Preparing contingency plans

The standard requires the supplier to prepare contingency plans to reasonably protect the customer s supply of product in the event of emergency, excluding natural disaster and force majeure. 

Force majeure is an event, circumstances, or an effect that cannot be reasonably anticipated or controlled - often called an act of God, which includes natural disasters caused by weather and land movement. Force majeure also includes war, riots, air crash, labor stoppage, illness, disruption in utility supply by service providers, etc. There is some contradiction in this requirement as you can take effective action to maintain business continuity as a result of certain events that may be classified as force majeure or natural disasters. 

Although such events cannot be prevented, their effects can be reduced and in some cases eliminated. Hence contingency plans should cover those events that can be anticipated where the means to minimize the effects are within your control. What may be a force majeure situation for your suppliers does not need to be the same for you. 

Start by doing a risk assessment and identify those things on which continuity of business depends power, water, labor, materials, components, services, etc. Determine what could cause a termination of supply and estimate the probability of occurrence. For those with a relatively high probability (1 in 100) find ways to reduce the probability. For those with lower probability (1 in 10000) determine the action needed to minimize the effect. The FMEA technique works for this as well as for products and processes. 

If you are located on or near an airport and a Boeing 747 descends upon your factory, can you claim it to be an event outside your control when you chose to site your plant so close to the airport You may have chosen to outsource manufacture to a supplier in a poorer country and now depend on them for your supplies. They may ship the product but because it is stopped at customs due to a change in government of the country concerned, it doesn t reach its destination - hence you may need an alternative source of supply. 

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Apply to all work activities with radioactive materials, including transport. The main provisions relevant to transport are those relating to driver training and the need, under some circumstances, to prepare contingency plans for emergencies and enforced stoppages. 

Carry out a risk assessment on your utilities, labor force, and suppliers and prepare contingency plans to minimize effect on business continuity. 

Potential emergency situations. Prepare contingency plans in case of fire, release of toxic or infectious materials, explosion, etc. 

Strategic items Develop supplier relationships and partnerships, switching suppliers is difficult, increase role of selected supplier, strive for effectiveness, supply continuity, and technical expertise is more important than price, prepare contingency plans, and requires a great deal of negotiation. 

Exploration activities are potentially damaging to the environment. The cutting down of trees in preparation for an onshore seismic survey may result in severe soil erosion in years to come. Offshore, fragile ecological systems such as reefs can be permanently damaged by spills of crude or mud chemicals. Responsible companies will therefore carry out an Environmental Impact Assessment (EIA) prior to activity planning and draw up contingency plans should an accident occur. In Section 4.0 a more detailed description of health, safety and environmental considerations will be provided. 

Abbott attacked the Form II problem in two ways. The first was to restore the ability to prepare Form I. The second was a more drastic contingency plan. 

Procedures and plans supporting business continuity (Disaster Recovery Plans and Contingency Plans) must be specified, tested, and approved before the system is approved for use. Business Continuity Plans will normally be prepared for a business or an operational area rather than for individual computer systems. It is likely that the only way to verify the plan is to walk through a variety of disaster scenarios. Topics for consideration should include catastrophic hardware and software failures, fire/flood/lightning strikes, and security breaches. Alternative means of operation must be available in case of failure if critical data is required at short notice (e.g., in case of drug product recalls). Reference to verification of the Business Continuity Plans is appropriate during OQ/PQ. 

Contingency plan — This is an action plan prepared in anticipation of an oil spill. This plan usually consists of guidelines developed for a specific industrial facility or an entire region to increase the effectiveness, efficiency, and speed of cleanup operations in the event of an oil spill and at the same time protect areas of biological, social, and economic importance. 

Preparing for accidental releases or spills from the piping to be hot-tapped, by establishing spill control, having Are extinguishers ready, etc. ( contingency planning ). 

C. Evacuation. Evacuation of NBC injured casualties entails more than transportation. Since some casualties may be contaminated, the casualty evacuation system must be organized in a way as to minimize the spread of contamination. Since mass casualties may occur, and the number of medical vehicles may be inadequate to meet the increased load, unit commanders need to have contingency plans to supplement medical vehicles for casualty evacuation, or be prepared to retain casualties within their units for longer periods of time. 

One other aspect of the excursion SOP that should be considered is a disaster plan. This might include pre-arrangement with an alternate facility for sample storage or some other contingency plan. While a widespread facility failure is less likely to occur, it is always better to be prepared (and to be able to show that you re prepared). 

Have all personnel received a safety and emergency procedures brief Has a project health and safety plan been prepared and implemented Have emergency contingency plans been put in place and posted Have alarm systems been functionally tested ... 

As mentioned above an EIA may be prepared in the case of accidents. This requires preparation of an operational hazards (HAZOP) study, which indicates the emissions during the accident. Obviously the concentrations of the chemical substances in this case would greatly exceed allowable levels inside the factory site and outside the fences. The duration of this exposure would have an impact on the environment and health of the local population. This case requires preparation of special plans, e.g., contingency plans. Because modem... 

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