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Quality Manual 9001 2015

This quality manual outlines the quality management system for Alpha (India) as per the ISO 9001:2015 standard. It includes sections on leadership and commitment, planning, support, operation, performance evaluation, and improvement. The manual establishes the scope and objectives of the quality system, documents procedures for controlling quality management processes and ensuring conformity of products and services, and defines roles and responsibilities for quality management at Alpha (India).

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RAHUL SINGH
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100% found this document useful (3 votes)
2K views40 pages

Quality Manual 9001 2015

This quality manual outlines the quality management system for Alpha (India) as per the ISO 9001:2015 standard. It includes sections on leadership and commitment, planning, support, operation, performance evaluation, and improvement. The manual establishes the scope and objectives of the quality system, documents procedures for controlling quality management processes and ensuring conformity of products and services, and defines roles and responsibilities for quality management at Alpha (India).

Uploaded by

RAHUL SINGH
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 40

ALPHA (INDIA) Doc No.

: - AI/QM/01
Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

QUALITY MANUAL
(AS PER IS/ISO 9001: 2015)

ALPHA (INDIA)
PLOT NO. 27/83A, LAXMI RATTAN COMPOUND,
INDUSTRIAL AREA, NEAR HARDWARE CHOWK,
N.I.T., FARIDABAD (HARYANA) 121 001

ISSUE NO.: 01

ISSUE DATE: 01.01.2017

COPY SR. NO.: 01

ISSUED TO: PROPRIETOR

ISSUED BY: MR

NATURE OF ISSUE: MASTER COPY

This Quality manual and the information contained therein is the property Of
ALPHA (INDIA), FARIDABAD. This must not be reproduced in whole or in
parts or otherwise disclosed without the prior consent in writing from the
Proprietor of the organisation.

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Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

Section 0.1
CONTENTS
Page Rev. ISO-9001:2015
Section Description Issue date
No. No. Clause Ref.

0.1 Contents 2-4 00 01.01.2017 --


0.2 Revision Sheet 5 00 01.01.2017 --
0.3 List of controlled copy holders 6 00 01.01.2017 --
1.0 Scope, Permissible Exclusions and Control 7 00 01.01.2017 4.3
2.0 Quality Policy 8 00 01.01.2017 5.2.1
3.0 Quality Objectives 9 00 01.01.2017 6.2.1
4 Context of the Organization 4
4.1 Understanding the organisation and its context 4.1
4.2 Understanding the needs and expectations of interested 4.2
10-11 00 01.01.2017
Parties
4.3 Determining the scope of the Quality Management System 4.3
4.4 Quality Management System and its Processes 4.4
5 Leadership 5
5.1 Leadership & commitment 5.1
5.1.1 General 5.1.1
5.1.2 Customer Focus 5.1.2
11-13 00 01.01.2017
5.2 Policy 5.2
5.2.1 Establishing the Quality policy 5.2.1
5.2.2 Communicating the Quality Policy 5.2.2
5.3 Organizational roles, responsibilities and Authorities 5.3
6 Planning 6

6.1 Actions to address risks and opportunities 13-14 00 01.01.2017 6.1


6.2 Quality Objectives and Planning to achieve them 6.2
6.3 Planning of Changes 6.3
7 Support 14-18 00 01.01.2017 7
7.1 Resources 7.1
7.1.1 General 7.1.1
7.1.2 People 7.1.2
7.1.3 Infrastructure 7.1.3
7.1.4 Environment for the operation of Processes 7.1.4
7.1.5 Monitoring and measuring resources 7.1.5
7.1.6 Organizational Knowledge 7.1.6
7.2 Competence 7.2

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7.3 Awareness 7.3


7.4 Communication 7.4
7.5 Documented information 7.5
7.5.1 General 7.5.1
7.5.2 Creating and updating 7.5.2
7.5.3 Control of documented information 7.5.3
8 Operation 00 01.01.2017 8
8.1 Operational Planning and control 8.1
8.2 Requirements for Products and Services 8.2
8.2.1 Customer communication 8.2.1
8.2.2 Determining the requirements for products & services 8.2.2
8.2.3 Review of the requirements for Products and services 8.2.3
8.2.4 Changes to requirements for products and services 8.2.4
8.3 Design and development of products and services 8.3
8.3.1 General 8.3.1
8.3.2 Design and development planning 8.3.2
18-24 00 01.01.2017
8.3.3 Design and development inputs 8.3.3
8.3.4 Design and development controls 8.3.4
8.3.5 Design and development outputs 8.3.5
8.3.6 Design and development changes 8.3.6
8.4 Control of externally provided processes, products and 8.4
services
8.4.1 General 8.4.1
8.4.2 Type and extent of control 8.4.2
8.4.3 Information for external providers 8.4.3
8.5 Production and service provision 8.5
8.5.1 Control of production and service provision 8.5.1
8.5.2 Identification and Traceability 8.5.2
8.5.3 Property belonging to customers or external providers 8.5.3
8.5.4 Preservation 8.5.4
8.5.5 Post delivery activities 8.5.5
8.5.6 Control of changes 8.5.6
8.6 Release of Products and Services 8.6
8.7 Control of nonconforming outputs 8.7
9 Performance Evaluation 9
9.1 Monitoring, Measurement, analysis and evaluation 9.1
9.1.1 General 9.1.1
9.1.2 Customer Satisfaction 9.1.2
9.1.3 Analysis and Evaluation 24-26 00 01.01.2017 9.1.3
9.2 Internal Audit 9.2
9.3 Management Review 9.3
9.3.1 General 9.3.1
9.3.2 Management Review Inputs 9.3.2
9.3.3 Management Review Outputs 9.3.3
10 Improvement 26-27 00 01.01.2017 10
10.1.1 General 10.1.1
10.1.2 Nonconformity and Corrective Action 10.1.2

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10.1.3 Continual Improvement 10.1.3


Annex. I Organization Chart 28 00 01.01.2017 5.3
Annex. II Responsibility and authority 29-34 00 01.01.2017 5.3
Annex III Sequence & Interaction of QMS Processes 35 00 01.01.2017 4.4.1
Annex IV Inputs and Outputs of QMS Processes 36-37 00 01.01.2017 4.4.1
Annex. V List of Procedures 38 00 01.01.2017 --
Annex. 39 00 01.01.2017
Abbreviations --
VI

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Section 0.2
Revision History
S. Page Rev. Level Appd.
Section No. Nature of Revision Remarks
No. No. From To By/date

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SECTION: 0.3
DISTRIBUTION SHEET

The CONTROLLED copies are covered by “change control” and are stamped in
blue on all pages. The controlled copies are distributed to Functional Heads.

