SOP - Saint Gobain

STANDARD OPERATING PROCEDURE
Procedure #: SOP-FLS-CORP-0032 TITLE

Revision: 1 Life Science Quality Manual
1. INTRODUCTION
Saint-Gobain Life Science sector of activity considers quality, compliance, and employee
health and safety as indispensable core values in providing safe and effective products.
Compliance is interpreted as adherence to applicable regulations, internal standards (e.g.
SOP’s, policies), and registrations for the ultimate purpose of reducing risk and ensuring
product quality. Any exclusion(s) to the standards or regulations will be documented and
justified within each individual site’s Quality Manual. For the Life Science Laboratory, there
are no exclusions to note within ISO 17025. The range of laboratory activities that are within
the scope of the ISO 17025 standard will be managed as a separate document.
Quality is measured and judged by both external and internal customers and indicates the
degree to which customers are satisfied and their objective needs, expectations, and
requirements are met. The QMS described in this Manual assures compliance with this
commitment.
The Saint-Gobain Life Science (LS) Leadership Team is accountable for the quality of the
Life Science (LS) product portfolio and for compliance to all applicable regulations. This
accountability is achieved through an effective QMS (Quality Management System).
Responsibility for the QMS is delegated to the Head of LS Quality. For sites governed by
ISO 13485, the Plant Quality Manager role is the site’s management representative. Business
leaders within Life Science are responsible for ensuring that the principles defined in the
QMS are adequately applied and resourced within their areas of responsibility.
Each plant must demonstrate ongoing compliance to the QMS by developing local Quality
Manuals based on the Life Science Quality Manual. Saint-Gobain expects that all employees
understand and actively follow the requirements of the QMS. In addition, Saint-Gobain’s
Quality Policy and Quality Vision Statement constitute fundamental inputs to the annual
Business and Quality objective setting process to cascade Quality Objectives throughout the
organization to the individual level.
2. QUALITY VISION STATEMENT
We live a culture of quality supported by a globally harmonized, ISO-based Quality

Management System.
Our Management supports employees in living our quality culture by providing appropriate
training, resources, business processes, and systems.
We foster an environment in which our employees understand and embrace their
responsibility for product quality and employee health and safety.
Page 1 of 22 Proprietary
We believe that excellence in innovation, technology, and processes are key to our
commitment of providing safe and effective products to our customers.
3. SCOPE OF THE QUALITY MANUAL
With the exception of the exclusions outlined herein, this Quality Manual contains the
requirements as outlined in ISO 13485:2016, ISO 17025:2017 and ISO 9001:2015 required to
manage the product life cycle and the end-to-end supply chain of our products, components
and laboratory services. The Quality Manual is binding for all Life Science sites and
business units manufacturing and distributing products. In addition, the QMS is binding for
all global and local functions involved in managing the end-to-end supply chain for, and
lifecycle of, the Life Science product portfolio. This includes functional groups such as
Information Systems (IS/IT), Purchasing, Human Resources, and Supply Chain Management.
4. RESPONSIBILITIES
4.1 Management: It is management’s responsibility, regardless of level, to establish

and adhere to quality and compliance standards. Senior management at LS and a
local level must:
• Establish a Quality Policy and respective Quality Manuals as guiding documents.

• Establish measurable and meaningful quality objectives and associated metrics that
aim to improve customer satisfaction.
• Establish a review process according to the Management Review Governance
Structure model (refer to Management Review Section below).
• Establish a process to share quality objectives with the employees, for example,
through the individual goal setting process.
• Ensure prompt communication, handling, and resolution of out of specification
investigations when applicable and nonconformities within their areas of
responsibility.
• Create and maintain an environment where continuous improvement and quality
decision making is recognized and rewarded.
• Provide necessary resources to maintain and continuously improve the
effectiveness of the QMS.
4.2 Senior Management:
• Provides a forum whereby exceptional decisions may be made for exceptional

situations where actions taken may be outside Standard Operating Procedures.
4.3 Quality: The Quality Unit is responsible for specific activities related to quality
oversight. The responsibilities are mandated by regulations, standards and defined
in SOPs. These responsibilities include:
• The authority and responsibility to disposition materials and products.

