SOP Title: Resource Management Process
- Objective:
To lay down the procedure for identification, evaluation, procurement/recruitment and implementation of resources to implement and improve the processes of the quality system
- Scope:
This procedure is applicable to all resources i.e. Personnel, Equipment, Instrument, Tools, Spares, Consumables, or other items that influence quality or quality related operations in the plant.
- Responsibility:
Senior Management: Responsible to appoint department Heads and approval of other resources.
Head of Departments: Responsible to appoint new manpower and to procure new machines and other resources.
- Accountability:
Plant Head/Department Head
- Procedure:
- Definition:
Concerned Department: To identify, initiate the need of resources, review and document the PO as per this SOP.
- Procedure:
| 5.2.1 | The need of resources shall be determine or identify and communicate to the Management adequate and appropriate resources (Human, Materials, Facilities, and Equipment) to implement and maintain the
Pharmaceutical Quality System and continually improve its effectiveness. |
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| 5.2.2 | Ensure the requirement of resources are appropriately evaluated, identified, communicated to management, procured and applied to a specific product, process, or site. | |
| 5.2.3 | A need assessment shall be conducted by the discussion with the Management/Resource Approval Authority to determine resource needed. Besides identifying specific resource for any task. | |
| 5.2.4 | The Needs Assessment should Consider the following Questions: | |
| · What quantity of resource is required?
· When will the resource be needed? · What capability does the resource need to have? Are there any limitations? · What is the cost of procuring the resource? |
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| 5.2.5 | To approve the resources as per requirements of different departments. | |
| 5.2.6 | Once the Preliminary Approval is obtained from Management, the procurement process shall be initiated as per Annexure. | |
| 5.2.7 | Requisition/Indent for supplies, services and financial commitment shall be prepared through competitive and non competitive process (as appropriate) by discussion with Purchase and Account Department as applicable and sent to the Management/Resource Management Authority for Approval. | |
| 5.2.8 | After Requisition/Indent Approval, request for quotation shall be sent to different Agencies/Suppliers/Manufacturer. | |
| 5.2.9 | Quotations for customized Products/Equipment/Instruments/Services shall be reviewed before an order made to the Supplier/Manufacturer. | |
| 5.2.10 | Review of quotation orders for Products/Services shall consist of verification of the user requirements specification, including requirements stated by the customer, are adequately defined and documented and have been fully understood. If the quotation order requires clarification, then it will not be accepted until the missing information is obtained from the Supplier/ Manufacturer. | |
| 5.2.11 | Consideration shall be given whether our capability and capacity are adequate to satisfy the product need. | |
| 5.2.12 | If required, a Site Inspection and Evaluation Programme shall be conducted to review the Product/Service/Equipment Design and Specification as per URS. | |
| 5.2.13 | After complete Evaluation and Analysis order shall be accepted from adequate Supplier/Manufacturer and decision shall be made in order to place Purchase Order (PO). | |
| 5.2.14 | Records of contract/order review shall be documented. A copy of the quotation, signed by authorized representatives of all participating functions, in addition to a copy of the PO order shall be filed. | |
| 5.2.15 | Purchase Order shall be generated and sent to the Supplier/Manufacturer. | |
| 5.2.16 | A suitable procurement plan shall be made by considering specification, method of delivery at site, time, mode of payment, financial approval and legal requirements. | |
| 5.2.17 | The procurement plan, product specification, supplier and contract details and specific responsibilities shall be communicated to all personnel involved in the procurement process. | |
| 5.2.18 | The procurement of resources shall be verified, documented and subjected to further Qualification as applicable. | |
| 5.2.19 | Requirement of Equipment, Instruments and other Items:
The resource requirements for Equipment and Instruments shall be identified on the following basis: |
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| 5.2.19.1 | Quality Requirements: | |
| · Up-gradation or improved version of existing equipment for particular operation.
· Requirement for current GMP or quality audit compliance. · Requirement due to wear and tear of existing equipment/instrument, spare, component etc. · Requirement of consumable for routine operation and activities. |
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| 5.2.19.2 | Quantity Requirements: | |
| · Additional quantity requirement shall be decided based on more output required, increase in production, smooth functioning of plant and maintain desire quality of product.
· For critical equipment/instruments the User Requirement Specification (URS) and Design Qualification details shall be prepared through defined and an approved procedure before procurement wherever applicable. |
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| 5.2.19.3 | Requirement of Personnel/Human Resource:
The requirement of Human Resources shall be identified as follow: |
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| 5.2.19.3.1 | To identify and appoint key personnel in the factory like Unit Head, QA Head, QC Head, Engineering Head, HR Head, Production Head etc. | |
| 5.2.19.3.2 | To identify the need of man power and communicate the request to Management for approval. After approval the request for recruitment shall be sent to the Human Resource Department. | |
| 5.2.19.3.3 | The recruitment for manpower may be required for New Expansion, Replacement (due to Resignation) or any additional purposes.
By following sources manpower pooling can be achieved: · Through manpower consultants/Employment agencies. · Through advertisement in news paper. · Through website posting. · Employee referral. · Walk in applicants. |
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- Abbreviation:
| Abbreviation | Expansion |
| HR | Human Resource |
| URS | User Requirement Specifications |
| GMP | Good Manufacturing Practice |
| etc | etcetera |
*Note – Ready to use SOP available in “DOWNLOAD” Section.