D-124

Laboratory Management System Manual

Section D — Laboratory Operations and Specifications Revision 0 27 pages

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1.0 Table of Contents

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2.0 References

2.1 A-113, SOP, Training Procedure

2.2 A-117, SOP, Personnel Qualifications

2.3 C-501, SOP, Document Control

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

2.5 D-103, SOP, Analytical Method Validation

2.6 D-105, SOP, Out of Specification/Out of Trend Investigation

2.7 D-108, SOP, Estimation of Measurement Uncertainty

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2.8 D-117, SOP, Laboratory Purchases and Receiving

29 D-118, SOP, Laboratory Quality Assurance Activities Plan (Proficiency Testing)

2.10 D-119, SOP, Sales — Laboratory Sample Submission

2.11 D-120, SOP, Laboratory Management Structure and Position Requirements

2.12 D-121, SOP, Management -- Laboratory

2.13 D-122, SOP, Laboratory Operations

2.14 D-123, SOP, Control of Laboratory Electronic Documentation and Data

2.15 D-202, SOP, Outsourced Testing Procedure

2.16 D-715, SOP, Microbial Limit Testing using the 3M" PetrifilmTM System

2.17 D-715.0, SOP, Microbial Limit Testing using Agar Plates

2.18 D-720, SOP, Caffeine, Theacrine, and Theobromine Determination using HPLC with
UV/VIS Detection

219 D-729, SOP, Determination of Tributyrin by GC-FID

2.20 D-776, SOP, Cannabinoid Determination and Identification by HPLC

2.21 D-778, SOP, Limit of Citrinin by LC-MS

2.22 D-780, SOP, Determination of Quercetin by HPLC using UV/Vis Spectroscopy

2.23 E-601, SOP, Vendor Qualification

2.24 G-208, SOP, Analytical Calibration and Equipment Control

Lut H-101, SOP, Internal Audits

2.26 QS-101, SOP, Complaints

2.27 QS-108, SOP, Corrective and Preventative Action (CAPA)

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2.28 QS-112, SOP, Core Quality Systems and Quality Events

3.0 Organization Information

Ion Labs is a leading contract manufacturer of dietary supplements, pet supplements, skin
care products and OTC drugs in the US. Ion Lab has 30 years’ experience in supplement

manufacturing.

The organization has established their testing laboratory as an independent legal entity

headquartered in Largo, FL. The lab was previously under the Parent company of Ion Labs
providing testing results for the internal products. The lab then separated from Ion Labs to

allow testing to be performed for external customers or internal customers to lon Labs.

4.0 Lab Management System Scope and Non-Applicable Requirements

This document is the sole property of Ion Labs and may not be used, copied, or referenced,

whole or in part, without the written consent of Ion Labs.

The organization’s ISO 17025:2017 laboratory management system applies to testing services
controlled by the operations at 8031 114th Ave, Suite 4000, Largo, FL 33773. Testing

activities included in the ISO 17025:2017 accreditation are listed in the table below.

Method ID Test Parameter
Caffeine, Theacrine, and Theobromine Determination using HPLC with UV/VIS
D-720
Detection (Caffeine Only)
D-715 Microbial Limit Testing using the 3M Petri film System
D-715.0 Microbial Limit Testing using Agar Plates
D-729 Determination of Tributyrin by GC-FID
D-776 Cannabinoid Determination and Identification by HPLC
D-778 Limit of Citrinin by LC-MS
D-780 Determination of Quercetin by HPLC using UV-VIS Spectroscopy

The Ion Labs’ Laboratory only claims conformity with ISO 17025 for this range of testing
services, and this excludes externally provided activities that are subcontracted on a

continuing basis.

All laboratory activities performed to address the testing services in the table above are
carried out in a manner that conforms to the requirements of this manual, customer

requirements, applicable regulatory authorities, laboratory accreditation agencies, the

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established methods listed, detailed testing procedures maintained by the organization, and

the requirements of ISO 17025.

All testing activities are performed in the Ion Labs’ Laboratory within environments

controlled by Lab personnel. Uncertainty budgets and testing procedures consider the
effects of environmental conditions on testing results, and assurance of testing outcomes is

provided by conforming with the requirements of the laboratory management system

described in this manual.

All test activities are performed in accordance with methods developed by established by
International standards organizations or recognized agencies, and where necessary, lab-

developed methods which are validated in accordance with the D-103 Analytical Method
Validation procedure.

The Lab performs testing services only. No calibration services are performed. Therefore,

requirements specific to calibration activities identified in ISO 17025 are not addressed by
the organization’s operations or within this Laboratory Management System Manual.

5.0 Laboratory Management System Overview

The Laboratory Management System (LMS), like the documentation describing it, is structured
around processes affecting the competence of our testing services and confidence in our testing

results. The LMS has been established, documented, implemented, and is maintained to assure

the quality of the laboratory results and to demonstrate consistent achievement of the
requirements of ISO 17025, assuring the quality of testing results.