• Review and approve deviations and investigation reports.
• Assess and determine the need for market action.
• Approve test methods, manufacturing/packaging/ labeling records, specifications,
SOPs, change controls, and CAPAs.
• Facilitate the overall creation and maintenance of the quality system.
4.4 Analytical Services & Quality Control (ASQC): The laboratory unit is
responsible for specific activities related to the oversight of the Life Science lab.
The responsibilities are mandated by standards, defined in SOPs and / or outlined
in customer test requests. These lab responsibilities include:
• The laboratory 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. However, such relationships do not
necessarily present a laboratory with a risk to impartiality.
• The laboratory shall inform the customer in advance, of the information it intends
to place in the public domain.
• When the laboratory 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.
• The authority and responsibility to disposition all test results.
• Review and approve deviations and out of specification (OOS) investigation
reports
• Approve test methods, specifications, equipment, utilities, supplier and SOPs using
the appropriate change management system
• Facilitate the overall creation and maintenance of the operation of the lab.
• Ensure adherence to ALCOA principles following good laboratory practices and
data integrity principles as outlined in the corporate procedures
4.5 Employees: Every employee is responsible for understanding and supporting the
quality objectives and adhering to policies and procedures. It is every employee’s
responsibility to immediately act on any issue that could have an impact on
product quality and compliance. To act on means:
• Resolve issues within their control and scope of responsibility.

• Escalate issues outside their control and scope of responsibility to their superior
who in turn will consult the respective quality person or Senior Management
where applicable.
4.6 Approved Delegates: The hiring manager of every role within Saint-Gobain has
the authority to sign for that position under their management provided the hiring
manager has the appropriate qualifications, training and training record evidence
where needed. An exception to this policy is with the Quality department roles
associated with the Medical or Pharmaceutical markets. Where the Plant Quality
Manager (PQM) role is involved, any member of the PQM’s quality department
and corporate Quality are approved delegates provided the appropriate training has
occurred and has been documented if needed. For Corporate Quality roles, any
member of the corporate team can sign for the other corporate role provided he /
she has the qualifications and training.
5. DEFINITIONS
Term Definition or Abbreviation
A quality management system (QMS) is a collection of business

processes focused on achieving quality policy and quality objectives
Quality Management
to meet customer requirements. It is expressed as the organizational
System
structure, policies, procedures, processes and resources needed to
implement quality management.
A means to translate the quality policy strategies into measurable
Quality Objectives activities. What will we do to meet the goals stated in the quality
policy?
Overall intentions and directions of an organization related to quality
Quality Policy
as formally expressed by LS Senior Management.
A systematic process for the assessment, control, communication and
Quality Risk
review of risks to the quality of the product across the product
Management
lifecycle.
Term Definition or Abbreviation
Person(s) who direct and control a company or site at the highest

levels with the authority and responsibility to mobilize resources
within the company or site (ISO 9001:2015 or ISO 13485:2016
depending on the LS site; ISO 17025 for Life Science Laboratory).
Management
For the purposes of this manual, Management refers to the Plant
Manager and his/her immediate staff and the General Manager and
his/her immediate staff. LS Senior Management refers to the CEO /
President of LS and his/her immediate staff.
6. SG LS QUALITY GOVERNANCE STRUCTURE
Saint-Gobain has established a Quality Governance model to ensure transparency of quality

status and issues to all levels of leadership within the organization. Information is cascaded
upward to successively higher levels through a system of Quality Review Committees. At
each level, the quality function chairs a cross-functional Quality Committee. The committees
will be provided Quality Key Performance Indicators (KPIs) consolidated in dashboards.
Quality Management Review is covered in Management Review section below as interpreted
from ISO 17025:2017, ISO 9001:2015 or ISO 13485:2016.
To reinforce Quality Unit’s role with respect to independent oversight of operations and
facilitate an appropriate escalation process, the LS Leadership Team has established a ‘dotted-
line’ reporting structure for the Plant Quality Manager to the LS Quality Systems Manager.
7. THE QUALITY MANAGEMENT SYSTEM
7.1 Hierarchy of the Quality Manual
The LS Quality Manual defines the minimum standards required across the Life
Science organization. The Life Science Leadership Team expects all plants or
functional units to comply with this Quality Manual.
7.2 Design of the QMS
7.2.1 The QMS is designed to achieve three primary objectives:
• Achieve product realization: The QMS shall facilitate delivery of products

