2. SOP No. 140 Rev 7
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 (Resumé), 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.
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3. SOP No. 140 Rev 7
3.0 ORIENTATION OF NEW EMPLOYEES
3.1 Prior to a new employee’s 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 employee’s name does not appear on the FDA’s website of debarred
individuals, the Health and Human Services/Office of the Inspector General (HHS/OIG)
List of Excluded Individuals/Entities, nor the Federal General Services Administration’s
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
employee’s intial curriculum to QA. The hiring manager will also open an IT ticket in
Exova Net indicating the computer system requirements and appropriate permission
levels 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:QATrainingNew 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 employee’s information. 2-hole punch and
insert on the left side of the folder.
3.5.4 Initial Qualification Instructions (Appendix II) - F:QATraining - 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:QATrainingSafety Manual sign off) - Change
the saved name on the form to the new employee’s name and print on letter head.
2-hole punch and insert on the right side of the folder.
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4. SOP No. 140 Rev 7
3.5.6 Quality Manual sign off form: (F:QATrainingQA Manual sign off) - Change
the saved name on the form to the new employee’s name and print on letter head.
2-hole punch and insert on the right side of the folder.
3.5.7 Debarment & Conviction Certification Statement: (F:QAGMP & Debarment
LetterEmployee Debarment Conviction Statement sign off) - Print on letterhead.
2-hole punch and insert on the right side of the folder.
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 during
their 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 the
laboratory area.
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5. SOP No. 140 Rev 7
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 to
months. The employee’s 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 client’s samples tested under the scope of
GMP/GLP or the laboratory’s 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 demonstrated
the 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.
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6. SOP No. 140 Rev 7
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 the
employee.
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 have
been 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.
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7. SOP No. 140 Rev 7
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 for
filing 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 employee’s 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 be
filed in the personnel file by the Office Manager or their designee.
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8. SOP No. 140 Rev 7
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)
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9. SOP No. 140 Rev 7
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 be
documented 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. All
analysts 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 HSEQ
Officer, 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.
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10. SOP No. 140 Rev 7
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 the
associated 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
laboratory’s 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 laboratory’s accreditation bodies: CA ELAP and A2LA.
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11. SOP No. 140 Rev 7
APPENDICES
TRAINING DOCUMENTATION TEMPLATES
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12. SOP No. 140 Rev 7
Appendix I
Analyst Qualification (example)
Analyst: John Doe Position: Chemist
Hire date: 04/15/09 Resume Reviewed by Supervisor/Date:
__________________
Demonstrate
Read/Understand Sign SOP Procedure/
SOP/Training Material Pass Quiz
Employee’s Employee’s
Initials/Date Initials/Date Trainer’s Initials/Date
101 SOP Policies and Procedures N/A
170 Sample and Waste Disposal N/A
210 Handling Controlled Substances N/A
500 Good Laboratory Practices N/A
900 Safety Manual N/A
930 Quality Assurance Manual N/A
2100 Analytical Standards Preparation N/A
2110 Calibration of Analytical Balances N/A
2160 Quality Assurance N/A
2170 Cal. and Maintenance of Pipettes N/A
2180 Detection Limits N/A
2190 Significant Figures and Rounding N/A
2200 Water Purification N/A
2220 Method Validation N/A
2230 Retest of OOS Results N/A
2240 Correction of Errors N/A
2260 Laboratory Notebooks N/A
2280 Chemical Inventory N/A
2290 Calibration and Use of pH Meters N/A
I have reviewed this analyst’s data and have verified that this analyst is qualified to perform the above
tasks independently:
_________________________________ ________________________________
Supervisor/Date QA Approval/Date
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13. SOP No. 140 Rev 7
Appendix II
Initial 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 your
supervisor 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 your
supervisor 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 of
the Standard Operating Procedures (SOPs) that the trainee must read and or train to
complete initial training. The SOPs are located in the V:QASOP 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 in
column 3 labeled “Sign SOP”. Each SOP has a page at the end where all employees who
have been trained to that SOP have signed and dated. It is acceptable to wait a few days
and sign several SOPs at once. However, the trainee should not let more than a week pass
between completing column 2 and column 3, except for SOPs where the procedure must be
demonstrated.
6. If the N/A box is NOT checked, then the trainee will need to demonstrate the procedure to a
qualified individual in their department. Once the trainee is deemed ready and able to
perform the task on their own (without supervision) then the trainer will initial and date in the
4th column. The trainee then signs the original SOP in the QA office and initial/dates in the
3rd 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 the
procedure, and place it in the training folder.
7. QA will audit this folder regularly to ensure your training documentation is progressing.
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14. SOP No. 140 Rev 7
Appendix III
Effectiveness of Training Form (example)
Analyst: John Doe Position: Chemist
Skill Level
SOP/Technique 1 2 3 4 Comments
2100 Analytical Standards Preparation
2170 Cal. and Maintenance of Pipettes
8100 Water Content by Karl Fischer
8250 Total Suspended Solids
8340 Shimadzu Spectrophotometer
8360 Melting Point Range
8390 Residue on Ignition
8400 Loss on Drying
1 = Has read/understands procedure, may review data 3 = Can perform task independently
2 = 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 third
party proficiency testing. I certify that the above is an accurate representation of this employee's training
requirements and skill level:
_________________________________ ______________
Employee Date
_________________________________ ______________
Supervisor Date
_________________________________ ______________
Quality Assurance Date
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15. SOP No. 140 Rev 7
Appendix IV
Proficiency Testing Schedule (example)
Proficiency Planned
Testing Date of Testing Previous Planned
Group Participation Testing Areas Group Analyst 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 Aug-11 Metals (Plastics) ICPMS
IIS Oct-11 Free formaldehyde (textile) IC/LC
IIS Oct-11 Mono Ethylene Glycol WET
IIS Jan-12 Free formaldehyde (textile) IC/LC
IIS Feb-12 Total lead in dried paint ICPMS
IIS Feb-12 Phthalates (plastics) ORG
IIS Aug-12 Metals (Plastics) ICPMS
IIS Oct-12 Free formaldehyde (textile) IC/LC
IIS Oct-12 Mono Ethylene Glycol WET
IIS Jan-13 Free formaldehyde (textile) IC/LC
IIS Feb-13 Total lead in dried paint ICPMS
IIS Feb-13 Phthalates (plastics) ORG
IIS Aug-13 Metals (Plastics) ICPMS
IIS Oct-13 Free formaldehyde (textile) IC/LC
IIS Oct-13 Mono Ethylene Glycol WET
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 <621> (PEP-015)
RTC Jun-10 Loss on Drying <731> (PEP-011)
RTC Jun-10 Melting Range <741> (PEP-012)
RTC Jun-10 pH Determination Kit <791> (PEP-010)
RTC Jun-10 Residue on Ignition <281> (PEP-006)
RTC Jun-10 Sugars (IR) Kit (PEP-004)
RTC Jun-10 UV Spectroscopy <197> (PEP-017)
RTC Jun-10 Water Determination <921> (PEP-007)
RTC Jun-11 HPLC <621> (PEP-015)
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16. SOP No. 140 Rev 7
Appendix V
Proficiency Testing Log (example)
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17. SOP No. 140 Rev 7
Appendix VI
Training Event
Subject: Trainer/Date: _______________________
Duration: _______________________
Printed Name Signature
Attach a copy of any training materials used and submit this form to QA.
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