It is the responsibility of CONTROLLED copyholder of this Manual to maintain


and incorporate all revision on receipt and keep it up to date.

Copy No. 01 WITH MR & PROPRIETOR


Master Copy

Copy No. 2
WITH PRODUCTION & QC INCHARGE
Controlled Copy

* All other Sectional heads can refer to the Quality Manual available with
Production and QC Incharge

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SECTION 1.0
SCOPE, PERMISSIBLE EXCLUSIONS AND CONTROL
Scope:
Policies and practices given in this manual are applicable to the operations of ALPHA (INDIA),
FARIDABAD. It covers all aspects and facts for
“Manufacturing of all Types of Plastic Injection Moulded Components
for Home Appliances”.

Permissible Exclusions:
The following requirements of the Quality Management System ISO: 9001:2015 neither affect the
organization’s ability nor absolve it from its responsibility, to provide products that meet customers’
and applicable regulatory requirements. The exclusions are limited, depending on the type of
product, customer requirements and applicable regulatory requirements.
1. Design & Development (Clause 8.3) – As the product design is based on the drawings/
samples/ requirements of Customers, therefore Design activity is excluded from scope of this
manual.
2. Post-delivery activities (Clause 8.5.5) At present, there is no Post delivery activities related to
the Products. So this Clause is excluded from the scope the certifications.

Structure: Structure of the quality manual is as indicated in the contents. Different sections of the manual
Correspond to various sections of ISO: 9001: 2015.

Control of Quality Manual:


Each page has a unique section number and as such this manual is subject to page wise revision as
and when required.
Master copy bears the signature of approving authority in original and is kept with Management
Representative. Controlled copies are issued to individuals as indicated in distribution list and is
Stamped controlled on each page.
Quality manual is returned to the issuing authority when holder has no further use or leaves the
organisation. Unnumbered / Uncontrolled copies, which are not subject to any revisions, may be
issued to Customer / outside agencies in the organization’s business interest. UNCONTROLLED
copies are not covered under “change control” but are current at the time of issue.
Issue, updation and approval:
Management Representative is responsible for preparation, issue, updation of the Quality manual
for which PROPRIETOR gives the approval. This quality manual is subject to periodic revisions as
and when necessitated in the business interest of the organisation or in case of amended version of
ISO: 9001:2015 standard. Initial issue of the Quality Manual bears Issue no. 01 and is revised either in
case of amended version of ISO: 9001:2015 standard or after it is subject to 10 revisions of any section
of the Quality manual. Issue no. is given on each page of the Quality Manual.

Revisions are formally released to the concerned persons and obsolete copies are withdrawn. The
Management Representative, for future references, retains copy of the earlier versions. Management
Representative maintains records of all these activities.

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SECTION 2.0

QUALITY POLICY

We, ALPHA (INDIA), FARIDABAD are committed to achieve


Total Customer Satisfaction by understanding and meeting
applicable Statutory/Regulatory as well as customer
requirements and providing quality plastic components as
per their Specifications, always at right time through
continual improvement of our Quality Management System.
We are also committed to create strong awareness on Quality
among all the employees through continuous training &
motivation.

SD/-
Date: 01.01.2017 PROPRIETOR

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SECTION 3.0

QUALITY OBJECTIVES

Top Management of
ALPHA (INDIA), FARIDABAD
Has defined & established Quality Objectives as under: -

1. GROWTH: TO INCREASE TURNOVER BY 10% AT THE END

OF FINANCIAL YEAR.

2. PROCESS: TO INCREASE PRODUCTION CAPACITY BY 10%

BY THE END OF YEAR BY ADDING MACHINERY,

INCREASING PRODUCTIVITY, REDUCING REJECTION.

3. REJECTION: TO REDUCE PROCESS REJECTION RATE BY 1%

EVERY YEAR

4. TRAININGS: TO PROVIDE MINIMUM 2 HOURS TRAINING

TO EMPLOYEES IN EVERY QUARTER.

5. PURCHASE: TO DECREASE PURCHASE BY CONTROLLING

INVENTORY OF RAW MATERIAL , & B.O.P ITEMS.

DATED: 01/04/2017 SD/-


PROPRIETOR

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Section-4
4 Context of the organization
4.1 Understanding the organization and its context
The organization has determined external and internal issues (AI/QMS/01) that are
relevant to its purpose and its strategic direction and that affect its ability to achieve the
intended result(s) of its quality management system.
The organization has monitored and reviewed information about these external and
internal issues.

4.2 Understanding the needs and expectations of interested parties


Due to their effect or potential effect on the organization’s ability to consistently provide
products that meet customer and applicable statutory and regulatory requirements (at
present, there are no applicable statutory and regulatory requirements), the organization
determines:
a) The interested parties that is relevant to the quality management system;
b) The requirements of these interested parties that are relevant to the quality
management system.
The organization has monitored and reviewed information about these interested parties
and their relevant requirements and documented the same in Doc. No. AI/QMS/02.

4.3 Determining the scope of the quality management system


In consideration of the business considerations as identified in sections 4.1 and 4.2, the
scope of the ALPHA (INDIA), FARIDABAD, QMS is as follows:

“Manufacturing of all Types of Plastic Injection Moulded


Components for Home Appliances”.

PLOT NO. 27/83A, LAXMI RATTAN COMPOUND, INDUSTRIAL AREA, NEAR


HARDWARE CHOWK, N.I.T., FARIDABAD (HARYANA) 121 001

4.4 Quality management system and its processes


4.4.1 The organization has established, implemented, maintained and continually improve
a quality management system, including the processes needed and their interactions, in
accordance with the requirements of this International Standard.

The organization has determined the processes needed for the quality management
system and their application throughout the organization (Annex.-III), and has:

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a) Determined the inputs required and the outputs expected from these processes
(Annex. IV);
b) Determined the sequence and interaction of these processes;
c) Determined and apply the criteria and methods (including monitoring, measurements
and related performance indicators) needed to ensure the effective operation and
control of these processes;
d) determined the resources needed for these processes and ensure their availability;
e) Assigned the responsibilities and authorities for these processes
f) Addressed the risks and opportunities as determined in accordance with the
requirements of 6.1
g) Evaluated these processes and implement any changes needed to ensure that these
processes achieve their intended results
h) Improved the processes and the quality management system.

4.4.2 To the extent necessary, the organization has:


a) Maintained documented information to support the operation of its processes (Annex.
III & IV);
b) Retained documented information to have confidence that the processes are being
carried out as planned.

