Our company is expanding its assembly line into an ISO Class 7 cleanroom. When should training begin? What and who should be trained?
Your company should create a cross functional team to coordinate all validation of the ISO Class 7 cleanroom and become the subject matter experts to perform the training of everyone in the company that will be associated with the ISO Class 7 cleanroom.
Initial training, cross functional team training, and refresher training is essential for proficiency in all areas of any company. Initial training is performed with all new hires and changes in the company such as new equipment or a new addition or renovation of a facility. Cross functional team training combines two or more departments to cross train individuals to perform job activities in each area. Refresher training is performed as a corrective action to a nonconformance or at periodic scheduled intervals. The training is performed by a subject matter expert. Subject matter experts are typically department supervisors, managers, or an outside consultant that is performing a “Train the Trainer” course for the department supervisors or managers. Subject matter experts receive their training through advanced education at universities, on-the-job experience, or attending industry conferences or workshops.
The type or style of training can be in a classroom setting, hands-on training, or online. All training should have a method of assessing the effectiveness of the training. Methods of assessing the effectiveness of the training include written tests, demonstration of an activity, or training a co-worker.
Written standard operating procedures are a training tool. Standard operating procedures provide clarity and consistency when followed. Even with detailed steps, it is necessary to train all workers to follow the procedure exactly. Otherwise, individuals will interpret the meaning of procedures in different ways, leading to inconsistency in work routines and performance. An audit of written standard operating procedures will show whether the procedure is being adhered to and whether the objectives are being met. Each standard operating procedure should be audited about three months after implementation and thereafter annually. Additionally, the standard operating procedures should be audited for errors when “near misses” occur, to identify ways of preventing their recurrence.
Training should initially begin during the validation of the construction or installation of the ISO Class 7 cleanroom. The Quality team and Maintenance team members of your company work with the company installing the cleanroom to understand how to maintain and operate the cleanroom when the installation is complete. The maintenance team learns and understands the design, function, and mechanics of the HVAC, electrical, plumbing, and vacuum systems, including preventive and corrective maintenance measures. The Quality team writes the standard operating procedures that will document the information gathered by the maintenance team. These standard operating procedures will direct the maintenance team in the methods to keep the HVAC, electrical, plumbing, and vacuum systems functional and operational over time. Preventive maintenance checklists and corrective action measures are based on manufacturer’s recommendations and are documented in the standard operating procedures. Integrated control systems can assist in monitoring the cleanroom and standard operating procedures will direct maintenance and cleanroom personnel on how and the frequency of monitoring the HVAC, electrical, plumbing, and vacuum systems and maintain records of these systems. The Quality team records the training of the maintenance team on the standard operating procedures and any additional safety procedures that may be necessary now.
The Quality team will also receive information about the components of the cleanroom structure including the floors, walls, and doors. The company constructing or installing the cleanroom recommends cleaning compounds that are compatible with the surfaces of the floors, walls, and doors. The Quality team may also consult with manufacturers of any equipment that will be installed in the cleanroom regarding the cleaning and maintenance of the equipment. The Quality team writes standard operating procedures on the cleaning of the cleanroom and any equipment in the cleanroom. The standard operating procedures direct the cleanroom cleaning operators on how to clean the cleanroom, the materials used to clean the cleanroom, and the frequency of cleaning. Checklists completed by the cleanroom operators provide documented evidence of cleaning the cleanroom. Training of the cleanroom operators to safely and effectively clean the cleanroom is based on the standard operating procedures. The Quality team writes inspection and monitoring standard operating procedures to monitor the cleanliness and efficacy of cleaning the cleanroom. Typically, the Quality team members will be trained on the inspection and monitoring standard operating procedures. All training records are stored in the Quality department.
The Quality team will write standard operating procedures for cleanroom operators on how to don, wear, and doff cleanroom garments and how to work inside the cleanroom complex. The ISO 14644-5 standard, Cleanrooms and Associated Controlled Environments — Operations, and the Institute of Environmental Sciences and Technology contamination control recommended practices, are good sources of information for writing the standard operating procedures directing the cleanroom operators on how to clean the cleanroom; how to don, wear, and doff cleanroom garments; and how to work in the cleanroom environment. The IEST has several courses that the Quality and Cleanroom Supervisors or Managers can attend to become subject matter experts in these areas of expertise. The subject matter experts will train the cleanroom operators on the standard operating procedures. Documentation of the training is recorded and retained in the Quality department.
A robust training program will engage and motivate workers, therefore increasing productivity. When following the written standard operating procedures, the product is of consistently high quality, therefore less rework, rejects, or recalls. Increased customer satisfaction with the consistently high quality products will increase profits.
Jan Eudy is a Cleanroom/Contamination Control Consultant as well as a Fellow and Past President, Institute of Environmental Sciences and Technology. She is located in Carolina Beach, N.C. and can be reached at janeeudy@gmail.com.
