1. PURPOSE

This document explains the process for establishing training requirements for employees and provides instructions for the facilitation of training.

These work instructions establish the minimum qualifications and competencies for trainers, communicate the necessary structure for the development and delivery of training, and describe the acceptable assessment methods used for evaluating training.

 

2. SCOPE

 

These work instructions apply to employees and contractors who perform or facilitate training functions

 

3. RESPONSIBILITIES

 

3.1 The Human Resources Department/the Training Function

Human Resources (HR) / the Training Function is responsible for administering these work instructions. HR/the Training function is responsible for maintaining and updating employee training records and training request forms.

 

3. 2 Trainers and Facilitators of Training

 

Trainers and training facilitators are responsible for following these work instructions, completing required documentation, and forwarding the required training documents to HR/the Training Function.

 

3.3 Managers/Supervisors

 

Department managers/supervisors are responsible for developing, reviewing, and supporting training requirements to ensure proper training of personnel for their job positions. Managers/supervisors and HR are responsible for identifying qualified individuals to conduct training..

 

4. DEFINITIONS

 

4.1. Training An event that is designed to meet specific goals and objectives, is delivered in an application focused format, and results in a change in the performance outcomes of the audience as measured by a predetermined assessment tool.

 

4.2 Training Function

 

Any personnel that work within the training system.

 

4.3 Trainer

 

A person who instructs, educates, or trains other personnel.

 

4.4 Facilitator

 

An employee or contractor who acts as the intermediary between HR/the Training Function and an external vendor.

 

4.5 Subject Matter Expert

 

An employee or contractor with expertise in the content area or subject matter to be documented.

 

4.6 Subject Matter Folder

 

A collection of completed Subject Matter Expert forms.

 

4.7 Core Curriculum

 

Core curriculum is identified training requirements, which includes quality system documents, procedures, and standards, for which all employees at a specific organizational level receive training.

 

4.8 Department Curriculum

 

Department curriculum is the identified training requirements, which includes quality system documents and procedures, for which all employees of a particular department receive training.

 

4.9 On-the-Job (OJT)

 

On-the-job (OJT) curriculum is the identified training requirements, which includes documents and procedures, for which all employees performing a specific job function receive training.

 

4.10 Temporary Employee

 

An employee hired for a limited amount of time to perform a job that directly impacts product quality.

 

4.11 Contractor or Consultant

 

An outside person with predetermined knowledge and skills that is offering guidance or a service to employees of the company.

 

4.12 Read and Understood (Signature)

 

A signature line inferring that an individual is cognizant of the importance and relevance of process requirements for a specific policy, procedure, or work instruction and that he or she is capable of referring to the respective document when necessary.

 

4.13 Awareness

 

Awareness is the cognizance of the importance and relevance of process requirements for a specific SOP or work instruction. Awareness training needs are determined by the job or position description. Awareness training is knowledge-based training and can be analogous to the Read and Understood signature on a training document.

 

4.14 Competency

 

Competency is the demonstrated ability to apply knowledge and skills within a job function. Competency requirements are determined by a combination of the position description and the process requirements for a specific SOP or work instruction. Competency training is skill-based training.

 

4.15 Assessment

 

Any method that is used to measure the effectiveness of training for competency or awareness of a given training subject (SOP, work instruction, etc.). Assessment tools may be in the form of a written test, a documented verbal test, or a documented performance evaluation.

 

4.16 Outstanding Training

 

Training that is required and assigned and has not yet been completed but which is still within the prescribed timeline for completion.

 

4.17 Delinquent Training

 

Training that is required and assigned and has not been completed within the prescribed timeline

 

5. REFERENCE DOCUMENTS

 

• Records Control Policy
• Training Attendance List
• Training Request Form
• Individual Employee Training Completion Form
• Subject Matter Expert Form
• Verbal Assessment Cover Sheet
• Change Management Procedure
• Personnel and Training Policy
• Training Administration, Documentation and Recordkeeping

 

6. PROCEDURE

 

6.1 Assignment and Issuing of Training

 

6.1.1 Assignment of Core Curriculum

 

Training Function assigns Core Curriculum to employee positions. Assignment is done manually in a paper-based system and electronically in a training database.

