Attachment J.7 FOIL Quality Manual.pdf

FEDERAL OUTDOOR IMPACT LABORATORY

6300 GEORGETOWN PIKE

McLEAN, VIRGINIA 22101 – 2296 Phone: 202 493 3291 FAX: 202 493 3417

Federal Outdoor Impact Laboratory

(FOIL)

17025:2017

QUALITY MANUAL

REVISION E

Issue Date 6/28/19

QUALITY MANAGER

FOIL 17025:2017 QUALITY MANUAL

Revision E, June 1st, 2019 2 of 58

Table of Contents

4. GENERAL REQUIREMENTS

4.1. Impartiality

4.2. Confidentiality

5. STRUCTURAL REQUIREMENTS

5.1

5.2

5.3

6. RESOURCE REQUIREMENTS

6.3. Facilities and Environmental Conditions

6.4. Equipment

7. PROCESS REQUIREMENTS

7.1. Review of Requests, Tenders and Contracts

7.2. Selection, Verification and Validation of Methods

7.3. Sampling

7.4. Handling of Test Items

7.5. Technical Records

7.6. Evaluation of Measurement Uncertainty

7.7. Ensuring the Validity of Results

7.8. Reporting of Results

7.9. Complaints

7.10. Nonconforming Work

7.11. Control of Data and Information Management

8. MANAGEMENT SYSTEM REQUIREMENTS

8.1. Options

8.2. Management System Documentation (Option A)

8.3. Control of Management System Documents (Option A)

8.4. Control of Records (Option A)

8.5. Actions to Address risks and Opportunities (Option A)

8.6. Improvements (Option A)

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8.7. Corrective Action (Option A)

8.8. Internal Audits (Option A)

8.9. Management Reviews (Option A)

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4. GENERAL REQUIREMENTS

FOIL POLICY STATEMENT AND COMMITMENTS

It is the policy of FOIL to provide testing services according to required standards, specifications, and delivery schedules. Our belief is that high quality results can be derived from the collective efforts of all employees.

COMMITMENT TO FOIL’S CUSTOMERS:

FOIL is committed to providing our customers with the best services the industry can offer.

Our testing results are accurate and reliable, and are guaranteed through stringent quality control processes. The integrity of our test results reflects the company’s integrity. We strive for 100% customer satisfaction.

COMMITMENT TO QUALITY:

FOIL is committed to providing quality testing services. Management and employees are trained year round on using testing procedures, specifications, equipment, and methodologies. They also are familiar with the requirements of the Quality System in accordance with ISO/IEC 17025:2017.

STRUCTURE AND GOAL OF THE QUALITY MANUAL:

The Quality Manual describes how the Quality System is implemented at FOIL. Quality policies and procedures provide control to ensure services and processes conform to the requirements of ISO/IEC 17025:2017. The Quality Manual provides the instructions for audits, reviews, training, and all other requirements.

4.1. Impartiality

4.1.1. FOIL laboratory activities shall be undertaken impartially and structured and managed so as to safeguard impartiality.

4.1.2. FOIL management shall be committed to impartiality.

4.1.3. FOIL shall be responsible for the impartiality of its laboratory activities and shall not allow commercial, financial or other pressures to compromise impartiality. The

Revision E, June 1st, 2019 5 of 58 need for impartiality shall be discussed during FOIL annual ISO 17025 training.

4.1.4. FOIL shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel. This shall include any risk to the lab’s impartiality as part of our risk management process.

During contract review if an unacceptable risk to accept the contract is identified it shall be mitigated (see contract review section). This shall include any risk to the lab’s impartiality.

Policies and Procedures adopted at FOIL to ensure that its personnel, including managerial staff are free of any kind of pressure.

FOIL fosters an environment where there is freedom from any commercial, financial, and other pressures that might affect the quality of employees’ work.

Policies and procedures adopted at FOIL shall ensure that its personnel, including managerial staff are free of any kind of pressure such as:

A. COMMERCIAL PRESSURES:

Personnel are forbidden to receive any type of compensation from FOIL customers or subcontractors. If a FOIL employee is found in violation, immediate termination may occur. A confidentiality / non-disclosure agreement shall be signed by all personnel.

B. FINANCIAL PRESSURES:

Wages paid are consistent with average wages paid in this area. No financial pressure is placed on FOIL employees.

4.1.5. If a risk to impartiality is identified, FOIL shall be able to demonstrate how it eliminates or minimizes such risk. This shall be completed as part of contract review.

4.2. Confidentiality

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4.2.1. FOIL shall be responsible, through legally enforceable commitments, for the management of all information obtained or created during the performance of laboratory activities. FOIL shall inform the customer in advance, of the information it intends to place in the public domain. Except for information that the customer makes publicly available, or when agreed between FOIL and the customer (e.g. for the purpose of responding to complaints), all other information is considered proprietary information and shall be regarded as confidential.

