QSP 05 Internal Audits

Download as doc, pdf, or txt
Download as doc, pdf, or txt
You are on page 1of 7

SPI/QSP/05/IQA

QUALITY SYSTEM PROCEDURE Issue: C


Rev. No: 00
Date: 01.12.2018
INTERNAL AUDIT
Page 1 of 7

1.0 Purpose
The purpose of this procedure is to establish a system for conducting internal quality audits in
order to determine whether the quality management system
a) Conforms to the planned arrangements, to the requirements of IATF 16949:20016 QMS
established by Sri Pandiyan Industries and,
b) Is effectively implemented and maintained.
1.1 Application
This procedure is applicable for all the activities covered under QMS at Sri Pandiyan Industries .
1.2 Responsibility
Audit Coordinator, Director is responsible for implementation of this system.
1.3 Terms and definitions
IQA : Internal Quality Audit
NCR : Non Conformance Report
Major Non-conformance:
A total absence of control or a systematic failure to implement standard requirements. Any
probability that non-conforming product will be dispatched to the customer

Minor non-conformance:
Isolated or non-systematic failures to implement standard requirements. There is no probability
that non-conforming product will be dispatched to the customer:
(Note: 4 or more minor non-conformances in one area will be upgraded to Major)

Observation:
Instances where weaknesses in the system are suspected, but there is no Objective Evidence
available to categorize as a non-conformance

Objective Evidence:

Facts that can be proven to be true

Audit criteria: Set of policies, procedures or requirements used as a reference

Audit evidence: Records, statements of fact or other information, which are relevant to the audit
criteria and verifiable. Audit evidence can be qualitative or quantitative.

SRI PANDIYAN INDUSTRIES


SPI/QSP/05/IQA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 00
Date: 01.12.2018
INTERNAL AUDIT
Page 2 of 7

Audit findings: Results of the evaluation of the collected audit evidence against audit criteria.
Audit findings can indicate either conformity or nonconformity with audit criteria, or
opportunities for improvement.
Audit conclusion: Outcome of an audit provided by the audit team after consideration of the
audit objectives and all audit findings
Nonconformity: Non-fulfillment of a requirement.
2.0 Procedures
2.1 Characteristics of the audits
1) Every internal quality audit shall be a compliance audit with requirements of IATF
16949:2016 and the quality management system established and implemented by Sri
Pandiyan Industries .
2) All functions covered under quality management system of Sri Pandiyan Industries are
subject to internal audits.

2.2 Selection of Auditors:

2.2.1 Director / QMS Coordinator selects a team of supervisors based on their educational
qualification and experience and arranges to impart training to them in conducting IQA.
2.2.2 The up-to-date list of Internal Auditors along with details of their training is maintained
by QMS-Co Ordinator.
2.2.3 Internal Auditor competency: Trained and qualified internal quality auditors (those who
have undergone IATF 16949:2016 internal auditors’ training and have passed the examination)
shall conduct the audit. Audit will be conducted by trained Internal Auditors and shall all be able
to demonstrate the following Minimum competencies
a) Understanding the automotive process approach for auditing including risk-based thinking
b) Understanding of applicable customer-specific requirements
c) Understanding of applicable ISO 9001 and IATF 16949 Requirements related to the scope of
the audit
d) Understanding of applicable core tool requirements related to the scope of the audit
e) Understanding how to plan , conduct, report and close out audit findings
Where training is provided to achieve competency, documented information shall be retained to
demonstrate the trainer’s competency with the above requirements
1) Maintenance of and improvement in internal auditor competence shall demonstrated
through;
f) Execute a minimum number of audits per year, as defined by the organization; and

