Training SOP

7/29/2019 Training SOP

1/17


2/17

1.0 SCOPE and APPLICATION

This SOP contains the policies and procedures for training and qualification of laboratory

employees, training event documentation, and effectiveness of training documentation.

2.0 SUMMARY

2.1 Curricula vitae (Resum), initial qualification documentation, proficiency testing results,

and ongoing training documentation are available to demonstrate that personnel are

qualified for the tasks they perform. Training requirements are met through

documentation of education, prior job experience, internal and external training activities,

on-the-job training, procedure and background reading, or any combination thereof, to

enable the employee to perform assigned job functions and comply with regulatory

requirements.

2.2 Due to the nature of contract laboratory work and the large number of methods executed

in the laboratory, training is based on general techniques and instrumentation.

Client-specific method or standard/compendial method specific training is not performed

unless specifically contracted by the client.

2.3 New employees participate in an orientation program and an initial training period,

followed by extended training and proficiency testing. Training records are maintained in

secure files. Reviews of training effectiveness and evaluation of training needs are

conducted once per year and documentation is maintained in the employee's training

folder. Job titles (refer to SOP 120) reflect progress in training, experience, and

responsibilities.

2.4 Three types of training periods are described below: (1) Orientation of new employees,

(2) Initial Training required to perform a task until the employee can operate adequately

with only oversight by their supervisor, and (3) Extended Training for continuing

education and professional growth.

2.5 Management personnel have the responsibility for planning ongoing professional growth

and development activities for each employee so that the employee can maintain a

current skill set to match job responsibilities.

SOP No. 140 Rev 7

Page 2 of 17

This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.


3/17

3.0 ORIENTATION OF NEW EMPLOYEES

3.1 Prior to a new employees first day of work, the Office Manager will notify QA in which

department the new employee will be working, and request a Debarment verification.

QA will confirm the employees name does not appear on the FDAs website of debarredindividuals,the Health and Human Services/Office of the Inspector General (HHS/OIG)

List of Excluded Individuals/Entities, nor the Federal General Services Administrations

List of Parties Excluded from Federal Programs. The employee must pass the drug

screening prior to their first day of work.

3.2 QA will issue an SOP list to the hiring department manager to indicate the initial training

curriculum.

3.3 The hiring department manager will submit the list of SOPs that will comprise the

employees intial curriculum to QA. The hiring manager will also open an IT ticket in

Exova Net indicating the computer system requirements and appropriate permissionlevels for the new employee.

3.4 QA will create an employee training folder as follows:

3.5.1 Supplies needed are:

1- Avery folder label # 5366 with the new employee name on it.

1- Colored Reinforced Tab Fastener Folder, Letter, Green

4- Sheets of Letterhead paper

3.5.2 Employee Resume - 2-hole punch and insert on the left side of the folder.

3.5.3 Initial Employee Qualification - (F:\QA\Training\New Employee Orientation) -

Based on the SOP list submitted by the hiring manager, prepare an initial

curriculum using a template from an existing employee in that group. This initial

curriculum will represent the training needs for the Initial Training Period per

Sec. 4.0 of this SOP (an example is given in Appendix I). Make sure to change

the name and title to match the new employees information. 2-hole punch and

insert on the left side of the folder.

3.5.4 Initial Qualification Instructions (Appendix II) - F:\QA\Training - Print a copy on

letterhead, 2-hole punch, and insert on the left side of the folder.

3.5.5 Safety Manual sign off form: (F:\QA\Training\Safety Manual sign off) - Change

the saved name on the form to the new employees name and print on letter head.

2-hole punch and insert on the right side of the folder.

SOP No. 140 Rev 7

Page 3 of 17



4/17

3.5.6 Quality Manual sign off form: (F:\QA\Training\QA Manual sign off) - Change

the saved name on the form to the new employees name and print on letter head.


3.5.7 Debarment & Conviction Certification Statement: (F:\QA\GMP & DebarmentLetter\Employee Debarment Conviction Statement sign off) - Print on letterhead.


3.5.8 Conflict of Interest Certification Statement - Print on letterhead. 2-hole punch

and insert on the right side of the folder.

3.5.9 Create a name label for the folder.

3.6 QA will forward the Training Folder to the Office Manager who will issue it to the new

employee on their first day. This Training Folder will remain with the new employee or

their supervisor until the completion of the Initial Training Period.