4.2.2. When FOIL is required by law or authorized by contractual arrangements to release confidential information, the customer or individual concerned shall, unless prohibited by law, be notified of the information provided.

4.2.3. Information about the customer obtained from sources other than the customer (e.g. complainant, regulators) shall be confidential between the customer and FOIL.

The provider (source) of this information shall be confidential to FOIL and shall not be shared with the customer, unless agreed by the source. FOIL shall receive customer approval to use their contact information as a reference for new customers.

4.2.4. Personnel, including any committee members, contractors, personnel of external bodies, or individuals acting on FOIL behalf, shall keep confidential all information obtained or created during the performance of laboratory activities.

Protection of FOIL customer’s confidential information and proprietary rights:

To protect customer’s confidential information and proprietary rights, FOIL provides a policy of non-disclosure and non-solicitation. All personnel shall sign confidential agreements with the company, which are kept in the training file.

Explanation of the policy of non-disclosure and non-solicitation implemented at FOIL is given below:

Non-Disclosure:

An employee shall not directly or indirectly disclose to any person or entity, except FOIL and its management and authorized employees, the customer lists, classifications, records, statistics, business procedures, financial information, or any other confidential information concerning the FOIL or its customers.

Proprietary information remains FOIL property in the event either party elects not to

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Non-Solicitation:

An employee shall not, directly or indirectly, ever solicit or accept business from any business entity that was a customer during employment period. The employee shall not directly or indirectly aid or participate in any acts that would tend to divert, diminish, or prejudice the business or good will of FOIL.

No employee is allowed to take any products or reports away from the premises.

How specifications are kept to protect the customer’s proprietary rights:

The testing specifications are filed and kept in a secure location with limited access.

Testing results, unless otherwise stated prior to testing, is considered government property and therefore available to the public upon request.

5. STRUCTURAL REQUIREMENTS

5.1.

FOIL shall be a legal entity, or a defined part of a legal entity, that is legally responsible for its laboratory activities. Legal identification of the Laboratory introduction.

LABORATORY INTRODUCTION:

FEDERAL OUTDOOR IMPACT LABORATORY (FOIL)

6300 Georgetown Pike McLean, Virginia 22101 – 2296 Phone: 202 493 3291 FAX: 202 493 3417

Compliance of testing activities with the requirements of ISO/IEC 17025

The Quality System of the FOIL is designed to meet the requirements of International Standard ISO/IEC 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories.

As it is shown throughout this Quality Manual, the FOIL carries out its activities in such a way as to meet the requirements of ISO/IEC 17025:2017, and to satisfy the needs of the customers

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5.2.

FOIL shall identify a management team that has overall responsibility for FOIL. This shall be done on an Organization Chart. See Section D “Employee Structure / Descriptions” of the FOIL ISO17025 Compliance and Forms Book.

5.3.

FOIL shall define and document the range of laboratory activities for which it conforms with this document. FOIL shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis.

SCOPE OF TESTING

The scope of FOIL Testing is listed in Section Y of the FOIL ISO 17025 Compliance & Forms Book

5.4.

FOIL laboratory activities shall be carried out in such a way as to meet the requirements of this document, FOIL customers, regulatory authorities and organizations providing recognition. This shall include laboratory activities performed in all its permanent facilities only.

General housekeeping/cleanliness responsibilities are assigned to employees for their immediate work area. The overall housekeeping in the lab and overall facility is monitored by the Senior Test Technician. Housekeeping is verified during FOIL internal quality audit process. All technicians are encouraged to maintain a clean work space and to clean up testing sites at the end of their workday

5.5.

FOIL Shall:

a) define the organization and management structure of FOIL, its place in any parent organization, and the relationships between management, technical operations and support services;

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b) specify the responsibility, authority and interrelationship of all personnel who manage, perform or verify work affecting the results of laboratory activities;

Organization and management structure of FOIL - relationship between services

Duties and responsibilities of employees of the managerial and FOIL staff shall be described in company job descriptions.

c) document its procedures to the extent necessary to ensure the consistent application of FOIL laboratory activities and the validity of the results.

FOIL procedures and testing specifications describe the methods for testing.

5.6.

FOIL shall have personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including:

a) implementation, maintenance and improvement of the management system;

b) identification of deviations from the management system or from the procedures for performing laboratory activities

c) initiation of actions to prevent or minimize such deviations;

d) reporting to FOIL laboratory management on the performance of the management system and any need for improvement;

e) ensuring the effectiveness of FOIL laboratory activities.

Organization and management structure of FOIL is shown in the FOIL Organization Chart.