Section-5 Leadership
5.1 Leadership and commitment
5.1.1 General
Top management demonstrates leadership and commitment with respect to the quality
management system by:
a) Taking accountability for the effectiveness of the quality management system;
b) Ensuring that the quality policy (Section 2.0) and quality objectives (Section 3.0) are
Established for the QMS and are compatible with the context and strategic direction of
the organization;
c) Ensuring the integration of the QMS requirements into the organization’s business
processes;
d) Promoting the use of the process approach and risk-based thinking;
e) Ensuring that the resources needed for the quality management system are available as
& when required;
f) Communicating the importance of effective quality management and of conforming to
the QMS requirements to all interested parties;
g) Ensuring that the quality management system achieves its intended results;
h) Engaging, directing and supporting persons to contribute to the effectiveness of the
QMS;
i) Promoting improvement;

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j) Supporting other relevant management roles (Section Heads) to demonstrate their


leadership as it applies to their areas of responsibility.

5.1.2 Customer focus


Top management shall demonstrate leadership and commitment with respect to customer
focus by ensuring that:
a) Customer and applicable statutory and regulatory requirements are determined,
understood and consistently met. List of Applicable Statutory and regulatory
requirements maintained in Doc. No. AI/QMS/03.
b) The risks and opportunities defined in Doc. No. AI/QMS/04 that can affect conformity
of products and services and the ability to enhance customer satisfaction are
determined and addressed
c) The focus on enhancing customer satisfaction is maintained.

5.2 Policy
5.2.1 Establishing the quality policy
Top management has established, implemented and maintained a quality policy (Section
2.0) that:
a) is appropriate to the purpose and context of the organization and supports its strategic
direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) Includes a commitment to continual improvement of the quality management system.

5.2.2 Communicating the quality policy


The quality policy:
a) Available and be maintained as documented information (Section 2.0 of this manual);
b) is communicated, understood and applied within the organization through Display and
Training Sessions;
c) is available to relevant interested parties, as appropriate through Copies/Displays.

5.3 Organizational roles, responsibilities and authorities


Top management has ensured that the responsibilities and authorities for relevant roles
are assigned and communicated within the organization.
Top management has assigned the responsibility and authority for:
a) Ensuring that the Quality management system conforms to the requirements of ISO
9001:2015
b) Reporting on the performance of the quality management system, including quality
performance, to top management
c) Organization Chart of the Organization prepared in Doc. No. (Ann-I)

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d) Responsibilities and Authorities are defined in Doc. No. (Ann-II)


e) Ensuring that the processes are delivering their intended outputs
f) Reporting on the performance of the quality management system and on opportunities
for improvement in particular to top management
g) Ensuring the promotion of customer focus throughout the organization
h) Ensuring that the integrity of the quality management system is maintained when
changes to the quality management system are planned and implemented.

Section 6 - Planning
6.1 Actions to address risks and opportunities
6.1.1 When planning for the QMS, the organization shall consider the issues referred to in
4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that
need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s)
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
e) Risk & opportunity assessment and actions are defined in Doc. No. AI/QMS/04

6.1.2 The organization has planned:


a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities has been proportionate to the potential
impact on the conformity of products and services. Same has been documented in Doc.
No. in Doc. No. AI/QMS/04

6.2 Quality objectives and planning to achieve them


6.2.1 The organization has established quality objectives (Section-3 of this manual) at
relevant functions, levels and processes needed for the quality management system.
The quality objectives shall:
a) be consistent with the quality policy
b) be measurable
c) take into account applicable requirements
d) be relevant to conformity of products and services and to enhancement of customer
satisfaction
e) be monitored
f) be communicated
g) be updated as appropriate

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The organization has maintained documented information on the quality objectives in


Section 3.0 of this manual.

6.2.2 When planning how to achieve its quality objectives, the organization has
determined:
a) what will be done
b) what resources will be required
c) who will be responsible
d) when it will be completed
e) how the results will be evaluated
Documented Information maintained in Quality Objective Achieving Plan Doc. No.
AI/QPL/03.

6.3 Planning of changes


When the organization determines the need for changes to the quality management
system, the changes has been carried out in a planned manner.
The organization has considered:
a) the purpose of the changes and their potential consequences
b) the integrity of the quality management system
c) the availability of resources
d) the allocation or reallocation of responsibilities and authorities.
The changes are initiated on Document Change Request in Doc. No. AI/CRF/01 by
concerned Person and are implemented only after review and approval by MR and
PROPRIETOR.

Section 7- Support
7.1 Resources
7.1.1 General
The organization has determined and provided the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management
system.
The organization has considered:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.
c) An Resources identification form is filled by department head and send the same to
PROPRIETOR through MR for approval. Records for the same are maintained in Resources
identification form Doc. No. AI/HR/02
The same are reviewed and provided during Management review or as and when required.

7.1.2 People

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The organization has determined and provided the persons necessary for the effective
implementation of its quality management system and for the operation and control of its
processes.
7.1.3 Infrastructure
The organization has determined, provided and maintained the infrastructure necessary
for the operation of its processes and to achieve conformity of products and services.
Infrastructure includes:
a) buildings and associated utilities
b) equipment, including hardware and software
c) transportation resources
d) Information and communication technology

List of Plant and machinery maintained in Doc. No. AI/MAINT/01. Plan for Preventive
Maintenance (PE/QPL/04) of machinery is maintained and Preventive Maintenance of
machines is carried out as per given schedule in Doc. No. AI/MAINT/04. Machine
Breakdown records are maintained in Doc. No. AI/MAINT/06. List of Moulds maintained
in Doc. No. AI/MAINT/02 and Maintenance/Cleaning record of the same maintained in
Doc. No. AI/MAINT/05. Refer Procedure No. AI/PR/09 for Infrastructure.

7.1.4 Environment for the operation of processes


The organization identifies and manages the human and physical factors of the work
environment necessary to achieve conformity to product requirements. Top management
ensures well-lit, noise and pollution free shop floor, offices, clean and safe working
environment, which guard people against excessive heat/cold and provides proper
ventilation. Appropriate care is taken to maintain hygienic conditions in the shop floor,
offices and public utilities areas.
Safety and protective equipments (Helmets, Masks, Safety Shoes and Goggles etc.) are
provided as appropriate depending upon the requirement at pertinent places. First Aid Box
Available at the security office.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
The organization determines and provides the resources needed to ensure valid and
reliable results when monitoring or measuring is used to verify the conformity of products
and services to requirements as defined in Quality Plans.
The organization has ensured that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being
undertaken;
b) are maintained to ensure their continuing fitness for their purpose.
c) Refer Procedure No. AI/PR/08 for Calibration of Monitoring and measuring Resources.
The organization retains Calibration Certificates as evidence of fitness for purpose of the
monitoring and measurement resources.

