Quality System Procedure - Personnel
Most recently edited by: Paul VanderWeele
Most recent edit date: Jan 9, 2021
Edits were authorized by: Paul VanderWeele
Purpose
This procedure describes:
- the assessment of employees’ training requirements needs to assure satisfactory performance
- the provision of specific training and general quality awareness training
- the maintenance of Training Records
Scope / Field of Application
This procedure applies to all employees.
Definitions and Acronyms
Competence – ability consisting of theoretical knowledge, practical skills, and attitudes.
Proficiency testing – determination of the laboratory calibration or testing performance by means of inter-laboratory comparison.
Skills – ability to apply knowledge effectively and readily in performance.
Training – a process to provide and control competence to meet requirements.
Responsibilities
Managers are responsible for assuring that the employees assigned to them are trained or otherwise qualified for the assigned jobs. Before assigning an employee for the first time to a new job, managers shall check their training to verify that the employee has been trained or qualified for the new job.
Managers ensure that records of these assessments and subsequent training are maintained using the Training Log sheets and stored as records, along with any supporting documentation (certificates, diplomas etc.).
All Employees shall: bring to the attention of the manager their needs for specific or general training attend and participate in training sessions provided, whether in-house or external
Human Resources shall: ensure new hires possess qualifications, such as education, experience, and professional credentials, which meet the requirements specified by job descriptions provide formal training for personnel and organizations as requested * maintain the Registry of Skills
Supervisor shall: identify and document the required education, experience, and professional credentials for each position that reports to them ensure that employees receive training in the quality management system identify continuing training requirements such as additional formal training, on-the-job training (OJT), and certification develop training plans that address any gaps between current and required knowledge, skills, and competencies needed to perform assigned tasks ensure training specified in the individual development plan section of the employee performance appraisal is completed retain records of required training and completed training identify positions needing certification or special process qualification ensure only qualified personnel perform work affecting quality or ensure that tasks performed by employees who have not yet received appropriate training are reviewed by an appropriately qualified individual
Materials Required
Training Record form
Appropriate procedures for On-the-Job training
Procedure
The Manager/Supervisor uses the job description to identify and document education, experience, and professional credentials of each position. The Supervisor shall prepare job descriptions when a new position is established or duties of the position change. The Training Review is an informal discussion between the manager and each employee in which the employee’s job description, current skills/knowledge and current/future responsibilities are compared in order to identify areas where additional training is necessary or beneficial. Introductory Training Upon date of hire, the manager introduces the new employee to a general set of training requirements that must be completed prior to any further activities in the laboratory. This training includes: an overview of the company’s history and its business philosophy a walk-through of the facility a review of the company’s personnel/orientation manual a review of the safety and chemical hygiene plan and a safety equipment walk-through/usage review
QA/QC Training
Prior to training in a specific laboratory, it is essential that the employee have a thorough understanding of the general quality assurance/quality control principles and objectives that are the underlying foundation of all work performed. Accordingly, a detailed review of the quality management system is performed with the Quality Manager, as well as all QA/QC relevant to their job (e.g., usage of logbooks, and proper protocols for accurate record keeping). Laboratory Specific Training (Test Methods and SOPs) Laboratory specific training includes: detailed training on the instrument(s) which the employee will use thorough coverage of the methods and SOPs to be employed laboratory specific technique training (e.g. sample aliquoting, sample introduction techniques, standards preparation, use of syringes, pipettes, burettes, etc.) a complete review of all quality control plans, including data interpretation, calculating, and reporting, for that lab area The trainee: reads the test method / SOP Material Safety Data Sheets (MSDS) of required materials observes the trainer perform the procedure practices the procedure performs the procedure, under the direction of the trainer, using split samples, spiked samples or proficiency samples performs the procedure, under direction of the trainer, using customer samples
reads and then reports results to the trainer
Unsatisfactory results require re-training. Revisions in SOPs require re-training of all affected employees. The trainee is deemed competent by the trainer when they produce satisfactory results. The trainer performs a follow-up evaluation to determine the effectiveness of training within one month after training. The department head is responsible for ensuring effective training. Upon completion of initial training, all analysts are required to prove proficiency prior to analyzing customer samples. Customer Complaints Receptionists, managers, representatives, salespersons, and other employees likely to receive complaints are trained in complaint handling procedures applicable to their functions. These employees are trained in the relevant policies and procedures of the Quality Manual. Change Control All employees are to be advised that they perform their jobs as instructed or as covered by standard operating procedures (SOP’s). They are NOT allowed to change tasks covered by SOP’s until the change is approved according to the QSP - Document Control and Management. Further procedures are defined on an ad hoc basis at the time training needs are identified for each employee. Performance Appraisal The Supervisor shall use the employee performance appraisal to address the following: performance planning discussions with each employee employee’s knowledge of current quality management system procedures and work instructions affecting the performance of their duties preparation of a performance plan to be signed by the employee a mid-term review of the current performance plan * a year-end discussion with the employee and assessment of the year’s performance
The Supervisor shall identify positions that need certification and ensure that employees who hold these positions have had the necessary training to become certified and remain certified. The Supervisor shall ensure that formal, informal, or OJT training is provided to fill the gap(s) identified in the performance appraisal. At each scheduled employee performance review, the Supervisor shall assess the effectiveness of training provided. Ineffective training will be addressed and a remedy will be identified and implemented. A review will take place in the next performance appraisal.
Supervisors shall ensure that only qualified personnel perform work affecting quality or ensure that tasks performed by employees who have not yet received appropriate training are reviewed by an appropriately qualified individual. Documentation Comprehensive training of all laboratory staff is vital to the continued development of the staff as well as the continued maintenance of the laboratory’s quality program. All staff training will be conducted under the direction of the Technical Manager. All activities relative to training will be thoroughly documented and maintained in each employee’s personnel training file. Included in this file are copies of academic transcripts and/or degrees, resumes, job descriptions, all in-house training records and all documents pertaining to external training (e.g. seminars, instrument manufacturer training courses, etc.). All classroom and on-the-job training are recorded on the training logsheet by the supervisor or trainer for the employee. Records should include orientation, Quality Manual review, and appropriate SOPs and test methods.