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Part 1 Auditing Fundamentals PDF
Part 1 Auditing Fundamentals PDF
• Having Training on Culture of Quality and Data Integrity Assurance by Dr. Ajaz S
Hussain.
• Why?
– To take a minute part, as a responsible individual, in a big mission of
improving continuously quality of products/ services for society through
mentoring professionals aspiring to become Certified Quality Auditor
• Who?
– Suitable to the professionals plan to become Certified Quality Auditor by
ASQ
Continues…
Mentoring Classes for ASQ CQA
• When?
– As per below calendar
For More Details: Certified Quality Auditor Body of Knowledge Back to Contents
A. TYPES OF QUALITY AUDITS
A. Types of Quality Audits
1. Method
2. Auditor-auditee relationship
3. Purpose
– System audit
Product
• Other Methods: Audit
– Desk audit or document review
– Department of function audit
– Management audit
For More Details: Certified Quality Auditor Body of Knowledge Continues…
1. Method
• Product Audit
– The system audit addresses the who, what, where, when and how
of the system used to produce its product
– Think of the system audit in terms of "an inch deep but a mile
wide" i.e., broad and general in nature rather than narrow and
limited in scope
For More Details: Certified Quality Auditor Body of Knowledge Back to Contents
2. Auditor-auditee relationship
Define, differentiate, and analyze
various audit types by auditor-
auditee relationship: first-party,
second-party, third-party, internal
and external. (Analyze)
Classification of Audits
– Audits are subject to the rules of contract law as they are providing
contractual direction from Customer to Supplier
– More formal than first party audit because audit results could influence
customer’s purchasing decisions
– Inspection:
• a tool to detect errors or defects before a product is approved for
release or distribution
• Normally part of manufacturing process
• May form quality control department to manage and conduct
inspection
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3. Purpose
Define, differentiate, and analyze
various audit types by purpose:
verification of corrective action
(follow-up) audits, risk audits,
accreditation (registration) and
compliance audits, surveillance and
for-cause audits. (Analyze)
For More Details: Certified Quality Auditor Body of Knowledge Back to Contents
4. Common elements with other
audits
Identify elements such as audit
purpose, data gathering techniques,
tracing, etc., that quality audits have in
common with environmental, safety,
financial, and other types of audits.
(Apply)
Inputs Outputs
• Competent auditors • Accumulated data that
• Authorizing supportive are transformed into
client useful actionable
• Cooperative auditees Audit information
• Defined audit plans and • Presenting formal
procedures Process report to client and
• Purpose and scope auditee
• Reference documents Planned sequence • Follow-up of CAPA
• Administrative and implementation to
of audit activities
infrastructure support support improvement
and mutual benefit
– Documentation review
– Audit follow-up
For More Details: Certified Quality Auditor Body of Knowledge Back to Contents
B. PURPOSE AND SCOPE OF
AUDITS
2. Benefits of audits
– Risk-based audit:
• Allocate resources specifically to areas that have been problematic or
that are high risk and could include
– product characteristics
– product or process hazards Risk-based Audit
– Personnel or process safety
– Environmental controls
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2. Benefits of audits
Analyze how audits can be used to
provide an independent assessment of
system effectiveness and efficiency,
risks to the bottom line, and other
organizational measures. (Analyze)
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2. Benefits of Audits
• Audits can verify ongoing conformance to requirements and promote
improvement of organization’s effectiveness and efficiency
• Management can utilize objective data to make informed decisions regarding
achievement of organization objectives
• Verification of conformance to requirements
• Identification of risks and monitoring of risk treatments
• Identification of opportunities for improvement
• Determination of readiness for new products and processes
• Verification of system effectiveness
• Identification of inefficiencies and ineffective controls
• Verification of CAPA
• Identification and reporting of best practices
• Advancing the achievement of organizational objectives
For More Details: Certified Quality Auditor Body of Knowledge Back to Contents
C. CRITERIA TO AUDIT
AGAINST
Define and distinguish between various audit
criteria, such as external (industry, national,
international) standards, contracts,
specifications, quality awards, policies,
internal quality management system (QMS),
sustainability, social responsibility, etc.