Typically temporary positions are assigned only through the manual process.

 

6.1.2 Assignment of Departmental and OJT Required Curriculum

 

Department-specific and on-the-job (OJT) required training curriculum include quality system documents and any process documents required to perform the activities affecting product quality, customer service, and safety. These requirements are assigned by managers and supervisors through a manual process. The steps are outlined below this section.

 

Step 1: HR notifies the Training Function electronically when a new employee is hired and when an existing employee changes positions.

 

Step 2a: If the position into which the employee is entering has established training requirements, the Training Function assigns training requirements to the employee in the training database within one business day from HR notification.

Or,

Step 2b: If the position into which the employee is entering does not have established training requirements, the Training Function sends a Position Requirement Request form to the responsible manager/supervisor within one business day of HR notification.

The manager/supervisor assigns appropriate training requirements for the new position and returns the completed, signed form to HR/the Training Function within 30 calendar days.

Upon receipt of the completed form, the Training Function assigns training requirements to the new position and to the respective employee, electronically and manually, within one business day.

 

6.1.3 Issuing and Completion of Training Requirements

 

Within one business day of assignment of training requirements, the Training Function issues training requirements to the employee.

Employees must complete training requirements as defined by Training Administration, Documentation and Recordkeeping.

 

6.2 Qualification of Trainers

 

 

6.2.1 Internal Trainers

 

Managers/Supervisors identify internal candidates to become trainers.

Each trainer candidate must complete Subject Matter Expert Form and submit to the Training Function for approval. This Form documents the education, background, experience, and/or training that potentially qualifies the individual to perform training in specified content areas.

The Training Function reviews this Form for completeness and accuracy, contacts the trainer candidates directly with questions or concerns about the content of the Form, and notifies the internal candidate when it is approved.

If a candidate is identified as requiring training skills, the Training Function notifies the trainer of the next date of the internal “Train the Trainer workshop”. The trainer may attend either the internal workshop or an approved external workshop. External Train the Trainer workshops are approved by the Training Function.

The Training Function places the completed and approved Subject Matter Expert form in the Subject Matter Expert folder. This folder is maintained by the Training function.

 

6.2.2 External Vendors

 

When external vendors are used as trainers, the Training function requests a bio or resume from the Facilitator of the training.

The Training Function places the bio or resume in the Subject Matter Expert folder. This folder is maintained by the Training Function.

 

6.3 Conducting Training

 

The following steps are the minimum requirements for conducting training. These steps are included in Appendix 1. These steps include identifying the content for training, the audience for training, and whether the training needs to be awareness or competency based.

 

6.3.1 Training that Impacts a Compliance System

 

For new internal training content or changes to existing internal training content that may impact a Compliance System, the trainer or facilitator must follow the Change Management Procedure as it applies to Training.

A Training Plan must be completed by either the Change Owner or the Training Contact, must contain the information in Steps 1 - 3 below, and must be approved by a member of the Training Function.

In addition, if the training is determined to be competency based training, the Change Owner or Training Contact must perform Step 4.

Step 1 - Identifies and names the specific content for training.

Step 2 - Determines the job functions that require the training by reviewing existing requirements, or using the Training Audience Request form or equivalent including minimum requirements (if applicable) as well as establishing the timeline for when the class (es) for the minimum requirements should be conducted. For existing training requirements or a copy of the Training Audience Request form, contact the Training Function.

Step 3 - Differentiates between awareness- and competency-based training.

Step 4 - Identifies training objectives or competencies for competency based training as well as any accompanying assessment(s), master with key, and grading and retraining plan.

 

6.3.2 Training that Does Not Impact a Compliance System

 

For new internal training content or changes to existing internal training content that does not impact a Compliance System, the requesting individual should complete Training Request Form and forward to the Training Function.

The Training Function reviews the form to determine if an existing training program meets the needs of the request and responds back to the requestor.

If there is no existing program that meets the needs identified on the form, the Training Function researches the Subject Matter Expert folder to determine if an internal employee can do the training.