The management system can be viewed as a system of processes that fall into two categories:
service provision processes, and support processes. The service provision processes involve

testing service activities directly affecting the confidence and capability of the testing services

provided to customers. Support processes are those necessary to support the successful
operation and control of the service provision processes and the LMS as a whole.

The D-119 Sales-Laboratory Sample Submission procedure describes practices implemented to

identify customer requirements, ensures the laboratory can satisfy requirements, and establishes

effective arrangements to communicate with customers and obtain feedback regarding whether
customers are satisfied with the service they have received.

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The D-122 Lab Operations procedure describes how activities specific to testing are controlled,

including control of nonconforming work, and how testing and reporting are performed.

Activities performed to validate and when necessary, identify improvement opportunities are
described in the D-118 Laboratory Qualities Assurance Activities Plan (Proficiency Testing)

procedure. The process for determining and reporting measurement uncertainty 1s described in
the Measurement Uncertainty procedure. The D-103 Analytical Method Validation procedure

ensures lab-developed and non-standard methods are effectively validated when standard

methods are not available.

The D-117 Laboratory Purchases and Receiving procedure ensures the products, services,

outsourced processes, and subcontracted testing services the organization requires are obtained
in a manner that safeguards the testing processes are consistent and reliable.

Support processes operate in parallel with the above realization processes. The C-501
Document Control procedure, D-123 Control of Laboratory Electronic Documentation

procedure, and C-502 Record Storage, Retention, and Destruction procedure ensures control

over process documents and records; the A-113 Training procedure and A-117 Personnel
Qualifications procedure ensures personnel performing work affecting the accuracy and

precision of the Lab are competent; the G-208 Analytical Calibration and Equipment Control
procedure ensures calibrated lab equipment used to perform tests are suitable for their

measurements, operates properly, and is traceable to national and international units of
measure, and non-measuring lab equipment is maintained to ensure it operates properly. The

H-101 Internal Audits procedure monitors all management system processes to ensure their

effectiveness and promote improvement. The D-118 Lab Operations, D-118 Laboratory
Qualities Assurance Activities Plan (Proficiency Testing) and QS-112 Core Quality Systems

and Quality Events, QS-101 Complaints, D-105 Out of Specification Test Results
Investigation, and QS-108 Corrective and Preventive Action procedures ensures actions are

taken to control nonconforming outputs and detected problems do not recur. The D-121

Management -Laboratory procedure ensures top management reviews the LMS as a whole
periodically to ensure its continuing suitability, adequacy, and effectiveness.

A documented procedure has been established, implemented, and maintained for each LMS
process, including both service realization and support processes. Each procedure identifies the

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inputs to and outputs of the process and describes how inputs are transformed into outputs

under controlled conditions. Each procedure also identifies responsibilities and authorities of

personnel performing the process, as well as those responsible for measuring or monitoring
process performance against established objectives, and for reacting appropriately to provide

confidence in the service and to promote improvement.

6.0 Laboratory Management System Processes

6.1 Organization

6.1.1 The organization provides testing services to meet the requirements of ISO
17025 and to satisfy the needs of customers. The LMS applies to work carried

out at the Ion Lab’s facility.

6.1.2 Management ensures all personnel are free from any undue internal or external

commercial, financial, or other pressures and influences that may adversely

affect the confidence in the work they are assigned to perform. This is
accomplished through training and through investigations of nonconforming

work and complaints.

6.1.3 All personnel have the authority and resources needed to carry out their assigned

duties, and to identify needed resources. As described in the LMS procedures,
personnel are responsible for, and authorized to, implement, maintain, and

improve the management system, and to identify departures from procedures or
methods and to initiate corrective action, as appropriate, to prevent or minimize

such problems.

6.1.4 The organization implements policies and procedures regarding involvement in
any activities that would diminish confidence in its competence, impartiality,

judgment, or operational integrity, as applicable. Documented operating
procedures specify how activities associated with testing services are conducted

to provide confidence in the organization’s competence, impartiality, judgment,
operational integrity, and ensure the consistent application of its activities and

the validity of testing results. Adherence to the documented procedures assures

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consistent application of testing activities, leading to valid and repeatable
results.

6.1.5 The Lab Director is responsible for ensuring the LMS is implemented and
always followed. The Lab Director has direct access to top management, who

makes decisions regarding policies and resources. The Lab Director is

responsible for establishing, implementing, and maintaining the LMS, for
reporting and reviewing performance information and improvement

opportunities during Management Review, for promoting awareness of
customer requirements throughout the organization, and for ensuring that all

personnel in the scope of ISO 17025 accreditation are aware of the relevance

and importance of their activities and how they contribute to the achievement of
objectives. (This is accomplished via a combination of orientation training, and

objective/performance reporting communicated appropriately in the
organization). Management has responsibility for the technical operations and

the provision of resources needed to ensure the Lab can achieve the accuracy
and precision necessary.

