The company has
established & documented an Integrated Management System (IMS)
as described in this Manual. This IMS has been implemented & maintained
throughout the organization, as applicable. A system has also been developed to
ensure continual improvements in the effectiveness of the IMS.Â
The processes needed for
the IMS including their sequence, deployment to organizational
functions & interaction have been identified as per the following:
a)Â Â Â Â Â Â Process Map (See 2.2).
b)Â Â Â Â Â Â Process Deployment Matrix (See 2.4).
c)Â Â Â Â Â Â Inputs & outputs as defined in each process description.
All processes of the
organization have been divided into the following four major categories:
a)Â Â Â Â Â Â Core processes for Quality,
b)Â Â Â Â Â Â Core Processes for Environment, Health & SafetyÂ
c)Â Â Â Â Â Â Support Processes
d)Â Â Â Â Â Â Management & Improvement Processes
The detailed list of
processes (including the sub-processes, if any) is available through the
Process Deployment Matrix.
Section 3-6 of this
manual provides a description of methods, procedures & controls needed for
these processes. Further details of specific activities, specifications &
other criteria and records to be kept, etc. are defined through other documents
referred to in this manual. These documents include the following:
a)Â Â Â Â Â Â Plans & instructions,
b)Â Â Â Â Â Â Standards and specifications,
c)Â Â Â Â Â Â Forms & records.
The various functions of
the company implement the provisions of these processes as per this manual
& other related documentation. Adequate resources & information is
continuously provided to support the operation & monitoring of processes.
The appropriate functions of the company monitor measure & analyses these processes as required to achieve desired results (product requirements & quality objectives) & continual improvement.
The company is getting various services as an outsourcing process like AMC of machines, transport, civil works, fabrications, etc. which are being controlled as per control of contracted services.
Organizational Structure
`
2.4 Process Deployment
Matrix
Sr. No. |
Process  |
Process Owner (Responsibility) |
Quality Manual Ref. |
|
3) Core Processes for Quality |
||||
1. |
Marketing |
V.P. Marketing |
Q-010 |
|
2. |
Design & Development |
HOD(R&D) |
Q-020 |
|
3. |
Purchasing |
HOS (Purchase) |
Q-030 |
|
4. |
Storage of Incoming Materials |
HOS (Store) |
Q-040 |
|
5. |
Incoming QA
/ QC |
HOS (QA / QC) |
Q-050 |
|
6. |
Production |
V.P.
/ Head (Operations) |
Q-060 |
|
7. |
In-process & Final QA
/ QC |
HOS
(QA / QC) |
Q-070 |
|
8. |
Finished Goods Storage & Dispatch |
HOS (LOGISTICS) |
Q-080 |
|
9. |
Customer
Complaints & Feed Back |
V.P. Marketing |
Q-090 |
|
4)
Core Processes for Environment & Health & Safety |
||||
10. |
Identification of Environmental
aspects & Health & Safety Hazards |
All
Heads |
E-010 |
|
11. |
Management of legal & other
requirements |
HOS
(Personnel &Â Admn.) |
E-020 |
|
12. |
Operational Control |
All
Heads |
E-030 |
|
13. |
Control of Contracted services |
All
Heads |
E-040 |
|
14. |
Emergency
Preparedness |
HOS
(Personnel &Â Admn.) |
E-050 |
|
5)
Support Processes |
||||
15. |
Communication & Organizational
knowledge |
All Heads |
S-010 |
|
16. |
Maintenance |
HOS (Maintenance & Utilities) |
S-020 |
|
17. |
Control & Calibration of
Equipment |
HOS (QA / QC) for Lab equipment’s HOS (Maintenance) for all except
lab equipment’s |
S-030 |
|
18. |
Control of Documents |
Management Representative |
S-040 |
|
19. |
Control of Records |
All Heads |
S-050 |
|
20. |
Human Resource Development |
HOS (Personnel & Admn.) |
S-060 |
|
6)
Management & Improvement Processes |
||||
21. |
Risks & Opportunities
Assessment |
All Heads |
M-010 |
|
22. |
Management of objectives &
Processes |
All Heads |
M-020 |
|
23. |
Product/Process Non-conformities
Control |
All Heads |
M-030 |
|
24. |
Corrective Action |
All Heads |
M-040 |
|
25. |
Internal Audits |
Management Representative |
M-050 |
|
26. |
Management Reviews |
Management Representative |
M-060 |
|
2.5Â Roles, Responsibilities, Accountability & Authorities
of Key Personnel
PERSONNEL & THEIR ROLE |
RESPONSIBILITIES &
ACCOUNTABILITY |
AUTHORITIES |
Chairmen & Managing Director |
·         Overall guiding force behind the system.  |
·         Overall management decisions at top |
Director       |
·         Overall guiding force behind the system. ·         Identification of resources required for the effective