3.7 Upon arrival on the first day, the employee will report to the Office Manager to fill out

the necessary Human Resources (HR) and other corporate forms. These will be filed in

the employee's Personnel folder.

3.8 The immediate supervisor for whom the employee will perform most of their work (or

their designee) is responsible for conducting the orientation. When complete, the

necessary forms will be returned to the Office Manager.

3.9 The Office Manager (or their designee) will give copies of the following documents and

training materials to the new employee. After reading and studying the materials duringtheir first day of work, the employee will sign the corresponding forms and/or complete

the associated quizzes.

3.9.1 Quality Assurance Manual (QAM)

3.9.2 Safety Manual

3.9.3 Corporate training materials for Safety, Good Manufacturing Practices (GMP),

and HR subjects.

3.10 The employee must pass the safety and GMP quiz prior to starting work in thelaboratory area.

SOP No. 140 Rev 7

Page 4 of 17



5/17

4.0 INITIAL TRAINING PERIOD

This is the period of time between the beginning of training an employee to perform a task and

the time at which the employee is sufficiently trained to perform the task adequately with little

supervision. Depending on the task and the individual, the time will vary from minutes tomonths. The employees supervisor or someone fully trained on the task (rated 3 or better on the

Effectiveness of Training Form, Appendix III) may conduct this training.

4.1 The employee is first given documentation on how the task is to be performed. This may

consist of an SOP, manual, book, or simple outlined instructions. After the material (such

as an SOP) is read and understood, the associated entry on the Initial Analyst

Qualification Form (Appendix I) will be signed and dated by the employee.

4.2 The employee is then physically trained to perform the task by working with an

experienced employee. This is done with sufficient oversight to assure that the task is

done adequately.

4.2.1 An analyst shall complete a minimum of four independent test runs consisting of

at least five samples with known analyte content (one of which is a certified

reference material or proficiency testing material) on four separate days before

being qualified to perform testing on a clients samples tested under the scope of

GMP/GLP or the laboratorys ISO 17025 accreditation.

4.2.2 When the employee has adequately demonstrated that they are able to perform the

task, the associated entry on the Initial Analyst Qualification Form (Appendix I)

will be signed and dated by the trainer. Trainers are encouraged to use quizzes or

other tools, as they deem appropriate, to ensure the employee has demonstratedthe effectiveness of training. For all test data generated by a trainee, the trainer or

their supervisor must review and approve the data package.

4.3 File copies of data package cover sheets, logbook pages, or other appropriate

documentation in the Training Folder as objective evidence of acceptable performance

for each unique type of analysis or task.

4.3.1 Analysts are not trained on individual compendial monographs or client test

methods. Documentation of training on associated techniques or use of associated

instrumentation is adequate to demonstrate that the analyst is qualified to perform

these methods.

4.3.2 When a client's test method is performed, the analyst will document training on

the method by signing and dating a copy of the test method filed with the data

package for that job.

SOP No. 140 Rev 7

Page 5 of 17



6/17

4.4 Training documentation for an SOP requires that the employee sign the paper copy of the

SOP kept in the QA files.

4.4.1 Once the original copy of the SOP has been signed, the associated entry on the

Initial Analyst Qualification Form (Appendix I) will be signed and dated by theemployee.

4.4.2 When the employee signs and dates the original SOP, the date will be entered into

the Training Spreadsheet by QA. Employees have read-only access to the

spreadsheet, with editing rights granted only to the QAU.

4.4.3 It is the responsibility of the Department Manager and the employee to ensure

that work is assigned only to employees that have documented training on the

current revision of the procedure, as indicated by the Training Spreadsheet.

4.5 At the end of the Initial Training Period, when all elements of the initial curriculum havebeen signed off by the supervisor, the employee's Training Folder is submitted to QA for

review and filing.

4.6 Employees assigned to new functional groups or returning to work after an extended

leave of absence must have their training documentation reviewed by their supervisor

before the employee begins work. Any training needs will be identified and remediated.

If demonstration of skill-sensitive procedures is deemed warranted, this may be

documented using an Analyst Qualification form (template in Appendix I).

4.7 Signatories on new SOPs or revisions are considered trained on that SOP.

4.8 Technical data reviewers must sign-off on associated SOPs for the data they will be

reviewing.

4.9 QA compliance or data audits do not require training on and signing of the associated

SOP or method by the auditor. Qualification of auditors is addressed in SOP 250.