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Master List of Measuring Equipments (AI/QC/01)


Calibration Record (AI/QC/02)

7.1.5.2 Measurement traceability


When measurement traceability is a requirement, or is considered by the organization to
be an essential part of providing confidence in the validity of measurement results,
measuring equipment shall be:
a) Calibrated or verified, or both, at specified intervals, or prior to use, from NABL
approved Lab; when no such standards exist, the basis used for calibration or
verification shall be retained as documented information.
Some of the Instruments are also calibrated in-house w.r.t. documented calibration
methods and records are maintained.
b) Measuring equipment is identified with a sticker to show its calibration status after
calibration.
c) It is ensured that the handling and storage of monitoring and measuring
Instrument/equipment is such that the accuracy and fitness for use are maintained.
In case, the instrument/equipment is found out of calibration during periodic calibration
(AI/QC/02), the results of previous calibration are assessed and reviewed. Materials
manufactured during the period of previous and current calibration, if available are
verified for affected characteristics and appropriate actions are taken.

7.1.6 Organizational knowledge


The organization has determined the knowledge necessary for the operation of its
processes and to achieve conformity of products and services. This knowledge has been
documented in form of Quality Plans, Work Instructions and Documents and is made
available to the extent necessary to all interested parties.
When addressing changing needs and trends, the organization has considered its current
knowledge and determined how to acquire or access any necessary additional knowledge
and required updates.

7.2 Competence
The organization shall:
a) Determine the necessary competence of person(s) doing work under its control that
affects the performance and effectiveness of the quality management system. Criteria
for recruitment maintained in Doc. No. AI/HR/01.
b) Ensure that these persons are competent on the basis of appropriate education,
training, or experience. Employees Education, Exp., Training and Skill records
maintained in Doc. No. AI/HR/06.
c) Retained appropriate documented information as evidence of competence. (AI/HR/06)
d) Where applicable, take actions to acquire the necessary competence, by providing
Training and evaluate the effectiveness of the actions taken. Training Given to

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employees is recorded in Doc. No. AI/HR/05and effectiveness of training given is


judged in same format by trainer.
e) Training Plan Doc. No. AI/HR/04
f) Training Need Identify by respective Department Heads in Training Need
Identification form Doc. No. AI/HR/03.
g) Induction Training Record maintained by HR Department in Doc. No. AI/HR/07.

7.3 Awareness
The organization provides Trainings as per training plan (AI/HR/05) and ensures that
persons doing work under the organization’s control are aware of:
a) The quality policy
b) Relevant quality objectives
c) Their contribution to the effectiveness of the quality management system, including
the benefits of improved performance
d) The implications of not conforming to the quality management system requirements

7.4 Communication
The organization has determined the method of internal and external communications
(AI/IEC/01) relevant to the quality management system, including:
a) On what it will communicate
b) When to communicate
c) With whom to communicate
d) How to communicate
e) Who communicates

7.5 Documented information


7.5.1 General
The organization’s quality management system includes:
a) Documented information required by this International Standard;
b) Documented information determined by the organization as being necessary for the
effectiveness of the quality management system.

The Organisation has listed all Documented Information in AI/ML/01.

7.5.2 Creating and updating


When creating and updating documented information, the organization ensures
appropriate:
a) Identification and description e.g. a Name of Document, Ref. No. of Document, Issue
date and Number, Rev. No. and Retention period. (AI/ML/01)
b) Format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
(AI/ML/01)

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c) Review and approval for suitability and adequacy. (AI/PR/01)

7.5.3 Control of documented information


7.5.3.1 MR ensures that the documented information required by the quality management
system and by this International Standard is controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of
integrity).

7.5.3.2 For the control of documented information, the organization has documented a
Procedure for Control of Documented Information (AI/PR/01) and Control of Records
(AI/PR/02), which addresses the following activities, as applicable:
a) Distribution, access, retrieval and use;
b) Storage and preservation, including preservation of legibility;
c) Control of changes (e.g. version control);
d) Retention and disposition.
e) Permission and authority to view and change the documented information

Documented information of external origin determined by the organization to be


necessary for the planning and operation of the QMS has been identified (AI/EOD/01)
and controlled.
Documented information retained as evidence of conformity is protected from
unintended alterations.

8 Operations
8.1 Operational planning and control
The organization plans, implements and controls the processes needed to meet the
requirements for the provision of products and services, and to implement the actions
determined in Clause 6, by:
a) Determining the requirements for the products and services;
b) Establishing criteria for:
1) Process Flow Charts of prepared in Doc. No. AI/PFC/01
2) The acceptance of products and services
c) Determining the resources needed to achieve conformity to the product and service
requirements
d) Implementing control of the processes in accordance with the criteria as per Quality
Plan for Incoming Raw Material, process Inspections and Final Inspections AI/QPL/01 to
02 respectively.
e) Determining, maintaining and retaining documented information to the extent necessary:
(AI/ML/01)

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Rev. No. 00

1) To have confidence that the processes have been carried out as planned;
2) To demonstrate the conformity of products and services to their requirements.

The output of this planning is suitable for the organization’s operations.

The organization shall control planned changes and review the consequences of
unintended changes, taking action to mitigate any adverse effects, as necessary.

The Organization has planned & manages the outsourced processes in accordance with
the QMS. At present, Calibration of instruments is carried out by external NABL certified
Lab. Outsourced suppliers are asked to maintain good quality system in accordance with
International Standard. The requirements are communicated through Verbal or Purchase
orders. The system shall include a framework for controlling any other process, which
shall be outsourced, as and when required.

8.2 Requirements for products and services


8.2.1 Customer communication
Communication with customers has included:
a) Providing information relating to products and services
b) Handling enquiries, contracts or orders, including changes
c) Obtaining customer feedback relating to products and services, including customer
complaints. Customer Complaint recorded in Doc. No. AI/CCR/01. Procedure for
Handling Customer Complaints prepared Procedure No. AI/PR/10.
d) Handling or controlling customer property in Customer Property Record if any
e) Establishing specific requirements for contingency actions, when relevant.
PROPRIETOR is responsible for the communication with Customers (AI/ORR/01). He
will also inform the customers if any specific Product/Process or equipment changes are
implemented in the Organisation and also shall inform the customer in advance if major
Breakdown or shut downs happens affecting supplies to the customer.

8.2.2 Determining the requirements for products and services


When determining the requirements for the products and services to be offered to
customers, the organization ensures that:
a) The requirements for the products and services are defined, including:
1) Any applicable statutory and regulatory requirements;
2) Those considered necessary by the organization;
b) The organization can meet the claims for the products and services it offers.
All orders are received and reviewed by PROPRIETOR and Documented the same in
related file of each project.