and services that meet the needs of customers without compromise to
quality.
• Establish and maintain a state of control: The QMS shall effectively
monitor and control process performance, product quality and service
quality.
• Facilitate continual improvement: The QMS shall support identification
and implementation of process improvements to improve consistent
delivery of products and services meeting quality requirements.
7.2.2 The QMS is made up of groups of interrelated processes that, together, support
achievement of these objectives. These processes can be grouped into the
following four categories:
• Product Realization Processes (PRP), a sequence of processes required for

successful product delivery without compromise to quality
• Measurement, Analysis and Improvement Processes (MAP), providing
monitoring of process performance and product quality / services and the
associated CAPA system
• Management Responsibility Processes (MRP), providing a framework for
management review of process performance and product quality / services
to drive continual improvement and ensure resource needs are supported,
and
• Resource Management Processes (RMP), a group of processes that ensure
provision and control of resources required to achieve quality objectives,
including the training and change management systems.
The general sequence and interrelation between the four groups and individual
processes within each group are illustrated in the QMS Process Map in Figure
1 below.
Figure 1: QMS Process Map
8. QMS PROCESSES
8.1 Management Responsibility Processes (MRP)
Saint-Gobain Life Science Management is responsible for ensuring successful

implementation and maintenance of the QMS. The Management Responsibility
Processes described below drive continual improvement and provide policies and
direction for the Product Realization and Resource Management Processes.
8.1.1 Planning and Objectives
LS Senior Management sets Quality Objectives that are aligned with the
Quality Policy and communicates them throughout the organization. Resource
needs are defined and provided to support achievement of the Quality
Objectives. Performance indicators are used to measure progress and are acted
upon as required.
8.1.2 Management Oversight and Management Review
The intent of Management Oversight and Management Review is to actively
engage, drive ownership, and hold responsible all levels of management, the
Quality Unit, and all Life Science employees in their respective responsibilities
for quality and compliance to include: reporting, action, review, and
communication. By providing the right information at the right time and at the
right level, the organization, including management, is enabled to take the right
action by recognizing and focusing on what’s important.
Proper Management Oversight and Management Review assure awareness,
provide control and drive continuous improvement in the manufacture, testing,
warehousing, and distribution of Saint-Gobain products and analytical services
through:
• Adequate identification and, as appropriate, escalation of issues;

• Assessment, reporting, review, and control measures to assure the overall
performance of the SG quality system; and
• Thorough effective communications from and to all levels of the
organization, including Senior Management and the shop floor.
Management is responsible to assure that all necessary enablers are in place to
allow for fulfillment of Management Oversight, to include the appropriate
resources, objectives and direction, organizational structures and leadership,
training, and communication forums. Additionally, Management is responsible
to assure that the Quality System is implemented and effective and to maintain
a formal Management Review process of that system.
• Quality Reporting
Quality Reporting is required for identification of events, for the tracking
and monitoring of the investigation and resolution of these events, and for
the trending and reporting of the events. This reporting occurs via our
established quality systems in accordance with procedures SOP-FLS-
CORP 0007, Event Process and SOP-FLS-CORP 0008, CAPA.
• Quality Communication and Escalation
Quality Communication occurs through a cascade of meetings from the job

board to Departmental Review meetings to Site Management Reviews and
LS Management reviews. The cascade of information flows up and down
to ensure issues are escalated and decisions are made and effectively
enforced.
In cases where there are exceptional events that require exceptional
decisions to the requirements in LS policies or plant SOPs, escalation is
made to the LS Quality Representative and Business Management.
Examples of exceptional events may be supplier issuance of Force
Majeure, risk to patient, or employee safety risk. Decisions made in this
forum are appropriately documented (e.g. event management, change
management).
• Management Review
Management Review is a formal ISO process. Management Review occurs
on three levels at SG. The first two levels of review are at the plant. The
first level review is considered a “Departmental” or “Job Board” or
“Quality Board” review. Key quality indicators are reviewed on a frequent
periodic basis (e.g. weekly/monthly). Examples of these reviews may be a
Change Board or Material Review Board.
The second level is called the Site Level QMR. Performance and trending
information related to the key quality systems elements are prepared in a
meaningful manner such that the health of individual quality system
elements can be determined, that product and process related trends can be
identified and most importantly, that actions can be identified and taken to
remedy any issues. The following quality indicators are included in the
scope of the Site QMR depending on the ISO certification that applies to
the LS site or laboratory:
 extent to which the quality objectives have been met (fulfillment of
objectives)
 changes in internal and external issues
 suitability of policies and procedures
 training
 monitoring and measuring of processes or process performance
 monitoring and measuring of products or conformances of products
 deviations (product nonconformities)
 complaints & handling
 customer satisfaction and feedback from relevant parties (e.g.