4.10 Participation in third party proficiency testing is part of the ongoing qualification

process. Appendix IV is an example of a four year rolling schedule. The group leader

alternates the chemists assigned to the individual studies to ensure each is qualified on at

least one method every six months.

SOP No. 140 Rev 7

Page 6 of 17



7/17

5.0 EXTENDED TRAINING

Training received for non-routine tasks, tests or expertise under development, expansion of the

business, and study or research into new areas is classified as Extended Training. Copies

of any certificates received as a result of this training must be given to the Office Manager forfiling into the Personnel files and to the QAU (except for non-technical training) for filing into

the employee's Training File. Receipt of extended training or certification, acceptance of an

article for publication, or presentations to industry may be documented on the Effectiveness of

Training Form, with the rating of 4 for the associated SOP (see Appendix III).

6.0 EFFECTIVENESS OF TRAINING

6.1 The employees skill level on elements of their curriculum is documented once each

calendar year using a personalized Effectiveness of Training Form similar to that in

Appendix III.

6.1.1 This form is created for each employee by the QAU from the employee's

curriculum (as indicated on the Training Spreadsheet), completed by the

employee, and approved by their supervisor. For department managers, the

Technical Director will additionally review and sign the Effectiveness of Training

Form.

6.1.2 Skill levels are based on a review of the employee's work, including data

packages, acceptability of QC parameters including certified reference materials,

and third party proficiency testing.

6.1.3 Any training remediation needed is noted on the form and tracked to completion

by the QAU through the use of the training spreadsheet. Additional training goals

may be noted on this form as well.

6.1.4 Once completed, this form is given to the QAU for review and inclusion in the

employee's training files.

6.2 Personnel reviews are conducted at least annually. The review is used to determine the

status or progress toward goals, setting goals (near and long term), and documenting

progress in training. A number of different forms have been used through the years. Any

form which accomplishes these objectives is adequate for the review. Reviews shall befiled in the personnel file by the Office Manager or their designee.

SOP No. 140 Rev 7

Page 7 of 17



8/17

7.0 TRAINING RECORDS

The following records will be kept with training and/or personnel records in a secure file. The

Office Manager is responsible for maintaining the personnel records and the QA Unit is

responsible for maintaining the training records. The records will be kept permanently.

7.1 Personnel File

7.1.1 Employment Application, Letter, and/or Initial Resume.

7.1.2 Orientation Checklist when completed.

7.1.3 Corporate HR Forms

7.1.4 Records of Reviews

7.1.5 Copies of First Aid/CPR Certificates.

7.1.6 Safety training documentation

7.1.7 Debarment verification email from QA.

7.2 Training File

7.2.1 Current Resume, signed by the employee

7.2.2 Quality Assurance Manual and Safety Manual Sign-off Sheets

7.2.3 Initial Training Qualification form and supporting documents

7.2.4 Effectiveness of Training forms

7.2.5 Copies of certificates from technical training courses or other outside training

events.

7.2.6 Copies of Training Event forms for each employee in attendance with the

exception of bimonthly QA Training events (Sec. 8.3), which are filed in a

separate binder in the QA office.

7.2.7 Proficiency Testing log (see Appendix V)

SOP No. 140 Rev 7

Page 8 of 17



9/17

8.0 ADDITIONAL TRAINING

8.1 Special Projects, especially GLP projects and method validations, should be initiated

with a meeting of all staff that will be significantly involved. This meeting will orient the

staff according to the protocol or project. Training on a study specific protocol may bedocumented on a Training Event Form (Appendix VI) or client provided form.

8.2 An "Introduction to GMPs" training session will be given to each new employee during

their Initial Training Period. This may be be given in the form of a presentation by the

HSEQ Officer, an on-line seminar, printed material, or other media that addresses the

basics of FDA and GMP history, the Food Drug and Cosmetic Act, 21CFR210,

21CFR211, 21CFR11, 21CFR820, FDA enforcement, Good Documentation Practices,

and potential consequences of non-compliance to the public, our clients, the company,

and the individual.

8.3 Training on CGMP, GLP, and ISO 17025 topics is held at least every other month. Allanalysts are required to attend and other employees may be required by their supervisor

or invited to attend, based on the scope of their job responsibilities. Training will be

conducted by the HSEQ Officer or their designee. The attendance sheet and agenda are

filed in the QA files in a separate binder from the individual training files. Employees

absent from the QA meeting will review and sign the training materials for that meeting

upon their return.