(Analyze)
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C. Criteria to Audit Against
• Audit Criteria:
– A universal term that describes the reference used by an auditor
against which the evidence collected during the audit can be
compared
1. Policies 3. Procedural
• Corporate policies
Documents
• Quality system standards
• Step-by-step requirements
• Regulatory standards
for doing job
• Business sector standards
2. Manuals 4. Detailed
• Corporate
Documents
• plant • Drawings, Purchase orders
• Function or department • Specifications & inspection
• Division plan
• Specific instructions
For More Details: Certified Quality Auditor Body of Knowledge Continues…
C. Criteria to Audit Against
Audit Basis
1. Management system, product, or process standards (e.g.: ISO
9001,ISO 14001)
2. Contracts (reference to specific standard like ANSI/ ASTM)
3. Specifications
4. Organization policies and objectives
5. Laws or regulations
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D. ROLES AND
RESPONSIBILITIES OF AUDIT
PARTICIPANTS
Define and describe the functions and
responsibilities of various audit participants,
including audit team members, lead auditor,
client, auditee, etc. (Apply)
D. Roles and Responsibilities of Audit Participants
• Audit Participants:
– Audit client: Organization or person requesting an audit
• Audit Participants:
External Audit:
Organization desires recognition or approval of its capability to meet standard ISO 9001
Participant Role
Client Top management of organization desiring certification/ registration
Auditee The organization desiring certification/ registration
Auditing The organization granting certification/ registration using an auditor employed
organization by the auditing organization or hired to conduct the audit
External Audit:
Customer Organization desires to evaluate a supplier
Participant Role
Client The interested purchasing agent, purchasing manager, or engineer
Auditee The potential or existing supplier
Auditing Member(s) of the customer organization staff or auditors under contract to
organization customer organization
• Audit Participants:
External Audit:
Regulatory organization verifies that supplier or operator is in compliance with requirements
Participant Role
Client Regulatory agency
Auditee The potential supplier or operator
Auditing Employee(s) of the regulatory agency or auditors under contract to the agency
organization
Internal Audit:
Organization desires to determine the degree of conformity of its own organization elements
of to a predetermined management system
Participant Role
Client Upper management team of the organization desiring to use auditing as a
management tool
Auditee The department/ function(s) of the organization to be evaluated
Auditing Employee(s) of the organization or individuals hired to conduct audit
organization
For More Details: Certified Quality Auditor Body of Knowledge Back to Contents
E. PROFESSIONAL CONDUCT
AND CONSEQUENCES FOR
AUDITORS
E. Professional Conduct and Consequences for Auditors
2. Legal consequences
3. Audit credibility
Striving to increase the competence and prestige of the quality profession, and
Using their knowledge and skill for the enhancement of human welfare.
Members and certification holders are required to observe the tenets set forth below:
– Previous employment of the auditor (or close relative) by the auditee or a major
competitor of the auditee, regardless of the reason for separation
– Holding of significant amounts of stocks or bonds in the auditee’s business or that
of major competitor
– Previous or current close working relationship with the organization
– Prior involvement by the auditor in developing the quality program or procedures
used by the group being audited
– Close relationships within the group being audited
– Offer by auditee of money, goods, of services in the nature of a bribe, kickback, or
secret commission
– Acceptance of gift (money, gratuity, or other thing of value) with more than a
nominal value, or involvement in auditee-sponsored sales promotions or other
activities that may represent or be constructed as a conflict of interest
– Performance of outside work for the auditee that might adversely effect the
auditor’s performance or judgement on the job
For More Details: Certified Quality Auditor Body of Knowledge Continues…
1. Professional Conduct and Responsibilities
• When a Conflicts of Interest Exists:
– Actions that management and audit team leader can take include:
• Ensuring that sufficient time has passed to eliminate the conflict
• Assigning a different auditor to cover the specific area of conflict
• Removing the audit or the audit team leader from the team
– Techniques:
• When auditing in an undisclosed area, the auditor can relay on memory and
not write audit notes
• Auditor must respect the auditee’s wishes and audit around the undisclosed
area
• Remove personnel from undisclosed area for interview
• Ask auditee to certify that the procedure does exist and covers the relevant
process
– Security:
• Companies in certain highly sensitive industries may require that auditors
have or obtain security clearances
• Alternatively to be constantly escorted
– Trust:
• Auditors are expected to exercise due care while performing activities
For More Details: Certified Quality Auditor Body of Knowledge Continues…
1. Professional Conduct and Responsibilities
• Discovery of Illegal or Unsafe Conditions or
Activities:
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2. Legal consequences
Identify potential legal and financial
ramifications of improper auditor actions
(carelessness, negligence, etc.) in various
situations, and anticipate the effect that certain
audit results can have on an auditee’s liability.
(Apply)
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3. Audit credibility
Identify and apply various factors that influence
audit credibility, such as auditor independence,
objectivity, and qualifications. (Apply)
Evidence- Fair
based
Approach Presentation
Auditing
Principles
Due
Independence Professional
Care
Confidentiality
For More Details: Certified Quality Auditor Body of Knowledge Back to Contents
Q&A
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