This chart shows relationship between personnel during their involvement in their daily duties. The Quality Assurance staff shall perform internal quality audits of each aspect of FOIL activities to ensure the structure is properly defined

Responsibilities, authorities and interrelationship of FOIL personnel

The authority of the FOIL personnel is concentrated in its managerial staff. The main

Revision E, June 1st, 2019 10 of 58 responsibilities of managerial staff concerning quality performance of FOIL are the following:

- The Quality Manager is responsible for strategic planning of the lab in compliance with ISO/IEC 17025:2017 and with developing internal policies concerning testing. The Quality Manager is vested with the authority to establish and ensure the adequacy of the Quality System.

- The Senior Test Technician is assigned as the Technical Manager who is responsible for assuring the high quality of the technical performance of FOIL. The Technical Manager has authority to ensure all tests are performed in accordance with specified requirements.

- The Quality Manager has final jurisdiction in all matters involving the quality, workmanship and the conformance of FOIL practices to the approved procedures, specifications, and established standards. The Technical Manager has the authority to ensure that all personnel who perform or verify work have the appropriate knowledge and are following the approved procedures.

Note: The Quality Manager is the backup person in the event the Senior Test Technician is not available, and vice versa

5.7. Sampling

a) Communication takes place regarding the effectiveness of the management system and the importance of meeting customers’ and other requirements; During annual quality training communications with each employee is done to ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system.

FOIL management shall ensure that appropriate communication processes are established within the company and that communication takes place regarding the effectiveness of the management system. During annual training and Management Review the effectiveness of the system is reviewed and communicated.

b) FOIL management shall ensure the integrity of the management system is maintained when changes to the management system are planned and implemented. All ISO 17025 Quality System changes must be reviewed and approved by the Quality Manager

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6. RESOURCE REQUIREMENTS

6.1. General

FOIL shall have available the personnel, facilities, equipment, systems and support services necessary to manage and perform its laboratory activities.

6.2. Personnel

6.2.1. All personnel of FOIL, either internal or external, that could influence FOIL activities shall act impartially, be competent and work in accordance with FOIL Quality System.

6.2.2. FOIL shall document the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience.

Competence of FOIL personnel

FOIL personnel shall have specific knowledge and skills necessary to perform their tasks within FOIL. The combination of education, experience, and on the job training provides each employee with the understanding of his functions and responsibilities within the Quality System. Through work experience and the training programs implemented at the FOIL they gain through individual familiarity with different testing methods.

6.2.3. FOIL shall ensure that the personnel have the competence to perform laboratory activities for which they are responsible and to evaluate the significance of deviations.

6.2.4. The management of FOIL shall communicate to personnel their duties, responsibilities and authorities. Training on the applicable aspects of the FOIL Quality System will be performed a minimum of once a year. This shall include ISO 17025 training and FOIL technical specification training. Any employee feedback shall be documented as part of the Quality System training meeting.

6.2.5. FOIL shall have procedures and retain records for:

a) determining the competence requirements;

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b) selection of personnel;

c) training of personnel;

d) supervision of personnel;

e) authorization of personnel;

f) monitoring of competence of personnel.

Training

Purpose:

The purpose of this procedure is to describe the FOIL employee training program.

They include methods used to identify lab training needs, and instructions on how training records are maintained.

Responsibility:

The FOIL Quality Manager is responsible for the coordination of the training program, authorizing training record, and the record keeping of all training activities.

Procedure:

The Quality Manager shall evaluate the overall training needs. Factors considered are each employees education and experience and the objectives of the company.

The identification of FOIL training needs shall be done on a yearly basis. The Quality Manager shall arrange for and track the progress of all employee training, whether company sponsored, or individually done by the employee, i.e., schooling, seminars attended, etc. Training records are kept for all contracted personnel and are tracked by the Quality Manager. The effectiveness of training performed shall be evaluated during the quality audit processes

Training on the applicable aspects of the FOIL Quality System will be performed a minimum of once a year. Training shall also be provided annually describing our SOPs including any SOP changes.

Employee training files include the following:

- Job descriptions/qualifications

- Training update forms

- Certificates achieved

- Confidentiality agreements

The Quality Manager shall review training provided to determine its effectiveness.

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On the performance is considered when determining the effectiveness of training provided. The Quality Manager shall sign each training record to show that it was effective. Results of internal audits and proficiency testing can also be used to determine the effectiveness of training provided.

6.2.6. FOIL shall authorize personnel to perform specific laboratory activities, including but not limited to, the following:

a) development, modification, verification and validation of methods;

b) analysis of results, including statements of conformity or opinions and interpretations;

c) report, review and authorization of results.

