ns automotive qsp

QUALITY SYSTEM PROCEDURE

QSP 01 4.2.3

Effective Date April 20, 2015

Revision Level 0

of 3

Control of Documents

Uncontrolled copy if NS Automotive Ltd logo NOT in RED

Issued By: Quality Manager Approved By: CEO

PURPOSE

To establish a process that ensures appropriate documentation to support the QMS is

established, maintained, and controlled.

SCOPE

This procedure applies to all documentation used to support the quality system in NS

Automotive Ltd. facilities and affects all employees whose work impacts the realization

of the quality objectives stated in the organization’s Quality Manual.

RESPONSIBILITIES

The Quality Manager is responsible to develop, implement and maintain the QMS and

control related documents.

The NS Automotive Ltd. Management is responsible to review and approve the quality

system documentation.

Functional area managers are responsible for identifying appropriate needs for

document revision and hand over to Quality Manager for consideration.

All the users of documents are responsible to ensure that they are using the latest

versions of the documents as mentioned in Documentation Master List on form QF-

A1.

DEFINITIONS

QM Quality Manager

QMS Quality Management System

Document Information and its supporting medium


QSP 01 4.2.3


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PROCEDURE

All system controlled documents (required by ISO 9001:2008) are identified by a

unique name, number, revision level and effective date to ensure that they are current

and up-to-date.

The Documentation Master List is maintained in form QF-A1 and made available to all

affected and users to ensure that the documents in use are the latest.

All QMS documents are created by the Quality Manager and approved by at least one

member of the Management Team. The creation of new documents and revision of

existing documents follow the same procedure. Any changes/revisions in the

documents are recorded on Document Change Log form QF-A2.

NS Automotive Ltd. Quality Manual, Quality System Procedures, and Work

Instructions have a red color logo of the organisation in the header as a means to

control to preclude the unauthorized use of photocopies. The colored logo does not

apply to system forms. Working copies of forms could be made by photocopying

and/or slight adjustments in the working space without affecting the main contents.

Computer generated documents are backed up once a month and computer software

is protected by anti-virus protection software.

Any changes to product specifications or drawings must be approved by the customer.

However, due to practical limitations and urgency of production priorities, sometimes,

the customer proposes and approves some changes on telephone. The Quality

Manager and the members of Management are authorized to sign and allow any

changes to any document on floor pending formal approval as per established

procedure.

All the users remove the obsolete documents from points of use and handover to the

Quality Manager. The Quality Manager then decides to retain for reference and/or

destroy them by any suitable means.


QSP 01 4.2.3


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Obsolete and photocopied controlled documents may be retained for reference and

training purposes only.

QUALITY RECORDS

Documented Master List form QF-A1

Document Change Log form QF-A2

ASSOCIATED DOCUMENTS

ISO 9001:2008, Clause 4.2.3

NS Automotive Ltd. Quality Manual


QSP 02 4.2.4


Revision Level 0

Page 1 of 2

Control of records

Uncontrolled copy if NS Automobile Ltd logo NOT in RED

Issued BY: Quality Manager Approved By: CEO

PURPOSE

To ensure that all records documenting the processes of the QMS are controlled in a

manner that ensures their retention and availability.

SCOPE

This procedure applies to all records identified in the QMS documentation as Quality

Records.

RESPONSIBILITIES

Quality Records are controlled by the functional areas generating the records or as

defined in QSP Manual.

All the employees are responsible for handing over current/obsolete records after

completion to Quality Manager for retention/destruction.

NS Automotive Ltd. Management is responsible for providing all necessary support to

Quality Manager in controlling of records.

DEFINITIONS


QSP Quality System Procedure

Quality Record Document stating results achieved or providing evidence of

activities performed

PROCEDURE

All Quality Records are identified and listed in Records Master List on form QF-A3.

All Quality Records are completed in pen and ink or computer-generated to ensure their

permanency.


QSP 02 4.2.4


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Control of records

Uncontrolled copy if NS Automobile Ltd logo NOT in RED


The integrity of Quality Records is ensured by:

Hard copy records:

Filing in cabinets designed to prevent damage and deterioration and with access

controlled.

Computer-generated records:

Maintaining back-up copies of all the data files (once a month) with access controlled to

prevent unauthorized changes.

