Quality Audit

Dr. Saima Amin

Definition
Quality auditing is the systematic examination of an organization’s quality
management system (QMS).

❖ A quality audit is typically carried out by an internal or external quality

auditor or audit team.
❖ It is a key component of the ISO 9001 quality system standard.
❖ Audits are usually conducted at agreed time intervals, ensuring that an
organization has a clearly defined system for quality monitoring.
❖ They can also help determine whether an organization is compliant
with the requirements of a specific quality system.
❖ A quality management system audit evaluates an organization’s existing
quality management system (QMS) to ascertain its conformance with
company policies, contract commitments, and regulatory requirements.
Importance of audits
➢ Audits are essential for assessing the success of processes, products
and systems—whether existing or newly-implemented.
➢ They are also a vital tool for verifying objective evidence of processes,
and providing evidence for the reduction and elimination of any problem
areas.
➢ To ensure maximum benefit for an organization, quality auditing should
highlight examples of good practice, rather than simply identifying
non-conformance, process issues, and corrective actions.
➢ They provide a space for continuous improvement .
Who is an auditor?
The auditor can either be an employee who understands but isn’t
directly involved in the process, product, or system being audited, or
somebody from outside the organization who understands the
business and industry standards.

They are the individuals who perform the audit on behalf of an

organization, customer, or supplier.
 Advantages of quality audits

1. The quality audit evaluates the effectiveness of a system and identifies the key
areas that need improvements.
2. It serves as an essential tool to increase organizational functionality.
3. Sharing feedback of the quality audit with other departments improves the overall
processes of the whole organisation.
4. The quality audit measures the different aspects of the quality management
system, track those said measurements, convert analysis to opportunities and
add viable value to the core business.
5. Increases the safety of workers by keeping an eye on the working conditions. It
reports any deterioration in the current conditions and monitors risks involved in
working in those conditions.
6. Serves as a learning tool that learns about the various aspect s of the company
so that it can lead to future growth
 7. Gathers input from the employees and uses these observations to gain valuable
insight into the company.
8. Provides the summary of the investigation and evaluation the auditor has
conducted so that the key considerations can improve the overall performance of
the company.
9. Helps the organisation to align policies and real-world procedures. It nudges the
company to follow all the rules diligently the right way so that it can maintain all
the expected standards.
10. Quality audit is considered an important activity that can measure gaps in the
organizational standards and processes.
11. Quality audit is an effective technique to identify the various opportunities that can
eliminate waste and help optimization in an organisation.
12. The quality audit has set parameters that include several checkpoints. It can
easily track issues before they occur.
13. Periodic quality audits keep a check to know whether the preventive actions have
been practical or not
Types of quality audit

Process audit

A process audit determines whether an organization’s processes are working within

established limits.

It measures conformance to any predetermined or industry standards, as well as the

effectiveness of any instructions.

This type of audit will check various aspects of a process, including:

● Conformance to defined requirements such as temperature, accuracy, time,

responsiveness, pressure and composition.
● The resources (materials, equipment, people) used to transform inputs into
outputs, the methods that are followed, the environment in which the process
takes place, and the measurements taken to determine process performance.
● Effectiveness and adequacy of the process controls.
Product audit

This type of audit examines whether a particular product or services conforms

to the necessary requirements (related to specifications, customer
requirements, or performance standards}.

System audit

A system audit verifies that all elements of a management system are

effective and appropriate, and have been developed, documented, and
implemented in accordance with the specified requirements.
First-party audit

A first-party audit is an internal audit designed to measure an organization’s

strengths and weaknesses against its own methods or procedures and/or
against external standards voluntarily adopted by–or imposed upon–the
organization.

The audit is conducted by auditors who are employed by the organization

being audited but who don’t have a vested interest in the audit results.

Second-party audit

This is an external audit performed on a supplier by a customer or contracted

organization on the customer’s behalf. Second-party audits are typically more
formal than a first-party audit because the audit results could influence the
purchasing decisions of the customer.
Third-party audit

A third-party audit is performed by an independent organization with no

conflict of interest. This independence is a key part of a third-party audit, as
it may result in certification, recognition, license approval, a fine, or a
penalty being issued by the third-party organization or another interested
party.
 Types of quality audits

Internal quality system audit – An internal quality system audit is a tool to

measure quality.
● It evaluates Electronic Quality Management System (EQMS) in an organization
to ensure maximum outcomes and highest efficiency levels.
● The software manual in this quality audit type is audited so that all the key
employees can access the document and the work instructions are audited so
that quality processes can meet set targets
Production Team Audit – In a production team audit, the quality auditors have to
evaluate past activity for escapes, evidence of training and changes to processes.

