A-113

Training Procedure

Section A — General and Personnel Revision 10 17 pages

Original Document

Scanned document (image-only PDF)

Extracted Text

Searchable text extracted from PDF

1.0 Purpose

The purpose of this procedure is to define the training requirements and procedures in terms of
new employee training, temporary employee training, new/revised document training, practical

training (OJT), continued training, training associated with employee _ status
changes/transfers/promotions, other training requests, and regulatory/certification requirements.

2.0 Scope

This procedure is applicable to all employees and contractors at Ion Nutritional Labs.

3.0 Responsibility

3.1 The Training Department will set up and maintain training programs based on the needs of
the company, employees, job functions, and current regulations and certification

requirements. The Training Department will use various methods to deliver the

information that may include, but are not limited to: written documents, videos, computer-
based training, and practical training (OJT).

3.2 The Training Department, under the supervision of Quality Assurance, will maintain GMP
Training. The Training Department will provide GMP training to all new employees

during New Hire Training activities and to all current employees annually at a minimum.

3.3 New Employees: It is the responsibility of a new employee’s Manager/Supervisor to
welcome the new employee and introduce themselves. The manager/supervisor must be

involved in the new employee’s training development.

3.4 Temporary Employees: It is the responsibility of the HR department to provide proper

[SOP

Standard Operating Procedure SOP No | RevNo | page
A113 | 10 | 90644
Training Procedure
training documents (e.g. cGMP Policy for Temporary Employees) to the approved staffing

agency to ensure all temporary employees have general GMP knowledge.

3.5 It is the responsibility of the Department Manager/Supervisor to ensure any temporary
employees in assessment are provided Practical Training (OJT) and SOP/Document

Training with the Training Department, if necessary.

3.6 It is the responsibility of the Department Manager or designee to complete an Employee

Access Form if the employee needs computer access/email etc. It is the responsibility of
IT to ensure the employee is setup prior to the start date/effective date.

Su It is the responsibility of the Hiring Manager or designee to ensure new employees have

the proper tools (pens, notepad etc.) prior to their start date and, if the new employee has a
desk/cubicle, contact facilities to clean and sanitize area. The same procedure applies if an

active employee is transferred or promoted.

3.8 It is the responsibility of the Department Manager/Supervisor or designee to provide the

training department a schedule if a new employee is not starting at the usual time.

3.9 It is the responsibility of Department Manager/Supervisor or designee to perform or

coordinate practical training (OJT), and to ensure that the training is effective and the

employee comprehends the job task/responsibility.

3.10 The Training Department will provide SOP training for new and current employees.

3.11 It is the responsibility of the Department Manager/Supervisor to provide/review the SOP
List that is assigned to each job position/department, to ensure all necessary training is

applicable and current. Each department will be required to review their SOP list annually
or when necessary.

3.12 It is the responsibility of the Department Manager/Supervisor to complete an Employee
Status Update form if an employee has a title change, department transfer, level change, or

shift change, and ensure that the Training Department reviews/signs off.

[SOP

Standard Operating Procedure SOP No | RevNo | page

A-LI3 | 10 | 36644
Training Procedure
3.13 It is the responsibility of the Department Manager/Supervisor to ensure that the employee

signs the appropriate job description (new employees and employee status changes,

transfers, or promotions).

3.14 It is the responsibility of the Department Manager/Supervisor requesting a training

session/training room (e.g. CRP/First Aid Training, Redzone, etc.) to coordinate the need
with the Training Department.

auld It is the responsibility of the Training Department to maintain the training matrix and all
employee training records.

4.0 Definitions

4.1 cGMP — Current Good Manufacturing Practice

4.2 SOP — Standard Operating Procedure

4.3 CFR — Code of Federal Regulations

4.4 QA — Quality Assurance

4.5 OJT — On the Job Training (see practical training)

4.6 Group Training — a trainer is presenting information to a group of individuals

4.7 Individual Training — training that is either self-done or a trainer is presenting

information to an individual

4.8 Practical Training — on the job training; instruction for employees that takes place at

work, typically involving a combination of observing others and hands-on experience
completing tasks under the supervision of a training manager, coworker or outsourced