8.2.3 Review of the requirements for products and services

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Rev. No. 00

8.2.3.1 The organization ensures that it has the ability to meet the requirements for
products and services to be offered to customers as per agreed quality plan. The
organization has conducted a review before committing to supply products and services
to a customer, to include:
a) Requirements specified by the customer, including the requirements for delivery. No
post delivery activities are applicable
b) Requirements not stated by the customer, but necessary for the specified or intended
use, when known
c) Requirements specified by the organization
d) Statutory and regulatory requirements
e) Contract or order requirements differing from those previously expressed.
All orders are received and reviewed by PROPRIETOR and Documented the same in
AI/ORR/01

The organization shall ensure that contract or order requirements differing from those
previously defined are resolved. The customer’s requirements shall be confirmed by the
organization before acceptance, when the customer does not provide a documented
statement of their requirements. In such case, we communicate the specifications being
followed by us.

8.2.3.2 The organization has retained documented information (AI/ORR/01), as


applicable:
a) on the results of the review;
b) on any new requirements for the products and services.

8.2.4 Changes to requirements for products and services


PROPRIETOR ensures that relevant documented information (Quality
Plans/Specifications) is amended, and that relevant persons are made aware of the
changed requirements, when the requirements for products and services are changed.

8.3 Design and development of products and services


As the product design is based on the drawings/ samples/ requirements of Customers,
therefore Design activity is excluded from scope of this manual.

8.4 Control of externally provided processes, products and services


8.4.1 General
The organization ensures that externally provided processes, products and services
conform to requirements. For this, the organisation has documented a Procedure for
Control of Externally Provided Processes, Products & Services (AI/PR/03).
The organization determines the controls to be applied to externally provided processes,
products and services when:

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a) Products and services from external providers are intended for incorporation into the
organization’s own products and services;
b) Products and services are provided directly to the customer(s) by external providers
on behalf of the organization; (At Present, this is not applicable)
c) A process, or part of a process, is provided by an external provider as a result of a
decision by the organization.
The organization shall determine and apply criteria for the evaluation, selection,
monitoring of performance, and re-evaluation of external providers, based on their ability
to provide processes or products and services in accordance with requirements. The
organization has retained documented information (AI/VRF/01, AI/AVL/01) of these
activities and any necessary actions arising from the evaluations.

AI/VRF/01 – SUPPLUER EVALUATION


AI/AVL/01 - LITS OF APPROVED SUPPLERS
AI/OSP/01 - LIST OF OUTSOURCES PROCESS AND THEIR CONTROL

8.4.2 Type and extent of control


The organization has ensured that externally provided processes, products and services
do not adversely affect the organization’s ability to consistently deliver conforming
products and services to its customers.
The organization issues Purchase Orders verbally and records the same in Verbal
Purchase Orders Register Doc. No. AI/VPO/01) which:
a) Ensure that externally provided processes remain within the control of its Quality
Management System;
b) Define both the controls that it intends to apply to an external provider and those it
intends to apply to the resulting output;
c) Take into consideration:
1) The potential impact of the externally provided processes, products and services on the
organization’s ability to consistently meet customer and applicable statutory and
regulatory requirements;
2) The effectiveness of the controls applied by the external provider;
d) Determine the verification, or other activities, necessary to ensure that the externally
provided processes, products and services meet requirements.

8.4.3 Information for external providers


PROPRIETOR ensures the adequacy of requirements prior to their communication to the
external provider.
The Verbal Purchase Order Register (AI/VPO/01) details the requirements for:
a) The processes, products and services to be provided;
b) The approval of:
1) Products and services

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Rev. No. 00

2) Methods, processes and equipment


3) The release of products and services
c) Competence, including any required qualification of persons
d) The external providers’ interactions with the organization
e) Control and monitoring of the external providers’ performance to be applied by the
organization
f) Verification or validation activities that the organization, or its customer, intends to
perform at the external providers’ premises.

8.5 Production and service provision


8.5.1 Control of production and service provision
The organization has implemented production and service provision under controlled
conditions.
Controlled conditions have included, as applicable:
a) The availability of documented information that defines:
1) The characteristics of the products to be produced, or the activities to be performed
2) The results to be achieved as defined in Final Product Inspection Plan (AI/QPL/02)
b) The availability and use of suitable monitoring and measuring resources (AI/QC/02);
c) The implementation of monitoring and measurement activities at appropriate stages
through the Process & Final Inspection Plan No. AI/QPL/02 and work instructions Doc.
No. AI/WI/01 to 07 to verify that criteria for control of processes or outputs, and
acceptance criteria for products and services, have been met
d) The use of suitable infrastructure and environment for the operation of processes
e) The appointment of competent persons, including any required qualification;
(AI/HR/01)
f) At ALPHA (INDIA), FARIDABAD Moulding process are identified as special
processes which required process validation because results of the job done cannot be
verified immediately after the work is executed. Validation has demonstrated the ability
of these processes to achieve planned results.
The organization has establish arrangements for these processes including, as applicable
a) defined criteria for review and approval of the processes
b) approval of equipment and qualification of personnel
c) use of specific methods and procedures
d) Validation records are maintained in Doc. No. AI/VAL/01.
e) Revalidation of process is carried out after one year.
f) Process Inspection and Instructions for molding are adequately displayed in Welding
Section.
g) The implementation of actions to prevent human error;
h) The implementation of release, delivery and post-delivery activities.

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Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

8.5.2 Identification and traceability


The organization identifies all incoming materials, work in process and finished goods
through different stages of product realization by Tags, boards or area marked in
different color. Status of the material with respect to inspection is indicated on the
board/Tag.
All rejected material lying in the plant, is kept inside the area marked as Rejection area
identified with Tags or boards.
Work in process is kept in area identified with Boards. All the finished material is kept in
area marked identified with Colour Codes/Tags.
At present there is traceability requirements specified by the customers. Traceability
requirements shall be determined; traceability has been maintained by embossing AI.
Records for the same maintained.

8.5.3 Property belonging to customers or external providers


At present, the organisation has customer Drawings/Samples and Moulds as customer
property in its possession. The organization receives the customer Drawings for
manufacturing of components the details of Drawings are entered in list of Drawings
(AI/CP/01). It is ensured that no damage takes place to the Drawings. In case of any
damage to the Drawings, customer is informed and the old drawing is replaced by a
fresh one. The organization ensures proper handling, identification, verification,
protection and safeguard of all customer property provided for use.

Where applicable intellectual property shall be considered as customer property.