If no internal employee is qualified to deliver the training, the training may be developed and delivered by an external vendor.

 

6.4 Development and Delivery of Training by an Internal Employee

 

 

6.4.1 Prior to training, the trainer completes the following steps:

 

Organizes the subject content including an outline or agenda of information.

Develops presentation materials and training aids.

Determines an acceptable assessment method and constructs an assessment tool. The assessment tool must include a retraining or reassessment plan in the event an individual learner is not successful on the first assessment tool.

Coordinates the preparation and duplication of training materials, if applicable.

Schedules the training and invites attendees, if applicable.

 

6.4.2 During the training event, the trainer completes the following steps:

 

Documents all training classes using Training Attendance List for a class of more than one person or Individual Employee Training Completion Form for training of one individual.

Delivers the training, requires each participant to complete the assessment (if applicable), and grades the participant assessments (if applicable).

Submits attendance lists and assessment scores (Pass or Fail) (if applicable) to the Training Function for file upon completion of training. Once assessment scores have been recorded and forwarded to HR/the Training Function, the assessments may be destroyed according to Record Control Policy.

 

6.5 Development and Delivery of Training by an External Vendor

 

An internal employee serves as the facilitator for training conducted by an external vendor. At a minimum, the external vendor must submit the following to the Training Function, through the facilitator:

An outline or summary of information to be covered during training.

A bio or resume.

One copy of presentation materials and training aids.

An acceptable assessment tool, if the training impacts the Quality System. The assessment tool must include a retraining or reassessment plan in the event an individual learner is not successful on the first assessment tool.

The facilitator or external vendor completes the following tasks:

The vendor prepares and duplicates training materials or negotiates these activities with the facilitator.

The facilitator schedules the training and invites attendees.

The facilitator contacts the Training Function regarding use of a course code for the Training Plan (if applicable).

The vendor or facilitator requires all attendees/participants to sign into the training event on Training Attendance List for a class of more than one person or Individual Employee Training Completion Form for training of one individual.

The vendor delivers the training, requires each participant to complete the assessment (if applicable), and grades the individual assessments.

 

6.6 Assessment of Training

 

For training that impacts a Compliance System, individual employee completion of training is evaluated per training content and type (awareness or competency).

Competency based training requires an assessment of effectiveness of the training. A “Read and Understood” signature on independent document review is the minimum requirement for awareness training.

Assessment methods or tools may include read and understand content review, true/false, multiple choice, or fill-in-the-blank written tests, verbal tests, a trainer summary of assessment or performance evaluations for competency assessment. If a verbal or performance evaluation assessment is used, the trainer submits to the Training Function documented evidence of questions asked or competencies observed as well as the learner assessment scores. When a verbal or visually assessed performance evaluation assessment is used, the Verbal Assessment Cover Sheet is attached to the Training Attendance List or Individual Employee Completion of Training form.

Once the assessment scores have been recorded and submitted to the Training Function, assessments may be destroyed in accordance with Records Control Policy.

The trainer or facilitator is responsible for notifying personnel who did not receive a passing score on the assessment and for administering the reassessment or retraining plan. The trainer or facilitator is responsible for reporting the reassessment/retraining scores to the Training Function.

 

6.7 SUMMARY OF POST-TRAINING DELIVERABLES:

 

 

6.7.1 The trainer or facilitator must submit the following to the Training Function at the completion of training PRIOR to training being entered into training records:

 

A completed Subject Matter Expert form, if the trainer is an internal employee, or a bio/resume if the trainer is an external vendor

Training Plan – a completed Training Attendance List or Individual Employee Training Completion Form

Training Audience Request Form or equivalent, if applicable

Training Request Form, if applicable

A copy of the training materials

A copy of the assessment tool, including the test, answer key, grading plan

Retraining or reassessment plan, if applicable.

The assessment scores (Pass or Fail), if applicable.

Evaluation of training / feedback forms, if applicable, that were completed by trainees at the close of the training session.

 

6.7.2 HR/the Training function completes the following steps:

 

Documents the training event and records assessment scores.

Maintains a copy of the submitted training materials associated to the training event.