Training records shall be maintained providing evidence each employee is capable of performing the tasks that are required for their position. A FOIL Training Records are maintained and kept in the corresponding employee section of the FOIL ISO 17025 Compliance and Forms Book. The Quality Manager shall sign and date each training record upon completion of training or upon recognition that the employee has learned a skill. Training shall be provided for new employees in order to acclimate him/her to their new position.

Knowledge of each task necessary to perform their job and an understanding of the requirements of the FOIL Quality System shall be achieved.

6.3. Facilities and Environmental Conditions

6.3.1. The facilities and environmental conditions shall be suitable for FOIL activities and shall not adversely affect the validity of results.

6.3.2. The requirements for facilities and environmental conditions necessary for the performance of FOIL activities shall be documented.

6.3.3. FOIL shall monitor, control and record environmental conditions in accordance with relevant specifications, methods or procedures or where they influence the validity of the results

Environmental conditions shall be such so that, where applicable there are no extreme temperature or humidity conditions which may cause an inaccurate test to occur.

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All FOIL calibrations are performed by a calibration subcontractor.

Environmental conditions are recorded on the calibration certificate as part of the calibration program. No work shall be performed during out of tolerance environmental conditions. If an out of control condition is noted all work must stop and any tests performed during this condition must be reviewed. Any problem shall be brought to the attention of the Senior Test Technician for evaluation.

6.3.4. Measures to control facilities shall be implemented, monitored and periodically reviewed and shall include, but not be limited to:

a) access to and use of areas affecting laboratory activities;

Restricted access areas at FOIL

In order to provide for the quality of our testing, FOIL maintains restrictions to the facility. Access to testing facilities is limited to FOIL employees. A visitor must register with our guard service and a FOIL employee must accompany visitors.

b) prevention of contamination, interference or adverse influences on laboratory activities;

FOIL follows all general laboratory cleanliness and equipment handling requirements.

c) effective separation between areas with incompatible laboratory activities. FOIL follows all established laboratory segregation and equipment handling requirements

6.3.5. When FOIL performs laboratory activities at sites or facilities outside its permanent control, it shall ensure that the requirements related to facilities and environmental conditions of this document are met.

6.4. Equipment

6.4.1. FOIL shall have access to equipment including, but not limited to, measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables or auxiliary apparatus which is required for the correct performance of laboratory activities and which can influence the result.

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6.4.2. In those cases where FOIL uses equipment outside its permanent control, it shall ensure that the requirements for equipment on this document are met. All 17025 standards and equipment are under FOIL control except when sent out for external calibration.

6.4.3. FOIL shall have a procedure for handling, transport, storage, use and planned maintenance of equipment in order to ensure proper functioning and to prevent contamination or deterioration.

Handling, transport, storage, use and planned maintenance of calibration equipment

FOIL shall provide for maintenance of calibration equipment, which includes information about proper maintenance of the equipment, its cleaning, daily calibration, and yearly (or as required) calibration by accredited laboratory.

FOIL personnel shall handle calibration equipment with all precautions required by the equipment manuals. When FOIL sends its equipment for calibration or repair, the FOIL employee shall ensure calibration equipment is properly packed for shipping, allowing for safe transportation. FOIL equipment Manuals describe the operating and calibrating of equipment used for testing.

6.4.4. FOIL shall verify that equipment conforms to specified requirements before being placed or returned into service.

Sampling routines and storage requirements for equipment used for testing are described herein. All equipment shall be identifiable during transport and storage. If any equipment is found to have been subject to overloading or mishandling, or which gives suspect results, or has been shown by verification to be defective, it shall be immediately removed from service. Each item shall be labeled as inactive and segregated from use by FOIL personnel.

6.4.5. FOIL shall ensure through calibration and intermediate check processes that all equipment used for measurement shall be capable of achieving the measurement accuracy or measurement uncertainty required to provide a valid result.

6.4.6. Measuring equipment shall be calibrated when:

- The measurement accuracy or measurement uncertainty affects the validity of the

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- calibration of the equipment is required to establish the metrological traceability of the reported result.

6.4.7. FOIL shall establish a calibration program, which shall be reviewed and adjusted as necessary in order to maintain confidence in the status of calibration.

FOIL ensures that all suitable calibration equipment is available for use. A Calibrated Item List of all equipment is maintained by the Senior Test Technician. If any of the equipment goes outside the direct control of FOIL, it shall be re-verified prior to placement back into service.

The Calibrated Item List provides details of required calibration and maintenance routines for all equipment. Testing Technicians shall be proficient in the use of each item. The Senior Test Technician shall ensure that the equipment being used is suitable for use.

Estimates for the uncertainty of measurements for all calibration equipment used under the scope of our accreditation shall be performed. These uncertainty measurements shall be presented through the use of an estimated uncertainty calculation and listed on the calibration certificate.