● An organization carries out a production team audit when it needs

re-qualifications related to skill management.
● It is also conducted when a Certified Operator program or Operator Acceptance
programs are in place.
Supplier Audit – This type of quality audit helps an organisation to join forces with its
suppliers directly in real-time.
● a quality audit in the supply chain, helps to identify the reason for poor
performance.
● The company can control the quality of the suppliers and even the sub-tier
suppliers by implementing supplier audits in its system.
● There is a higher level of transparency because of quality audit, and this
encourages the identification of the areas that needs improvement via KPIs or
Key Performance Indicators (KPIs).
● The supplier audit can easily view purchase order activities like receipts to take
the necessary corrective actions.
 Miscellaneous Audits
Safety Audits
★ Safety policies in an organization are a necessity because it can prevent accidents from
happening.
★ A successful safety policy improves the overall well-being of an employee.
★ Safety audits are aimed at protecting the safety of the employees in an organization by viewing
the plans and designs.
★ It also examines organizational procedures and reviews equipment operation to ensure routine
safety in the company.
Environmental Audit
★ The environmental audit helps to create a safe environment by identifying workplace risks.
★ It also ensures that all the employees are using personal protective equipment and taking the
necessary measures in the workplace.

Facilities Audit
★ A facilities audit reviews building systems, technology, and manufacturing equipment to ensure
safety.
★ It also helps to identify the improvements that can encourage quality outcomes
Risk Assessment Audit – As the name suggests risk assessment audit helps to create
and implement an effective strategy for risk mitigation. It prioritizes preventive measures
and makes sure that they are implemented as per the need of the hour.
Regulatory Audit – This type of audit helps to verify compliance with set standards and
regulations. It reviews the data collection method and quality practices to identify the areas
of non-conformance.
Design Control Audit – The design control audit helps to review the design plan, output,
and input for proper acceptance. It ensures the recognition of formalized processes in the
workplace so that it can meet acceptable safety and quality standards and perform risk
analysis.
Method Validation Audit – The method validation audit ensures standardization of
analytical test methods that are used during the manufacturing process for accuracy and
consistency in case of products.
 Audit process

1. Determining the scope of the audit

Before appointing an auditor, it’s important to establish the criteria and scope of an
internal audit—this is usually best placed with a quality manager. The criteria should
focus on risk areas in the business or process lifecycle, and remain consistent over
time wherever possible. This makes it easier to analyse performance and gives
employees clear goals to work towards between audits.

2. Planning and preparation

A fair amount of preparation is required ahead of an audit. The first priority for the
organization being audited is to appoint an auditor, whether from inside or outside the
company. Together with the auditor, the organization will then establish the format of
the audit, ensuring it aligns with its objectives and that all employees have time to
prepare.
3. Audit execution

The audit consists of various activities including interviews with employees, on-site
audit management, assessing process and system controls, and regular
communication with other relevant parties within the organization. This phase of an
audit is often called the ‘fieldwork’ and tends to conclude with an exit meeting between
the auditor and auditee.

4. Reporting

The audit report outlines the results of an auditor’s investigation, providing accurate
data to management along with recommendations on any corrective actions that need
to be taken. It should also enable an organization to effectively track quality and
performance over time, identify areas for improvement, and highlight any successes or
achievements.
5. Corrective action

If the audit has uncovered any areas of

non-compliance with industry or
company standards, an organization
will need to ensure they act on the
findings promptly. It can be beneficial to
focus on one or two areas at a time and
monitor their impact regularly, thus
following the kaizen methodology of
continuous improvement.
Involving all employees in this process
is a key part of complying with quality
standards over the long term.
Audit Process
audit preparation: we must define the purpose of the audit (quality, configuration, etc.) and scope
(enterprise, department, service, project, team, activity). From there, it is possible to identify the input
elements required to perform the audit (quality plan, etc.);

–
audit planification: following the preparation stage, it is necessary to produce an audit plan that will
identify the date, scope, audit program (themes, expected people, timing, etc.), etc.;

–
performing the audit: based on the audit plan that was established in the previous phase, the audit is
performed. During the audit, elements are collected in order to verify the audit objectives;

–
formalization of audit results: we must formalize the audit results as an audit report to take into
consideration the evidence presented during the audit and the list of identified non-conformities or
observations;

–
follow-up of observations: observations and non-conformities of the audit are to be monitored. Actions