6.1.6 Though responsibilities and authorities ultimately reside with top management,
they are delegated to competent personnel as necessary. All personnel who

perform, manage, and/or verify work are responsible for the services provided

by the organization. All employees are responsible for complying with
documented procedures and the direction of management. All employees are

authorized to identify and record problems relating to services, processes, and
the management system as a whole, and to provide suggestions for improvement

or recommendations for solving problems by initiating corrective actions

according to the QS-112 Core Quality Systems and Quality Events, D-105 Out
of Specification Test Results Investigation, QS-108 Corrective and Preventive

Action procedures. All employees are also responsible for cooperating fully
with internal audits, customer audits, and assessments conducted by

accreditation bodies.

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6.1.7 Personnel are responsible for ensuring control over their activities and to

complete work in a safe and responsible manner. All employees are responsible

for maintaining work areas in a state of order, cleanliness, and repair consistent
with service and processing needs. They are also responsible for identifying

nonconforming work, stopping processing as necessary, and controlling further

processing until management has been promptly notified and the problem has
been corrected. A general description of responsibilities and authorities

associated with each position are controlled as described in the A-113 Training,
A-117 Personnel Qualifications, and D-120 Laboratory Management Structure

and Position Requirements procedure and in specific LMS process procedures.

6.2 Confidentiality

6.2.1 Management ensures responsibilities and authorities are defined and
communicated to all employees. Management is ultimately responsible for the

quality of the organization’s services and processes.

6.2.2 Management is responsible, through legally enforceable commitments, for the
management of all information obtained or created during the performance of

the Lab’s activities. Although it typically does not occur, the Lab Director will
notify the customer in advance, o the information the Lab intends to place in the

public domain.

6.2.3 Except for information that the customer makes publicly available, or when
agreed between Ion Labs and the customer (e.g. for the purpose of responding to

complaints), all other information is considered proprietary information and is
regarded as confidential.

6.2.4 When the Lab is required by law or authorized by contractual arrangements to
release confidential information, the customer or individual concerned will,

unless prohibited by law, be notified of the information provided. Records of
the notifications will be retained.

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6.2.5 Information about the customer obtained from sources other than the customer
(e.g. complainant, regulators) is kept confidential between the customer and the

Lab. The source of this information is also kept confidential to the Lab and is
not shared with the customer, unless agreed by the source.

6.3. Management Responsibility

6.3.1 Management is committed to maintaining and improving the management

system to continually satisfy customers by providing them with services that

meet their requirements. Management ensures customer requirements are
determined and met along with providing accurate testing services. This

commitment is demonstrated by the development and implementation of the
laboratory management system, by establishing policies, and by establishing

measurable objectives against which management system performance is

evaluated and acted upon in an effort to improve processing and the resulting
services. Management ensures employees understand the importance of

meeting requirements and providing accurate and precise testing services.

6.3.2 Management also demonstrates a commitment the performance of the Lab by

conducting periodic management reviews of the LMS and its processes. Based
on factual information regarding performance and other feedback from

customers, and in consideration of future customer needs, management allocates
resources as necessary to ensure conformity of service, to improve the

management system, its processes, and resulting service.

6.3.3 As established in previous sections of this manual, the Lab has established,
implemented, and continues to maintain a LMS appropriate to the scope of our

testing activities. Policies, procedures, testing methods, equipment operating
instructions, etc. have been documented to the extent necessary to assure

confidence in testing results. | Management system documentation is
communicated to, understood by, and available to appropriate personnel, who

process work accordingly.

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6.3.4 Management reviews its policies and objectives periodically during

management review to ensure its continuing suitability, ensuring it remains

appropriate for the organization, that it includes a commitment to comply with
requirements and to continually improve the management system, and that it

provides a foundation for measurable objectives against which performance can
be evaluated. Top management also ensures employees understand the policies,

how they apply to their work, how their performance relates to the achievement

of the policy objectives, and the importance of meeting customer requirements
and the requirements of ISO 17025.

6.3.5 Management has established measurable objectives for management system
performance. Such objectives serve as a foundation for reviewing performance

at both the process and system level, to both the management system processes

and to the system of processes in aggregate.

6.3.6 Key objectives and measurements are addressed during management review

meetings, along with an indication of a timeframe for their achievement.
Objectives, associated targets, and relative performance information is

communicated to affected personnel.

6.3.7 Monitoring and measurement methods to evaluate performance against

established objectives have been identified, where suitable and applicable to
improve performance. The Metrics worksheet of the LMS Planning Tool

describes each objective, the monitoring and/or measurement(s) applied, and the

frequency of measurement analysis. Management provides details regarding
responsibilities and authorities for reviewing the resulting performance

information, for analyzing it, for reacting appropriately, and for reporting
management system performance to employees.