personnel)
 maintenance & calibration
 audits (internal & external including assessments from external bodies)
 corrective actions
 preventive actions
 reporting to the regulatory authorities (where applicable)
 performance of external providers
 adequacy of resources
 the effectiveness of actions taken to address risks and opportunities
 results of risk identification
 outcomes of the assurance of the validity of results
 changes in the volume and type of work or in the range of laboratory
activities
 changes that could affect the QMS
 recommendations (opportunities) for improvement
 applicable new or revised regulatory requirements
 status of actions from prior Management Reviews.
The third level of Management Review is the LS Management level. This

review consists of the leaders with oversight at a business level and
includes the Business Managers, Operations Directors, Application
Engineering Management, R&D Management and LS Quality
Management. This review is a roll up of key information from the Site
QMRs as appropriate. This review evaluates the overall performance of
the Life Science quality system and product and process quality
performance. Decisions for necessary actions are made at this level
including alignment on areas of highest risk, resources, and priorities.
Actions necessary to mitigate risks are determined and the LS Quality
Objectives are evaluated for necessary adjustments. Large capital
expenditures and strategic resource necessary to address the LS Quality
Objectives are identified at this level for input to the LS Strategic Plan and
Budget Plan.
Minutes of all three Management Reviews should be maintained by the
Quality Lead of the meeting and action items are tracked and monitored in
the CAPA system where appropriate.
8.1.3 Continual Improvement
Meaningful Quality Objectives, appropriate resource planning, and the

management review process drive continual improvement. Management
objectives are reviewed and established annually to identify areas of focus for
performance improvement and effective execution for the following year.
8.2 Resource Management Processes
8.2.1 Personnel Competence and Skills

Saint-Gobain and contracted employees shall have the education, documented
training, and/or experience to perform their job duties. A job description is
used for documenting what the required knowledge, skills, and abilities are for
each function within the organization. An individual’s training needs are
determined by Management according to the knowledge and skills required to
perform a specific job function. Site level training procedures describe the
organization of, requirements for, and implementation of training and
development for Saint-Gobain and contract employees.
Management and/or designated trainers evaluate training competency through
activities such as on-the-job observation, employee performance reviews, and
customer feedback (internal & external). Training records shall be maintained
to document training appropriate to the job function has been performed.
8.2.2 Facilities, Equipment, and Work Environment
• Facilities are designed to be of a suitable size, construction, and

classification to facilitate efficient and clean manufacturing operations to
conform to product requirements. Procedures are in place to meet ISO and
GMP (as applicable) requirements including room classification, pest
control, material and personnel flow, sanitation, and maintenance according
to the LS Engineering Standard, ENG-FLS-CORP-0021, Cleanroom
Control Program. Utilities are designed, controlled, and maintained
according to SOPs to support product quality.
Commissioning, validation, implementation, subsequent changes to, and
decommissioning of ISO or GMP facilities and utilities are managed
through Saint-Gobain’s Change Management Program, SOP-FLS-CORP-
0009, Change Management. Requalification is performed as required
according to the SOP-FLS-CORP-0001, Validation Master Plan.
• Environmental, Health, and Safety (EHS) procedures are in place to

promote the health and well-being of personnel at SG facilities, and to meet
regulations by agencies such as OSHA, EPA, ISO, and local ordinances.
Processes are in place to identify and monitor exposure limits to hazardous
materials and products. Safety Data Sheets (SDS) sheets are maintained in
an appropriate system at the LS plants to be readily accessible. Safety
orientation is conducted for all contractors, new SG employees, and
visitors.
• Equipment, computerized systems, and software that supports production

processes and facilitates business processes (e.g. QAD, Factivity, eQMS,
etc.) are qualified for their intended use according to SOP-FLS-CORP-
0001, Validation Master Plan. Implementation and subsequent changes to
these systems are controlled through SG’s Change Management Program.
• Equipment is protected from damage and deterioration. Preventive

