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16) Internal Quality Audit

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125 views11 pages

16) Internal Quality Audit

Uploaded by

Sagar Daund
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Doc No - REPL/QAP/QMS/02

Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

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.

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Doc No - REPL/QAP/QMS/02

Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

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.

21. Internal Auditor Competency:

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Doc No - REPL/QAP/QMS/02

Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

Criteria for Internal QMS Auditor shall be as Following:


a) Certified Internal Auditor for IATF 16949
b) Understanding the automotive process approach for auditing, including risk-based thinking;
c) Understanding of applicable customer specific requirements;
d) Understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the
audit.
e) Understanding of applicable AIAG core tool requirements related to the scope of the audit;
f) Understanding how to plan, conduct, report and close audit findings.

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

Criteria for Internal Product Auditor shall be as Following:


a) Understanding Product requirements, Part Drawing and Control Plan
b) Use of relevant measuring and test equipment to verify product conformity

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)

22. QUALITY MANAGEMENT SYSTEM AUDIT

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Doc No - REPL/QAP/QMS/02

Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

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.

23. MANUFACTURING PROCESS AUDIT


The organization should audit all manufacturing processes at every year to determine their effectiveness and
efficiency using customer-specific required approach for process audits. Where not defined by customer, the
organization shall determine the approach to be used.
Within each individual audit plan, every manufacturing process shall be audited on all shifts where it occurs,
including the appropriate sampling of the shift handover.
The manufacturing process shall audit include an audit of the effective implementation of the process risk
analysis (such as PFMEA), control plan, and associated documents.
Special Process audit to be conducted as per Customer requirement of CQI9.

24. PRODUCT AUDIT

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:

 Inform to Production Supervisor and Quality Inspector


 Containment of relevant lot’s material & 100 % Inspection of NG Parameter. Record of this
Inspection shall maintained.
 After Correction Pick further 5 Samples for Product Audit.
 NC will be raised and will be closed through NCR Analysis Report.

25. Audit Planning

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Doc No - REPL/QAP/QMS/02

Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

Audit planning consists of preparing the internal audit schedule.


The schedule covers all processes of the quality management system at least once a year - although
particular processes/activities may be audited more frequently depending on their
importance/performance results. Also we can follow below rule for Audit frequency
1) In case of increased Customer Complaint – 8 Months
2) In case of any warranty failure – 8 Months
3) If all objectives are meeting – 1 Year
Unscheduled audits may be performed in response to:
 Anticipated problem areas
 Increased Customer Complaints /Disruption
 Warranty Failure
 Internal Complaint / Rejection.
 actual problems
 requests from Management
 unforeseen changes in circumstances
The schedule defines, for each audit:
 The type of audit planned (e.g. product, procedure or process),
 The scope of the audit (Identification of the process – e.g. Calibration of inspection
equipment, process control, training),
 The Auditor
 The Auditee
 The tentative date (at the planning stage the month for the audit will be sufficient - as the
time approaches the auditor will set a firm date in consultation with the auditee).

26. Audit Preparation

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Doc No - REPL/QAP/QMS/02

Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

The auditor will prepare for each audit as follows:


By studying previous audit reports covering the same area (in order that previous 'problem
areas' can be examined in more detail, or that areas previously unexamined can be
looked at more closely).
By familiarising himself with the requirements of the ISO/IATF 16949:2016 and the local
standards (Quality Manual / Procedures / Work Instructions).
By contacting the auditee and confirming the date/time for the audit.
By preparing an Audit Checklist or similar aide-memoir.

27. Performing the Audit


During the Audit, the Auditor will:
 make use of standard auditing techniques to collect objective information concerning the
subject being audited;
 not respond to rumour and hearsay;
 avoid confrontational situations and arguments;
 Sampling of Customer Specific requirement (CSR) to be done during Internal Quality Audit.
 make notes to aid in the writing of the Audit Report (Form No-REPL/MD/F/AOS/R2)
 collect documentary evidence of conformity or nonconformity;
 note where current procedures could be improved;
 Keep the auditee informed as to the progress of the audit and any findings.
 Ensure the use of safety Equipments during process audit.
28. Writing and Presenting the Audit Report
As soon as practical after the audit, the auditor will prepare an audit report using the form “Non-
Conformance Report” (REPL/F/IQA-NCR/R2) on findings for each non-conformity covering
following information.
i. Process/Function audited
ii. Name of the auditee
iii. Name of the auditor/s
iv. Audit Sr. No.

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Doc No - REPL/QAP/QMS/02

Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

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.

13.1. Criteria for Major & Minor Non conformance


Major Non Conformance
If there was the absence of, or a significant failure to implement and/or maintain conformance to the
requirements of the applicable standard (i.e. the absence of or failure to implement a complete
management system clause of the standard) or a situation which would on the basis of available objective
evidence, raise significant doubt as to the capability of the management system to achieve the stated policy
& objectives of the customer.

Minor Non Conformance

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Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

If system fulfil partial requirements then it consider as minor non-conformance.

29. Corrective Action & Follow Up


It is responsibility of the auditee to initiate and complete the corrective action. He has to inform the
auditor and Management Representative of completion of the corrective action and invite
auditor for verification and closure of the NCR.
The auditor/s will follow up on proposed corrective action to verify that it is indeed implemented.
Auditor/s will close the NCR if corrective action is found to be satisfactorily implemented.
Effectiveness may be judged during next audit.
If corrective actions are not addressed, a meeting of Management Representative, auditors and the
auditee will be conducted to review the constraints.
If corrective action has not been implemented, the matter will be raised by the Management
Representative in the management review meeting.

30. Timeframe of Core Activities :

Activity Timeline Responsibility

Release Of IQA Schedule 1 week before start MR

Issuance of IQA Report within a week after audit date Auditor


within a week after report
Submission of NC Analysis Report Auditee
submission
Closure of NC within a month from Audit date Auditee

Follow - up Audit within a month after NC Closure MR / Auditor

Note - Timeline for Closure of NC can be extended according to nature of Corrective Action
by intimating MR

31. Management Review:


Management Representative will compile and analyse the audit reports to present for review. Analysis
will focus on
 types of problems and identifying the most common problems
 response and correction times
 recommendations to improve performance

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Doc No - REPL/QAP/QMS/02

Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

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

Sr Description Form No Retention Custodian


No Period
1 List of Internal Auditors IATF 16949:2016 REPL/MD/LOA/R1 3 Years MR
2 Internal Quality Audit Check sheet REPL/MD/F/IQACS/R0 3 Years MR
3 Internal Audit Schedule REPL/MD/F/IAS/R2 3 Years MR
4 IQA NCR Summary Report REPL/F/IQA-NCRS 3 Years MR
5 Management Review Meeting REPL/F/ MRM/R2 3 Years MR
6 Product Audit Plan REPL/MD/F/PAP/R3 3 Years QA
7 Product Audit Report REPL/MD/F/PAR/R4 3 Years QA
8 Process Audit Plan REPL/MD/F/PAP/R1 3 Years QA
9 Process Audit Report REPL/MD/F/PA/R3 3 Years QA

35. REVISION HISTORY

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Doc No - REPL/QAP/QMS/02

Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

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

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Doc No - REPL/QAP/QMS/02

Internal Quality Audit Date – 01.12.2003


Rev. No. / Date – 10 / 28.02.2024

36. Flow Chart of the Internal Audit Process

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