It’s important to have a good sense of not just what your company’s cleanroom suite looks like, but also how it will function for accreditation now and in the long run. Part of this process is being able to identify risk to your cleanroom and manage that risk appropriately in order to maintain the integrity of your lab. So, how do you identify risk for a cleanroom and manage it appropriately after construction? Keep reading to find out more from LCS Constructors.  

What is Risk for a Cleanroom?

Risk for cleanrooms is defined by ISO 14644-6 stating that risk is, “the combination of the probability of occurrence of harm and the severity of that harm.” William Whyte, the author of Cleanroom Technology: Fundamentals of Design, Testing, and Operation, further elaborates that risk in a cleanroom “can be considered as being the amount of contamination transferred to the product from a hazard, where a ‘hazard’ is a source of contamination.” Because cleanrooms are a space where particulate matter is regulated, controlled, and eliminated, risk involves anything where unwanted particles enter the controlled space.

In order to properly identify and manage risk associated with a cleanroom space after the lab is designed and constructed, there are six steps you can follow in order to implement an ideal risk management plan for your company’s new cleanroom. The following six steps are based on the Risk Management of Contamination (RMS) system, developed with cleanrooms specifically in mind.

Identifying Sources

The first step in cleanroom risk management involves being able to identify your potential sources of contamination and also get a sense of which sources provide you with the greatest amount of risk. Sources can include the following:

  • Unfiltered Air Supplies
  • Cleanroom Surfaces
  • People/Employees
  • Production Machines
  • Materials
  • Packaging

Because there are so many microscopic particles that are problematic for cleanroom applications, you have to understand the many, many points of possible contamination. In addition to the many points of contamination, there are several different routes of transfer. The most common route are airborne and through contact.

Risk Assessment

After you identify the possible points of contamination, the second step involves a risk assessment and addressing ways to control the potential sources of contamination. This process looks at how likely a particular risk, identified in the first step, is to happen, causing contamination of a product or process. There are specific equations available to calculate the risk of various types of contaminants, however they all boil down to the “criticality of the occurrence” times the “frequency of occurrence.” Note that the criticality is the amount of particulate released from the source that is then transferred to the product. Keep in mind that assessing risk can get very complicated, so turn to an expert for further information.

Monitoring Program

The third step outlined by the RMC system involves creating a plan to monitor and act upon any contaminants that may enter the cleanroom. This plan should include what has to be monitored, how frequently sampling should occur, utilizing valid sampling methods, and setting sample limits that would trigger a course of action to care for the cleanroom. Having a team responsible for the maintenance and upkeep of the cleanroom is critical to protect products and mitigate the risk that could cause further problems for your cleanroom.

Verification

Step number four involves verifying not only your risk management plan, but also going back and addressing if your monitoring program is performing as expected. Ask yourself if any of the risk factors have changed. Reassess the risk ratings. Test and see if your control methods in your monitoring program are working. Review the sampling program associated with the monitoring process to see if you have any action items and to make sure the sampling process is valid.

Documentation

As with any certification standard, it’s critical to document the entire process of your RMC system. This includes documenting the risk, clearly documenting the monitoring and sampling process with any changes, and providing regular sampling results for long-term tracking. It’s important to keep the documentation updated and to release regular reports to any interested parties.

Staff Training

The last step is almost as critical as the third step with the monitoring program. It’s exceptionally important to provide proper staff training in cleanroom risk management and the expected tasks that are meant to prevent contamination. Training is critical to help employees do the right things in order to minimize contamination and keep company assets in the best possible working condition.

For all your lab design and cleanroom construction needs, turn to LCS Constructors. Contact us for more information today!