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 (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.

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SOP No. 140 Rev 7

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 debarred individuals, 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 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:\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.

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SOP No. 140 Rev 7

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. 2-hole punch and insert on the right side of the folder. 3.5.7 Debarment & Conviction Certification Statement: (F:\QA\GMP & Debarment Letter\Employee 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 3.9.2 3.9.3 Quality Assurance Manual (QAM) Safety Manual 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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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 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. 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.

4.2.2

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. 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.

4.3.2

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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. 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. 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.

4.4.2

4.4.3

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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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 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. 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. 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. Once completed, this form is given to the QAU for review and inclusion in the employee's training files.

6.1.2

6.1.3

6.1.4

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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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 7.1.3 Orientation Checklist when completed. Corporate HR Forms

7.1.4 Records of Reviews 7.1.5 7.1.6 Copies of First Aid/CPR Certificates. Safety training documentation

7.1.7 Debarment verification email from QA. 7.2 Training File 7.2.1 7.2.2 7.2.3 7.2.4 7.2.5 Current Resume, signed by the employee Quality Assurance Manual and Safety Manual Sign-off Sheets Initial Training Qualification form and supporting documents Effectiveness of Training forms Copies of certificates from technical training courses or other outside training events. 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.

7.2.6

7.2.7 Proficiency Testing log (see Appendix V)

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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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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 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.

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SOP No. 140 Rev 7

APPENDICES TRAINING DOCUMENTATION TEMPLATES

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SOP No. 140 Rev 7

Appendix I Analyst Qualification (example)

Analyst: John Doe
Hire date: 04/15/09 __________________ Position: Chemist Resume Reviewed by Supervisor/Date:

Read/Understand SOP/Training Material

Employees Initials/Date 101 SOP Policies and Procedures 170 Sample and Waste Disposal 210 Handling Controlled Substances 500 Good Laboratory Practices 900 Safety Manual 930 Quality Assurance Manual 2100 Analytical Standards Preparation 2110 Calibration of Analytical Balances 2160 Quality Assurance 2170 Cal. and Maintenance of Pipettes 2180 Detection Limits 2190 Significant Figures and Rounding 2200 Water Purification 2220 Method Validation 2230 Retest of OOS Results 2240 Correction of Errors 2260 Laboratory Notebooks 2280 Chemical Inventory 2290 Calibration and Use of pH Meters

Sign SOP
Employees Initials/Date

Demonstrate Procedure/ Pass Quiz

Trainers Initials/Date N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A

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

_________________________________ Supervisor/Date

________________________________ QA Approval/Date

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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:\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 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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SOP No. 140 Rev 7

Appendix III Effectiveness of Training Form (example)

Analyst: John Doe
Position: Chemist

SOP/Technique
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

Skill Level 2 3

Comments

1 = Has read/understands procedure, may review data 2 = Can perform task with supervision

3 = Can perform task independently 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 _________________________________ Supervisor _________________________________ Quality Assurance

______________ Date ______________ Date ______________ Date

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SOP No. 140 Rev 7

Appendix IV Proficiency Testing Schedule (example)

Proficiency Testing Group ERA ERA ERA ERA ERA ERA ERA ERA ERA ERA ERA ERA IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS IIS FAPAS FAPAS FAPAS FAPAS FAPAS RTC RTC RTC RTC RTC RTC RTC RTC RTC Planned Date of Participation Testing Areas Apr-10 WS-165 Jul-10 WP-186 Oct-10 Soil-72 Apr-11 WS Jun-11 WP Oct-11 Soil Apr-12 WS Jun-12 WP Oct-12 Soil Apr-13 WS Jun-13 WP Oct-13 Soil Aug-10 Metals (Plastics) Oct-10 Free formaldehyde (textile) Oct-10 Mono Ethylene Glycol Jan-11 Free formaldehyde (textile) Feb-11 Total lead in dried paint Feb-11 Phthalates (plastics) Aug-11 Metals (Plastics) Oct-11 Free formaldehyde (textile) Oct-11 Mono Ethylene Glycol Jan-12 Free formaldehyde (textile) Feb-12 Total lead in dried paint Feb-12 Phthalates (plastics) Aug-12 Metals (Plastics) Oct-12 Free formaldehyde (textile) Oct-12 Mono Ethylene Glycol Jan-13 Free formaldehyde (textile) Feb-13 Total lead in dried paint Feb-13 Phthalates (plastics) Aug-13 Metals (Plastics) Oct-13 Free formaldehyde (textile) Oct-13 Mono Ethylene Glycol Jul-10 Chili Powder/Arsenic, Cadmium, Lead Aug-10 Edible Oil/Arsenic, Copper, Iron, Lead Oct-10 Chili Sugar Paste/ Lead Feb-11 Fruit Juice/ Iron, Cadmium, Lead, Tin Mar-11 Canned Fish/ Arsenic, Methyl Mercury, Mercury Jun-10 HPLC <621> (PEP-015) Jun-10 Loss on Drying <731> (PEP-011) Jun-10 Melting Range <741> (PEP-012) Jun-10 pH Determination Kit <791> (PEP-010) Jun-10 Residue on Ignition <281> (PEP-006) Jun-10 Sugars (IR) Kit (PEP-004) Jun-10 UV Spectroscopy <197> (PEP-017) Jun-10 Water Determination <921> (PEP-007) Jun-11 HPLC <621> (PEP-015) Testing Group ALL ALL ALL ALL ALL ALL ALL ALL ALL ALL ALL ALL ICPMS IC/LC WET IC/LC ICPMS ORG ICPMS IC/LC WET IC/LC ICPMS ORG ICPMS IC/LC WET IC/LC ICPMS ORG ICPMS IC/LC WET ICPMS ICPMS Previous Analyst Planned Analyst

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SOP No. 140 Rev 7

Appendix V Proficiency Testing Log (example)

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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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