SOP for Machine Safety

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

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.

  • The site head shall identify a focal point to implement the Machinery Safety standard at the 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 personnel who is having knowledge on machines for implementing the Machinery safety standards and conducting the Machine Risk assessments. Site focal point shall lead the team.
  • A team shall list out all the machines in the site and shall have a unique identification number for each machine.
  • The team shall prioritize the machine for risk assessment based on the scores from the qualitative assessments. Machines with High risk shall be prioritized, and medium and low-risk machines followed after that. Red - Amber - Green prioritization matrix in Appendix A shall be used for machine prioritization.
  • The team shall prepare a complete schedule for the Machine Risk assessment involving all the High, Medium, and low-risk machines.
  • The site Head needs to approve the Machine Risk Assessment plan and ensure adequate resources available for executing the plan
  • The team shall complete the Machine Risk assessment as per the plan and needs to identify the gaps with the machines. 
  • An action plan shall be developed for each gap with the machine reference number and loaded in the global EHS portal CAPA management system for follow-up.
  1. A very high-risk machine identified during assessment shall keep away from operations until the issues are addressed or can be managed with administrative control (warning alarm, Hazard labels, Procedures, etc.,) with EHS and Site Head approval.
  2. All the high-risk gaps identified in the machinery safety risk assessments are to be addressed in 30 days and the medium risks shall address in 90 days as per the CAPA standard.
  3. The action plan developed shall include the responsible person's name and target dates for each and every action.
  4. The team shall review all the corrective actions periodically to understand the progress.
  5. All the actions that are completed shall be verified for their 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.
  • The risk assessment team shall meet 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 new machines for the site
  • The site focal point shall review the machine design and provide his input to the team before procuring the machine.
  • The procurement team shall provide a document to the vendor along with the machine Purchase Order.
  • New machines shall be inspected by the Machine risk assessment team before they arrive at the sites based on EHS.
  • The machine risk assessment team shall complete a machine risk assessment for all the new machines before their installation at the site. In case any gaps with the new machines shall be notified to the vendor and fixed before installation.
  • The site focal point shall review the machine risk assessment documents for the machines that are transferred from one (Company Name) site to other (Company Name) sites. He can initiate an MRA for the machine if the document provided is not satisfactory.
  • If any gaps are identified for the machines during MRA at the origin sites , shall be included in the transferred site action plan and shall be approved by the Site head.
  • The 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 a 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.

EHS: Environmental Health and Safety


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