6.3.8 Planning at the process level focuses on processing a customer order for testing
services to ensure conformity of the service to applicable requirements

according to the original equipment manufacturer specifications and if required,
customer specifications. This planning is to establish processes and information

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specific to the service, and to identify service-specific resource requirements.
This level of planning results in resource allocation and identification of

processing steps, records demonstrating conformity and reporting testing results,
and methods for reacting if planned arrangements are not achieved.

6.3.9 Planning at the system level involves establishing the LMS processes and

infrastructure necessary to meet general requirements of performing accredited
testing focusing on the ability of the system to meet these requirements

effectively and efficiently. Such planning results in system-level processes and
procedures that represent the planned arrangements described by management

system documentation.

6.3.10 Where changes to the LMS are planned, due to changes in the volume of work,

technology or in the accredited testing offered to customers, changes caused by

suppliers, changes to processes, procedures, or service requirements,
introduction of new processes or services, etc., Management will ensure the

integrity of the LMS is maintained to ensure conformity of service to
requirements. The full impact of changes will be determined, as appropriate.

Changes will be verified and validated to ensure conformity to customer
requirements before implementation. Management system planning and change

management is conducted during management review, or more frequently as

circumstances dictate. See the D-121 Management - Laboratory procedure.

6.3.11 Management ensures resource requirements are determined and met where they

are needed to effectively operate and control management system processes, to
maintain and improve the management system, and to provide testing services

that demonstrate accuracy and precision.

6.3.12 Resource requirements include human resources (including personnel and
training resources), infrastructure resources (including buildings, workspace,
process equipment, operating supplies, documentation, and supporting services

and utilities), and work environment resources (including human/physical

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aspects of work being performed where necessary to provide confidence in
testing results).

6.3.13 Resource needs may be identified within any management system process, or
they may arise in connection with management reviews, corrective actions,

internal audits, employee observations, etc. These needs are fulfilled according
to the D-117 Laboratory Purchases and Receiving procedure and human

resources are fulfilled according to the A-113 Training, A-117 Personnel

Qualifications, and D-120 Laboratory Management Structure and Position
Requirements procedures.

6.4 Document Control

6.4.1 The C-501 Document Control and C-502 Record Storage, Retention, and

Destruction supports all LMS processes. The process assures control over all
documents comprising the management system, whether generated internally or

externally, including standards, manuals, forms, testing methods, specifications,

instructions, etc.

6.4.2 As a support process, the objective of document control is to ensure legible,

approved documentation is available when and where it is needed in order to
perform laboratory activities. Management system documents are uniquely

identified, including (as appropriate) document number, title, and revision date.
The procedure also describes how documentation is initially approved and how

it is re-approved after being updated. Revision histories are retained for

management system documents to identify new or changed contents. The
control of documents originating externally is also described to ensure current

revisions are known and used.

6.4.3 Document control ensures documentation is approved by relevant authorities

and that current, controlled documentation is used, and obsolete documentation
is removed from use and suitably marked or disposed of to prevent unintended

use.

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6.5 Sales-Laboratory Sample Submission

6.5.1 Relationships with customers and potential customers are established as

described in the D-119 Sales-Laboratory Sample Submission procedure.
Policies are in place to ensure customers are aware of the accredited testing

services available. Accredited testing service references, such as use of the
accreditation body’s logo (indicating “accredited”), are strictly controlled to

ensure customers are not misled regarding accredited vs. non-accredited testing

activities.

6.5.2 The D-119 Sales-Laboratory Sample Submission procedure also describes

service agreements and/or non-disclosure or confidentiality agreements that are
executed with customers.

6.5.3 Requirements for testing services are expressed in Test sheets submitted Sales
or Lab personnel on the customers’ behalf. Each Test Request is reviewed to

ensure the requirements and activities are clear and that it can be fulfilled within

the requested service delivery date. See D-119 Sales-Laboratory Sample
Submission procedure.

6.5.4 When customers initiate changes to requirements, the same review process
described above is repeated. All accepted changes are communicated to

appropriate personnel. When deviations from quote requirements occur due to
unexpected variations which may affect testing results, customers are notified.

Records of communications are maintained in accordance with the D-119 Sales-

Laboratory Sample Submission procedure.

6.5.5 Feedback indicating customers’ perception of the organization’s performance

(both positive and negative) is actively collected and assessed to determine
customer perception of the organization’s performance. Records of customer

feedback are maintained in the Customer Feedback Log. The organization
reacts appropriately to customer feedback and complaints, initiating corrective

action as appropriate, per the D-122 Laboratory Operations and QS-112 Core
Quality Systems and Quality Events, QS-101 Complaints, and QS-108

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Corrective and Preventive Action procedures and the Customer Complaint

Policy.

6.5.6 The organization is willing to cooperate with customers or their representatives
in clarifying and monitoring performance in relation to work performed. This

cooperation may include providing the customer or the customer’s
representative reasonable access to relevant areas of the facility for

demonstration of testing services, and/or provision of information regarding

testing processes, observations, and results.

