16) Internal Quality Audit
16) Internal Quality Audit
1. PURPOSE
To define and provide for a system for a system and instructions, and to assign responsibilities for planning
and performing internal quality audits.
2. SCOPE OF APPLICATION
Quality Management System at RIJ Engineering Pvt. Ltd.
3. RESPONSIBILITY AND AUTHORITY
4. Management Representative – Ultimate responsibility for planning and performing internal audits and
implementation of appropriate corrective and preventive actions.
5. Responsible Persons – Participate in the audit program and implement corrective and improvement actions
based on the audit results in their own functional areas.
6. DEFINITIONS AND ACRONYMS
7. For this procedure the definitions given in the International Standard IATF16949:2016 Quality Management
Systems – Fundamentals and Vocabulary apply.
8. Responsible Person – An employee who has been assigned responsibility for a functional area.
9. Internal Audit – An internal quality audit is a structured and independent examination to determine whether
activities and their related results comply with planned arrangements, and whether these arrangements are
implemented effectively.
10. Internal Auditor - An auditor is a person who is qualified/trained to perform internal audit of the company's
Quality Management System. He will survey and sample the Quality Management System by questioning,
listening, observing, challenging, and noting facts, which allows him to compare the activity with the
planned arrangements in an impartial manner. The Auditor will be independent of the process / activity
being audited.
11. Auditee - A person who is being audited. Expected to provide relevant information to the auditor.
12. Internal Quality Audit - An internal quality audit is a structured and independent examination to determine
whether activities and their related results comply with planned arrangements, and whether these
arrangements are implemented effectively. Audits are of following different types:
13. Product Audit - An examination of any number of units, at any stage of production, conducted to verify
compliance to the applicable blueprints, parts lists, drawings or checklists.
14. Process Audit - An examination of a manufacturing process conducted to verify compliance to the
appropriate manufacturing standard, process sheet or process plan.
15. Procedure Audit - An examination of the activities of a functional area/department conducted to verify
compliance with procedural requirements of the Quality Manual and the requirements of ISO/IATF
16949:2016.
16. Quality Audit Observation - Statement of fact made during a quality audit or substantiated by objective
evidence.
17. Objective Evidence – Information, which can be proven true based on facts obtained through observation,
measurement, test, or other means.
18. Nonconformance - A deficiency in a characteristic, documentation, or application of a procedure that
renders the quality of an item or service or the process of realization of quality unacceptable or
questionable.
19. Following examples of nonconformances include physical defects, test failures, incorrect or inadequate
documentation of data, or deviation from prescribed norms of processing, inspection, or test procedures.
A failure to follow established procedures
A failure to develop, document, or implement any required element of a program (i.e.,
Quality Assurance, Conduct of Operations, Maintenance or Environmental Management
System) or activity established by mutual agreement with the customer
A situation in which the quality of an activity or document is questionable (e.g., where the
stated or implied purpose has not been met or where insufficient information exists to
support the results that have been produced)
Not adhering to contractual, legal or other requirements, including administrative ones,
such as labelling, recording or other documentation requirements mandated by the quality
system.
20. PROCEDURE
The process shall include the development and implementation of an internal audit programmer that covers
the entire quality management system including quality management system audits, manufacturing process
audits, product audits.
The programme shall be prioritized based upon risk, internal and external performance trends and
criticality of the processes.
Where the organization is responsible for software development, the organization shall include software
development capability assessments in their internal audit programme.
The frequency of audit shall be reviewed and, where appreciate, adjusted based on occurrence of process
changes, internal and external nonconformities, and/or customer complaints. The effectiveness of the audit
programme shall be reviewed as a part of management review.
Additional criteria for Internal Process Auditor and Product Auditor shall be as following:.
Criteria for Internal Process Auditor shall be as Following:
a) Technical understanding of the relevant manufacturing process
b) Knowledge of Risk Analysis, mainly in Process failure Mode and Effects Analysis (PFMEA)
c) Knowledge of Control Plan
The internal Auditor Competency will be achieved and enhanced by providing Training. Such Requirement
will be incorporated in Annual Training plan by effective Training Need Identification (TNI). The Training
Record or Certificates will be maintained to demonstrate the competency of Internal Auditor.