functioning of IMS. ·         Review of IMS at defined intervals.  |
·         Formulation of unit organization, responsibilities, IMS
policy. ·         Provide for the required resources & sanctions for
taking appropriate corrective & preventive action. ·         Authorization of IMS Manual. |
V.P. / Head (Operations) |
·         Overall, in charge of the operations of the unit. Purchase
and Personnel & Administration activities. ·         Handling of customer complaints.  |
·         Decision of disposition release of non-conforming
products. · Deviation/concession permits for non-conforming
products. ·         Redress customer complaints |
V.P.(Marketing) Â |
·         To handle all customer queries & coordinate with
other functionaries. ·         Enquiries & orders review. ·         Customer visits, interaction, and finalization of customer
orders. ·         Organizing customer complaints & feedback |
·         Acceptance of customer orders. ·         Sending of offers to parties. ·         Sending quotation to parties on behalf of the company |
HOS Purchase |
·         New supplier selection. ·         Purchase of material. ·         Evaluation & monitoring of suppliers.  |
·         Purchase orders placement. |
HOS (Personnel &
Administration) |
·         All recruitment & training activities. ·         Coordination of all compliance obligations including legal
& other requirements ·         Implementation of an onsite Emergency Plan. ·         Managing scrap yard & disposal |
·         Preparation of training schedule. ·         Authorized to obtain resources as per on-site Emergency
Plan. |
HOS Production |
·         Process control during all production stages. ·         Maintain identification, traceability & status of in-process material. ·         Control of in-process non-conforming
material. ·         Implementation of work instructions. |
·         Deployment of production operators. ·         Production planning. |
HOS Stores |
·         Receipt, storage& issue of all incoming materials. ·         Preservation, identification & stock maintenance of
all materials in the Stores. ·         Control of incoming non-conforming
material.   |
·         Issue of Materials. ·         Inventory control. ·         Storage & preservation. |
HOS (Logistic) |
·         Receipts, storage & dispatch of the finished product. ·         Preservation, identification & stock maintenance of
all materials in the FG Stores. |
·         Selection of transport. ·         Prioritization of dispatch.  |
HOS (Maintenance & Utilities) |
·         Projects as per requirement. ·         Preventive & breakdown maintenance of machines &
utilities. ·         Control & operation of utilities. ·         Calibration of all except Lab Equipment’s |
·         Preparation of maintenance schedules. ·         Project implementation schedule. ·         Process modifications. |
HOD (R&D) |
·         Responsible for all design & Development activities. ·         Troubleshooting of in the process. |
·         Preparation of design & development plans ·         Substitution of Raw material.  . |
||
HOS (QC/ QA) |
·         Monitoring & measurement of raw materials, packing
materials, intermediates & finished products. ·         Calibration of Lab Equipments. ·         Management of hazardous waste ·         Operation & control of ETP & STP ·         Environmental compliances |
·         Approval of F.G. & Raw material. ·         Preparation
of calibration schedule. |
||
Management Representative (M.R.) |
·         Control of documents. ·         To coordinate internal audit of all activities & their
follow-up. ·         To liaison with external bodies like certification bodies. ·         To organize periodic management review & follow up for
actions as decided. ·         To suggest improvement in the systems to a management review
committee.    |
·         Selection of internal auditors. ·         Conduct MR review meeting ·         Preparation of manual ·         Schedule of Internal Audit. · Coordinate with certifying agency.   |
||
ALL HEADS OF DEPTT / SEC. Â Â Â Â Â Â Â Â |
·  Control
of Records including their Retention ·Communication
& organizational knowledge acquisition, preserving & updating as per
process ·AIA, HIRA,
Risk & opportunities assessment w.r.t. all processes, relevant issues
& interested parties monitoring, implementation & updating ·      Identification
of training needs of the department personnel. · Maintaining