maintenance activities are planned and performed to maintain process
capability and optimize availability for production. Maintenance activities
are managed through a work order system. Calibration is managed and
documented and if limits are exceeded, appropriate actions are taken to
assess validity of previous measuring results utilizing the Event Process,
SOP-FLS-CORP-0007. Damaged or deteriorated equipment is removed
from use until repaired. Maintenance to equipment is made by qualified
personnel. In the event equipment that was utilized in the manufacturing
process is found to be defective, a product impact assessment will occur
and appropriate actions taken and documented according to SOP-FLS-
CORP-0007, Event Process.
8.3 Product Realization Processes
8.3.1 Product and Process Development

The Research & Development, Application Engineering, Advanced Concept
Engineering, or plant-based technical departments are responsible for
developing new materials, new applications to existing materials, new
processes, and new engineered systems. Development activities, methods, and
data are appropriately documented to enable ongoing support of product
manufactured at Saint-Gobain. A stage/gate process coupled with the Design,
Development and Change Control Checklist are employed in support of the
development process following SOP-FLS-CORP-00009, Change Management.
8.3.2 Technology Transfer and Commercial Launch Preparedness

Saint-Gobain ensures that products, processes, and technology transfers to
commercial production will meet the requirements of our customers and
regulatory requirements through our Validation Program. The Validation
Master Plan and Design, Development and Change Control Checklist describe
the process and requirements for a technology transfer.
Commercial launch readiness from R&D projects is ensured through a
systematic review and Design, Development and Change Control Checklist
executed in the HPS (High Performance Solutions) Gate process at Gate 5.
This is executed within the R&D database or other applicable site level
procedure and tool by a Technical Project Leader. Both Regulatory Affairs
and Quality Assurance have review and approval roles in this process.
8.3.3 Production Planning and Purchase/Receipt of Starting Materials
The Supply Chain organization is responsible for forecasting customer demand
and putting in place both short and long-term feasible production plans based
upon customer forecast data provided by the Marketing & Sales organization.
Additionally, Supply Chain is responsible for forecasting long-term capacity
requirements and alerting management to deficiencies. Saint-Gobain
purchases starting materials that meet company (Internal Controls Reference
Framework), Pharmacopoeia (USP, NF, EP, etc.), or agreed upon
specifications as defined in material specifications, purchase orders, and
Quality Agreements (where applicable). Materials are inspected upon receipt
and stored in appropriately qualified access-controlled areas under designated
storage conditions to maintain the quality and integrity of the materials.
Procedures are established for handling damaged, mishandled, or incorrectly
labeled materials. Materials that have not yet been tested and released are
quarantined from released materials. Labeling and ERP are used as the
primary means for quarantining nonconforming materials. Where physical
space is available, separate areas are designated for physical storage of
nonconforming materials.
A supplier management program is in place according to SOP-FLS-CORP-
0032, Supplier Quality Management, to ensure the quality of goods and service
provided to SG, and is described in the Measurement, Analysis and
Improvement Processes section.
8.3.4 Material Testing/Inspection and Release to Production
All starting materials undergo inspection and release according to established

procedures and material specifications. Depending on the material and
specification, some may undergo testing. Only starting materials from
approved suppliers that meet pre-determined specifications and have been
approved for use by Quality may be used in Production. The material handlers
assign released starting materials to production according to a system of first
in-first out. Exceptions to this from specific customers are handled on a case-
by-case basis. Inventories are managed through an ERP system (e.g. QAD),
and are reconciled for each material.
8.3.5 Finished Product Testing
Commercial product manufactured and released by SG undergoes finished
product inspection and for some products, testing according to established
specifications. This testing may be performed by SG or by a contracted
laboratory. Finished product testing (e.g. lot release testing) is performed by or
contracted by SG, a certificate of analysis is issued for conforming product or
the test reports are forwarded along with a certificate of conformance. For
product that does not have testing performed, a certificate of conformance is
issued stating the lot has been manufactured in accordance with approved
procedures and specifications.
8.3.6 Product Release
The completed batch record for each product manufactured at SG consists of
the executed manufacturing record and/or production router, as well as any
relevant forms, system printouts, material CoA’s, and reference to any
deviation investigation(s). The completed batch record is reviewed by Quality
for completeness, accuracy, and conformance to SOPs, manufacturing
instructions, and specifications for all product manufactured for regulated
industries. Conforming batches are released with a Certificate of Conformance
(CoC) stating that the batch was manufactured in accordance with the sites’
QMS.
8.3.7 Distribution
Finished product is stored in controlled warehouse environments if required in
the storage requirements. Distribution records are maintained to ensure
traceability should a recall or other market action become necessary.
Procedures are in place describing the requirements for market action should
this become necessary. Agreements are in place with distributors of SG
product that ensure cooperation and participation as necessary when market