Where applicable the decision rule shall be utilized when our Test Uncertainty Ration (TUR) is greater than four to one. This shall be communicated to our calibration subcontractors, See section 7.8.6.1

6.4.8. All equipment requiring calibration or which has a defined period of validity shall be labeled, coded or otherwise identified to allow the user of the equipment to readily identify the status of calibration or period of validity.

Each calibrated item shall be identifiable via markings or labeling. The calibration interval and calibration due dates are maintained on the Calibrated Items List.

Identification of FOIL calibration equipment and software used for testing All FOIL equipment is identified with the unique FOIL asset number. FOIL software is identified with the file names and version numbers.

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6.4.9. Equipment that has been subjected to overloading or mishandling, gives questionable results, or has been shown to be defective or outside specified requirements, shall be taken out of service. It shall be isolated to prevent its use or clearly labeled or marked as being out of service until it has been verified to perform correctly. FOIL shall examine the effect of the defect or deviation from specified requirements and shall initiate the management of nonconforming work procedure (see 7.10).

If any equipment is found to have been subject to overloading or mishandling, or which gives suspect results, or has been shown by verification to be defective, it shall be immediately removed from service. Each item shall be labeled as inactive and segregated from use by FOIL personnel.

When a calibrated item is determined to be out of tolerance the Senior Test Technician shall evaluate the previous uses of the equipment. If deemed necessary, recalibration of equipment for the lab may be required. All results regarding equipment recalibration will be kept on file.

6.4.10. When intermediate checks are necessary to maintain confidence in the performance of the equipment, these checks shall be carried out according to a procedure.

Intermediate checks of calibration equipment The applicable FOIL or manufacturer’s procedure describes the details of calibration standards required. Intermediate checks are made by FOIL staff before each test, where possible. Otherwise our standards shall be checked a minimum of one half way through the calibration cycle.

6.4.11. FOIL does not calibrate using reference material data. include reference values or correction factors,

6.4.12. FOIL shall take practicable measures to prevent unintended adjustments of equipment from invalidating results.

Safeguarding of hardware and software from adjustment influencing testing results Tamper resistant seals may be affixed by the calibration subcontractor to operator accessible controls or adjustments on applicable FOIL calibrated equipment, which if moved will affect the testing process. If any such seal is broken, the calibration of that item is invalid and the item must be submitted for recalibration. Passwords shall

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6.4.13. Records shall be retained for equipment which can influence FOIL laboratory activities. The records shall include the following, where applicable:

a) the identity of equipment, including software and firmware version;

b) the manufacturer’s name, type identification, and serial number or other unique identification;

c) evidence of verification that equipment conforms with specified requirements;

d) the current location;

e) calibration dates, results of calibrations, adjustments, acceptance criteria, and the due date of the next calibration or the calibration interval;

f) documentation of reference materials, results, acceptance criteria, relevant dates and the period of validity;

g) the maintenance plan and maintenance carried out to date, where relevant to the performance of the equipment;

h) details of any damage, malfunction, modification to, or repair of, the equipment

Records maintained for calibration equipment FOIL shall maintain a file with information about all equipment owned by FOIL and used for calibration. This database is filed chronologically and makes reference to the asset number of each piece of equipment.

Calibration Certificates are required for all subcontractor-calibrated items.

Calibration Certificates shall include:

1. The description and unique identification of the equipment.

2. The date that the calibration was completed.

3. The calibration results obtained after and, where relevant, before any adjustment and repair.

4. The assigned calibration interval.

5. The identification of the calibration procedure or program.

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6. The designated limits of permissible error.

7. The source of the calibration used to obtain traceability.

8. The relevant environmental conditions and a statement about any corrections thus necessary.

9. The details of any maintenance such as servicing, adjustments, or repairs.

There are no maintenance requirements for our calibration standards other than those performed during their calibration.

6.5. Metrological Traceability

6.5.1. FOIL shall establish and maintain metrological traceability of its measurement results by means of a documented unbroken chain of calibrations, each contributing to the measurement uncertainty, linking them to an appropriate reference

6.5.2. FOIL shall ensure that measurement results are traceable to the International System of Units (SI) through one of the following:

a) calibration provided by a competent laboratory;

FOIL shall maintain a calibration equipment database, where the calibration status of equipment is shown.

FOIL has established relations with lab accredited calibration companies for calibration of its equipment.

Calibration services provided by these companies are traceable to NIST. They are required to establish traceability of their own measurement standards.

FOIL shall coordinate a process of testing validation including participation in a suitable program of internal proficiency testing. The Quality Manager shall coordinate review data of each lab comparison.

b) When used certified values of certified reference materials provided by a competent producer shall be stated showing metrological traceability to the SI;

c) When used there shall be a direct realization of the SI units ensured by comparison, directly or indirectly, with national or international standards.

