Laboratory Control System Operations in a GMP Environment. David M. Bliesner

It will include all the necessary SOPs required for the position, qualification tasks, safety training, etc. This “standard position” will serve as a template. It then lays the basis for an individual's training record, which will grow and change as the employee is trained and qualified in that position. 2.2.5 Does each employee have a training file or similar record within the training system? 2.2.6 Are the training histories for each individual employee kept current? 2.2.7 Have all laboratory personnel been properly trained and qualified? This point seems obvious; however during auditing it is not unusual to see someone who was “thrown into a position” because of labor shortages, who has never been trained on the tasks they are preforming in the laboratory. 2.2.8 Are the training histories for each individual employee readily available for review? 2.2.9 Is SOP training conducted in a fashion other than “read and understand” as appropriate? Unfortunately, organizations have a tendency to perform all SOP training in this fashion. It is not effective in many circumstances and the practice should be restricted to review of minor changes on previously trained-on procedures. 2.2.10 Are metrics, related to the execution of training, collected, analyzed, and used to determine the effectiveness of the employee training system in general? 2.2.11 Do the metrics used to evaluate training system effectiveness include the following: Metrics can take many different forms; these are just a few suggestions. 2.2.11.1 Number of courses completed versus courses scheduled? 2.2.11.2 Percent of training that is overdue? 2.2.11.3 Evaluation of training course content by attendees? 2.2.11.4 Evaluation of instructor effectiveness by course attendees? 2.2.11.5 Evaluation of test questions to determine their appropriateness and effectiveness in evaluating knowledge? 2.2.12 Is there an analyst qualification program (e.g. proof-of-proficiency for laboratory skills) in place? 2.2.13 Has an individual been designated as the training coordinator or manager? If the training manager or coordinator is not someone with a laboratory background, make sure they are supported by someone who has a science background with hands-on laboratory experience. 2.2.14 Is there evidence of management support for training and training programs? 2.2.15 Does a formal training budget exist? 2.2.16 Do vendor and consultant training records exist? 2.2.17 Is there evidence that newly hired employees are evaluated for skill level, competency, and proof-of-proficiency with respect to laboratory, supervisory, and managerial skills as appropriate? One of the adages with respect to finding qualified personnel is we hire too quickly and fire too slowly. Take your time when hiring and verify, to the best of your organization's ability that who you are hiring truly does possess the education, training, and experience to do the job you need them to do. Also be aware that no matter how competent and experience a new hire is, it will most likely take them at least six months to come fully up-to-speed within your organization. And if you doubt this, you are fooling yourself. 2.2.18 Is there evidence that newly hired employees are evaluated for their language and literacy skills? In culturally diverse workplaces, it is not unusual to encounter personnel who are not native speakers, readers, or writers in the primary language used at the facility. Since it is a GMP requirement that procedures exist and such procedures shall be followed, personnel should be evaluated for their ability to read, understand, and execute the SOPs for which are required to be followed in performance of their job responsibilities. 2.2.19 Is there a formal training schedule in place and is it being executed? 2.2.20 Is there evidence of employee re-training and re-qualification? The GMPs in Section 211.25 (a) state “Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.” Although this section of the GMPs is targeted to GMP training, it should be expanded to cover the broader arena of job skills in general. 2.2.21 Do managers, supervisors, or training coordinators/managers periodically meet with each employee and review the employee's training record and discuss training and qualification effectiveness and needs? 2.2.22 Is there a positive attitude with respect to training on the part of management and laboratory personnel? Experience has shown that most employees will openly discuss their pleasure (or displeasure) in the content, effectiveness, and frequency of training and qualification.Employees are also the best to know what needs to be done to upgrade existing training efforts or what new efforts need to be undertaken. 2.3 Laboratory Budgeting, Purchasing, and Requisition 2.3.1 Are levels of approval defined and appropriate for the purchasing and requisitioning needs of the laboratory? There should be more than one person who can sign, initiate requisitions, and sign purchase orders in the laboratory. This needs to be defined in writing. 2.3.2 Are items purchased from qualified vendors (e.g. reagents, standards, instruments, etc.)? 2.3.3 Does the laboratory have a defined yearly expendables budget? 2.3.4