for questions then find other ways to keep the audit moving

– Avoid irrelevant information by focusing on the topic of interest without alienating the OperatorCo

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Document all evidence

• Auditors must record ALL evidence. Regardless if there was a nonconformance.

• If a nonconformance is discovered, it is important to record all details of the finding, why it is a finding and the original requirement.

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NCR system

• All findings must be entered into the NCR system.

• The form requires the NCR number be documented.

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Management Review• Over the course of the year, the trends

in findings of audits will be gathered by the Quality Manager.

• During Management Review, these trends will be reviewed by top management.

• Trends may reveal weak/strong processes, resource needs or other important revelations.

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What is Evidence?• As you audit, you are gathering

evidence to record whether or not practice matches documentation and requirements.

• Evidence can take many forms:• Physical records (electronic or paper)• Interview results (comments by employees)• Witnessed actions• Physical samples

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Acceptable Evidence

• This is important:

• ONLY OBJECTIVE EVIDENCE IS ALLOWABLE AS AN AUDIT FINDING!

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Objective Evidence is...

• ... "Information which can be proven true, based on facts obtained through observation, measurement, test or other means."

• In other words, objective evidence must have a component that can be verified.

• Think: “will someone else be able to verify my evidence at a later date?”

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Types of Evidence

ADMISSABLE ON AUDIT REPORT

INADMISSABLE!

STRONG OBJECTIVE EVIDENCE

MODERATE OBJECTIVE EVIDENCE

WEAK OBJECTIVE EVIDENCE

SUBJECTIVE EVIDENCE

BEST

WORST

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Strong Objective Evidence

• Physical records with all data intact and signatures, etc.

• Verified electronic records • Physical samples, objects, parts, able

to be measured, observed, inspected. • Direct observation of practice by

multiple parties

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Moderate Objective Evidence

• Physical records lacking some data but with enough information to satisfy audit or to track back to originators for verification

• Verbal statements with some form of supporting proof (documentation, other witnesses, etc.)

• Direct observation of practice by one qualified individual

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Weak Objective Evidence

• Informed opinions: verbal statements without supporting proof but made by authorized personnel and/or multiple people.

• Records with suspect validity but lacking any evidence of outright deception, error or nonconformity

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Subjective Evidence

• Verbal statements of opinion• Records that contain subjective

information or opinions.• Guesses made without evidence• Any biased view, observation, comment

or statement

INADMISSABLE!

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Recording Your Evidence

• Write clearly, presenting FACTS• Indicate your objective evidence.• If there is a disconnect between practice

and requirement, indicate BOTH. • When referencing a document, indicate

TITLE and REVISION LEVEL.

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Record All evidence

• Remember. you must record all evidence even if a nonconformance was not discovered.

• For example:• “Reviewed CARs #18, 22, 36, 54.

All CARs were closed and resolved in a timely manner.”

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Anatomy of a finding • All findings should have 3 parts:1. The clause or requirement that has

not been met.2. A record of the evidence.3. Detail of why the evidence or

situation did not meet the requirement.

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Example

• Section 8.5.2 of ISO 9001:2008 states “A document procedure shall be established…” Currently the Company does not have a procedure for Corrective Action. The ISO 9001 standard requires a documented procedure for Corrective Action.

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Some Bad Examples

• “Dave isn’t doing what he’s told to.”

• “Product was found without identification.”

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Still Bad, but Better

• “Product was found without identification in the receiving area, this is against procedure.”

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A Very Bad Example

• “Everything’s cool.”

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Never Assume

• You must never assume an answer to a question or assume evidence exists where it doesn’t.

• Let the evidence provide the answer.

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No Baggage

• “Baggage” is the personal experiences we bring to an audit that sometimes get in our way of objectivity.

• An Auditor must not “fill in the blanks” to an audit based on his or her own experience, which may or may not be relevant.

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Distinguishing Facts from Assumptions

• Read the story on the following slide.• Answer the questions on the next slide.• YOU MAY LOOK BACK AT THE STORY

FOR YOUR ANSWERS.• Answer only ONE of the following for each

question:• TRUE FALSE UNCLEAR

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• Jones and Smith work for ABC Iron Manufacturing, Inc. Smith works the 4 to 12 shift and Jones works 12 to 8 shift. Both workers began work on January 1st. New employees for ABC Iron must undergo one month training on first shift before being assigned to their permanent shift. Smith earns $10.00 per hour and Jones earns $11.00 per hour; in most cases, workers earn more per hour due to seniority.

• During one manufacturing operation, Smith burns his leg and loses seven days of work. Returning from work, Smith pokes out an eye whilesharpening a pencil and is hospitalized for another month. Returning from this injury, Smith's eye is patched and he cannot see his equipment properly. As a result, Smith sets his automatic cutting machine for 0.5 instead of 1.0 and parts begin to eject from the machine 1/2" too short. Smith is called into the office by his Supervisor, Lee, and is reprimanded for poor work performance; during the conversation, Smith gets agitated and causes Lee's temper to flare. Lee yells, causing Smith to have a psychotic episode. Smith picks up a welding torch and tries to attack Lee but Teddy Jones interrupts and breaks up the fight before any injuries occur. Smith is fired from the Company.

• At midnight, Smith tells his wife of the incident and she announces her intention to divorce him as a result. Smith has a nervous breakdown and is put into an asylum for the next six years. Smith's chief therapist, Dr. Jekyll, teaches Smith a way to properly vent his anger. Upon his release, Smith begins work again as an ISO 9000 Auditor and is hugely successful.

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Internal Auditing of the - elsmar.com Internal Auditor Training.pdf · OF MATERIAL REVIEW OF...

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