relevant IMS process effectiveness to achieve key performance results. ·       Â
Action
on audit non-conformities. ·  Implementation
of Management programs as applicable. ·     Control
of all operations related to significant aspects & hazards in their
respective areas. · Monitoring
of On-site contractor’s activities, as applicable. ·Maintaining
of Key process parameters related to significant aspects & Hazards of
their area. ·Identifying
non-conformities and taking corrective actions in their relevant areas. |
·         Raising
Indents/requisitions for resources for the achievement of IMS effectiveness. ·         Raising
requests for changes to IMS documents, as required. ·         Stop
operations in case of deviation to meet IMS requirements. Â |
Â
Management Representative
HOS (QC/QA) has been
appointed as the Management Representative (MR) of the company. He shall
discharge the responsibilities of MR irrespective of his other duties. He has
been given adequate authority for performing his function as an MR and reports
to the Director for this function. His responsibilities & authorities have
been defined at 2.5.
Workers Representative for OH & S matters, Participation & Consultation
Workers in safety committee meetings have been nominated as worker's
representatives for OH & S matters. Workers of all activities are considered
for participation, consultation & involvement, development, planning,
implementation, performance evaluation, and actions for improvement of the
OH&S management system removing all obstacles or barriers. Apart from
this town hall meeting is conducted involving all levels of employees and
available contractors at least once in six months covering all requirements as
per Cl 5.4 of ISO 45001: 2018; any improvement issue arising from this address/
discussion is recorded for planning & execution.
Resources, Infrastructure & Work Environment
Xyz Limited has provided
all required resources for implementing & maintaining the IMS and
continually improving its effectiveness. Any additional needs for resources are
identified by the respective personnel from time to time and conveyed to the
Director for organizing the same.  The resource requirements are also
ascertained during the management review meeting & provided for by the top
management. The resource requirements related to meeting customer requirements
& improving their satisfaction levels are given top priority.
The Director of the
Company is responsible for determining the infrastructural needs of the Company
from time to time and during discussions in Management Reviews.  The
facilities like proper building, workspace furniture, required plant and
machinery, other hardware, including test equipment, computer and related other
supporting services like communication systems, etc. are identified and the
same is organized by him, through interaction with various
sections.  The respective HODs with the help of other utility
services also ensure the proper maintenance of these facilities.
In order to achieve the
product conformity as per the customer requirements, the required work
environment as follows have been determined and provided for:
a) The proper lighting
& cleanliness in the plant
Any changes required in
the above due to new or revised product design/ development are determined
during the design process and provided for.
Product Specifications & Requirements
Product specifications
are decided through R & D activities carried out based on the study of customer
requirements. Â
Statutory & Regulatory Compliance
The statutory &
regulatory requirements applicable to the organization for Quality, Environment
& Health & Safety have been determined to be as follows:
a) Environment Acts &
Rules
b) Health & Safety
Acts & Rules
The company is meeting
all the above requirements through their deployment to various processes as
defined through different IMS documents, as well as by obtaining requisite
consents/ authorizations and by regular submission of required reports to the
regulatory bodies. The detailed list of applicable regulations and their
compliance has been documented threw’ other references as given in the process
for Management of Regulations & other requirements
Change Management
Whenever any significant
change is to be made in the system it is carried out through risk &
opportunity assessment, AIA, HIRA, and reviewing all linked processes as per
process mapping to ensure the integrity of the entire system.
Â