8.5.4 Preservation
The organization preserves the outputs during production and service provision, to the
extent necessary to ensure conformity to requirements. All raw materials are well stored
at defined place in store. Record of Raw material in and out well maintained in Stock
Book doc. no. AI/STR/01

8.5.5 Post-delivery activities


At present, there is no Post delivery activities related to the Products. So this Clause is
excluded from the scope the certifications.

8.5.6 Control of changes


The organization shall review and control changes for production, to the extent necessary
to ensure continuing conformity with requirements. PROPRIETOR is authorized to
review and approve any changes to Control of Production. Records of any changes are

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Rev. No. 00

maintained describing the results of the review of changes, the person(s) authorizing the
change, and any necessary actions arising from the review.

8.6 Release of products and services


The organization has implemented planned arrangements at appropriate stages, to verify
that the product requirements have been met.

Finished goods are dispatched to customer’s only after all requisite measurements and
monitoring as per Quality Plan is completed and found accepted, unless otherwise
approved by a relevant authority (if any) and, as applicable, by the customer.
The organization retains Copy of Process Log Sheets and Final Inspection Reports as
evidence that all the Inspection /Tests have been carried out. The Process control Record
includes:
a) evidence of conformity with the acceptance criteria;
b) traceability to the person(s) authorizing the release.

8.7 Control of nonconforming outputs


8.7.1 The organization ensures that outputs that do not conform to their requirements are
identified and controlled to prevent their unintended use or delivery.
The organization takes appropriate action based on the nature of the nonconformity and
its effect on the conformity of products. This shall also apply to nonconforming products
detected after delivery of products, during or after the provision of services.
The organization has documented procedure for Control of Non conforming Products
(AI/PR/04) and shall deal with nonconforming outputs in one or more of the following
ways:
a) Correction;
b) Segregation, containment, return or suspension of provision of products;
c) Informing the customer;
d) Obtaining authorization for acceptance under concession.

Conformity to the requirements is verified when nonconforming outputs are corrected.


8.7.2 The organization has retained documented information (AI/NCP/01) that:
a) Describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) Identifies the authority deciding the action in respect of the nonconformity.

The control and related responsibilities and authorities for dealing with non-conformance
products are defined in a documented procedure for Control of non-conforming products
(AI/PR/04)

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Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

9 Performance Evaluations
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
For Products and Processes, the organisation has documented Quality Plans to
determined:
a) What needs to be monitored and measured
b) The methods for monitoring, measurement, analysis and evaluation needed to ensure
valid results
c) When the monitoring and measuring shall be performed
d) When the results from monitoring and measurement shall be analysed and evaluated.
The organization shall evaluate the performance and the effectiveness of the quality
management system during Management Reviews (AI/MRM/01).
The organization retains appropriate documented information in the forms of record as
evidence of the results as defined in Quality Plans.

9.1.2 Customer satisfaction


The organization shall monitor customers’ perceptions of the degree to which their needs
and expectations have been fulfilled.
PROPRIETOR sends the Customer Feedback (AI/CFF/01) to all the customers for
furnishing the required information and the customer is asked to rate AI, FARIDABAD
for its past months performance against its competitors in each category.
Customer satisfaction is also monitored through meetings with customers, market-share
analysis, compliments, warranty claims etc.

9.1.3 Analysis and evaluation


The organization shall analyse and evaluate appropriate data and information arising
from monitoring and measurement.
The results of analysis shall be used to evaluate:
a) conformity of products and services;
b) the degree of customer satisfaction; (AI/CFF/01)
c) the performance and effectiveness of the quality management system;
d) if planning has been implemented effectively;
e) the effectiveness of actions taken to address risks and opportunities;
f) the performance of external providers
g) the need for improvements to the quality management system.
Statistical techniques are used to monitor the various Quality Parameters for Finished
Product.

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Issue Date: - 01/01/2017
Rev. No. 00

9.2 Internal audit


9.2.1 The organization has conducted internal audits at planned intervals (Once in a 6
MONTHS) to provide information on whether the quality management system:
a) Conforms to:
1) The organization’s own requirements for its quality management system;
2) The requirements of this International Standard ISO 9001:2015;
b) effectively implemented and maintained.
The Process of Internal Audit is outsourced to Consultancy Firm Namely M/s Global
Management Consultants, Panchkula based on their Experience and Competency Level.

9.2.2 The organization has established a procedure for Internal Audits (AI/PR/05),
specifying the responsibilities and requirements for planning and conducting audits, and
for reporting results and maintaining records.
The Organisation retains documented information as evidence of the implementation of
the audit programme and the audit results as defined in Procedure for Internal Audits
AI/IQA/01= IA PLAN
AI/IQA/02= IA SCHEDULE
AI/IQA/03= IA CHECKLIST
AI/IQA/04= IA NC REPORT

9.3 Management review


9.3.1 General
Top management reviews the implementation of Organization’s QMS Once in a 6 months
as defined in Procedure for Management Review (AI/PR/06), to ensure its continuing
suitability, adequacy, effectiveness and alignment with the strategic direction of the
organization.
9.3.2 Management review inputs
Agenda Points for the Management Review are as defined in Procedure for Management
Review (AI/PR/06).
9.3.3 Management review outputs
The outputs of the management review shall include decisions and actions related to:
a) Opportunities for improvement;
b) Any need for changes to the quality management system;
c) Resource needs.
The organization retains documented information as evidence of the results of
management reviews.
AI/AGM/01= AGENDA OF MRM
AI/MRM/01 = MRM

10.1 General

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Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

The organization determines and selects opportunities for improvement and implements
any necessary actions to meet customer requirements and enhance customer satisfaction
including;
a) Improving products and services to meet requirements as well as to address future
needs and expectations;
b) Correcting, preventing or reducing undesired effects;
c) Improving the performance and effectiveness of the quality management system.
The same are reviewed during Management Reviews for Implementation and
effectiveness.

10.2 Nonconformity and corrective action


10.2.1 In case of any nonconformity, including any arising from complaints, the
organization has:
a) Reacted to the nonconformity and, as applicable:
1) Taken action to control and correct it
2) Deal with the consequences
b) Evaluate the need for action to eliminate the cause(s) of the nonconformity, in order
that it does not recur or occur elsewhere, by:
1) Reviewing and analysing the nonconformity
2) Determining the causes of the nonconformity
3) Determining if similar nonconformities exist, or could potentially occur
c) Implement any action needed
d) Review the effectiveness of any corrective action taken
e) Update risks and opportunities determined during planning, if necessary
f) Make changes to the quality management system, if necessary.
Corrective actions are appropriate to the effects of the nonconformities encountered
(AI/PR/07).