6.6 Purchasing and Receiving

6.6.1 Consumables, equipment, measurement equipment, calibration services,
maintenance services, consulting services, and internal audit services are

obtained through the process described in the D-117 Laboratory Purchases and
Receiving, E-601 Vendor Qualification, and D-202 Outsourced Testing

procedures. These procedures also describe the process for evaluating,

approving, and re-evaluating external providers and outsourced service
providers.

6.6.2 The procedure also establishes controls for identifying approved suppliers,
ensuring requirements are known for critical materials, and for tracking the

performance of subcontracted testing service providers. The controls also
provide records of received items where lot identification and/or lot traceability

are required.

7.0 Test Services

7.1 Personnel

7.1.1 The A-113 Training and A-117 Personnel Qualifications and D-120 Laboratory
Management Structure and Position Requirements procedure describes how the

Lab determines and provides personnel with the competence required to operate
specific equipment, perform testing activities, record/evaluate results, and

manage organizational activities. Training records have been developed to

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identify competence requirements for each position affecting the outputs of the

activities performed, based on appropriate education, training, experience and/or

demonstrated skills. Although staff undergoing training to perform tests,
trainees operate under the direct supervision of experienced personnel and/or

management until deemed competent.

fy Facilities and Environmental Conditions

Tosh All testing activities are performed in the controlled environment in the Ion

Labs’ Laboratory. This ensures any variation or impact on the accuracy of the
testing activities performed is minimized.

Toca Uncertainty budgets and testing procedures consider the effects of
environmental conditions on testing results, and assurance of testing outcomes is

provided by conforming with the requirements of the laboratory management
system described in this manual. Controls described in testing methods protect

testing results from conditions which would adversely affect testing outcomes.

7.2.3 Access to the organization’s facilities by personnel who are not members of
organizational staff (including customers or their representative witnessing

testing) is controlled to ensure confidentiality and security are maintained.

7.3 Equipment

7.3.1 Management furnishes all equipment and measuring instruments needed for the
correct performance of testing activities within the defined laboratory scope.

7.3.2 All calibrated equipment is uniquely identified. Before measurement equipment
is released for use, it is calibrated or verified, and its software confirmed (where

applicable) to be capable of achieving the accuracy required and complies with
specifications relevant to the activities for which it is intended. Measurement

equipment is calibrated periodically and/or prior to use as described in the G-
208 Analytical Calibration and Equipment Control procedure.

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7.3.3 Measurement equipment is identified with calibration labels, wherever practical,
displaying the date of previous calibration and the due date for the next

calibration.

7.3.4 Equipment records contain information regarding equipment used in testing

activities. Equipment maintenance records and records of any malfunctions are

maintained for all equipment used to perform accredited tests. All records for
equipment and measurement equipment are retained in accordance with the C-

502 Record Storage, Retention, and Destruction.

7.3.5 Equipment that has been subjected to overloading or mishandling, provides

suspect results, or has been shown to be defective is taken out of service and is
marked clearly so it is not used.

7.4 Measurement Traceability

7.4.1 All measurement equipment which can affect the accuracy or validity of testing

results is calibrated before being released for use in accordance with the G-208

Analytical Calibration and Equipment Control procedure. The process ensures
suitable, accurate measuring equipment is used. The process also ensures

measuring devices are selected and used in a manner consistent with testing
requirements, and devices are calibrated or verified periodically (or before use)

to ensure their continuing fitness for use, in order to impart confidence that the
devices are suitable in their precision and the resulting measurements are

accurate.

7.4.2 The G-208 Analytical Calibration and Equipment Control procedure also
ensures calibration results are traceable to international or national standards.

The procedure ensures devices are appropriately identified, handled, stored, and
safeguarded to prevent damage and deterioration. Monitoring or measurement

software is treated as a calibrated device and will be confirmed and reconfirmed
as necessary to ensure its continuing suitability.

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7.4.3. When a measuring device is found to be out of calibration, the Lab Director will

investigate the impact of potentially errant measurements on calibrations

previously performed with the device to ensure the impact is known, it is
corrected or otherwise resolved, and all affected parties including customers, are

notified, as appropriate. Unsuitable devices are withdrawn from use, or their

use is limited to be appropriate for the measurements being carried out.

7.5. Testing Methods

7.5.1 Lab personnel use appropriate methods and procedures for all testing within the
accredited scope of laboratory operations. The D-122 Lab Operations procedure

and applicable testing instructions provide controls for handling, transport,
storage, and preparation of equipment used during the testing process.

Instructions for operating and using testing equipment are available to Lab
personnel, as appropriate. All instructions, standards, manuals, and reference

data is controlled and made available according to the C-501 Document Control

and C-502 Record Storage, Retention, and Destruction procedures and the D-
122 Lab Operations procedure.