actions are undertaken. SOPs govern the handling and destruction of returned
goods.
8.3.8 The following controls are in pace to support the production realization
process:
• Identification and Traceability

Procedures ensure that identification of raw materials, components, and in-
process product is maintained from receipt, through manufacturing and
packaging, to release, warehousing and distribution. Where required, the
use, cleaning, and maintenance of production equipment and areas are
documented in site specific SOPs for traceability. Procedures are also in
place to ensure the identification of test samples from receipt through
proper disposal.
• Validation Program
Validation is defined as the collection and evaluation of data, from the
process design stage to process discontinuation, with established scientific
evidence that a process is capable of consistently delivering quality
products. Validation activities at SG are conducted using a lifecycle
approach in four stages:
Figure 2: Validation Lifecycle
Process Process Process Process

Design Qualification Monitoring Discontinuation
o Process Design consists of building and capturing process knowledge,

understanding and developing the strategy, and rationale for process
control.
o Process Qualification confirms that the Process Design is capable of
reproducible commercial manufacturing.
o Process Monitoring ensures that the process remains in a state of
control during the operation of the system or manufacturing of product
through review, trending, and analysis of relevant data, such as system
performance, process changes, raw material changes, and process

deviations.
o Process Discontinuation is the removal of commercial product from
the SG portfolio and inactivation of the related documents.
• Monitoring & Measuring Equipment

Measuring equipment is controlled, calibrated, and maintained. Equipment
is uniquely identified and records are maintained that document the results
of each calibration where calibration is required. Calibration of measuring
equipment employs standards traceable to NIST, ASTM, or other
appropriate standards.
Where required, monitoring and measuring equipment is documented in
site specific SOPs for traceability.
• Warehousing
Raw materials, components, in-process product, and packaged finished
goods are stored and transported to meet label requirements and customer
specifications to ensure quality and integrity of the material or product is
maintained throughout the shelf life. Warehouses are secure and access
controlled, minimally by controlled access to the plant. Environmental
conditions are monitored as appropriate. Inventory remains traceable from
receipt through shipping or destruction. Appropriately segregated storage
areas are used where appropriate.
• Product Destruction
SOPs describe the requirements for handling and destruction of production
waste, laboratory waste and finished goods to ensure conformance to GMP,
EPA, and Foreign Trade Zone requirements.
• Control of Non-Conforming Product

Deviations and non-conformances are identified, investigated, and
documented according to SOP-FLS-CORP-0007, Event Process. Non-
conforming product is withheld from use until appropriately dispositioned.
Root cause is investigated and corrective and/or preventive actions
(CAPAs) are implemented when appropriate.
• Customer Complaints/Satisfaction
The LS Leadership Team and site Management Teams monitor customer

satisfaction through indicators such as on-time delivery, backorder levels,
customer complaints, customer returns, customer surveys and customer-
related corrective actions.
Procedures are established for handling and investigating product
complaints. Required notifications are made within established timeframes
to meet regulatory reporting requirements and customer Quality
Agreements. A product complaint may be received in different ways to
different employees. If an employee receives a product complaint via
email, phone or other mode of communication, they must report it to
Quality as soon as they become aware of it.
• Audits and Data Analysis

o Internal Audits
The performance of the QMS is measured according to site internal
audit procedure with regular and systematic independent internal audits
conducted by qualified auditors. The audit program uses a risk-based
approach to determine frequency and depth of audits of each system or
process.
o A supplier management program is in place to assure the control of
external providers and the quality of materials used in the
manufacturing of products. The scope of the supplier management
program includes all suppliers of goods and services to SG, including
third-party contract manufacturers, materials, components, calibration
and testing services, and sister sites. Assessment of suppliers may
include paper assessments, review of regulatory or ISO inspection
results, and/or an on-site audit. The supplier management program is
described in SOP-FLS-CORP-0032, Supplier Quality Management.
• Monitoring & Measurement of Product

