SOP for Guidelines for Maintenance Procedures

Learn how to write an SOP for Guidelines for Maintenance Procedures in Pharmaceutical plant.

1.0 PURPOSE

To describe the maintenance procedure, which provides a clear guideline on how to deal with preventive maintenance and breakdown maintenance in the plant.

 2.0 SCOPE

Applies to the activities associated with the preventive and breakdown maintenance of equipment in the pharmaceutical industry.

3.0 ASSOCIATED DOCUMENTS

3.1 SOP for Planned Preventive Maintenance Schedule     

3.2 SOP for Equipment Maintenance Request Procedure 

3.3 SOP for Permit to Work – General

4.0 DEFINITIONS

4.1 Preventive Maintenance: Preventive maintenance deals with the servicing of a piece of equipment (which has no observed faults) to prevent any breakdown. This may be carried out by trained Allied staff, an approved contractor who has received a maintenance contract, or the vendor’s service engineer.

4.2 Breakdown Maintenance: Breakdown maintenance deals with any piece of equipment that breaks down and needs to be repaired or replaced by trained Allied staff, an approved contractor who has received a maintenance contract, or the vendor’s service engineer.

Read Also: SOP for Planned Preventive Maintenance Schedule (PPM)

5.0 RESPONSIBILITIES

5.1 Engineering Department is responsible for preparing and implementing the planned maintenance  

Program.

5.2 Users of different Department   (Production, Quality Control, Quality Compliance and Utilities)

Departments are responsible for reporting Engineering Department abnormalities in equipment through the Equipment Maintenance Request Procedure.

5.3 Executive or Officer of Engineering is responsible for taking action after receiving              

maintenance request from the user(s).

5.4 Trained staff of the Engineering Department and/or contractor are responsible for carrying out assigned tasks.

The head of the engineering department is responsible for approving the procedure.

6.0 PRECAUTIONS

 Nil

7.0 PROCEDURE

7.1 Break-down maintenance: when a piece of equipment breaks down, follow the procedure given below:

7.1.1 Submit an Equipment Maintenance Request Form to the Engineering Department.

7.1.2 Proceed by using the most appropriate of the following:

7.1.2.1 Repair in-house if within the Engineering Department’s capabilities. OR

7.1.2.2 Contact the contractor with whom there is an existing contract to carry out such repairs. OR

7.1.2.3 Contact a manufacturer or suitably experienced contractor who does not have an existing contract to carry out repairs. Appropriate contractors for each piece of equipment should be identified in advance, wherever possible.

7.1.3 To select a suitable contractor who does not have an existing contract, obtain more than one quotation from different contractors along with a method statement and evaluate the quotes. 

Choose one contractor and get approval from the authority. Send papers to the Commercial Department to issue a work order.

7.1.4 In case of emergency work, select a contractor who is competent to perform the work with the level of acceptance.

7.1.5 Get necessary spares and materials from the store after filling out and approving the store requisition form. If the items are not available in the store, instruct the store officer to purchase them. The items urgently. Make sure that any spares that are required to replace those are similar to or equivalent to the damaged ones.

7.1.6 Lease with the user of the equipment and set a suitable time with the contractor for the equipment to be repaired.

7.1.7 Obtain a work permit: After completion of work, complete the request form, sign it, and then send the form to the user and the document controller.

7.2 Planned preventive maintenance: setting up a contract

7.2.1 Decide which pieces of equipment are required to be placed on a maintenance contract. If necessary, consult with user departments.

7.2.2 Obtain quotes from suitably experienced contractors (typically, specialized pieces of equipment are maintained by the manufacturers), complete with a method statement detailing the scope of work.

7.2.3 Quotations are then assessed based on the value and quality of the service.

7.2.4 Ensure that the quotation is supplied with a detailed method statement by either the plant or the contractor.

7.2.5 Ensure that spare parts are available at the store; otherwise, procure them along with appropriate  

Material, pressure, electrical safety certificate, etc.

7.2.6 Contact the contractor and arrange for the contracted visit to be carried out within the recommended time frame. e.g., monthly, quarterly, six months, or annually.

7.2.7 Update planned preventive maintenance schedule.

7.2.8 Provide service report after each service visit by contractor.

7.2.9 File the service report in the appropriate file.

7.2.10 The maintenance schedule will be dependent on production. It may be changed on per emergency basis.

7.2.11 If any case, fails to do the maintenance work on schedule time. It will be done by paying over time or it will be shifted on another day.

8.0 ABBREVIATIONS

8.1 SOP: Standard Operating Standard

9.0 ANNEXURES

Nil