10.2.2 The organization has retained documented information (AI/CA/01) as evidence of:
a) The nature of the nonconformities and any subsequent actions taken;
b) The results of any corrective action.
The control and related responsibilities and authorities for dealing with non-conformance
products are defined in a documented procedure for Control of non-conforming products
(AI/PR/04).

10.3 Continual improvement


The organization continually improves the suitability, adequacy and effectiveness of the
quality management system.
The organization considers the results of analysis and evaluation, and the outputs from
management review, to determine if there are needs or opportunities that shall be
addressed as part of continual improvement.

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Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

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Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

ANNEXURE-1 = ORGANIZATION CHART

PROPRIETOR

MANAGER INCHARGE PRODUCTION & MAINTENANCE/ STORE


TOOL ROOM
PURCHASE ADMIN. QC INCHARGE INCHARGE
INCHARGE

SECURITY

PROD. QC
SUPERVISORS SUPERVISORS

OPERATOR

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Rev. No. 00

ANNEXURE-2 Responsibility and authority


Designation Responsibility Authority

 Responsible for defining QMS Policy &  Ultimate authority for decision making
Objective in all areas of company
 Responsible for defining authority &  Authorized to take decision related to
responsibility, providing resources and QMS
appointing Management Representative  Authorized to update
 Responsible for continual improvement of process/machinery
QMS  Ultimate authority for decision making
 Responsible for complaint handling related to in all areas of company
Service & Quality  Authorized to take decision about
 Ensuring customer satisfaction contract review & disposal of
 Responsible for any technical issue or aid in complaints
the plant  Acting as MR in his absence.
 Responsible for defining authority and
responsibility
 Responsible for providing resources
 Responsible for appointing Management
PROPRIETOR Representative
 Selection of Market for purchase of RM
 Evaluation of approved suppliers
 Responsible for purchase of RM
 Responsible for development of markets &
Brand
 Responsible for contract review
 Responsible for complaint handling related to
Quality
 Ensuring customer satisfaction
 Communication with regulatory bodies.

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Rev. No. 00

 Conveying to management about  Authorized for Validation of QMS.


requirement related to Quality.
 Authorized for verification of records
 Developing Quality System. related to QMS.

 Verification of effectiveness of system through  Authorized for conducting regular


Internal Audits. training of staff on QMS.
MR  Verification of Process flow.

 Review of QMS.

 Training of staff for QMS.

 Monitoring of objectives related QMS.

QUALITY  Quality Planning.  Fully authorized to stop production in


CONTROL  Maintaining quality of product at all stages by case of non-compliance to Quality
INCHARGE regular inspection Standards.
 External tests related to product integrity  Authorized for approving & verifying
 Preparation & review of sop’s, Specifications, test results and reports.
protocol & test procedure.  Authorized to take decisions for
 Implementation of systems as per ISO 9001 process control as per documented
Documentation, SOP’s. procedure
 Training to team.  Authorized for verification of QA
 Update all documents related to QC & QA. Records
 Implementing Production, Productivity,  Authorized for decisions related to
Quality, & Customer-service strands. Quality & Process Control.
 Identifying & resolving customer problems;  Acting as MR in his absence.
Factory problems, completing audits;  Authorized for approving & verifying
determining system improvements; test results and reports.
implementing change.  Authorized to take decisions for
 Develops quality assurance plans by process control as per documented
conducting risk assessment; identifying procedure
critical control points & preventive measures;  Authorized for verification of QC
establishing critical limits, monitoring Records
procedures, corrective actions, & verification  Authorized for approving & verifying
procedures. Laboratory instrument & processes.
 Investigating customer complaints;
collaborating with other members of
management to arrive at the solution.
 Prepares quality documentation & reports by
collecting, analysing & summarizing
information & trends including failed
processes, stability studies, corrective actions,
& re-validation.
 Generate COA
 Generate control data.
 Raw material and finished goods Quality.
 Quality checks schedule monitoring &
control.

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Rev. No. 00

 Maintaining quality of product at all stages by


regular inspection
 Calibration of lab equipments
 Analysis record data generation & timely
reporting.
 Establish Laboratory Documentation.
 Checking of analytical raw data, test results
against specifications & conforming the result
before approval.

 Monitoring of Production Activities  Authorized for calibration of


 Supervising production in the respective area equipments.
 Maintenance of smooth production and  Authorized for segregating
hygiene nonconforming products.
 Maintain sanitation at the process area.  Acting as MR in his absence in all the
 Controlling process deviations related to areas related to production.
product quality
PRODUCTION  To attend to break down maintenance.
INCHARGE  To attend preventive maintenance.
 Handling the shift & labours
 Preparing Preventive maintenance schedule
for all machines
 Responsible for maintenance of all the
documents & records related to maintenance
& breakdown
 Responsible for all type of electrical
maintenance
 Maintenance of hygiene in the respective area

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Issue Date: - 01/01/2017
Rev. No. 00

 To conduct preventive & breakdown electrical  Authorized for routine maintenance


maintenance work.
 All types of electrical maintenance  Acting as Head Maintenance in all the
 Maintenance of documents & records areas related to maintenance.
Maintenance  To conduct preventive maintenance &  Authorized for routine maintenance
Incharge breakdown maintenance of machines work.
 Maintenance of documents & records  Acting as Head Maintenance in all the
 All types of mechanical maintenance areas related to maintenance.

 Maintains smooth flow in & out of vehicles in  Authorized to check vehicles &
factory premises. personnel from security safety point of
 Maintenance of smooth flow at shift change. view.
Security  Screening of goods and manpower.
Incharge  Deployment of security personal as per plan.
 Maintaining food security.
 Emergency preparedness for identified
emergency situations.

 Ensure timely recruitment, selection and  Schedule expenditures; analyzing


training employees. variances; initiating corrective actions
 Attendance management system – monitor  Ensure that the company is in
 Payroll Creation and Updation compliance of all HR related legal
 Hotel bookings requirements.
 Implement and update the training calendar  Ensure payments are made as per legal
 Leave Balance Management requirement
 Overtime Management  Housekeeping
 Induction Training  Guest Management
 Termination  Grievances handling and disciplinary
HR/ADMIN.  Resignation formalities along with all management
INCHARGE settlement of Full and Final dues
 Maintaining Personnel files, Salary
 Maintaining Personnel files of all employees
Files, Legal Files
 Manpower Planning
 Performance Appraisal  Handling govt. officer (fact. inspector,
 HR Policies – Make and implement health & safety officer, etc.)
 Termination and Resignation formalities
 Full and Final
 Motivational activities like employee of the
month, employee of the year
 Medical Checkup for employees

 Gratuity/Bonus management

PURCHASE  To ensure timely supply of  To verify and approve


MANAGER materials as per quality standards for purchase orders of all items and
continuous production equipments (raw materials,
components, packaging and
 Identifying new materials /
engineering items).
suppliers and products that may be required
by the company.  To receive product

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Issue Date: - 01/01/2017
Rev. No. 00

 Initiating, implementing and requirements from marketing and


maintaining QMS in his area of work communicate to production.
including stores.
 To do vendor rating in co-
 To co-ordinate with marketing ordination with QC & Production
and maintaining logistic related data’s.
 Initiating corrective and
 To identify the training needs / preventive actions as appropriate based
resources needed for effective functioning of on QC / Production feedback.
his department.

