SOP for Guidelines for Engineering and Maintenance

Purpose

To provide guidelines to ensure that different maintenance activities to support production are carried out in compliance with safety & cGMP requirements, at a pre-determined frequency.

Objective

To provide documented guidelines to ensure that different maintenance activities to support production are carried out in compliance with safety & cGMP requirements, at a pre-determined frequency.

Scope

The scope of this SOP covers all the maintenance disciplines viz. mechanical, electrical & instrumentation as well as building maintenance.

Responsibility

Primary: Technician Engineering

Secondary: Manager Engineering

Procedure

Organization and Function

• The department must have a maintenance team that would perform all the maintenance functions meeting cGMP and good engineering requirements. It must also address documentation, audits, and training aspects of maintenance jobs.
• The Engineering Department organization must be structured to ensure that engineering functions are carried out safely, per cGMP requirements, and efficiently and promptly to support production and other service areas. It must be resourced with adequate numbers of appropriately qualified and trained staff.

Maintenance Strategies

• A maintenance strategy must be in place for all types of equipment. It should consist of a blend of planned (preventive) maintenance and corrective maintenance (history card).
• Corrective maintenance arises out of breakdowns and hence should be minimized / not repeated and filled history cards for each breakdown maintenance.
• A list must be prepared where all the equipment of the plant shall be listed. That list would be duly reviewed by the Production Manager, Engineering Manager, and General Manager and approved by the QA Manager must be prepared.
• This list must indicate the frequency of maintenance/calibration and tolerance as applicable.

Preventive Maintenance

• Preventive maintenance for equipment must be scheduled on a basis appropriate for particular equipment – this should be based on the statutory requirements, safety requirements, manufacturer’s recommendations, and the history of the equipment.
• The frequency must be reviewed and changed to bringing-in improvement in the performance of equipment and to build in reliability.

Corrective Maintenance

• Corrective Maintenance must be carried out promptly to ensure that production downtime is minimal. This shall be recorded in an equipment history file.
• The nature of failures must be identified and understood and should be predictable. The preventive maintenance checklist must be amended by incorporating recommendations arising out of the investigation.

Prevention of Contamination and Cross-Contamination

• Before taking the equipment for maintenance, it must be cleaned by production staff.
• The post-maintenance cleaning must address the removal of replaced parts and materials, waste, cleaning materials, and physical maintenance debris from the plant. The impact of maintenance operations such as footprints oils and greases must also be addressed.
• After the maintenance, the equipment, pipe, pipe fittings, etc. will be handed over to production for cleaning before its use. The adjacent clean equipment must be protected from contamination during maintenance operations on particular equipment.

ALSO READ: SOP for Planned Preventive Maintenance

Building Maintenance

• Building maintenance shall be carried out as per statutory and site requirements. Documents like statutory records like a painting of the building, stability of building/structures etc. must be maintained to ensure that the building maintenance is carried out satisfactorily.

Validation

• If maintenance service interfaces with other systems then the interfaces must be validated.

Change Control

• All changes must be fully documented, assessed and authorized before the work being carried out.
• In line with good documentation practice, the ELD (Engineering Line Diagram) should be updated to accurately reflect the as-installed status following, a change as soon as is practicable after the change is implemented. Changes must be controlled as per good engineering practices.

Training

• All the staff shall be covered for cGMP, Safety, and Job-related training as per the training procedure.

Standard Operating Procedures

• Standard operating procedures must be prepared for all activities that are quality-critical or safety-critical or relate to key business areas. These SOPs must be prepared, reviewed & authorized, and controlled by the Site SOP.
• The SOPs must include specific maintenance instructions, lubrication details, Spare requirements, frequency of maintenance, responsibilities for carrying out the job & documentation, etc. as appropriate. The department activities must be reviewed to identify operations that need preparation of SOP and the current SOPs must be updated/reviewed as scheduled.

Audits

• Department audits must be carried out to monitor the Engineering aspects of departmental activities regarding their impact on SHE, Energy Conservation, and Quality matters.

Documentation 

• A separate list must be made for the numbering and authorization of documents.
• The documents will include the following:

1. Forward Plan: A plan must be drawn up for all equipment for routine maintenance as per the schedule and followed. In case of any deviation, it must be recorded and prior authorization obtained from the appropriate Manager.
2. Postponement of the scheduled maintenance: Postponement of scheduled maintenance for equipment may be required if, the equipment can not be released for maintenance due to production exigencies or non-availability of an external expert agency. A form requesting postponement of maintenance would be initiated by the Production or Engineering Manager indicating the reason for the postponement and its impact and will be reviewed by the Q.A. Manager and Authorized by G.M. (Works).
3. Equipment file: Each piece of equipment must have an equipment file. The history of the equipment must be recorded in the equipment file. The maintenance checklist after carrying out preventive maintenance job must be filled up and filed in the Equipment history file.
4. Checklist: A Checklist must be prepared specifically for each critical piece of equipment indicating the job to be carried out. The checklist will be of help to ensure that any item of maintenance has not been missed. However, the preventive maintenance checks shall not be limited to only what has been mentioned in it but surrounding site conditions must also be examined to ensure that the equipment continues to function as expected after the maintenance.
5. Validation Documents: Documentation about validation would include protocol and reports for DQ, IQ, and OQ activities and would be in line with the Guidelines given. Protocols and reports must also include the supplier’s documentation (e.g. pressure test, calibration certificate, etc.) besides the reports generated at the site.

Abbreviation

DQ: Design Qualification

IQ: Installation Qualification

OQ: Operational Qualification

QC: Quality Control

QA: Quality Assurance

Annexure

Nil

Revision History

Nil

ALSO READ: SOP for Accident Prevention Guidelines