Quality Records clearly identify the process or product they are traceable to.

The retention times for Quality Records are mentioned in Records Master List QF-A3.

Obsolete Quality Records, when they are due for disposal, are handed over to Quality

Manager for destruction by shredding or any other suitable means.

Once the data is fed into computer and/or records are maintained electronically, there is

no need to save hard copies. Hard copies may be destroyed, or saved for reference only.

QUALITY RECORDS

Records Master List on form QF-A3


ISO 9001:2008, Clause 4.2.4



QSP 03 8.2.2


Revision Level 0

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Internal Quality Audits



PURPOSE

To ensure that internal quality management system audits are planned, scheduled,

and concluded thoroughly and effectively.

SCOPE

This procedure applies to all internal quality management system audit activities.

RESPONSIBILITIES

The Quality Manager is responsible for planning, scheduling, and conducting the

internal audits.

The Quality Manager is responsible for leading the internal audit activities with

assistance from functional area staff where required.

Where functional area personnel are part of the audit team, the Quality Manager is

responsible for training them in internal auditing techniques and ensuring that they are

independent from the area being audited.

All the employees are responsible for cooperating with the audit team for required

activities.

The Management team is responsible for extending full support to the audit team and

provides necessary resources in conducting internal audits.

The Quality Manager is responsible for advising the Management Team of audit

findings and plans for their resolution.

DEFINITIONS

CAR Corrective Action Request

PROCEDURE

The following process map and table give details of the steps in conducting the internal

audits.


QSP 03 8.2.2


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Process Map for Internal Audit

Internal Audit

Team

Requirements

Train Audit

Team

Notify

Functional

Area

Develop Audit

Checklist

Brief Audit

Team

Conduct

Internal Audit

Generate CARProduce Audit

Report

Distribute

Audit Report

Audit Follow-

Up


QSP 03 8.2.2


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Steps Action

Internal Audit

Team

Requirements

The Quality Manager determines the makeup of audit team based on:

Impact on the overall quality system

Corrective Action history

Results of previous audits

Customer Feedback

Train Audit

Team

The Quality Manager conducts audit team training:

For training internal auditors

Refresher training only (4 Hours)

For new internal auditors

Full internal audit training (8 Hours)

Notify

Functional

Area

The Quality Manager notifies the functional are to be audited 5 working

days in advance before the scheduled audit. This notice includes:

Date and time of audit

Scope of audit

Audit team membership

Any special resources required

Develop Audit

Checklist

The Quality Manager develops audit checklist based on:

ISO requirements

Customer and regulatory requirements

Previous audit findings

New process implemented

Brief Audit

Team

The Quality Manager holds audit team briefing meeting to review audit

checklist and any potential area of conflict

Conduct

Internal Audit

The Audit team conducts internal audit using checklist

Notes are made during the audit for findings with objective evidence as

well as opportunities for improvement

Generate CAR Audit team generates CAR

Opportunities for improvement are not subject to CAR process


QSP 03 8.2.2


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Produce Audit

Report

The Quality Manager produces the audit report with assistance from audit

team, including:

Date and time of audit

Scope of audit

Audit team members and lead auditor

CAR raised

Observations for improvement

Distribute

Audit Report

The Quality Manager processes the completes CAR and distributes the

audit report:

One copy for Quality record

One copy for concerned functional are audited

Audit Follow-

up

The Quality Manager follows up with functional areas to ensure that CAR

are promptly acted upon

QUALITY RECORDS

Internal Audit Plan on form QF 15a

Internal Audit Checklist on form QF 15b

Internal Audit Nonconformity Report on form QF 15c

Internal Audit Summary on form QF 15d


ISO 9001:2008, Clause 8.2.2


QUALITY SYSTEM PROCEDDURE

QSP 04 8.3


Revision Level 0

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Control of Non-Conforming Product

Uncontrolled copy if NS Automotive LTD. logo NOT in RED


PURPOSE

To ensure the integrity of products is maintained by identifying and controlling

nonconforming products.

SCOPE

This procedure applies to all nonconforming products.

RESPONSIBILITIES

Quality Control and production personnel are responsible for identifying

nonconforming products in their inspections.

