Seiko Maraica Electrical Manufacturing (India)

Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

Material Resources Process Risks for Human Resources

Company, System, Product, Interfaces
IATF 16949:2016 requirements Non-availability of documents at points of use, existence of Knowledge in Quality Management System, knowledge in
obsolete documents without proper identification, poor documents & records control & knowledge in record
retrievability, lost data / records maintenance & data back-up techniques

1.0 Purpose:

The purpose of this procedure is to provide for a system,

 to determine the hierarchy of Quality Management System documentation to ensure the effective planning, operation and control of its processes,
 to establish & maintain records to provide evidence of conformity to requirements and of the effective operation of the QMS, and
 to define the controls needed,
 to approve documents for adequacy prior to issue
 to review & update as necessary and re-approve documents, and to ensure that changes and the current revision status of documents are identified
 to have a process to assure the timely review, distribution and implementation of all customer engineering standards / specifications and changes based on
customer required schedule
 to ensure the relevant versions of applicable documents are available at points of use,
 to ensure that documents remain legible and readily identifiable,
 to ensure that documents of external origin are identified and their distribution controlled,
 to prevent unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose, and
 to maintain legibility, proper identification, storage, protection, retrieval , retention period and disposal of records

2.0 Scope:

The scope covers the activities as detailed above for verification of compliance to IATF 16949:2009 and any additional QMS requirements, as determined

Document & Data Management Process

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 Seiko Maraica Electrical Manufacturing (India)
Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

3.0 Process Responsible:

MR is the key responsible for implementing this procedure. The functional / department heads are responsible for timely actions as specified in this procedure
4.0 Detailed Steps – Hierarchy of Quality System Documentation:

QUALITY
POLICY &
OBJECTIVE
S

LEVEL: I
QUALITY SYSTEM MANUAL
(Why)

LEVEL: II
QUALITY SYSTEM PROCEDURES
(Who, What, When & Where)

LEVEL: III
MASTERLIST / WORK INSTRUCTIONS / QSF / PRODUCT
SPECIFICATIONS
(How)

Document & Data Management Process LEVEL: IV

SM-QSP-4210-DDC QUALITY SYSTEM RECORDS
(Evidence)
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 Seiko Maraica Electrical Manufacturing (India)
Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

4.1 Detailed Steps – Determination of Quality System Documentation:

Input Process / Activity – Detailed Steps Desired Output Related Documents & Records

 Customer requirements  Identify the processes needed for the QMS and  Comprehensive Quality System Documents:
their application throughout the organization, Documentation to ensure the effective
 Statutory & Regulatory 1. Quality System Manual
including controls established over out-sourced planning, operation and control of its
requirements
processes processes
2. Master List of Quality
 Standard’s requirements
 Determine the sequence and interaction of these  To demonstrate the ability to consistently System Documents
 Size of the organization & processes provide product that meets customer and (SM-QSD-4230-01)
type of activities involved applicable regulatory requirements
 Determine criteria (process measures) and 3. Master List of External
 Complexity of processes and methods needed to ensure that both the operation  To enhance customer satisfaction Origin Documents
their interactions & control of these processes are effective through the effective application of the (SM -QSD-4230-02)
 Competence of personnel system, including processes for continual
 To ensure the availability of resources and
improvement 4. Master List of Quality
information necessary to support the operation and
System Records
monitoring of these processes.
(SM -QSD-4240-01)
 Monitor, measure and analyze these processes,

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 Seiko Maraica Electrical Manufacturing (India)
Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

and Implement actions necessary to achieve

planned results and continual improvement of
these processes

4.2 Detailed Steps – Evolution of Quality System Documentation:

Input Process / Activity – Detailed Steps Desired Output Related Documents & Records
Level – I: Quality System Manual
 Customer requirements  Comprehensive Quality System Documents:
QMS Manual is the prime directive documentation of the
Documentation to ensure the effective
 Statutory & Regulatory Quality System, and shall include the following:
planning, operation and control of its 1. Quality System Manual
requirements
 Scope of the QMS, including details of and processes
 Standard’s requirements justification for any exclusions
 Company profile
 Size of the organization &
 Documented Statements of Quality Policy & ref to
type of activities involved
Quality Objectives
 Complexity of processes and  Process Interactions
their interactions  Reference to the established procedures
 Competence of personnel  Organization Chart
 Responsibility & Authority

Mgmt Representative is responsible for the preparation

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 Seiko Maraica Electrical Manufacturing (India)
Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

of QMS Manual & its revision & MANAGING

DIRECTOR shall approve the same for adequacy prior
to issue.
Review of QMS Manual – Annual basis

4.2 Detailed Steps – Evolution of Quality System Documentation: (contd.,)

Input Process / Activity – Detailed Steps Desired Output Related Documents & Records

 Customer requirements Level – II: Quality System Procedure Manual  Comprehensive Quality System ----
Documentation to ensure the effective
 Statutory & Regulatory Quality System Procedure Manual includes mandatory
planning, operation and control of its
requirements procedures as required by this International Standard
processes
and outlines,
 Standard’s requirements
 Purpose, Scope & Process Responsible
 Size of the organization &
 Material & Human Resources
type of activities involved
 Process Risks for Company, System, Products &
 Complexity of processes and interfaces
their interactions  Input-Detailed Activity-desired Output
 Competence of personnel  Process Measures in terms of Effectiveness &
Efficiency
 Monitoring and / or measuring mechanism
 Related Documents & Records

Mgmt Representative is responsible for the preparation

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 Seiko Maraica Electrical Manufacturing (India)
Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

of QSPM & its revision & MANAGING DIRECTOR shall

approve the same for adequacy prior to issue.

