Risky Business: Does your Staff Measure Up – Prove it!
Risky Business: Does your Staff Measure Up – Prove it!
This title is a little sassy (so says my office staff), but I want to get your attention. This part of quality assurance is important not only for DAMAS certification, but also to meet the requirements of the FDA’s quality system regulation. Being able to show competency of technicians seems to be a real challenge for dental laboratory owners. There’s no time like the present to begin documenting all the training whether it’s in-house or outside the lab at tradeshows, conferences, and other events that provide technical training.
So you understand the FDA and DAMAS requirements, here are some excerpts from FDA and DAMAS that address this issue:
FDA Title 21, Subchapter H, Part 820 Quality System Regulation:
“820.20 Management responsibility; Item (b)(2) Resources: Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.
“820.25 Personnel:
(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.
(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.”
DAMAS Specifications
“Clause 4.5 Defined Manufacturing Processes.
The manufacturer shall ensure that suitably competent persons in compliance with the documentation referred to above manufacture dental appliances.
“Clause 4.6 Training
The manufacturer shall establish and maintain procedures for identifying training needs and provide for the training of all personnel carrying out dental appliance manufacturing and management system tasks.
“Personnel shall be verified as competent to carry out assigned dental appliance manufacturing and management system tasks. The verification of personnel qualified as DTs, RDTs, MDTs, or CDTs or other recognized credential serve this purpose.
Records of training and competence in assigned tasks shall be maintained.”
So where do you begin?
Let’s start with the group that’s already tracking their own training and that’s your CDTs/RGs/MDTs. Prior to their annual renewal, they receive from NBC a list of courses they’ve attended. Have them make you a copy and place that in their personnel or training file. NBC purges this information annually so a historical account may not be available when you need it.
Other sources of your staff’s competency could be pulled from:
- Their completed employment application.
- Pre-employment trade tests.
- Induction training.
- Formal academic training.
- Training and competency in manufacturing and management system tasks, including the use of associated computer software.
- In-house hands-on training by you or your staff.
- In-house or off-site training by your vendors and equipment and materials manufacturers.
- These are just some of the types of training that could be included in your training file on each worker.
Things to think about.
This is a comprehensive topic so my intention is just to give you some food for thought.
If you don’t have them, you should develop job descriptions. Remember these are not only technical in nature, but must include any physical requirements of the job, i.e. lifting of a certain weight, working with high temperatures, etc. Identify the ideal characteristics of the candidate to fill this position. Because you already have people in these positions, then you will need to review this information with each worker and place a copy in their personnel file. From this point forward, you can use them in your hiring process. Any areas where they may fall short can be used for their professional development.
Establish professional development tracks for each of your staff members. These tracks include not only training that you’ve identified as essential to meet your business needs, but also areas they identify to further their career goals.
If you perform annual performance reviews, you should include goals for improvement you as the employer want to see over a certain period of time, but also find out what your employees wants to increase his proficiency in his job.
Monitor the goals at set intervals (and not just annually) so that you stay on track to accomplish the goal. Most employees appreciate knowing your expectations and that you’re willing to help them achieve their career goals.
One of the critical requirements for FDA and DAMAS is documentation of training for the individuals who review licensed dental client requirements, perform quality checks and final inspection. A final inspection checklist must be developed for each type of device and each person who is qualified to perform that task must sign-off that they agree to follow those guidelines. This could be a part of the training portfolio for those individuals.
Like we’ve discussed in the past, you need to document all of this. Tools for documenting this training need to be handy since many of you perform mini-training sessions on the production floor, when a situation arises or if a vendor comes in to show you how to use a new piece of equipment or how to use a new material properly. Capturing this educational session is part of building your training portfolio for each worker. One of my clients has made up small pads that managers keep at their workbench. After the training they have each technician sign it and then it’s turned in to the person who retains the training records.
This document must include the subject covered, the name and qualifications of the person performing the training, and the signature of the recipient of the training. Having this information easily retrievable is critical in quality audits and FDA inspections.
So begin now to document training and build a portfolio for you and each of your employees. Then when you’re asked to show competency, it’ll be a piece of cake.
