(red parts will not be in the presentation, just additional info and will be super summarized during

reporting)

Quality audit (inspection)

The American Guru Joseph M. Juran in his book. Quality Control Hand Book defined quality audit as "an
independent review conduct 1 to compare some aspects of quality performance with a 1 standard for
that performance"

Quality audit - A systematic and independent examination and evaluation to determine whether quality
activities and results comply with planned arrangement and whether these arrangements are
implemented effectively and are suitable to achieve objectives.

QA - process of systematic examination of a quality system carried out by an internal or external quality
auditor or an audit team.

QA - important part of organization's quality management system and is a key element in the ISO quality
system standard, ISO 9001

QA - typically performed at predefined time intervals and ensure that the institution has clearly defined
internal system monitoring procedures linked to effective action.

-helps determine if the organization complies with the defined quality system processes and can involve
procedural or results-based assessment criteria.

-what must be done for the management system to be effective and look for improvement
opportunities

3 classifications

1. 1ST PARTY/Internal Quality Audit – conducted within the company by a qualified employee in
which the independence of the area being audited is taken into consideration
2. 2nd PARTY – conducted by employee of a company in their subcontractor, or supplier, mother
company to check the conformance and customer requirements
3. 3RD PARTY/External Independent Audit – conducted by an independent organization or person
hired by the company to check conformity to a specific standard

PURPOSE

1. Adequacy
2. Compliance
3. Effectiveness

 (The quality audit evaluates the effectiveness of a system and identifies the key areas that need
improvements. It serves as an essential tool to increase organizational functionality
 Sharing feedback of the quality audit with other departments improves the overall processes of
the whole organisation
 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
  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.
 Serves as a learning tool that learns about the various aspect s of the company so that it can
lead to future growth
 Gathers input from the employees and uses these observations to gain valuable insight into the
company
 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
 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
 Quality audit is considered an important activity that can measure gaps in the organizational
standards and processes.
 Quality audit is an effective technique to identify the various opportunities that can eliminate
waste and help optimization in an organisation.
 The quality audit has set parameters that include several checkpoints. It can easily track issues
before they occur
 Periodic quality audits keep a check to know whether the preventive actions have been practical
or not)

AUDIT – FACT FINDIND AND NOT FAULT – FINDING

PHASES OF AUDITING

1. Initiation – appoint lead auditor, he plans the audit

2. Preparation – define the objectives, criteria and scope
3. Execution – actual audit
4. Reporting
5. Follow-up

- With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the
audits has shifted from purely procedural adherence towards measurement of the actual effectiveness
of the Quality Management System (QMS) and the results that have been achieved through the
implementation of a QMS.

Quality audits can be an integral part of compliance or regulatory requirements.

APPLICATION

1. US Food and Drug Administration - QSR

*which requires quality auditing to be performed as part of its Quality System Regulation (QSR) for
medical devices (Title 21 of the US Code of Federal Regulations part 820).

2. Higher Education System

Several countries have adopted quality audits in their higher education system (New Zealand, Australia,
Sweden, Finland, Norway and USA) Initiated in the UK, the process of quality audit in the education
system focused primarily on procedural issues rather than on the results or the efficiency of a quality
system implementation.
 4. Safety

Audits can also be used for safety purposes. Evans & Parker (2008) describe auditing as one of the most
powerful safety monitoring techniques and 'an effective way to avoid complacency and highlight slowly
deteriorating conditions', especially when the auditing focuses not just on compliance but effectiveness.

The processes and tasks that a quality audit involves can be managed using a wide variety of software
and self-assessment tools. Some of these relate specifically to quality in terms of fitness for purpose and
conformance to standards, while others relate to Quality costs or, more accurately, to the Cost of poor
quality. In analyzing quality costs, a cost of quality audit can be applied across any organization rather
than just to conventional production or assembly processes.