Review of QSPM Manual – Annual basis

4.2 Detailed Steps – Evolution of Quality System Documentation: (contd.,)

Input Process / Activity – Detailed Steps Desired Output Related Documents & Records

 Customer Drawings, Level – III: Master List of Documents / Quality System  Comprehensive Quality System ----
Technical / Engineering Formats (QSF) & Work Instructions Documentation to ensure the effective
Specifications planning, operation and control of its
These are the level three documents and outlines as to
processes
 Standard’s requirements how an activity or a task has to be carried out at a micro
level
 Need to capture process
information & other data Master List of Documents are prepared & maintained as
soft copy in a PC. Master List bears only the document
 Customer requirements
reference. However no revision number or revision
status provided to the master list. The List is updated by
the Management Representative as and when required.

QSF / Work Instructions are prepared by the respective

process owners MANAGING DIRECTOR shall approve
the same for adequacy prior to issue.

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 Seiko Maraica Electrical Manufacturing (India)
Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

4.2 Detailed Steps – Evolution of Quality System Documentation: (contd.,)

Input Process / Activity – Detailed Steps Desired Output Related Documents & Records

 Customer Drawings, Level – III: Technical / Engineering specifications  A process has been established to 1. Customer Engineering Change
Technical / Engineering assure the timely review, distribution and Note (SM -QSF-4230-01)
Manager – Operations shall review all customer
Specifications implementation of all customer
engineering standards / specifications and changes
engineering standards / specifications
based on customer-required schedule. This timely
and changes based on customer-
review is ensured at the earliest possible and controls
required schedule
exercised to monitor not to exceed two working weeks.
Records are maintained for the dates on which each
change is implemented and documents are updated as
appropriate for the changes effected

Level – IV: Quality System Records:  To establish & maintain records to provide
 Regulatory & Customer QSF when filled become records and cannot be altered. evidence of conformity to requirements 1. Master List of Quality
requirements Mgmt Representative maintains a Master List of and of the effective operation of the QMS System Records
Records detailing,

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 Seiko Maraica Electrical Manufacturing (India)
Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

 Description & Document reference  To define the controls needed for (SM -QSD-4240-01)
 Revision Number identification, storage, protection &
 Indexing Method, retrieval
 Custodian & location
 To define appropriate retention period to
 Retention period & means of disposal
satisfy regulatory and customer
requirements

4.3 Detailed Steps – Quality System Documentation – Identification & Change Control:

Input Process / Activity – Detailed Steps Desired Output Related Documents & Records

 Quality System Classify the QMS documentation as,  To distinguish the Internal & External ----
Documentation Origin Documents within QMS
Internal – Quality System Manual, Procedures,
Documents, Work Instructions, Drawings & sketches &  To ensure documents remain legible and
formats etc., readily identifiable

These are maintained by the Mgmt Representative  To determine a mechanism to update the
through controlled distribution. availability of latest version of external
All master copies is retained by the MR. documents
Process owners do have the controlled version

All documents & records are identified duly by reference

numbers, labeling or marking for easy retrievability

External – Customer Drawings & specifications,

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 Seiko Maraica Electrical Manufacturing (India)
Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

National or International Standards etc., 1. Master List of External

Origin Documents
Mgmt Representative maintains relevant master list
(SM-QSD-4230-02)
against which the distribution is controlled.
 Source & frequency of updating is determined

Information & data maintained in computers / electronic

media are ensured for password protection and periodic
back-up to prevent tampering & loss of data

4.3 Detailed Steps – Quality System Documentation – Identification & Change Control: (contd.,)

Input Process / Activity – Detailed Steps Desired Output Related Documents & Records

 Changes to Customer Review documentation for adequacy w.r.t. 4 M’s – MAN,  To ensure control over documents for any Documents:
Drawings & External MACHINE, MATERIAL, METHOD etc., revisions to prevent duplication &
1. Master List of Quality
specifications unambiguous situations
Use of 5W’s & 1H: System Documents
 Statutory & regulatory  To prevent the unintended use of (SM-QSD-4230-01)
When, What, Where, Why, Who & How
requirements Obsolete documents
2. Master List of External
Ascertain the impact of the changes and its significant
 Product / Process Origin Documents
effect on the integrity of the QMS.
enhancements (SM-QSD-4230-02)
Make relevant changes and review for adequacy for the
 Corrective / Preventive
changes made prior to issue 3. Master List of Quality
Actions

Document & Data Management Process

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 Seiko Maraica Electrical Manufacturing (India)
Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

Record the revision history for nature of changes made System Records
 Improvement Projects
& Update Master List. Withdraw the obsolete (SM-QSD-4240-01)
 Changes to Company, documents & re-issue the current version of documents
product, process, system and as per the distribution control Records:
other interfaces
Note:
1. Revision Record
Any obsolete documents retained for any purpose to be
History
identified as “OBSOLETE”

5.0 Process Measures:

Process Measures
Monitoring & or measuring mechanism
Effectiveness Efficiency

 User friendliness ----  Management Review Forum

 Review & changes made to the QMS documentation  Internal Audits
 Retrieval of Information

6.0 Related Documents:

6.1. Quality System Manual
6.2. Master List of Quality System Documents – Internal (MR/4.2.3/F/01/00)

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 Seiko Maraica Electrical Manufacturing (India)
Private Limited.,
Manufacturers of supply of wiring Harness Assemblies

6.3. Master List of System Documents - External (MR/4.2.3/F/02/00)

6.4. Master List of Quality System Records (MR/4.2.4/F/01/00)

7.0 Related Records:

Description Format No Indexing Method Custodian Retention Period Means of Disposal

Engineering Change Note (ECN) MR/4.2.3/F/06/00 Date wise Mgmt Rep 3 yrs Periodical Back-up

Revision Record History MR/4.2.3/F/05/00 Date wise Mgmt Rep 3 yrs Periodical Back-up

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