professional trainer

4.9 New Hire — a person hired as a new employee to Ion Nutritional Labs

[SOP

Standard Operating Procedure SOP No | RevNo | page

A113 | 10 | gorag
Training Procedure
4.10 Job Description —a document which explains the tasks, duties, function and

responsibilities of a position

4.11 Temporary Employee — individual contracted from an approved Staffing Agency

4.12 Day Temp — day laborer; if a day temp comes in and stands out, they would be asked to

return

4.13 Temp in Assessment — a temporary employee showing potential; management approves

to proceed and provide with additional tasks to continue assessment

4.14 Core Temp — a temp that passes the initial assessment period and returns to meet their

required hours so they can be hired on as an employee

4.15 SME — Subject Matter Expert; a person who possesses a deep understanding of a

particular subject such as a job task, process, piece of equipment, software, etc.
Employee Access Form — HR Form which includes employee name, personnel
4.16 equipment requirements, personnel IT requirements, access requirements, and approval

signatures

Employee Status Update Form - HR Form which includes employee name,
4.17 date/effective date, job title change, department transfer, shift transfer, reason, and

approved signatures

Qualification Manual — manual utilized for associates in operations to document job
4.18 level skills; Practical and SOP training is signed off by the associate and

supervisor/manager/trainer

4.19 HR — Human Resources

4.20 IT — Information Technology

[SOP

Standard Operating Procedure SOP No Rev No
Page
A-113 10
Training Procedure 5 of 14
5.0 References

Dd A-113-F1, Form, Group Training Form

a A-113-F2, Form, Individual Training Form

53 A-113-F3, Form, Practical Training Form

5.4 A-114- F1, Form, Employee Register

as A-108, SOP, Good Manufacturing Practices and Personal Hygiene

5.6 A-117, SOP, Personnel Qualifications

5.7 C-403, SOP, Change Control Procedure

5.8 C-502, SOP, Record Storage, Retention, and Destruction

5.9 Employee Access Form

5.10 Employee Status Update Form

3.11 cGMP Policy for Temps

3.12 Employee Training Matrix/Records

5.13 21 CFR part 111, 114, 117, 121, 210, and 211

6.0 Procedure

6.1 Employee Training

6.1.1 New Hire Orientation/Training

6.1.1.1 HR will send a New Hire announcement email to all associated personnel
and training department. Email consists of New Hire name, title,

department, shift, and start date.

[SOP

Standard Operating Procedure SOP No | RevNo | page
A-113 | 10 | 6 o¢44
Training Procedure
6.1.1.2 An Employee Access Form needs to be filled out five business days prior

to New Hire Start Date if possible. Ensure the new hire has the proper

tools such as pens/notepad and the desk/cubicle is clean, if applicable.

61.13 HR will submit the completed Employee Access Form through the

ticketing portal to IT. IT in turn needs to ensure all items on the
Employee Access Form are completed prior to new hire arrival. If there

are items on the Employee Access Form not completed or issues with the

request, this must be communicated to the Hiring Manger/Training
Department prior to new employee arrival.

6.1.1.4 Hiring Manager/HR must communicate to the Training Department New
Hire arrival time.

6.1.1.5 Arrival of New Hire: HR will ensure new hire onboarding is complete
and employee receives a badge. New Hire onboarding may include but

not limited to review the employee handbook, policies and requirements
as well as general company information. Background and drug screens

are required; reference A-117 Personnel Qualifications.

6.1.1.6 HR will accompany the employee to the Training Department, if the
hiring manager does not have a scheduled prepared.

Gad HR will provide a copy of the New Hire Job Description to the Training
Department for the employees training record.

6.1.1.8 If an Employee Access Form was completed prior to New Hire arrival, IT
Orientation will be necessary to ensure the employee can access their

account/email setup, phone, company files (e.g. F: drive/U: drive), shown
printer location, and knows how to submit a help ticket, etc.

6.1.1.9 Training Department will provide New Hire Training. Each new hire will

be trained to pre-determined SOPs that are appropriate for that respective

[SOP

Standard Operating Procedure SOP No | RevNo | page
A-13 | 10 | 7ortg
Training Procedure
job description/task. Every New Hire must complete any Mandatory

DCC Training assigned to them. New Hire Training, Standard Operating

Procedure, and DCC training will be conducted in the training room,
although training maybe conducted in other areas as needed or online.

