a) Process Map (See 2.2).
b) Process Deployment Matrix (See 2.4).
c) Inputs & outputs as defined in each process description.
All processes of the organization have been divided into the following four major categories:
a) Core processes for Quality.
b) Core Processes for Environment, Health & Safety.
c) Support Processes.
d) 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) Plans & instructions,
b) Standards and specifications,
c) 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
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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 & Admn.) | E-020 | |
12. | Operational Control | All Heads | E-030 | |
13. | Control of Contracted services | All Heads | E-040 | |
14. | Emergency Preparedness | HOS (Personnel & 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 | |
2.5 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) | · 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. | · 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. ·
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. |
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.
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.