Competence, Awareness and Communication (Training)

1. Purpose

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.

2. Approval

(Version at end of page)

Signed V15  HJM  11.04.2024

3. Scope

The process covers requirements  for staff and interested parties that impact the QMS and regulatory requirements; and includes the requirement for Pharmacy staff test

4. Responsibilities

Approval & Changes: Author of the document, Alexis Arhondonis, medicines; RP SC Rudolph-Shortt

5. Definitions

Training - Organized 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 behaviors 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

6. Abbreviations

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

7. References

ISO13485 clauses 6.1, 6.2, 5.5.3 

8. Procedure

The resource requirements are reviewed in the management review.

8.1 Human Resources (clause 6.2)

Job functions and roles are defined either as Job descriptions or through instruction in procedures (SOP) or work instructions - Refer Job Descriptions  and formal Contractual employment agreements are in place.

8.2 Competence and Training

Management recruit suitable staff as required for the roles to be performed and job descriptions are provided

Management are responsible for ensuring that the training needs of their employees are identified - refer TRAINING MATRIX 

On-the-job training is to be supplied by Managers and training records (including on-the-job training) are kept by the administrative department. refer TRAINING RECORD TAB i.e. REGISTER 

8.3 ESSENTIAL REQUIREMENTS

The Organization

• 1. determines the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;

  2. 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 RECORD.

8.4 Training Process

1. Management determine training needs and/or plans for training and completes the TRAINING MATRIX plan - 1. SAHEALTH and 2. SAHealth Pharmacy

2. The TRAINING REQUEST FORM maybe generated by the Manager / Employee "REQUESTER" and submitted, where Google populates a REQUEST REGISTER or Training maybe be adhoc and the Matrix is used to follow and record the training

3. Colour Coding is used

    4.  On completion  the FORM RECORD RESPONSE is concluded and the TRAINING MATRIX is populated

    5.   The TRAINING MATRIX  is updated e.g. Planned 27/9/2018,  Done 27/9/2018, Competent 27/9/2018 

 8.4.1 Training Policy

i. For New Employees an Induction and / or Temporary staff training is performed by the Manager by one on one review or training in SOPs on their role, on the quality and safety, and the Manager completes a FORM RECORD RESPONSE 

ii. 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

iii. 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

iv. Training could be through the use of consultants or suppliers, as experts in the specified area.

v. Visitors or untrained personnel are escorted by trained employees where appropriate, the prescribed protective clothing requirements are ensured by following the standard Operating procedures, where applicable.

vi Temporary staff may not complete training where supervision is followed to ensure the requirements are followed.

8.4.2 Records

1. Records on TRAINING MATRIX  are indicated on the matrix as; Indicate whether in-House (IH), External (ET), Internal formal (IF) or Awareness (A) training 

2. Some training records Records of training are found in TRAINING RECORD TAB i.e. REGISTER  in the Google DRIVE FOLDER   

3. An option is also to keep a copy of proof of payment and/or invoice, if applicable

4. Records can be saved as a pdf on the DRIVE 

8.4.3 Training Competence Criteria

Type of assessment (as determined by the Manager dependent on the significance of the Training in regards to the effect on the QMS) 

• Indicate if a Assessment (As),

•  Certificate (Ce), 

• Test (Te) (for medicines a pass of 60% required and any failures require retraining or replacement with a move to another non medicines role), 

• On the Job Observation (Otj) or 

• Attendance register (Ae) is used to determine Competence

8.5 Awareness 

Persons doing work under the organization’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.

8.6 Communication

The organization determines the internal and external communications relevant to the quality management system through SOP Internal & External Communication

9. Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT   refer Document]

9.1 Trend Analysis and Continual Improvement

The analytical reviews of supplier performance, and any other quality related matters, are reported to management and as part of the Data Analysis input to management review

The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.

10. REVISION HISTORY

Revision 15, 11/04/2024 HJM - 8.1 - Correction of clause from 7.1.2 to 6.2 Human Resources

Revision 14, 19.08.2021 AA - 24.05.2022 SCR (RP) inclusion of medicines GWP

Revision 13, 19.08.2021 AA - updating  and relinking chart

Revision 12, 11.08.2021 TNA - updating responsibilities / deletion of sentence from definitions

Revision 11, 03.05.2021 AA Approved

Revision 10, 23.04.2021 TNA - New format with Responsibilities, Scope, Risk based approach and Records added and new google site format. Amending links and forms

Revision 9, Digitally signed on 19.06.2020 by AA

Revision 1-8, unknown due to google site change to new google site

 11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

TRAINING MATRIX   Google DRIVE indefinite n/a

TRAINING RECORD TAB i.e. REGISTER Google DRIVE indefinite n/a