7.5.2 The Lab may have the need to establish lab-developed testing methods. It is not
likely that non-standard methods will be required. When lab-developed

methods are necessary, the method will be validated in accordance with the D-
103 Analytical Method Validation procedure. This ensures that all tests are

performed using established testing methods that meet original equipment

manufacturer needs are adequately supplemented and are appropriate for the
equipment being calibrated. Unless otherwise specified, the latest valid edition

of any published testing method is used, or the latest lab-developed method is

used.

7.5.3 Computers or automated equipment used for performing testing or acquiring
testing data are validated before being placed in use or after changes to the

function of the equipment are made. Provisions for protecting data, including
the integrity and confidentiality of data entry or collection, data storage, data

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transmission, and data processing appear in the C-501 Document Control and C-

502 Record Storage, Retention, and Destruction procedures.

7.6 Measurement Uncertainty

7.6.1 Estimates of measurement uncertainty are determined to ensure the capability of

the Lab’s measurement equipment and other factors that can influence the
results of the testing are known. Testing results are reported in accordance with

established testing methods and include measurement uncertainty values where

relevant. The estimate of measurement uncertainty for each accredited testing is
determined in accordance with the D-108 Estimation of Uncertainty procedure.

7.7. Assuring the Quality of Testing Results

7.7.1 Personnel monitor testing processes while they are being performed to ensure

conformity to established testing methods. Data generated during testing are
reviewed by personnel prior to issuing testing certificates. When data suggests a

processing problem, the testing may be repeated or the process for controlling
nonconforming service as described in the D-122 Lab Operations procedure is

followed.

7.7.2 The Lab Director plans for and ensures additional measures are taken to assure
the quality of testing results. In accordance with the D-118 Laboratory Qualities

Assurance Activities Plan (Proficiency Testing) procedure, one of several
methods identified in the procedure is used on an ongoing basis. The methods

include retesting of retained items. use of check or working standards

correlation of results for different characteristics of an item, and participation in
Intralaboratory exercises, interlaboratory comparison or third-party proficiency

testing programs. Data obtained from the quality assurance activity is analyzed
and if found to be outside pre-defined criteria, correction and corrective actions

are taken to mediate the problem and to prevent incorrect results from being
reported. The results are also reported during management review. See the D-

118 Laboratory Qualities Assurance Activities Plan (Proficiency Testing) and
D-121 Management -Laboratory procedures.

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7.8 Reporting Testing Results

7.8.1 Lab personnel performing the testing service is ultimately responsible for

ensuring the results of each testing is reported accurately, clearly,
unambiguously, and objectively, and in accordance with any specific instruction

specified by the customer and established testing method. Requirements for
reporting results are described in the D-122 Lab Operations procedure.

7.8.2 Test Reports are formatted using appropriate templates and undergo reviews and

checks before release. These controls ensure the accuracy and integrity of the
data upon release. The procedures that are followed and relevant controls in

place ensure consistency and reliability and ensure conformance with
established testing requirements.

7.8.3 Certificate of Analysis (CoA) or Test Reports are typically provided in hard
copy and electronic copy per the customer requirements. Electronically

transferred data is protected in accordance with the C-501 Document Control

and C-502 Record Storage, Retention, and Destruction procedures.

7.8.4 If amendments are necessary for test reports after issue, the supplemental

documents are identified and associated to the original certificate in accordance
with the D-122 Lab Operations procedure. When it is necessary to issue a

complete, new test report, the new report is uniquely identified and contains
clear reference to the original test report it replaces.

7.9 Reporting Statements of Conformity

7.9.1 Lab personnel indicate conformity against the specifications through the test
reports or CoA. The test report or CoA indicate to which results the statements

of conformity apply, when specifications, standards, or parts thereof are met or
not met, and the decision rule applied. The decision rule is stated on the Test

Reports or CoA.

7.10 Reporting Opinions and Interpretations

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7.10.1 Opinions and interpretations may be included on Test Reports or CoA provided

to customers.

7.10.2 Opinions and interpretations are provided to customers upon Management
discretion. Only Lab personnel authorized to provide the information do so.

7.11 Control of Nonconforming Work

7.11.1 The D-122 Lab Operations and QS-112 Core Quality Systems and Quality

Events, D-105 Out of Specification Test Results Investigation, QS-108
Corrective and Preventive Action procedures describes the process when work

does not conform to methods, procedures, or to the agreed requirements of the

customer. If nonconformities are discovered (during or after testing):

7.11.1.1 Testing is stopped immediately if feasible. A designated authority

determines if the nonconformity work impacts testing results and
evaluates the significance of the nonconforming work. Reports and

certificates are withheld until the issue has been resolved. A record is
initiated as described in D-122 Lab Operations and QS-112 Core

Quality Systems and Quality Events, D-105 Out of Specification Test

Results Investigation, QS-108 Corrective and Preventive Action
procedures.