The Internal Auditor Competency will be maintained and improved by following methods:
Executing at least one Department / Function audit in a year
If any auditor fails to meets this criteria, He shall allowed to audit independently after assisting in a
other Department / Function Audit with qualified auditor
For maintaining knowledge of relevant requirements, Training shall provide in case of following
Changes:
1. Change in Process / Product Technology
2. Changes in Standard requirements of ISO 9001 & IATF 16949
3. Changes in AIAG Core Tools
4. Changes in Customer Specific Requirements (CSR)
The organization shall audit all quality management system processes at every year according to an annual
programme, using the process approach to verify compliance with this Automotive QMS Standards. Integrated
with these audits, organization shall sample customer-specific quality management system requirements for
effective implementation.
The organization shall audit products using customer—specific required approaches at appropriate stages of
production and delivery to verify conformity to specified requirements. Where not defined by the customer, the
organization shall define the approach to be used.
Parts selection for Product audit to be done as per selection criteria given in product audit plan.
In case of any Customer Complaint Product audit plan to be planned for that part.
If any NG part occurs while Product Audit, Following Reaction Plan shall execute:
v. Audit date
vi. NCR No
vii. Reference documents as described
viii. Requirement
ix. Observation.
x. Details of objective evidence
xi. Details of failure mode
xii. Category of Non-conformance (Major or Minor)
xiii. Auditee’s declaration
xiv. Proposed Corrective action with completion date
xv. NCR clearance by auditor (after CA completion or during follow-up/next audit).
Auditor/ audit team leader prepares the IQA NCR summary (REPL/F/IQA-NCRS/R1).
This report indicates the non conformance detail and closing status of the non conformance of all
process.
Auditor submits Internal Quality Audit Check sheet and non-conformance report to the auditee and a
copy to the Management Representative.
Auditee writes his comments on the audit findings.
Corrective Actions plan will be required within a seven days period to be submitted to the auditor and
the Management Representative.
Note - Timeline for Closure of NC can be extended according to nature of Corrective Action
by intimating MR
Management review will focus on the effectiveness of the internal audit process.
Improvement opportunities will be identified and actions planned to continually improve the company’s
Quality Management System.
32. Records
All reports pertaining to quality audits and supporting documents are quality records governed by the
procedure “Control of Quality Records”, (REPL/QAP/CQR/R5).
Management Responsible is responsible for control of audit reports and supporting documents and will
make previous audit reports available to auditors (internal and external) upon request.
33. REFERENCES
ISO/TS 16949:2009; Clause 8.2.2
REPL Quality Manual, Section 8.2.2
Procedure “Quality System Review” (REPL/QAP/QSR/R5).
Procedure “Control of Quality Records” (REPL/QAP/CQR/R5).
34. RECORDS
REVISION HISTORY
Rev Description of Change Section Effective Date
0 Initial release - 01-12-2003
1 Ensuring use of safety equipment while process audit added 5.3.1 08-06-2004
2 Reviewed and reprinted. 10.06.2007
3 Reviewed and in reference TS std.edition changed. 6.1 05.01.2010
4 ISO 9000 revision changed to ISO 9001 4 28.5.2013
5 Reviewed and reprinted - 04.01.2015
6 Updated to incorporate IATF16949:2016 requirement 5,6,7 & 8 26.12.2017
7 Special Process audit requirement added, also Added rule 8,10.0 & 12.0 17.05.2020
for IQA frequency & also Incorporated sampling of CSR
during Internal Quality Audit.
8 Process shall be audited in all the shift including appropriate 8&9 21.03.2022
sampling of the shift handover, Parts selection criteria for
Product audit has been added
9 Criteria for major & minor non-conformance added & 13.1 23.07.2023
Change of Audit preparation Checklist
10 The Internal Auditor Competency maintenance methods, 6,9,15 28/02/2024
Product Audit Reaction Plan, Time frame etc. added