8.4 Safety training is held at a minimum of every other month. All personnel are required to

attend. The attendance sheet and agenda are maintained by the HSEQ Officer.

8.5 Ethics training will occur at least annually. Training will be conducted by the HSEQOfficer, the General Manager, or their designee. All personnel are required to attend.

8.6 Refresher and ongoing training occurs through various means, which may include but are

not limited to, training in or independently reviewing new/updated SOPs (per SOP 101),

review of updated compendial chapters and pharmacopoeial forums, in-house technical

seminars, review of published material (such as GMP Trends, e-zines, and technical

journals), attendance at technical conferences, and off-site classes or seminars.

SOP No. 140 Rev 7

Page 9 of 17



10/17

9.0 PROFICIENCY TESTING

9.1 Proficiency testing by third party agencies or through participation in multi-laboratory

round-robin studies occurs on an ongoing basis. Results are reviewed by the Technical

Director and then filed in the Proficiency Testing folders, with a copy included in theassociated job envelope. A copy is automatically forwarded to CA ELAP for proficiency

testing in the scope of accreditation. For proficiency testing in the scope of the

laboratorys ISO/IEC 17025 accreditation, a copy will be sent to A2LA by the HSEQ

Officer or their designee following review by the Technical Director. Alternately,

automatic forwarding of results may be requested of the proficiency testing provider,

when available.

9.2 An entry on the Proficiency Testing form for each participating chemist will be made by

the QAU (Appendix V). Proficiency testing should be equally distributed amongst

analysts.

9.3 Unacceptable results will be investigated per SOP 270. The results of the investigation

will be forwarded to the laboratorys accreditation bodies: CA ELAP and A2LA.

SOP No. 140 Rev 7

Page 10 of 17



11/17

APPENDICES

TRAINING DOCUMENTATION TEMPLATES

SOP No. 140 Rev 7

Page 11 of 17



12/17

Appendix IAnalyst Qualification (example)

Analyst: John Doe Position: Chemist

Hire date: 04/15/09 Resume Reviewed by Supervisor/Date:__________________

N/A2290 Calibration and Use of pH Meters

N/A2280 Chemical Inventory

N/A2260 Laboratory Notebooks

N/A2240 Correction of Errors

N/A2230 Retest of OOS Results

N/A2220 Method Validation

N/A2200 Water Purification

N/A2190 Significant Figures and Rounding

N/A2180 Detection Limits

N/A2170 Cal. and Maintenance of Pipettes

N/A2160 Quality Assurance

N/A2110 Calibration of Analytical Balances

N/A2100 Analytical Standards Preparation

N/A930 Quality Assurance Manual

N/A900 Safety Manual

N/A500 Good Laboratory Practices

N/A210 Handling Controlled Substances

N/A170 Sample and Waste Disposal

N/A101 SOP Policies and Procedures

Trainers Initials/DateEmployees

Initials/DateEmployees

Initials/Date

DemonstrateProcedure/Pass Quiz

Sign SOPRead/UnderstandSOP/Training Material

I have reviewed this analysts data and have verified that this analyst is qualified to perform the abovetasks independently:

_________________________________ ________________________________Supervisor/Date QA Approval/Date

SOP No. 140 Rev 7

Page 12 of 17



13/17

Appendix IIInitial Qualification Instructions

Things to know

- You have 90 days to complete your Initial Qualification.

- If you have any questions or problems with the training folder, please ask yoursupervisor or anyone in the Quality Assurance Department.

- Train on no more than 5 SOPs a day. See your supervisor for prioritization.

Completing the Initial Qualification Form

1. The Resume reviewed by supervisor space should be initialed and dated by yoursupervisor prior to you beginning your training. Please ensure that this is complete prior to

starting.

2. The first column labeled SOP/Training Material contains the number and the name ofthe Standard Operating Procedures (SOPs) that the trainee must read and or train tocomplete initial training. The SOPs are located in the V:\QA\SOP directory.

3. Once the trainee has read the SOP then he/she will sign and date the second column

labeled Read/Understand.

4. Once the trainee has signed the second column, he/she should verify in column 4 labeled

Demonstrate Procedure/Pass Quiz if the N/A box is checked or not checked.

5. If checked, the trainee is ready to sign the hard copy of the SOP, and initial and date incolumn 3 labeled Sign SOP. Each SOP has a page at the end where all employees whohave been trained to that SOP have signed and dated. It is acceptable to wait a few daysand sign several SOPs at once. However, the trainee should not let more than a week passbetween completing column 2 and column 3, except for SOPs where the procedure must bedemonstrated.

