A shutdown is a planned event that impacts a manufacturing or laboratory function by taking the area off line either in partially or entirely for a significant maintenance event or to implement a major project. All major shutdown events require a formally documented plan. A shutdown procedure consists of the following steps:
- Pre-Shutdown Activities (Planning and Scheduling)
- Phase Two: Declassification and Handover
- Phase Three: Day-To-Day Management and Handover
- Phase Four: Reclassification and Handover
- Phase Five: Post-Shutdown Activities and Completion of the Shutdown Report
This paper will present a Standard Operating Procedure describing what need to be done in each of the phases in order to “conduct a planned shutdown.
These are activities that need to be done before the initiation of the shutdown procedure; they include;
- Dividing the responsibilities among the various personnel involved. This process entails confirming who must do what. The allocation of specific responsibility for key shutdown roles. This process requires the establishment of shutdown coordinators/planners who lead the shutdown team in the maintenance of plants and equipment and ensure the major shutdown management process is followed. The Shutdown leader Provides operational direction for the maintenance systems and programs, he also Document plant shutdown procedures. Plant owner assists the coordinators and shutdown leader in making critical decisions regarding the shutdown. The coordinators, the shutdown leader together with the plan owner should head the shutdown management team. Which comprises of the following departments: Engineering, Validation/technical operations, Manufacturing operations, QA, QC, Procurement and Safety as well as the, Planning team. Together they should discuss and come up with guidelines on how the shutdown will be conducted with minimum or no adverse effects. They should Generate a list of all shutdown activities to assess: Resources required (who, what, when) , Timelines for each shutdown activity, Lockdown dates to prevent any further additions to the schedule that can’t be planned for , Pay particular attention to any task that will directly impact all others, e.g. power supply outage and smoke pattern testing.
- Hiring of contractors; at this stage Competency screening and risk ranking should be done. Are the contractors skilled and competent?, how much is the contract cost? What they can and can’t do should be clearly defined and documented, there should be proper Control, communication supervision and management. Contractual arrangements should be signed and sealed.
- Equipment replacement, consumables and spare parts availability: the project shutdown coordinators should make sure there is plenty of the obvious available: Gowns/Tyvek suits, cleaning agents of all types and Filters.
- Completion and publication of a Gantt chart: this chart shows key activities, resource requirements, roles and responsibilities for all key stakeholders and the exact support requirements ought to be done. This will facilitate timely completion of the projects.
- Change control: The coordinators and the shutdown leader should make sure that any planned changes to the plant and equipment are approved well in advance of the shutdown, not on the day.
- Developing the Criteria for handovers between each shutdown phase: The QA should be involved in the approval process so that oversight can be maintained and the impact on products release assessed.
Procedures during the shutdown process
Declassification and Handover
- Removal of everything that can be moved from the plant: All movable equipment and materials should be bagged, tagged and stored to prevent contamination. Equipment that can’t be moved should be securely covered. Open pipes must be sealed/capped off to prevent contamination,
- Protection of walls and floors: During major shutdowns, walls and floors can be damaged requiring costly delays for additional repairs. If you expect a lot of heavy shutdown work, make sure you protect them.
- Capping /sealing monitoring points: If you there are monitoring points, make sure these are sealed off.
- Audit (plant review) and sign-off vs. detailed checklist: Before you move to the next Phase, make sure you walk the plant to ensure that everything that should have been done has been done.
The procedures involved in day to day management are:
- Controlled access: Shutdowns are not a free invitation for anyone to enter the plant. The more people wandering around, the greater the chance of losing control of the shutdown. Restrict access to those that matter.
- Clothing requirements use. Tyvek suits should be the minimum.
- Contractor management: Permit to work system (or equivalent) to ensure that contractor’s tasks are agreed to beforehand and verified upon completion. A central location (“control room”) for all work management is critical. Some contractors may not have a detailed understanding of the demands of working in a GMP environment. Make sure you provide an experienced local guide to oversee and to make sure they meet GMP requirements.
- DAILY change control committees: Shutdowns can involve a lot of changes to equipment and the plant. Make sure these can be fast tracked for speedy approval with daily, face-to-face change control committee meetings for review and approval.
- Requalification of equipment and plant: Any significant change to the plant and equipment usually requires requalification. Make sure it’s done
- Waste removal: Major shutdowns can lead to considerable waste. Make sure this is removed immediately and is not allowed to build up
- Cleaning: During major shutdowns make sure cleaning accompanies every major activity to ensure contamination is controlled throughout, making the final clean down easier.
- Daily “snagging.”: Even the best planned shutdown rarely goes according to plan! After each day, complete a review of what is on track and what is not. What has gone according to plan…and what has not. This review of the snags or problems helps you in your contingency planning.
- DAILY contingency planning with all key stakeholders. This involves determining what extra resources are needed and how manage or contain additional risks.
Reclassification and Handover
This entails the following procedures:
- Review and approval of requalification activities: Making sure that all equipment is operating within its validated state.
- Deep clean.” This is one of the most vital activities of any shutdown and yet the one activity often poorly done. Sanitizing agents should be applied to dirty surfaces and hard to clean locations, activities should not be rushed; there should be sufficient contact time and proper environmental control.
- HVAC cleanup: Shutdowns and the cleaning and sanitization activities can generate a lot of contamination and the plant requires time to “clean up” in the resting state. Good HVAC systems will remove contamination and return the plant to its “at rest” state within 24 hours.
- Confirmation that “at rest” conditions have been achieved for non-viable particulates
- Plant visual inspection. One last walk-through to make sure everything is shipshape
- Formal handover and sign-off. This is when the plant is formally handed back to operations
Post Shutdown Activities and Completion of the Shutdown Report
The procedures involved in this step include:
- Confirming environmental monitoring results. The question often asked is “Should we wait for a full set of microbiological environmental results before we can start to make product. Delays are costly and therefore, Cleaning and sanitization should be done effectively and signed off.
- Confirm plant and equipment is working within validated parameters. you often operate equipment to different parameters based on operational history, performance and validation studies.
- Close out any remaining change controls
- Close out any deviation incidents
- Compile lessons learned: It’s vital for everyone involved in the shutdown to do a lessons learned review before memories fade.
- Complete shutdown report. It’s vital the report is completed quickly to include: Executive summary i.e. A short paragraph of what went well, what didn’t, any risks and how these have been managed or contained, Completed handover checklists covering all activities, Engineering status, Validation status, Change controls. Environmental control.
- Gain approval of the report by the shutdown leader (the author), QA and the plant owner.