7.11.1.2 A disposition is made for the testing activities and testing reports
affected.

7.11.1.3 Corrective action is initiated when a systemic problem is suspected
that would allow the nonconformity to recur, or when compliance to

policies and procedures is in doubt the D-122 Lab Operations and QS-
112 Core Quality Systems and Quality Events, D-105 Out of

Specification Test Results Investigation, QS-108 Corrective and

Preventive Action procedures.

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7.11.1.4 Personnel correct the problem immediately, if possible. Testing
activity will not resume until the problem has been corrected and the

correction has been verified to be effective.

7.11.1.5 When appropriate, customers are contacted to inform them of the

problem, and actions taken as agreed with the customer. Records of

correspondence are maintained.

7.11.1.6 If it is determined additional tests have been affected by the situation,

including test reports that have been published and made available to
customers, the Lab Director determines if retests are required. The

decision is recorded and actions to recall reports taken as necessary.

8.0 Laboratory Management System Foundations

8.1 Requirements Addressed

8.1.1 The LMS has been established, documented, implemented, and is maintained to
promote accuracy, precision, and improvement, and to support and demonstrate

consistent achievement of the requirements of ISO 17025 and assuring the
quality of testing results. The documented LMS defines the management

system to plan and demonstrate the consistent fulfillment of the Lab’s
requirements. The Lab’s management system addresses Option A of ISO

17025. The requirements of Option A are as follows, supported by the

documented management system procedure listed:

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Requirement Applicable Procedure(s)
C-501 Document Control
Management system documentation C-502 Record Storage, Retention, and Destruction
D-121 Management-Laboratory
C-501 Document Control
Control of management system documents
C-502 Record Storage, Retention, and Destruction
C-501 Document Control
Control of records
C-502 Record Storage, Retention, and Destruction
Actions to address risks and opportunities D-121 Management-Laboratory
D-121 Management-Laboratory
D-122 Lab Operations
QS-112 Core Quality Systems and Quality Events
D-105 Out of Specification Test Results
Improvement
Investigation
QS-108 Corrective and Preventive Action
procedures
D-119 Sales -Laboratory Sample Submission
D-122 Lab Operations
QS-112 Core Quality Systems and Quality Events
D-105 Out of Specification Test Results
Corrective actions
Investigation
QS-108 Corrective and Preventive Action
procedures
Internal audits H-101 Internal Audits
Management reviews D-121 Management-Laboratory
8.2 Improvement

8.2.1 Improvement is achieved anytime an increased ability to fulfill requirements is
demonstrated by measurable results or quantifiable benefits (or estimates

thereof). The Lab continually improves the effectiveness of the LMS through

use of its policies, objectives, audit results, analysis of data, corrective actions,
and management review. (See the H-101 Internal Audit, D-121 Management-

Laboratory, D-122 Lab Operations and QS-112 Core Quality Systems and
Quality Events, D-105 Out of Specification Test Results Investigation, QS-108

Corrective and Preventive Action procedures.)

8.3 Actions to Address Risks and Opportunities

8.3.1 While planning and controlling laboratory activities, Management considers the
risks and opportunities present in the LMS, facility, equipment, personnel

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competency, and other aspects of the operation. Risks and opportunities are

addressed to give assurance the management system achieves its intended

results, prevents, or reduces undesired impacts and potential failures in
laboratory activities, and achieve improvement. Opportunities will be enhanced

to achieve the purpose and objectives of the laboratory. The process for

addressing risks and opportunities is described in the D-121 Management-
Laboratory procedure.

8.4 | Nonconformity and Corrective Action

8.4.1 The nonconformity and corrective action process supports all LMS processes

and improvement activities. As a support process, the objective of the
nonconformity and corrective action process is to identify systemic or process-

related problems or undesirable situations, to determine their causes, and to take

actions to eliminate those causes so they do not recur. Corrective actions are
taken appropriate to the magnitude of problems and risks involved. Error-

proofing methods, including those to prevent human error, are employed
wherever applicable.

8.4.2 Corrective actions are taken in response to audit results, customer feedback or
complaints, supplier performance data, testing performance information

regarding nonconforming work, process monitoring and measurement results,

etc. Actions also arise in connection with improvement efforts associated with
any management system process. Requests for corrective action are processed

as described in the D-122 Lab Operations and QS-112 Core Quality Systems
and Quality Events, D-105 Out of Specification Test Results Investigation, QS-

108 Corrective and Preventive Action procedures.

8.4.3 According to the procedure, the following steps are taken for each corrective

action initiated: the problem is reviewed, and its root cause(s) determined using
appropriate problem-solving methods; possible actions to eliminate its root

cause to prevent its recurrence are evaluated and an appropriate action is

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selected and implemented; records of the completed action are maintained; the
effectiveness of the action taken is verified and recorded.

8.4.4 When serious issues, risks, or problems cast doubt on compliance with policies
or procedures, or our compliance with ISO 17025, the Lab Director ensures

appropriate problem areas are addressed as soon as possible.