SRI PANDIYAN INDUSTRIES


SPI/QSP/05/IQA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 00
Date: 01.12.2018
INTERNAL AUDIT
Page 3 of 7

g) Maintaining knowledge of relevant requirements based on internal changes (e.g process


technology, product technology ) and external changes (e.g ISO 9001, IATF 16949, core tools
and Customer Specific Requirements)
Manufacturing Process Auditor Competency: Additionally manufacturing process auditors shall
demonstrate technical understanding of the relevant Manufacturing processes to be audited
including risk analysis (Such as PFMEA) and control plan.
Product Auditor Competency: Product auditors shall demonstrate competence in understanding
product requirements and use of relevant measuring and test equipment to verify product
conformity.
Second-party auditor competency: Sri Pandiyan Industries shall demonstrate the competence
of the auditors understanding the second-party-audits. Second-party-auditors shall meet customer
specific requirements for auditor qualification and demonstrate the minimum following core
competencies, including understanding of;
a) The automotive process approach to auditing including risk based thinking
b) Applicable customer and organization specific requirements
c) Applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit
d) Applicable Manufacturing process(es) to be audited , including PFMEA and control plan
e) Applicable core tool requirements related to the scope of the audit
f) How to plan, conduct, prepare audit reports and close out audit findings.
2.3 Planning of audits
2.3.1 Annual Audit Plan is prepared for every year indicating the week / Month of the proposed
audit, Process / function to be audited, duration of audit etc. Periodicity of Quality
Management System audits shall be once in Six months (twice in a year).
2.3.2 The frequency of audit of a particular functional area in the subsequent years is
determined taking into consideration the status and importance of the processes and the
areas to be audited as well as the results of previous audits.
2.3.2 QMS-Co Ordinator plans conduct of each IQA by allotting the auditors for each process /
function.
2.3.3 It is ensured that the auditor does not have direct responsibility in the areas being
audited by him / her and he or she does not audit his / her own work.
2.3.4 Auditors / Auditees are informed of the proposed audit at least 3 working days in advance
in writing through IQA Schedule
2.3.6 A unique reference number is allotted for each audit schedule.

2.4 Conducting and Reporting of Audit results

SRI PANDIYAN INDUSTRIES


SPI/QSP/05/IQA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 00
Date: 01.12.2018
INTERNAL AUDIT
Page 4 of 7

1) All functional heads shall ensure their availability on the scheduled date. In case of
exigencies changes may be allowed with prior intimation to QMS-Co Ordinator.

2) The internal auditors should make effort to surface-out facts other than nonconformities
which may include information with regard to:
a) Effective and efficient implementation of processes,
b) Opportunities for continual improvement,
c) Capability of processes,
d) Effective and efficient use of resources,
e) Analysis of quality cost data.
Audit observation is classified as below:

+O è Conformance

Observations conforming to IATF 16949:2016 requirements and the documented Quality


System

OI è Opportunity for Improvement

Nor a nonconformance or the results evidenced could have been better (eg. More time
taken to demonstrate compliance, higher variability within specification, documents are not
user friendly, no logical flow, improper document/record maintenance, etc)
NC è Nonconformity
Non-fulfillment of a requirement.
 Does not meet the requirements of the standard.
 Does not meet the requirements of the contract.
 Does not do what it claims
 There is a significant gap in the system
 Problem of similar kind is observed through out the company
 The product is (will be) highly affected
 It is occasional, insignificant lapses are noted
 It has no impact on product
 It is an isolated incident
3) Audit observations may be recorded in the Audit Observation sheet.

2.5 Audit Reporting:


SRI PANDIYAN INDUSTRIES
SPI/QSP/05/IQA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 00
Date: 01.12.2018
INTERNAL AUDIT
Page 5 of 7

2.5.1 Each NCR is allotted unique serial number.


2.5.2 The details of non-conformance are recorded by the auditor in the NCR and the signature
of the Auditee is obtained.
2.5.3 Details of proposed corrective action and the target date for its completion are entered
by the Auditee with signature.
2.5.4 NCR is prepared in duplicate and one copy is given to the auditee and the other to QMS-Co
Ordinator after completion of audit.
2.5.5 A status report on the number of non-conformities observed in each department is
Prepared by the QMS-Co Ordinator and recorded in Audit Summary
2.6 Follow up of Corrective Action:

