Question: I am a production supervisor working in an ISO Class 7 cleanroom in Florida. Our cleanroom has not been affected by the hurricanes in Florida in the past but I have been assigned to write a disaster plan for the clean-room. How does one prepare, respond, and recover a cleanroom operation from a natural disaster?

It is wise to develop a disaster prevention plan and a disaster recovery plan now, when you don’t need it, in order to reduce the financial impact and ensure a quick recovery, should a disaster occur. I assume you are a member of a cross-functional team that is developing a comprehensive disaster plan for the entire facility and you have been given the responsibility and authority for the clean-room. I will focus only on the prevention, response, and recovery as it pertains to the cleanroom operations. However, to be successful, the plan for the cleanroom operations should be incorporated into the overall master plan.

The source of the disaster can be from nature or man-made. A disaster plan should be a documented, comprehensive plan that addresses three key areas:

• Prevention of the disaster
• Response to the disaster
• Recovery from the disaster

Prevention of the Disaster
The focus of this section of the plan should be on the importance of being prepared to continue operations in any unplanned event for the welfare of the customer and the employees. A crisis management team can implement and execute procedures and policies designed to continue operations in the event of a disaster. If not already in place, your facility should install security systems, back-up generators, fire protection systems, and contract for data back-up and document storage off-site.

Response to the Disaster
Your facility should already have developed an emergency response group and plan in the event of a fire and perform routine fire drills. From this group you can build a strong cohesive disaster response team to train all employees how to respond to a disaster, such as a procedure for evacuating the cleanroom in the event the disaster occurs while the facility is in operation, and how to preserve the product.

Recovery from the Disaster
Your approach to recovery depends upon the nature of the disaster and the extent of the damage. Therefore the disaster prevention/response/recovery plan should address all types of potential events that could stop production. The recovery plan for the cleanroom should tie into each scenario. In order to write the disaster recovery plan for the cleanroom, one must know every detail of the operation of the cleanroom just as one must know every detail of the business for writing the master plan. This information is usually found in the validation documentation performed initially on the cleanroom and subsequent routine quality testing. The most recent certification of the cleanroom can provide the basis for the recovery plan framework.

From: “Developing a Cleanroom Disaster Prevention Plan”