This document provides the process for establishing competence, proving awareness and communication and defines the provision of adequate resources, recruitment, performance management and training and provision of Production and Service facilities.
(Version at end of page)
Signed V25 RB 15.07.2024
The procedure covers employees who undertake activities which may have an impact on the quality or safety of products. It covers assessment of competency when staff are recruited, training of employees according to quality management system documentation and the planning and recording of more general training. This document serves as the primary document meeting the regulatory requirements for competence, awareness and training as defined in Envision Africa's Quality Manual.
Approval: Author of the document, Marelize Robertson
Changes: Author of the document, Rachel Belcher
Training Process Owner: Provides oversight and encouragement of training overall as well as monitoring of the training process - QA and RA Officer.
Managers: Managers are responsible for ensuring that each employee has documented requirements for competency and training. The minimum competency requirements will be documented in a job description for each employee and training requirements shall be documented, this shall be done in collaboration with the training process owner.
Training: Organised activity aimed at imparting information and/or instructions to improve the recipient's performance or to help him or her attain a required level of knowledge or skill.
Competence: The quality of being competent or capable of performing an allotted function. The quality or condition of being legally qualified to perform an act. The mental ability to distinguish right from wrong and to manage one's own affairs.
Communication: The act or process of using words, sounds, signs, or behaviours to express or exchange information or to express your ideas, thoughts, feelings, etc., to someone else, human communication, nonverbal communication.
Interested parties: This could be contractors, community workers, customers.
Internal Training - Training done in house e.g. SOPs
NCCA - Non-Conformance Corrective Action
QMS - Quality Management System
SOP - Standard Operating procedure
n/a - Not Applicable
References
ISO 13485 clauses 6.1 Provision of resources, 6.2 Human resources, 5.5.3. Internal Communication
Documents
The Organisation:
Determines the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;
Ensures that these persons are competent on the basis of appropriate education, training, or experience;
Where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
Retains appropriate documented information as evidence of competence with;
Progress of all training and development recorded and competence determined – refer Training Records
For New Employees an Induction is performed by the line manager and management representative;
Training appropriate to the duties assigned to employees is identified and provided by the Manager; are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;
The concept of Quality Assurance and all the measures capable of improving its understanding and implementation are provided by the Manager in consultation with the Management Representative in the role to maintain the system;
Training could be through the use of consultants or suppliers, as experts in the specified area;
Visitors or untrained personnel are escorted by trained employees where appropriate;
Competence requirements are established in the Job Description and Roles and Responsibilities of the employee;
An ongoing training plan for the continual improvement of knowledge and skill within the organisation shall be established and updated during management review meetings;
The resource requirements are reviewed in the management review;
Trello is used as the platform for processing activities.
Job functions and roles are defined under responsibility and within the procedures of SOP’s (Standard Operating Procedures) and in the Job Descriptions that are kept on file by the company. Top Management is responsible for identifying requirements for each position that affects product quality and documenting these requirements in a job description. Top Management shall recruit suitable staff as required for the roles to be performed and job descriptions are provided.
Management is responsible for ensuring that the training needs of their employees are identified, and they should prepare action plans accordingly. The action plan may include on the job training, group training or outside training courses. On-the-job training is to be supplied by Managers and training records (including on-the-job training) are uploaded by the line manager onto the SharePoint. If the training is not effective retraining must be scheduled or other corrective action should be taken.
Requirements for training may arise from:
Recruitment of someone new to the organisation;
A role change/ role extension for an existing employee;
Release of a new QMS document;
Implementation of changes through the Change Control SOP;
A routine refresher training.
The line manager is responsible for
a) Induction training of a new employee.
b) Carrying out a competence assessment at induction according to the competence requirements
c) Record of the competence assessment must be kept in the "employee training records folder" in the relevant employee's file on SharePoint.
d) All training activity is to be registered with the use of the Training Conducted Form. This does not replace attendance registers, or an acknowledgement of training received, which is to be kept with the relevant training record.
e) Line managers are responsible for scheduling training with their employees and to measure the effectiveness of the training.
f) Line managers are responsible for maintaining the database for their employees.
g) Should an employee prove to be deficient in the tests, a retraining on the area of deficiency is conducted. Additional and update training will be prescribed by management in accordance with the continual improvement plan.
h) A training plan is developed by the line manager and the training plan must be a calendarised schedule of training sessions that is kept in the Training Schedule Folder.
i) Training is provided to the employee in line with the training plan. Depending on the criticality of the training, formal assessment may be included. A record of training is kept in the training records folder in the relevant employee's file on SharePoint.
j) Critical skills and knowledge are retested periodically, at a period determined in the management review meetings.