8.4.5 Once closed, corrective action records provide evidence of actions taken and

verification of their effectiveness. Documentation revisions required as the

result of actions are done according to the C-501 Document Control and C-502
Record Storage, Retention and Destruction procedure.

8.4.6 If corrective action proves ineffective, alternative solutions will be evaluated
and applied until the issue is resolved.

8.5 Control of Records

8.5.1 C-501 Document Control and C-502 Record Storage, Retention and Destruction

procedures supports all management system processes. As a support process,
the purpose of records control is to ensure records of testing service activities,

general lab activities, and management system activities are maintained for the

required retention period. Records demonstrate the effective operation of the
management system and conformity to applicable requirements.

8.5.2 Records control ensures LMS records are stored and protected from damage and
deterioration, they are readily identifiable and retrievable when needed, and they

are disposed of properly once their retention period has expired. All records are
held secure and in confidence. The Records Retention Matrix specifies

responsibilities for maintaining records, their storage and protection, their

retrieval or filing method, their retention periods, and their method of disposal.
The C-501 Document Control and C-502 Record Storage, Retention and

Destruction procedures describes actions for protecting and backing-up
electronic records.

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8.5.3 Technical records include original observations, which are recorded in the
appropriate hard or soft copy media and reports to document testing results.

Observations, data, and calculations are recorded at the time they are made and
are identifiable to the specific customer and order.

8.5.4 Records of original observations, derived data, calculations, etc., are sufficient

to establish an audit trail along with equipment calibration records, training
records, and a copy of each calibration certificate issued. Records contain

sufficient information to facilitate, if possible, identification of factors affecting
uncertainty and to enable the testing activity to be repeated under conditions as

close as possible to the original.

8.6 Internal Audits

8.6.1 Internal audits support all LMS processes. As a support process, the objective
of internal audits is to monitor processing activities at planned intervals to

ensure their effective implementation, and to ensure they comply with the

planned arrangements described by management system documentation and
confirm continuing conformity with ISO 17025.

8.6.2 Internal audits are conducted, reported and the results acted upon according to
the H-101 Internal Audit procedure. Internal audits verify working practice is

conducted in accordance with the Lab’s policies and objectives, procedures, and
provisions in this manual, ensuring issues regarding conformity are resolved.

All LMS processes are audited at least annually.

8.6.3 Internal Audits are scheduled according to the status and importance of the
activities being audited, and changes affecting the Lab and/or its activities.

Audits are conducted by trained, impartial internal auditors or contracted
auditors, according to the instructions, scope, criteria, and any specific methods

appearing on internal audit schedules and plans.

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8.6.4 Where working practice fails to conform to planned arrangements, or when
problems or opportunities for improvement are discovered, auditors generate

findings, which become corrective actions as necessary.

8.6.5 Upon completion of an audit, auditors summarize their findings and conclusions

on an internal audit report, and submit the report and findings to management,

who take timely action.

8.6.6 When audit findings cast doubt on the effectiveness of operations or the

correctness or validity of the testing results, the Lab Director ensures corrective
action is taken in a timely manner and will notify customers in writing when

necessary.

8.6.7 Corrective actions arising from audits will be followed-up according to the QS-

112 Core Quality Systems and Quality Events, D-105 Out of Specification Test
Results Investigation, QS-108 Corrective and Preventive Action procedures to

verify actions taken demonstrate effectiveness and were completed in a timely

manner.

8.7 Management Review

8.7.1 The D-121 Management-Laboratory procedure describes how performance data
from various sources is analyzed and acted upon, including information relating

to process or service performance trends suggesting need for improvement or
corrective action, and supplier performance. Measurements are analyzed and

acted upon in an effort to improve performance.

8.7.2 Inputs to management review meetings include corrective action data, actions
decided during previous management reviews, supplier performance

information, internal performance information regarding service conformity and
process monitoring and measurement (including internal performance data and

internal audit results), external performance information (including external
assessments, feedback, any benchmarking data, etc.), any identified

improvement opportunities or recommendations, and any identified internal or

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external changes, including changes in the volume of work, that could impact
the LMS.

8.7.3 Top management periodically reviews the management system as a whole to
determine its effectiveness in meeting objectives and applicable requirements,

including those of our customers and those of ISO 17025. Top management
also determines whether the LMS, the quality policy, procedures, and objectives

are suitable and adequate for the organization. The Management Review

Meeting Minutes form is the control that identifies the agenda and when
complete, stands as the record of the completed review. Actions are initiated

and documented and are processed according to the D-121 Management-
Laboratory procedure.

8.7.4 Once performance levels are analyzed and management system effectiveness

has been determined, performance information and updated objectives/targets
are communicated to staff, so they understand how their performance affects the

achievement of established objectives. Communication occurs through verbal
reporting during staff meetings, via email, or on an individual basis.

9.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 12/06/21 | New procedure. N/A J. Sassman | - | - |