Product is measured and monitored on a batch basis primarily through
inspection by Quality Control and is documented in the batch record or
production router. Product is monitored under the Management Review
process by trending events (e.g. nonconforming material, product
complaints, and audit nonconformances).
• Environmental Monitoring
In Life Science facilities with an ISO classified cleanroom, the
environmental monitoring program is managed and governed according to
LS Engineering Standard ENG-FLS-CORP-0018, Environmental
Monitoring Program. Monitoring data reviewed includes viable and non-
viable particulate, temperature, humidity, and differential pressure.
Compressed gases and facility water systems are also reviewed.
• CAPA System
SG ensures that appropriate, timely corrective action is taken whenever
systemic, major or critical non-conformities are discovered, and when
preventative actions are identified. CAPAs are the means by which formal
action is taken to address causes(s) (root, probable, or contributing) of any
event (examples include deviations, trends, audit observations, and
complaints).
SG utilizes either an electronic QMS software tool or a manual, paper-
based system to document CAPAs. The effectiveness of CAPAs is
reviewed and documented within the same system.
Corrective and Preventive actions which have the potential to impact the
following examples are within the scope of the CAPA system: product
registration, GMPs where applicable, product attributes, the state of
validation of processes, equipment, instruments, facilities (design or
cleanliness), record control, production and process controls, validations
and systems.
8.4 QMS enablers
In order to support an effective and successful QMS, Saint-Gobain has established

policies and procedures relating to data integrity, documentation practices, risk
management and knowledge management.
8.4.1 Data Integrity
Saint-Gobain policy SOP-FLS-CORP-0030, Policy on Data Integrity, outlines
the key elements necessary to help ensure the reliability and integrity of
information and data throughout all aspects of a product's lifecycle.
Data integrity is the extent to which all data are complete, consistent, and
accurate throughout the data lifecycle. Ensuring data integrity means
collecting, documenting, reporting, and retaining data and information in a
manner that accurately, truthfully and completely represents what actually
occurred.
Employees shall adhere to established company procedures that describe
documentation control and retention requirements, such as SOP-FLS-CORP-
0012, Good Documentation Practices for Validation Activities, and SOP-FLS-
CORP-0031, Good Documentation Practices.
8.4.2 Quality Risk Management
Saint-Gobain Corporate Policy SOP-FLS-CORP-0010, Quality Risk
Management Policy, provides the model for risk management that is used at
SG. Each site is expected to have a Risk Management Plan in alignment with
the policy and implement the identified risk management practices into the
sites Quality System Elements (e.g. CAPA, Change, Validation, etc.)
8.4.3 Knowledge Management
It is important to manage product and process knowledge throughout the
product lifecycle. Mechanisms and examples of documents contributing to
knowledge management and transmission at SG include:
• Product development studies

• Technology transfer documentation
• Process validation studies
• Raw material and finished product testing data
• Manufacturing history (executed batch records)
• Stability studies
• QMS data
o Investigations
o CAPA
o Change controls
o Complaint reports
o Deviations
• Trend evaluation and reporting in Management Reviews

• Supplier audits
• Supplier Management dossiers

• Internal audits
• Employee training curricula
• Laboratory records
9. CROSS REFERENCES
Document Number Document Title

SOP-FLS-CORP-0012 Good Documentation Practices for Validation Activities
SOP-FLS-CORP-0001 Validation Master Plan
SOP-FLS-CORP-0010 Quality Risk Management Policy
ENG-FLS-CORP-0021 Cleanroom Control Program
SOP-FLS-CORP 0008 CAPA
SOP-FLS-CORP-0009 Change Management
SOP-FLS-CORP-0007 Event Process
SOP-FLS-CORP-0032 Supplier Quality Management
ENG-FLS-CORP-0018 Environmental Monitoring Program
SOP-FLS-CORP-0030 Policy on Data Integrity
SOP-FLS-CORP-0031 Good Documentation Practices
10. EXTERNAL REFERENCES
• ISO 9001:2015 (E) Quality management systems—Requirements

