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SOP for Machine Safety

Purpose
To prevent adverse events associated with the operation, cleaning, maintenance and repair of work equipment.

Scope
This SOP applies to all work equipment used by Pharmasky employees including contractors working under Pharmasky control. Work equipment includes all tools, production and non-production machinery, mobile equipment and lifting equipment.

Expectations
  • The site head shall identify a focal point to implement the Machinery Safety standard at site.
  • A person from the maintenance department who is knowledgeable about machines can be named as a site focal point.
  • The engineering Head shall integrate all the EHS considerations for bringing new equipment into the site and operating the same in a safe way as expected in the standard as per the guidance document.
  • An inter-department team shall be formed involving all the department person who is having knowledge on machines for implementing the Machinery safety standards and to conduct the Machine Risk assessments. Site focal point shall lead the team.
  • Team shall list out all the machines in the site and shall have a unique identification number for each machines.
  • Team shall priorities the machine for risk assessment based on the scores from the qualitative assessments. Machine with High risk shall prioritized, medium and low risk machines followed after that. Red - Amber - Green prioritization matrix in the Appendix A shall be used for machine prioritization.
  • Team shall prepare a complete schedule for the Machine Risk assessment involving all the High, Medium and low risk machine.
  • Site Head needs to approve the Machine Risk Assessment plan and ensure the adequate resources available for executing the plan
  • Team shall complete the Machine Risk assessment as per the plan and needs to identify the gaps with the machines. 
  • Action plan shall developed for each gaps with the machine reference number and loaded in global EHS portal CAPA management system for follow up.
  1. A very high risk machine identified during assessment shall kept away from operations until the issues are addressed or can be managed with administrative control (warning alarm, Hazard labels, and Procedures etc.,) with EHS and Site Head approval.
  2. All the high risk gaps identified in the machinery safety risk assessments to be addressed in 30 days and the medium risks shall addressed in 90 days as per the CAPA standard.
  3. Action plan developed shall include the responsible person name and target dates for each and every actions.
  4. Team shall review all the corrective actions periodically to understand the progress.
  5. All the actions that are completed shall be verified for its effectiveness in the field by the EHS Head and Site Head.
  • The engineering head has to ensure that all the guards and interlocks are designed as per the guidance.
  • Risk assessments team shall meets once in a month to discuss the progress of the implementation and MRA status.
  • Department Head shall communicate to the MRA site focal point in case of procuring a new machines for the site
  • Site focal point shall review the machine design and provide his input to the team before procuring the machine.
  • Procurement team shall provide document to vendor along with the machine Purchase Order.
  • New machines shall be inspected by the Machine risk assessment team before it arriving to the sites based on EHS.
  • Machine risk assessment team shall complete machine risk assessment for all the new machines before its installation at site. In case any gaps with the new machines shall be notified to the vendor and fixed before installation.
  • Site focal point shall review the machine risk assessment documents for the machines that are transferred from one (Company Name) sites to other (Company Name) sites. He can initiate a MRA for the machine if the document provided are not satisfactory.
  • If any gaps identified for the machines during MRA at the origin sites , shall be included in the transferred site action plan and shall approved by the Site head.
  • Site focal point shall also review the machine risk assessment priorities list and change the priority of the machine according to the inclusion/exclusion of the machines.
  • Site focal point and Machine risk assessment team members shall be trained on the Machine Risk standard and on conducting Machine risk assessment. Their training effectiveness shall be documented.
  • All the employees at the site working on the machine shall be trained on the machinery hazards, LOTO and human machine interactions based on guidelines. Their training effectiveness shall be documented.
  • Visual displays of all the key hazards identified for the machine shall be displayed based on the guidance document.

Abbraviation
EHS: Environmental Health and Safety

Annexure
Nil

Revision History
Nil

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