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6.5.3. When metrological traceability to the SI units is not technically possible, FOIL shall demonstrate metrological traceability to an appropriate reference, for example.

a) certified values of certified reference materials provided by a competent producer;

b) results of reference measurement procedures, specified methods or consensus standards that are clearly described and accepted as providing measurement results fit for their intended use and ensured by suitable comparison.

6.6. Externally Provided Products and Services

6.6.1. FOIL shall ensure that only suitable externally provided products and services that affect laboratory activities are used, when such products and services:

a) are intended for incorporation into FOIL own activities;

b) are provided, in part or in full, directly to the customer by FOIL, as received from the external provider;

c) are used to support the operation of FOIL.

6.6.2. FOIL shall have a procedure and retain records for:

a) defining, reviewing and approving FOIL requirements for externally provided products and services;

b) defining the criteria for evaluation, selection, monitoring of performance and re-evaluation of the external providers;

c) ensuring that externally provided products and services conform to FOIL established requirements, or when applicable, to the relevant requirements of this document, before they are used or directly provided to the customer;

d) taking any actions arising from evaluations, monitoring of performance and re-evaluations of the external providers.

Subcontractors perform calibrations of FOIL calibration reference standards.

Calibration Certificates received are reviewed by the Senior Test Technician to

Revision E, June 1st, 2019 21 of 58 ensure that all required information is present, including evidence of lab accreditation. If the subcontractor is ISO/IEC 17025:2017 lab accredited, they are considered approved for calibration. FOIL does at times subcontract calibrations to outside ISO 17025 companies. All calibrations are reviewed by the Senior Test Technician. Subcontractor performance is evaluated each Management Review.

All Subcontractor Purchase Orders will provide all quality and delivery requirements, and any other applicable purchasing data. Purchase Orders shall be reviewed and approved by the Senior Test Technician. This review shall ensure that all purchasing data including quality requirements are accurately stated. The Purchase Order shall contain the initials of the reviewer.

FOIL uses outside support and supplies in order to properly ensure all testing activities are properly accomplished. Calibration subcontractors are used only to perform calibration of FOIL standards. FOIL is responsible for ensuring the quality of all outside services and suppliers. The Senior Test Technician shall maintain a list of all subcontractors that it uses for calibrations and a record of the evidence of lab accreditation to ISO/IEC 17025:2017.

Supplies of reference material, such as silicone oils, and other consumable materials are controlled. Where there is a shelf life requirement this shall be stated on the container to prevent the use of expired material. A suppliers list shall be maintained which describe sources of materials. Materials shall be reviewed upon receipt to ensure they are suitable for their intended purpose.

Purchasing services and supplies Our purchasing policy is to procure our needed supplies and services only from approved suppliers and ISO 17025 subcontractors.

Inspection of purchased supplies FOIL buys only such calibration equipment, which could ensure compliance of testing performed at FOIL within the standard specifications and requirements.

No employee is allowed to use any received calibration equipment until it is inspected upon receipt. The Quality Manager shall verify that the equipment and supplies procured complies with the Purchase Order.

FOIL shall ensure that purchased supplies and consumable materials that affect the quality of testing are not used until they have been inspected.

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Evaluation of suppliers A list of approved suppliers for FOIL shall be available to personnel. No supplies are allowed to be procured unless the source is on the approved list

6.6.3. FOIL shall communicate its requirements to external providers for:

a) the products and services to be provided;

b) the acceptance criteria;

c) competence, including any required qualification of personnel;

d) activities that FOIL, or its customer, intends to perform at the external provider’s premises.

Quality related information required for the purchase orders FOIL Purchase Orders connected with accredited equipment calibrations shall contain data reflecting important technical parameters and characteristics for the equipment, such as type, class, grade, technical data including each parameter measured with the device, inspection instructions, and traceability of calibration results, The Purchase Order shall be reviewed and approved by the Purchasing and Inventory Manager.

7. PROCESS REQUIREMENTS

7.1. Review of Requests, Tenders and Contracts

7.1.1. FOIL shall have a procedure for the review of requests, tenders and contracts. The procedure shall ensure that:

a) the requirements are adequately defined, documented and understood;

b) FOIL has the capability and resources to meet the requirements;

c) where external providers are used, the requirements of 6.6 are applied and FOIL advises the customer of the specific laboratory activities to be performed by the external provider and gains the customer’s approval;

d) the appropriate methods or procedures are selected and are capable of meeting the customers’ requirements.

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Review of requests for tenders and contracts Purpose and Scope

The purpose of this procedure is to define the requirements within FOIL for performing contract review.

Responsibility

The Quality Manager and Senior Test Technician are authorized to perform contract reviews.