6.11.10 After New Hire Training is complete, the new employees’
manager/supervisor or designee will escort the employee to their

respective department/location for Practical Training. Documented

training used for employee comprehension of a subject(s) will be
provided to the Training Department (Form A-113-F1 Group Training

Form, A-113-F2 Individual Training Form, A-113-F3 Practical Training
Form, or Qualification Manual if applicable).

6.1.2 Temporary Employee Training

6.1.2.1 Ion Nutritional Labs utilizes approved Staffing Agencies when temporary

employees are needed. Background and drug testing is

required/completed by the temp agency.

6.1.2.2 The approved temp agency will provide temporary employees any

required training documents (e.g. cGMP Policy for Temps) to
review/sign.

6.1.2.3 HR will send the Training Department an updated list for Temps in
Assessment/Core Temps on a frequent basis.

6.1.2.4 Temps in Assessment that have potential to complete additional tasks will
come to the Training Department to complete SOP Training/any other

related documents. Temps in Assessment are identified by their
respective department manager/supervisor and is communicated to HR.

6.1.2.5 Training Department will request a copy of the Temp cGMP Policy once

training has been completed.

[SOP

Standard Operating Procedure SOP No | RevNo | page
A-113 | 10 | gortg
Training Procedure
6.1.2.6 Core Temps must have completed any necessary training for their job

function.

6.1.2.7 Any temp that receives additional training will have an Employee
Training Record and will be maintained by the Training Department.

Note: If the employee/temp is proficient in any language other than English, a translator or
translation device will be provided if the training department’s translation tools are not

effective.

6.1.3 For Laboratory employees, the New Employee Orientation will include the

following:

6.1.3.1 New employees will undergo initial orientation to introduce the
management system, basic laboratory operations, and awareness of

actions required to address ISO 17025 accreditation.

6:1,3.2 As part of orientation, employees will participate in ISO 17025

Awareness Training to ensure they understand the laboratory
management system structure and the location of the associated

procedures. This training will also ensure employees are aware of the
relevance and importance of their job as it relates to the Ion Nutritional

Labs quality policy, how their work activities contribute to the

achievement of objectives, the importance of meeting customer
requirements and the importance of understanding and following

procedures.

6.1.3.3 Orientation activities will include information regarding the importance
of performing work in an impartial manner, and the necessity of keeping
confidential all information obtained or created during the performance

of laboratory activities (except as required by law).

[SOP

Standard Operating Procedure SOP No | RevNo | page
A-113 | 10 | oof14
Training Procedure
6.1.4 Annual Training

6.1.4.1 Current employees will be provided GMP training, including an

assessment. General Training consists at a minimum an overview of
cGMP based on 21 CFR part 111, 114, 117, and 121 for Pet Products,

Food Products, and Dietary Supplements.

6.1.4.2 Additional training may consist of an overview of HACCP/HARPC,

Food Safety/Food Defense, Allergen Control and safety-related SOPs. An
interactive computer presentation is provided for each type of

GMP/safety-related topics as to engage the employee in the training.

6.1.4.3 Employees will be trained on the different types of Product Certifications
such as Non-GMO Project Verified, Certified Organic, Kosher, Halal,

and Gluten-Free. Training will include a basic understanding of the
certification, material segregation, and tasks related to the manufacture

and handling of certified products.

SOP/Form Training

6.1:3.1 An employee may train on an SOP or a Form by using a copy (paper or
electronic) of the most current revision or through electronic access to the

SOP file located under the company’s shared files.

6.1.0.0 New or Revised SOPs or Forms that require training will be submitted to
the Training Department by the QA Director or designee (training copy

of the SOP/form).

6.1.5.3 Authors, reviewers, or approvers of new or revised SOPs and forms do

not have to complete the training since they already
wrote/reviewed/approved the document. The QA Director or designee

will provide the Training Department the names of additional reviewers

listed on the change control.