Purchasing Manager is responsible for identifying nonconforming products/parts

purchased from suppliers.

Quality Manager and NS Automotive Ltd. Management are responsible for final

disposal of nonconforming product.

DEFINITIONS

Nonconforming Product Products that do not meet the specified requirements

Reuse Use the product with customer approval again

Rework Action on a nonconforming product to make it conform to

the requirements

Repair Action on a nonconforming product to make it acceptable

for intended use

Scrap Action on a nonconforming product to preclude its

originally intended use


QSP 04 8.3


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PROCEDURE

Quality Inspector identifies all nonconforming products from in-house production.

A red tag is issued to nonconforming products bearing job #, part #, quantity affected,

date, and suspected nonconformity. A yellow tag may be issued in case of any

ambiguity or when the product requires re-inspection.

Nonconforming products are kept in segregated quarantine area to preclude its

misuse.

Quality Manager logs the details on form QF 10. He then records the details of the

discrepant condition on quality form QF 18. In the event of non-availability of Quality

Manager, any member of the Management takes care of his responsibilities.

Quality Manager, in consultation with a member of Management decides the action to

be taken for disposition of the nonconforming product that may be:

Reuse

Rework

Repair

Scrap

Customer approval may be necessary of it affects them. A new tag is issued to the

product after a disposition decision is taken stating the status of the product. Green

tag may be issued if the product has been approved for use. Corrective action request

may have to be initiated, if necessary.

The activities are recorded on CAR by the Quality Manager who finally closes CAR

after its completion

QUALITY RECORDS


QSP 04 8.3


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Corrective Action Request on form QF 18

NCR Log form QF 10


ISO 9001:2008, Clause 8.2.2



QSP 05 8.5


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Corrective and Preventive Actions



PURPOSE`

To establish a process that promptly identifies the root cause of nonconformities so

that corrective and preventive actions could be taken to prevent recurrence of the

problem.

SCOPE

This procedure applies to all elements of the QMS and the applicable functional

departments.

RESPONSIBILITIES

The Quality Manager is responsible for coordination, recording, and verification of

corrective and preventive actions related to the QMS.

Functional area management is responsible for providing appropriate technical

expertise in the analysis and execution of corrective and preventive actions in a prompt

and efficient manner.

NS Automotive Ltd. Management is responsible for extending full support to the

Quality Manager in ensuring prompt and effective corrective and preventive actions.

DEFINITIONS


CAR Corrective Action Request

Root Cause The fundamental reason for the nonconformity that, if

corrected, would prevent recurrence

Corrective Action Action to eliminate the cause of a detected nonconformity

Preventive Action Action to eliminate the cause of a potential nonconformity

Nonconformity

Non-fulfillment of a requirement


QSP 05 8.5


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PROCEDURE

The following process map and table give details of the steps for corrective and

preventive actions.

Identify

Nonconformity

Evaluate

Nonconformity

Analyse for

Root Causes

Determine

Appropriate

Corrective/

Preventive

Action

Monitor

Corrective/

Preventive

Action

Dispose

Nonconformin

g Product


QSP 05 8.5


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Steps Action

Identify

Nonconformity

Quality related nonconformities are identified through:

Internal Audits

Customer complaints/concerns

Inspections

Quality Manager logs identified nonconformities on NCR

Log form QF 10

Evaluate

Nonconformity

Non-conformance are evaluated by Quality Manager and

affected functional area personnel for impact on:

Performance

Customer satisfaction

Application requirements

Analyze for Root

Causes

Quality Manager, with inputs from functional area, analyzes

for root causes and enters on CAR form QF 18

Determine

Appropriate

Corrective/Preventive

Action

Functional area management with assistance from Quality

Manager develops corrective and preventive actions

Monitor

Corrective/Preventive

Action

Quality Manager monitors the corrective and preventive

actions

Dispose

Nonconforming

Product

Nonconforming product is disposed in accordance with

QSP 04(8.3)


QSP 05 8.5


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QUALITY RECORDS

Corrective Action Request on form QF 18

Preventive Action Report on form QF 19

NCR Log on form QF 10


ISO 9000:2005, Clause 3.6

ISO 9001:2008, Clause 8.5


NS Automotive Ltd. Quality System Procedure QSP 04 (8.3)