The Senior Test Technician shall review the internal task order, when product is received. When it is determined that all the testing and any customer's requirements can be met the order.

The details of the test are entered into the FOIL database.

Customer Communication

FOIL personnel shall communicate information about services during the contract review. Entries on task orders shall be made as needed for inquiries, handling issues, and amendments. When a customer complaint is received, the information shall be documented in the customer complaint log. Follow-up of complaints will be documented. Each complaint is reviewed for possible immediate corrective action.

Management reviews conducted includes addressing customer complaints. The Quality Manager shall perform root cause analysis, trending, and corrective action, as required. When customer complaints indicate a problem with a particular process, an internal quality audit shall be performed of that process.

The customer shall be informed of any deviation from the contract.

7.1.2. FOIL shall inform the customer when the method requested by the customer is considered to be inappropriate or out of date. This shall be resolved prior to the completion of the contract review.

Any risks associated with the specific test shall be identified and mitigating action taken to reduce the level of risk to an acceptable level.

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7.1.3. When the test requires a statement of conformity to a specification or standard for the test (e.g. pass/fail, in-tolerance/out-of-tolerance) the specification or standard, and the decision rule shall be clearly defined. Unless inherent in the requested specification or standard, the decision rule selected shall be communicated and agreed upon. See 7.8.6.1.

7.1.4. Any differences between the requested task order and customer requirements shall be resolved before laboratory activities commence. Deviations requested by the customer shall not impact the integrity of FOIL or the validity of the results.

7.1.5. The customer shall be informed of any deviation from the testing process.

7.1.6. If a task order is amended after work has commenced, the contract review shall be repeated and any amendments shall be communicated to all affected personnel

Amendments made to existing orders may be initiated by the customer. When needed, these changed requirements are communicated to the affected personnel to ensure that all jobs in process include the revised requirements. A summary of any changes shall be made on a revised task order.

7.1.7. When needed, FOIL shall cooperate with customers or their representatives in clarifying the customer’s request and in monitoring FOIL performance in relation to the work performed.

7.1.8. Records of reviews, including any significant changes, shall be retained. Records shall also be retained of pertinent discussions with a customer relating to the customer’s requirements or the results of FOIL activities

7.2. Selection, Verification and Validation of Methods

7.2.1. Selection and Verification of Methods

7.2.1.1 FOIL shall use appropriate methods and procedures for all laboratory activities and, where appropriate, for evaluation of the measurement uncertainty as well as statistical techniques for analysis of data.

7.2.1.2 All methods, procedures and supporting documentation, such as instructions, standards, manuals and reference data relevant to FOIL activities, shall be kept up to date and shall be made readily available to personnel (see 8.3). FOIL shall ensure that it uses the latest valid version of a method unless it

Revision E, June 1st, 2019 25 of 58 is not appropriate or possible to do so. When necessary, the application of the method shall be supplemented with additional details to ensure consistent application.

7.2.1.3

7.2.1.4 When the customer does not specify the method to be used, FOIL shall select an appropriate method and inform the customer of the method chosen.

Methods published either in international or national standards, or by reputable technical organizations, or as specified by the manufacturer of the equipment, are recommended. Laboratory developed or modified methods can also be used.

7.2.1.5 FOIL shall verify that it can properly perform any laboratory developed methods before introducing them by ensuring that it can achieve the required performance. Records of the verification shall be retained. If the method is revised, verification shall be repeated to the extent necessary. The testing program shall be validated when any changes are made.

7.2.1.6 When method development is required, this shall be a planned activity and shall be assigned to competent personnel equipped with adequate resources. As method development proceeds, periodic review shall be carried out to confirm that the needs of the customer are still being fulfilled. Any modifications to the development plan shall be approved and authorized.

7.2.1.7 Deviations from methods for all FOIL laboratory activities shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer

7.2.2. Validation of Methods

7.2.2.1 FOIL shall validate any non-standard methods, laboratory developed methods and standard methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application.

a) evaluation of bias and precision using reference standards or reference materials;

b) systematic assessment of the factors influencing the result;

c) testing method robustness through variation of controlled parameters;

d) comparison of results achieved with other validated methods;

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e) inter-laboratory comparisons;

f) evaluation of measurement uncertainty of the results based on an understanding of the theoretical principles of the method and practical experience of the performance of the sampling or test method.

FOIL maintains detailed procedures for the tests performed. Internal and external procedure (i.e. MASH) procedures are controlled documents, which are approved for use by the Quality Manager and Senior Test Technician.

Testing procedures are maintained which detail the vehicle testing. Testing procedures describe the particulars of the various maintenance and test routines required to meet industry and customer specifications. They also describe required sampling methods, handling and preparation of items under calibration.

