Everyone trains their employees, so the requirement of training itself is not usually the issue. The real challenge is in documenting the training and resulting competency appropriately to meet the demands of ISO 9001, ISO 17020 and ISO 17025.
In this webinar, “Competency and Training: Methods, Actions & Requirements,” we invited Melanie Ross, a Training Products Specialist with ANAB to join us and share some insights into this process. You can view the recording here. The webinar reviews the standard requirements for training and personnel competence determination and evaluation, and provides an overview of methods for determining necessary competence. We also address how Qualtrax simplifies the process by automating processes like proficiency tests and documents training records and continuing education credits through workflows, streamlining the audit process and ensuring that every employee has access to his or her own personnel file.
Competence, as defined in ISO 19011 (guidelines for auditing management systems), is the demonstrated personal attributes of personnel and the demonstrated ability to apply knowledge and skills. Organizations need to ensure that personnel are competent to perform the tasks and activities necessary to achieve the intended results.
Melanie notes that this is not only a good business practice, but also a requirement of your organization’s management system if you are certified or accredited.
“Without competent personnel,” she says, “organizations would fail to thrive.”
Regardless of the standard that governs your management system, all of the standards have requirements for the competence of personnel. In ISO 9001:2015, competence requirements are in clause 7.2. In ISO 17025:2017, for testing and calibration laboratories, reference clause 6.2. In ISO 17020:2012, for inspection bodies, the requirements for competence are contained in clause 6.1.
While each standard has slight differences in wording, the overarching theme is that personnel have requirements for education, qualification, training, technical knowledge, skills and experience. Under this broad declaration, organizations are at liberty to adhere to these requirements in a manner that they deem appropriate. There are no “must-have” tests for a certain position that an assessor or auditor is looking for. They will, however, be checking to ensure that whatever testing and competency methods you have put in place are being followed.
There are many ways an organization can determine the competence of personnel. It can be as simple as the written job description for the positions within the organization. Job descriptions document responsibilities, skills, knowledge, education and authorities. One thing to consider with this approach, however, is that job descriptions can sometimes be written with a broad brush to cover the full gamut of responsibilities for one type of position. If there are specific competencies for personnel that are more broadly described in the job description, it may be worthwhile for your organization to document those competency requirements in more detail.
One way to do this is by defining the key activities of the organization. Are all key activities covered by the job descriptions? Are there sufficient competent personnel to perform those key activities? Are the organizational needs met with the competency of the personnel available? If new activities are planned, such as the introduction of a new product line, new test or calibration, or new technology, are there competent personnel available to perform those new activities? For certified or accredited organizations, using the scope of certification or accreditation can aid in determining if sufficient competent personnel are available, or if additional training is required to ensure personnel are competent to perform all of the activities related to the organization’s needs and requirements.
There are a wide variety of options for organizations to ensure necessary competence. The most common is on-the-job training, where a more senior employee with the necessary competence mentors a newer employee. Internal training can take many forms. It can be a coordinated classroom-type training or simply reading and understanding a procedure. Individuals within the organization develop, plan and execute the training for internal personnel.
External training is provided by professional organizations or contractors that possess the skills and knowledge to pass on competence to trainees. Typically, external training ends with a certificate that documents the competence of the individual who completed the training.
Conferences are a great way for personnel to develop their competence. Conferences often have short courses, technical talks or tutorials that can further the competence of personnel. Formal education in the form of a degree or technical program is another way to determine necessary competence. Finally, there has been a steady increase in the availability of online courses to further personnel competence in many areas, including standard requirements, risk-based thinking and cause analysis and corrective action.
A few of the ways organizations can evaluate the effectiveness of actions taken include a comprehension test or exam, which is most common. Participants complete the exam to demonstrate that they understand the information provided during the training. A certificate of participation or completion can also be used as a demonstration of competence. The certificate attests that the individual attended the training, participated in the activities and is deemed competent in the related areas. This is similar to “sign-off by the trainer.” Sign off by the trainer is often performed after demonstration and observation by the trainee. The trainer is attesting to the abilities of the trainee to perform the tasks and activities related to the training.
One way that laboratories can evaluate the effectiveness of actions taken is by personnel participation in formal proficiency testing programs. These programs provide samples for individuals to test or calibrate to demonstrate that they are competent to perform the test or calibration. Finally, reviewing records generated by personnel can also evaluate the effectiveness of actions taken. Are the records accurate, complete and traceable? If so, the individual completing those records may be deemed competent.
An obvious example is the good old training record, whether it’s electronic or hard copy. Other records can include proficiency testing results for laboratories, manufacturing records or test/calibration/inspection records, certificates of completion and diplomas. The records maintained depend on the organization and the competence requirements that are being demonstrated. Some organizations use a variety of documentation as evidence of necessary competence. That’s ok. The key takeaway is to make sure evidence is readily available for audits or assessments and that it accurately reflects the competence of personnel involved in the certified or accredited activities. Having competency records readily available will facilitate your audit or assessment and provide confidence in the competence of personnel involved in key activities.
Organizations can leverage technology to facilitate competence evaluation and documentation. Some organizations use Excel matrices to document competence for specific positions and then document the competence of personnel within those positions. Other organizations may have a LIMS or ERP to maintain competence requirements and documentation. Another way to document competence evaluation and documentation is through a document management system such as Qualtrax. Qualtrax has a variety of ways to document competence requirements, from linking standards to documents to providing quizzes or tests related to documents and to workflows, all of which could be tied to individual personnel for a comprehensive online training program.
Qualtrax has an entire segment of its all-inclusive platform dedicated to testing and training. Tests are fully customizable and can be as simple as an acknowledgement of having read the document or as complex as a multiple-choice/true-false test with documents to read and videos to watch.
The system automatically grades the tests and records the scores, which are visible to the employee and system administrators. The reporting function of the Qualtrax platform enables you to see how an entire team performed on a certain assessment and also shows who has completed the required training and who has yet to do so.
Some of our customers have also built custom workflows to manage CEU credits, employees to manage the upkeep of their individual credentials.
Automation allows you to spend more time on continuous improvement rather than scoring tests and following up with delinquent personnel. The system handles all of that for you. It also stores everything in a permanent record, so you’re always audit ready!