The management representative is responsible for:
a) Conducting QMS training to the employee that is relevant to their current role as indicated by the line manager.
b) Conducting induction training regarding QMS for example the QMS policy and the importance to the organisation.
c) Competence assessment is conducted by the management representative (in terms of QMS) at induction according to the competence requirements. A variety of methods can be employed, including verification of prior work experience, formal tests and interview.
d) A gap analysis is performed by the management representative which compares the competence requirements to the competence assessment. The output is a list of training requirements. Record of the gap analysis and the list of training requirements is to be kept in the training survey folder. The survey assists Envision Africa to identify external training needs.
e) The training survey feedback will be distributed to top management, should the requested training be approved the training plan is developed by the line manager/ manage representative (QMS related).
Representatives providing training
a) The Envision Africa Training Register Form must be completed when a representative provides training
b) Complete the Training Conducted Form and upload the evidence when completing the training conducted form
Persons doing work under the organisation’s control are aware of the following from awareness induction:
the quality policy and relevant quality objectives;
their contribution to the effectiveness of the quality management system, including the benefits of improved performance;
the implications of not conforming with the quality management system requirements.
For 8.4.2 to 8.5 The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided
In the event of non-compliance follow SOP Non-Conformance Corrective Action.
The Risk Assessment to is found in SOP Preventative Action Risk Assessment refer Document.
Monitoring of the training process is the responsibility of the Training Process Owner. This may be achieved by systematic reviews of training records, spot-checks and internal auditing. The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.
Revision 25; 15.07.2024 - RB - Change over to SharePoint Site
Revision 24; 22.02.2024 - MR - 22.02.2024 - RB - Relinked section 11. Records
Revision 23; 21.12.2022 - MR - 21.12.2022 - DK - 7. Changed to References and Documents; 8.4.2.Records moved to section 11; 8.4. Updated Training Procedure; 3. Updated the Scope, 4. Responsibilities Training process owner added & Managers responsibility; 8.3. Essential requirements added to training Policy
Revision 22; 21.10.2022 - MR - DK - 21.10.2022 - 9.1. Supplier performance section removed not applicable , Removed section 8.6. Communication - Refer to Internal and External Communication SOP
Revision 21; 13.09.2022 - MR - DK 13.09.2022 - Added the Training register for back office use under number 11. Records
Revision 20; 05.08.2022 - MR - DK 05.08.2022 - Link V2_ Representative training register
Revision 19; 19.07.2022 - MR - DK 19.07.2022 Restructured the training process and added the training survey link, Updated 8.2 reference Trello.
Revision 18; 06.07.2022 - MR - 8.4. Training process updated - DK 06.07.2022
Revision 17; 25.05.2022 - MR - Purpose corrected, 8.1 . Human Resources updated, 8.2 Competence & Training, 8.4. Training Process
Revision 16; 07.01.2022 - MR - 8.2 Updated
Revision 15; 14.10.2021 - MR - Updated, Training plan folder linked
Revision 14; 05.08.2021 - MR - Website reviewed
Revision 13; 22.06.2021 - TNA - updating forms, links and information
Revision 12; digitally signed 11.1.2021 by WJW
Revision 1-11; unknown due to google site classic change to google site new format
Name Retained in Retention period Hard copies Destroyed by
Training Register Head Officer SharePoint indefinite N/A
Training Register - Representative SharePoint indefinite N/A
Training Conducted Form Microsoft Forms indefinite N/A
Employee Training Records SharePoint indefinite N/A
Training Activity (Summary) Current SharePoint indefinite N/A
Training Activity Records Previous SharePoint indefinite N/A
Departmental Training Schedules SharePoint indefinite N/A
External Training Survey SharePoint indefinite N/A