Test procedures are used to ensure consistency of the measurement process when performed at different times by different operators. Each procedure is structured to provide:

- clear unambiguous instructions

- unique document identification number

- date of latest revision

- data detailing reproducibility of measurements and significant figures to be recorded.

- identification of any limitations to the test results

These procedures are based on manufacturing or industry specifications and do not require validation.

They shall be verified by the Senior Test Technician as being current on an annual basis. If a lab developed procedure is needed the validation of the methods, including the uncertainty of measure shall be documented and performed.

7.2.2.2 When changes are made to a validated method, the influence of such changes shall be determined and where they are found to affect the original validation, a new method validation shall be performed.

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7.2.2.3 The performance characteristics of validated methods as assessed for the intended use, shall be relevant to the customers’ needs and consistent with specified requirements.

7.2.2.4 FOIL shall retain the following records of validation:

a) the validation procedure used;

b) specification of the requirements;

c) determination of the performance characteristics of the method;

d) results obtained;

e) a statement on the validity of the method, detailing its fitness for the intended use.

7.3. Sampling

7.3.1. FOIL does not perform sampling during our testing processes.

If a specific sampling routine the details of sampling used shall be annotated on the test data sheet.

7.3.2. The sampling method shall describe:

a) the selection of samples or sites;

b) the sampling plan;

c) preparation and treatment of sample(s) to yield the required item for subsequent testing.

Where testing is performed by FOIL as part of our ISO 17025:2017 accreditation

7.3.3. FOIL shall retain records of sampling data that forms part of the testing that is undertaken. These records shall include, where relevant.

In the event that sampling is required, the following factors shall be assured:

a) reference to the sampling method used;

b) date and time of sampling;

c) data to identify and describe the sample (e.g. number, amount, name);

d) identification of the personnel performing sampling;

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e) identification of the equipment used;

f) environmental or transport conditions;

g) diagrams or other equivalent means to identify the sampling location when appropriate;

h) deviations, additions to or exclusions from the sampling method and sampling plan.

7.4. Handling of Test Items

7.4.1. FOIL shall have a procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test items, including all provisions necessary to protect the integrity of the test item, and to protect the interests of FOIL and the customer. Precautions shall be taken to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for testing. Handling instructions provided with the item shall be followed.

Transport and storage FOIL personnel handle its testing equipment with all precautions required by the Quality Manual and calibrated equipment manuals.

Most of the calibration equipment is used for designated types of testing and it is kept in segregated areas. FOIL may maintain extra replacements for equipment when it is damaged or when it is send out for calibration, etc.

When FOIL sends its equipment for calibration, repair, or for some other reason out of the FOIL facility, the equipment shall be properly packed by FOIL personnel, who are responsible for safe transportation of the equipment.

7.4.2. FOIL shall have a system for the unambiguous identification of test items. The identification shall be retained while the item is under the responsibility of FOIL.

The system shall ensure that items will not be confused physically or when referred to in records or other documents. The system shall, if appropriate, accommodate a sub-division of an item or groups of items and the transfer of items.

Identification of FOIL testing equipment and software used for testing All FOIL equipment is identified with the unique FOIL asset number. FOIL software is identified with the file names and version numbers.

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7.4.3. Upon receipt of the calibration item, deviations from specified conditions shall be recorded. When there is doubt about the suitability of an item for test purposes, or when an item does not conform to the description provided, FOIL shall consult the customer for further instructions before proceeding and shall record the results of this consultation. When the customer requires the item to be tested and acknowledge a deviation from specified conditions, FOIL shall include a disclaimer in the report indicating which results may be affected by the deviation.

Dealing with defective equipment Equipment that has been subjected to overload or mishandling, gives suspect results or has been shown to be defective or to be outside of specified limits is taken out of service and a label “out of service” is applied. After this that equipment is removed from service and the Senior Test Technician shall be provided with information about what has happened. The calibration certificate shall be annotated. The equipment may be sent for repair or recalibration. Upon receipt of the equipment from repair the Senior Test Technician shall investigate any effect that this broken equipment could produce on tests already performed. In cases when this effect could influence equipment performance the customer shall be notified in writing. The notification shall quantify the magnitude of error created in the testing results.

7.4.4. When items need to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded. A calibrated instrument is required to monitor conditions when they impact the testing accuracy.

FOIL personnel shall review calibrations performed by subcontractors. Each Calibration Certificate provided by accredited subcontractors is required to contain information concerning the environmental conditions in which the calibrations were performed. Temperature and precipitation have been determined to be the only environmental conditions, which may affect the quality and validity of FOIL testing processes. Corrective action shall be taken when environmental conditions fall out of the required tolerance.

7.5. Technical Records

7.5.1. FOIL shall ensure…