[SOP

Standard Operating Procedure SOP No | RevNo | page

AIS} 10 | 100f14
Training Procedure
6.1.5.4 New or Revised SOP paper hard copies (stamped COPY) that are

distributed with Training Packets must be shredded when training is

complete. Under no circumstance can the training copy be kept by the
trainer/trainees, nor can it replace the official copy. All training copies

will be clearly stamped as such.

Note: Any new or revised SOPs or forms will not be considered effective until

all training has been conducted and documented by the appropriate
designee (reference C-403 Change Control Procedure). Only laboratory

methods are excluded from this requirement (D-700 / D-1000 SOP

number series). SOP training is not required for laboratory methods.

6.1.6 Continued Training

6.1.6.1 Continued Training may be used to develop and strengthen the skills of
the employee. Continued Training may be in the form of on-line courses,

in-house training, seminars/webinars, and educational conferences.

6.2 Employee Status Change/Transfers/Promotion

6.2.1 Department manager/supervisors must complete the Employee Status Update
Form and submit to HR. HR will ensure the employee signs a new job description,

if necessary.

6.2.2 An Employee Access Form will need to be completed if the employee needs
computer access, etc. and submit to HR.

6.2.3. Employee Training needs to be scheduled with the training department before the
training department signs off on the Employee Status Form. If the department

manager/supervisor has prior knowledge of the upcoming employee status change,
training must be completed prior to the change.

6.2.4 The training department will review the employee’s current training records to see
if there is additional Practical or SOP training that needs to be complete. If the

[SOP

Standard Operating Procedure SOP No | RevNo | page
BATS! | WO’ | 11 of 14
Training Procedure
employee needs practical training, the department manager/supervisor should

document the training and provide the form to the Training Department (Form A-

113-F1 Group Training Form, A-113-F2 Individual Training Form, A-113-F3
Practical Training Form, or Qualification Manual).

6.2.5 Once training has been reviewed, scheduled and/or completed, the Training
Department will sign/submit the Employee Status Update Form to HR. HR will

maintain completed forms.

6.3 Laboratory Training

6.3.1 In addition to SOP and form training as described above, QC Laboratory personnel

are required to perform specific practical training activities.

6.3.2 When a QC laboratory analyst is trained on a new testing technique, the following

activities should occur:

6.3.2.1 Observe trainer perform testing technique

6.3.2.2 Perform testing technique alongside trainer

6.3.2.3 Execute testing technique under the observation of the trainer

6.3.3 All practical training activities will be documented on Form A-113-F3 Practical
Training Form. Data generated during these activities will be identified for

training purposes only.

6.3.4 After successful completion of practical training, both the trainer and trainee will

sign form A-113-F3 Practical Training Form.

6.3.5 If the trainee fails to successfully complete the practical training, further review by

departmental management and HR should occur.

6.3.6 Any data generated from training activities will be filed with all other training in

the personnel training record.

[SOP

Standard Operating Procedure SOP No | RevNo | page

A113 | 10 | 12 0f14
Training Procedure
6.3.7 Experienced Analysts

6.3.7.1. QC Laboratory personnel that have previous experience on specific
laboratory testing techniques are not required to complete practical

training.

6.3.7.2 In lieu of completing this testing, these techniques can be captured at
time of hire on Form A-113-F3 Practical Training Form as “N/A,

previous experience”.

6.4 Employee Rehire

6.4.1 HR will inform the training department of any rehires (by email with name, title,
department, shift, date of rehire). If the rehire has been absent for more than (6)

months, the employee will have to complete the New Hire/SOP/Practical/Annual

GMP Training or any other requested training during their absenteeism as a
refresher.

6.5 Other Training

Department heads and/or Quality may determine that one or more employees need
6.5.1 training/retraining/counseling. A trainer will be designated and a training session

will be conducted as appropriate.

Any department can request a training session on any subject, or request the use of
6.5.2 the training room. These steps must be followed to ensure the training is conducted

appropriately:

6.5.2.1. Department manager/supervisor must give the training department
advance notice of the training request and verify the scheduled training

dates are available. (Requests may be approved or denied)

6.5.2.2 If the training department is conducting a training session per the request

of department manager/supervisor, an SME must be appointed to ensure

[SOP

Standard Operating Procedure SOP No | RevNo | page
Re a al 18 ofa
Training Procedure
employees are given the proper information and questions can be

answered. The SME must be available during the scheduled training

dates and times. If the SME is not available during the scheduled training,
another designated person must be assigned and it must be communicated

to the training department.