6. If the N/A box is NOT checked, then the trainee will need to demonstrate the procedure to aqualified individual in their department. Once the trainee is deemed ready and able toperform the task on their own (without supervision) then the trainer will initial and date in the4th column. The trainee then signs the original SOP in the QA office and initial/dates in the3rd column. Be sure to make copies of any objective evidence (e.g. cover pages from

analytical work or other examples of successful completion) as the trainee demonstrates theprocedure, and place it in the training folder.

7. QA will audit this folder regularly to ensure your training documentation is progressing.

SOP No. 140 Rev 7

Page 13 of 17



14/17

Appendix IIIEffectiveness of Training Form (example)

Analyst: John Doe Position: Chemist

8400 Loss on Drying

8390 Residue on Ignition

8360 Melting Point Range

8340 Shimadzu Spectrophotometer

8250 Total Suspended Solids

8100 Water Content by Karl Fischer

2170 Cal. and Maintenance of Pipettes

2100 Analytical Standards Preparation

4321 Comments

Skill Level

SOP/Technique

1 = Has read/understands procedure, may review data 3 = Can perform task independently2 = Can perform task with supervision 4 = Extended training

Training Remediation needed No Yes:__________________________________________________________________________________

____________________________________________________

Training goals for the next year:____________________________________________________________________________________________________________________________________________

The above ratings are based on a review of this employee's work, including data packages and thirdparty proficiency testing. I certify that the above is an accurate representation of this employee's trainingrequirements and skill level:

_________________________________ ______________Employee Date

_________________________________ ______________Supervisor Date

_________________________________ ______________Quality Assurance Date

SOP No. 140 Rev 7

Page 14 of 17



15/17

Appendix IVProficiency Testing Schedule (example)

SOP No. 140 Rev 7

Page 15 of 17

Proficiency

Testing

Group

Planned

Date of

Participation Testing Areas

Testing

Group

Previous

Analyst

Planned

Analyst

ERA Apr-10 WS-165 ALL

ERA Jul-10 WP-186 ALL

ERA Oct-10 Soil-72 ALL

ERA Apr-11 WS ALL

ERA Jun-11 WP ALL

ERA Oct-11 Soil ALL

ERA Apr-12 WS ALL

ERA Jun-12 WP ALL

ERA Oct-12 Soil ALL

ERA Apr-13 WS ALL

ERA Jun-13 WP ALL

ERA Oct-13 Soil ALL

IIS Aug-10 Metals (Plastics) ICPMS

IIS Oct-10 Free formaldehyde (textile) IC/LC

IIS Oct-10 Mono Ethylene Glycol WET

IIS Jan-11 Free formaldehyde (textile) IC/LC

IIS Feb-11 Total lead in dried paint ICPMS

IIS Feb-11 Phthalates (plastics) ORG






IIS Feb-12 Phthalates (plastics) ORG






IIS Feb-13 Phthalates (plastics) ORGIIS Aug-13 Metals (Plastics) ICPMS



FAPAS Jul-10 Chili Powder/Arsenic, Cadmium, Lead ICPMS

FAPAS Aug-10 Edible Oil/Arsenic, Copper, Iron, Lead ICPMS

FAPAS Oct-10 Chili Sugar Paste/ Lead

FAPAS Feb-11 Fruit Juice/ Iron, Cadmium, Lead, Tin

FAPAS Mar-11 Canned Fish/ Arsenic , Methyl Mercury, Mercury

RTC Jun-10 HPLC (PEP-015)

RTC Jun-10 Loss on Drying (PEP-011)

RTC Jun-10 Melting Range (PEP-012)

RTC Jun-10 pH Determination Kit (PEP-010)

RTC Jun-10 Residue on Ignition (PEP-006)

RTC Jun-10 Sugars (IR) Kit (PEP-004)

RTC Jun-10 UV Spectroscopy (PEP-017)RTC Jun-10 W ater Determination (PEP-007)

RTC Jun-11 HPLC (PEP-015)



16/17

Appendix VProficiency Testing Log (example)

SOP No. 140 Rev 7

Page 16 of 17



17/17

Appendix VITraining Event

Subject: Trainer/Date: _______________________

Duration: _______________________

SignaturePrinted Name

Attach a copy of any training materials used and submit this form to QA.

SOP No. 140 Rev 7

Page 17 of 17

Documents

Training SOP