• ISO 13485:2016 (E) Medical Devices – Requirements for Quality Management Systems –
Requirements for Regulatory Purposes
• ISO 17025:2017 (E) General Requirements for the Competence of Testing and Calibration
Laboratories
• ICH Q10 Pharmaceutical Quality System, International Conference on Harmonization of
Technical Requirement for Registration of Pharmaceuticals for Human Use
11. ATTACHMENTS
None
12. APPENDICES
None
13. FLOW CHARTS
None
14. DIAGRAMS
None
15. REVISION INFORMATION
Page(s)
Revision Revision Date Revision Description
Affected
0 January 31, 2017 All Original Issue
Updated title. Added in designation of management
representative for ISO 13485 registered sites. Added
ISO 13485 and 17025 to external references section
and requirements where needed throughout document.
Added in management review inputs from ISO 13485
and 17025. Updated product realization section to
include new Design, Development and Change Control
1 14 Jan 2019 All
Checklist. Clarified primary means of quarantining
product throughout LS. Added Prepared By signature
in approval section and remove General Manager role.
Updated titles to align with organizational change.
Removed Quality Policy since it is controlled as a
standalone document. Added Approved Delegates to
Responsibilities section.
16. PROCEDURE APPROVAL SIGNATURES
Prepared By Job Title Date

Approved
Genine Dale
Worldwide Quality System Manager
Approved by Job Title Date
Approved
Ernst Breinig
LS Operations Director
Jim Ding
LS R&D Director
Polly Hanff
LS Global Regulatory Affairs & Quality Director

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STANDARD OPERATING PROCEDURE

Procedure #: SOP-FLS-CORP-0032 TITLE

2. QUALITY VISION STATEMENT

We live a culture of quality supported by a globally harmonized, ISO-based Quality

3. SCOPE OF THE QUALITY MANUAL

4.1 Management: It is management’s responsibility, regardless of level, to establish

• Establish a Quality Policy and respective Quality Manuals as guiding documents.

4.2 Senior Management:

• Provides a forum whereby exceptional decisions may be made for exceptional

• The authority and responsibility to disposition materials and products.

• Resolve issues within their control and scope of responsibility.

Term Definition or Abbreviation

A quality management system (QMS) is a collection of business

Term Definition or Abbreviation

Person(s) who direct and control a company or site at the highest

6. SG LS QUALITY GOVERNANCE STRUCTURE

Saint-Gobain has established a Quality Governance model to ensure transparency of quality

7. THE QUALITY MANAGEMENT SYSTEM

7.1 Hierarchy of the Quality Manual

7.2.1 The QMS is designed to achieve three primary objectives:

• Achieve product realization: The QMS shall facilitate delivery of products

• Product Realization Processes (PRP), a sequence of processes required for

Figure 1: QMS Process Map

8.1 Management Responsibility Processes (MRP)

Saint-Gobain Life Science Management is responsible for ensuring successful

• Adequate identification and, as appropriate, escalation of issues;

• Quality Communication and Escalation

Quality Communication occurs through a cascade of meetings from the job

 customer satisfaction and feedback from relevant parties (e.g.

The third level of Management Review is the LS Management level. This

Meaningful Quality Objectives, appropriate resource planning, and the

8.2.1 Personnel Competence and Skills

8.2.2 Facilities, Equipment, and Work Environment

• Facilities are designed to be of a suitable size, construction, and

• Environmental, Health, and Safety (EHS) procedures are in place to

• Equipment, computerized systems, and software that supports production

• Equipment is protected from damage and deterioration. Preventive

8.3.1 Product and Process Development

8.3.2 Technology Transfer and Commercial Launch Preparedness

All starting materials undergo inspection and release according to established

product that ensure cooperation and participation as necessary when market

• Identification and Traceability

Figure 2: Validation Lifecycle

Process Process Process Process

o Process Design consists of building and capturing process knowledge,

performance, process changes, raw material changes, and process

• Monitoring & Measuring Equipment

• Control of Non-Conforming Product

The LS Leadership Team and site Management Teams monitor customer

• Audits and Data Analysis

• Monitoring & Measurement of Product

In order to support an effective and successful QMS, Saint-Gobain has established

• Product development studies

• Trend evaluation and reporting in Management Reviews

• Supplier Management dossiers

Document Number Document Title

10. EXTERNAL REFERENCES

• ISO 9001:2015 (E) Quality management systems—Requirements

13. FLOW CHARTS

15. REVISION INFORMATION