Note: Review the internal company calendar “Training Room” prior to

scheduling to ensure the training room is available.

6.6 Documentation and Filing of Training Records

6.6.1 HR will provide the Training Department a copy of the New Hire Job Description

to be placed in the employees training records.

6.6.2 Any required training should be reviewed with the Training Department prior to

training to verify all documentation is correct.

6.6.3 Supporting training aids and documents may be provided with forms for proof or

verification of the training.

6.6.4 The Training Department will provide the Trainer and/or Employee with the

appropriate form(s) based on the type of training that is needed.

6.6.5 After training has been completed, the Group/Individual/Practical Training Form
or Qualification Manual will be returned to the Training Department, who will

verify the document for accuracy and completeness and enter the information into
the Training Matrix.

6.6.6 The Training Department retains all employees training records and any other
documents pertaining to training (i.e. certifications, presentations, handouts,

6.6.7 QA department may, at its sole discretion, conduct an evaluation of any part of the

training process (i.e. training sessions, trainees, trainer, training material, etc.) to

[SOP

Standard Operating Procedure SOP No Rev No
Page
A-113 10
Training Procedure 14 of 14
verify training effectiveness.

6.7 Record Management

6.7.1 Records are maintained per SOP C-502 Record Storage, Retention, and

Destruction.

8.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 04/19/10 | New - - | - | - |
| 1 | 07/11/11 | Added sections 4.2 and 4.3. Changed forms. - - | - | - |
| 2 | 04/04/13 | Changed SOP format and number. Updated SOP and forms. | 13-271 | V. Iltcheva |
| 3 | 04/02/14 | Revised entire SOP. Updated format. | 14-0272 | S. Millar |
| 4 | 02/09/15 | Added 210 and 211 for OTC requirements | 14-1062 | D. Popp |
| 5 | 03/05/18 | Complete rewrite to incorporate new training program. | 18-0082 | K. Tyrell |
| 6 | 11/05/21 | Added in ISO 17025 requirements for laboratory personnel. CC- | 21-0419 | J. Sassman |
| 7 | 02/02/22 | Complete rewrite to current procedures. CC- | 22-0076 | C. Horelle |
| 9 | 08/15/23 | eee 6.1.4 to Annual Training and to add Product Certification CC- | 23-0411 | C. Horelle |

10 | 1283 | Aaded laboreties oomba asia aM CC-23-0617 | J. Sassman

[SOP

Group Training Form
Form: A-113-F1 CCR No. CC-23-0411 Revision: 8

Topic/Document Name

Document Number [N/A Document Revision [N/A

LJ New Employee Orientation CL) Continuous Training CL] New/Revised Documents
Type of Training
CL) Comprehension Training 1 Other
Name of the Trainer
Date of Training
(print clearly)
My signature below means that I understand the material presented/ read/ discussed during the training session.
Training is translated in native language or a translator/translating device is used.

[SOP

Individual Training Form
Form: A-113-F2 CCR No. CC-23-0411 Revision: 8

Employee Name
(print clearly)
Department Name of Trainer [ |N/A

| LI New Employee Orientation LI Continuous Training LI New/Revised Documents
Type of Training
CL] Comprehension Training 1 Other

My signature below means that I understand the material presented/ read/ discussed during the training session.
Training is translated in native language or a translator/translating device is used.

'Document as N/A if not applicable

[SOP

Practical Training Form

Form: A-113-F3 CCR No. CC-23-0617 Revision: 3

Employee Name Employee Initials
(Printed Name) (Print)

Department Job Title

Type of Training LJ New Learning CL) Continued Training

Task(s) to perform: How to instruct task(s):

Task Observations of Instructor Failed Attempts
Pass
1 2% 3**

I understand the task(s) that have been demonstrated.

Employee Name (print) Employee Signature Date

Employee has performed all tasks and shown understanding. Employee can perform task without direct supervision.

Instructor Name (print) Instructor Signature Date
* 2"¢ Failure in training: reassess training needs per SOP.
*k 31d Failure in training: send issue to HR for review.