How does one prepare, respond, and recover a cleanroom operation from a natural disaster?
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 masterplan.
The source of the disaster can be from nature (i.e. tornado, hurricane, earthquake, flood, etc.) or man-made (i.e. power outage, terrorist attack, uncontrolled wildfires, etc.). A disaster plan should be a documented, comprehensive planthat addresses three key areas:
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. One can use routine quality system audits to spot a crisis waiting to happen. Performance of a failure mode analysis and evaluation will produce a plan to keep the impending crisis from happening. 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. Additional planning should include both internal redundancy of equipment and back-up facilities within your company that follow the samepolicies and procedures in the case of a severe disaster.
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 groupyou 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. Additional information should be given to eachemployee such as:
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 (Installation Qualification, Operation Qualification, Performance Qualification) performed initially on the cleanroom and subsequent routine (daily, weekly, monthly, quarterly, semi-annual, and annual) quality testing. The personnel and process flow charts, procedures, and controlled documents are good references for information. The most recent certification of the cleanroom can provide the basis for the recovery plan framework. The parameters and specifications from this documentation are used to determine when full recovery has been achieved. The Institute of Environmental Science and Technology recommended practice, IEST-RP-CC006.3, Testing cleanrooms, is a good resource for information to aid in writing a recovery plan for your cleanroom. Other recovery plan documentation and testing requirements are being developed in IEST working Group 41, Recovery Plan Following Disaster Disruption. This working group, chaired by Mike Dingle is meeting at the IEST Fall Conference, November 5 – 8, 2006. The working group discusses and documents thebest practices from a variety of different disciplines and companies.
Jan Eudy is Corporate Q.A. Manager for Cintas Cleanroom Resources.
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 masterplan.
The source of the disaster can be from nature (i.e. tornado, hurricane, earthquake, flood, etc.) or man-made (i.e. power outage, terrorist attack, uncontrolled wildfires, etc.). A disaster plan should be a documented, comprehensive planthat addresses three key areas:
- -Prevention of the disaster
- -Response to the disaster
- -Recovery from 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. One can use routine quality system audits to spot a crisis waiting to happen. Performance of a failure mode analysis and evaluation will produce a plan to keep the impending crisis from happening. 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. Additional planning should include both internal redundancy of equipment and back-up facilities within your company that follow the samepolicies and procedures in the case of a severe disaster.
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 groupyou 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. Additional information should be given to eachemployee such as:
- -Contact information of key people
- -Contact information of media disseminating information regarding status of the facility
- -Contact number (preferably an 800 number) for employees to call for assurance that they are needed at work and will be safe
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 (Installation Qualification, Operation Qualification, Performance Qualification) performed initially on the cleanroom and subsequent routine (daily, weekly, monthly, quarterly, semi-annual, and annual) quality testing. The personnel and process flow charts, procedures, and controlled documents are good references for information. The most recent certification of the cleanroom can provide the basis for the recovery plan framework. The parameters and specifications from this documentation are used to determine when full recovery has been achieved. The Institute of Environmental Science and Technology recommended practice, IEST-RP-CC006.3, Testing cleanrooms, is a good resource for information to aid in writing a recovery plan for your cleanroom. Other recovery plan documentation and testing requirements are being developed in IEST working Group 41, Recovery Plan Following Disaster Disruption. This working group, chaired by Mike Dingle is meeting at the IEST Fall Conference, November 5 – 8, 2006. The working group discusses and documents thebest practices from a variety of different disciplines and companies.
Jan Eudy is Corporate Q.A. Manager for Cintas Cleanroom Resources.