 Control further processing, delivery


or installation of nonconforming product until
the deficiency or unsatisfactory condition has
been corrected.

 Maintain Quality Records.

 Comply with instructions  Review work instructions on an on-


applicable to the work area & production going basis and report findings /
schedules. suggestions for improvements if any to
Department Head.
 Initiate, recommend and provide
solutions to the problems in their areas.  Initiate corrective and preventive
actions.
 Comply with defined
procedures, Sop’s, Quality Plans, etc to  To transfer workman from one machine
produce quality product and reduce / / production line to another within his
eliminate rework / wastage. area of operation.

 Carry out corrective and  To stop production in the event of


preventive actions against non-conformances production machine is malfunctioning
and potential non-conformances. & likely to affect quality of the product,
PRODUCTION
likely to generate high rejection &
SUPERVISORS  Comply with the specific
wastage.
AND QC responsibilities outlined in procedures of
INSPECTORS Quality Management System.

 To maintain quality and


communication records and data generation.

 Control further processing, delivery


or installation of nonconforming product until
the deficiency or unsatisfactory condition has
been corrected.

 To educate line operators / workman


and inculcating a sense of pride for making
good quality components & finished product.

 To maintain good housekeeping and


work environment in their area of work.

STORE  Issue and receipt of raw material  Give direct orders to suppliers in case
INCHARGE PROPRIETORs not available.
 Implement FIFO System in store.

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Rev. No. 00

 Housekeeping of store

 Give Req, to Purchase Deptt. For


Purchase of material

 Maintain Stock Ledgers

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Issue No.: - 01
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Rev. No. 00

ANNEXURE-III INPUTS AND OUTPUTS OF QMS PROCESSES

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Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

ANNEXURE-IV INPUTS AND OUTPUTS OF QMS PROCESSES


S. NO PROCESSES AND SUBPROCESSES
1. MANAGEMENT PROCESS
 Policy development, deployment and periodic review
 Establishing quality objectives & periodic review
 Defining responsibility & authority of personnel
 Appointment of management representative
 Providing infrastructure & work environment
 Conducting management review
 Internal communication
2. DOCUMENTATION PROCESS
 Document preparation
 Document dissemination
 Document retrieval
 Document modification
 Record control
3. HUMAN RESOURCE DEVELOPMENT PROCESS
 Establishing competence & its maintenance
 Identifying training needs of employees
 Conducting training programmes
 Coordinating activities to enhance involvement of employees in
Organization wide activities
4. PRODUCT PLANNING & CUSTOMER PROCESSES
 Planning for product realization
 Understanding customer requirement
 Reviewing customer requirements
 Customer communication
5. PURCHASE PROCESS
 Identifying the correct supplier of required materials and services
 Procurement of raw materials, ingredients, packaging materials and services.
 Periodic evaluation of the quality and services of supplier
 Establishing supplier relation
6. MANUFACTURING PROCESS
 Controlled Condition for product realization.
 Identification and trace ability
 Maintenance of plant and machinery
7. CONTROL AND CALIBRATION PROCESS MEASURING DEVICES
 Maintenance of tools and equipment
 Calibration of measuring instruments
 Safeguarding calibration status

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Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

8. STORAGE AND WAREHOUSE PROCESSES


 Receipt of material in the store
 Issue of materials from store
 Accountability of stored material
9. AUDITING AND APPRAISAL PROCESS
 Training of auditors
 Scheduling audit
 Conducting audit
 Corrective action and follow up
10. MONITORING AND MEASUREMENT OF PROCESSES
 Monitoring of processes
 Measurement of processes
 Deployment of suitable methods
11. MONITORING AND MEASUREMENT OF PRODUCTS
 Inspection and test planning
 In-process inspection and testing
 Final product inspection and testing
12. CONTROL OF NONCONFORMING PRODUCT
 Identification & evaluation
 Root Cause analysis
 Finding solution for the problem
 Implementation of solution
 Verification of effectiveness of solution
13. CONTINUAL IMPROVEMENT PROCESS
 Analysis of data
 Corrective action
 Preventive action

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Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

ANNEXURE- V List of Procedures

S. No. Description Doc. No. ISO-9001:2015 Clause Ref.

Procedure for Control of Documented


1. information AI/PR/01 7.5.3

2. Procedure for Control of Records AI /PR/02 7.5.3


Procedure for Control of Externally
3. Provided Processes, Products & AI /PR/03 8.4
Services
Procedure for Control of non-
4. conforming products AI /PR/04 8.7

5. Procedure for Internal Quality audits AI /PR/05 9.2

6. Procedure for MRM AI /PR/06 9.3

7. Procedure for Corrective Action AI /PR/07 10.2


Procedure for Calibration of Monitoring
8. and measuring Resources AI /PR/08 7.1.5

9. Procedure for Infrastructure AI /PR/09 7.1.3


Procedure for Customer
10. Communications AI /PR/10 8.2.1

Procedure for Competence, Awareness


11. & Training AI /PR/11 7.2, 7.3

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Issue No.: - 01
Issue Date: - 01/01/2017
Rev. No. 00

ANNEXURE- VI ABBREVATIONS
Abbreviation Description Abbreviation Description
APPD Approved PD/Prod. Production

Doc No. Document Number PR Procedure

AI ALPHA (INDIA) Prep. By Prepared By

Elect. Electrical PUR Purchase

EXEC Executive PPE Personal Protective Equipment.

FM Formats QA Quality Assurance

FIFO First In First Out QM Quality Manual

H.O.D. Head of department QMS Quality Management System

IQA Internal Quality Audit QP Quality Plan


International Organisation for
ISO REF Reference
Standardization
MC Modulus Cosmetics Ref. Std Reference standard

Mgr. Manager Rev. No. Revision Number

MIS Management Information System RG Registers

MK T Marketing SCAR Supplier correction action Report.

ML Master List ST Stores.

MR Management Representative Std. Standard

MRM Management Review Meeting TECH Technical

MSDS Material Safety Data Sheet TG Training

NC Non Conforming TS Technical Specification

Asstt. Assistant WI Work Instruction

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