2.61 The Auditee responsible for the area being audited shall ensure that actions are taken
without undue delay to eliminate detected non-conformities and their causes.
2.6.2 The head of the Auditee’s department reviews the corrective action and records the
satisfactory implementation of the same in the NCR given to him.
2.6.3. The auditor reviews all the proposed corrective actions as agreed to by the auditee in the
NCR either soon after completion of the corrective action as reported by the auditee.
2.6.4 If the corrective action has been effectively implemented, the auditor closes the NCR by
signing the NCR copy available with functional head.
2.6.5 The QMS-Coordinator /Director in turn will verify the closure with objective evidence and
will certify in his NCR that the NC is closed.
An exceptional statement on NCR’s pending completion of timely action is prepared by QMS-Co
Ordinator and submitted to the management for review during

2.7 Manufacturing Process Audit

Manufacturing process audit is conducted based on the respective Manufacturing Process Audit
Checklist at the frequency defined in their Manufacturing Process Audit Plan and the results are
recorded in the Manufacturing Process Audit Report. For any nonconformance’s identified,
appropriate corrective actions are initiated.

2.8 Product Audit

To ensure the consistency in the product quality (Dimensions, Functionality, Packaging and
Labeling), Product Audits are conducted at periodic intervals (at least once in a year) according to
Product Audit Plan and the audit is carried out as per the product audit plan and the results are
recorded in the Product Audit Report. Product audit will be carried out after packing before
dispatch stage.

SRI PANDIYAN INDUSTRIES


SPI/QSP/05/IQA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 00
Date: 01.12.2018
INTERNAL AUDIT
Page 6 of 7

3.0 Associated Documents and Records


Sl. Authorizing Custodian of Retention
Name of the Record
No Personnel record time

1 Annual Internal Plan QMS-Co QMS-Co 3 years


Ordinator Ordinator
2 Audit Schedule QMS-Co QMS-Co 3 years
Ordinator. Ordinator
3 Audit Observation Sheet QMS-Co QMS-Co 3 years
Ordinator Ordinator
4 Internal audit NC report QMS-Co QMS-Co 3 years
Ordinator Ordinator
5 Audit Summary QMS-Co QMS-Co 3 years
Ordinator Ordinator
6 List of Internal Auditors QMS-Co QMS-Co 3 years
Ordinator Ordinator.
7 Process Audit Plan QMS-Co Quality
3 years
Ordinator Manager
8 Process Audit Report QMS-Co Quality
3 years
Ordinator Manager
9 Product Audit Plan QMS-Co Quality
3 years
Ordinator Manager
10 Product Audit Report QMS-Co Quality
3 years
Ordinator Manager

4.0 Reference
1) IATF16949:2016 clause number 9.2
5.0 Associated Procedures
1) Procedure for control of documents QSP 01
2) Procedure for control of records QSP 02
3) Procedure for corrective and preventive action QSP 07

6.0 Changes

Required changes of this Procedure have to be directed in writing to the team leader of
this Procedure. Such change requests will be discussed within the team and in case of
improvement implemented into the Procedure. The changes have to be described in the
revision sheet. Responsible for documentation and change of the Procedure on the sheet
“Revision” is the team leader.

SRI PANDIYAN INDUSTRIES


SPI/QSP/05/IQA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 00
Date: 01.12.2018
INTERNAL AUDIT
Page 7 of 7

7.0 Distribution

After release by the QMS-Co Ordinator this Quality System Procedure will be released with
controlled copy to related department as per the distribution list of documents by QMS-Co
Ordinator.

8.0 Revisions
Sl:
Revision Date Description of change
No
1 C/00 01.12.2018 New Release for IATF 16949:2016 Standard

Revisions authorized by:

Prepared: _____________________________ _______________________________________________________________________________________________________________

Date QMS-Coordinator

Approved: ___________________________ _______________________________________________________________________________________________________________

Date Proprietor

SRI PANDIYAN INDUSTRIES

You might also like