QUALITY MANUAL

Authorized By: Date:

________________________________________________ __________________________
Chuck Kummeth, Chief Executive Officer/President

________________________________________________ __________________________
James Hipple, Chief Financial Officer

________________________________________________ __________________________
Kevin Reagan, Sr. VP Biotech

________________________________________________ __________________________
Marcel Veronneau, Sr. VP Clinical Controls Division

________________________________________________ __________________________
Diane Wotta, Sr. Director of Quality and Regulatory Affairs

540308.15
 Number: 540308
Revision: 15
Supersedes:540308.14
Section: 1.1
QUALITY MANUAL Page: 1 of 1
Revision Date: 7/28/14

SECTION TITLE: CONTENTS

TABLE OF CONTENTS
Section 1
1.1 Page 1 Table of Contents
1.2 Page 2 Quality Policy
1.3 Page 3, 4 Company Profile

Section 2
Quality System Requirements:
2.1 Page 5, 6, 7 Management Responsibilities
2.2 Page 8 Quality Audits
2.3 Page 9 Personnel
2.4 Page 10 Design Controls
2.5 Page 11 Document Controls
2.6 Page 12 Purchasing Controls
2.7 Page 13 Identification and Traceability
2.8 Page 14, 15 Production and Process Control
2.9 Page 16 Acceptance Activities
2.10 Page 17 Non-Conforming Product
2.11 Page 18 Corrective and Preventive Action
2.12 Page 19 Statistical Techniques
2.13 Page 20 Labeling and Packaging Control
2.14 Page 21 Material Handling, Storage and Distribution
2.15 Page 22 Records

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Section Title: Quality Policy Section: 1.2
Page: 1 of 1
Revision Date: 7/28/14

R&D Systems Inc. Quality Policy:

R&D Systems is committed to the highest level of quality in the manufacture, sale and support of
our products. Product quality, compliance to all applicable regulatory requirements, continuous
improvement and customer satisfaction shall underlie all of our efforts in development,
manufacturing, advertising, sales, shipping and technical support.
Definitions:
Quality: the totality of features and characteristics that bear on the ability of a product to
satisfy fitness for use, including safety and performance (§ 820.3 (s)).
Quality system: the organizational structure, responsibilities, procedures, processes and
resources for implementing quality management (§ 820.3 (v)).
Assurance of quality and integrity are the responsibility of:
1. the Chief Executive Officer (CEO), who has responsibility for creation of an atmosphere of
high standards;
2. the officers, directors, managers and supervisors, who are charged with development and
implementation of quality systems; and
3. each employee, who is responsible for the quality of his or her work and for suggesting
quality improvements.
This Quality Manual is the top tier of our documentation system. It provides an overview of our
Quality System. It is supported by corporate and division standard operating procedures (SOPs)
which represent the second tier of our Quality System documents. Relevant SOPs are listed in
this Quality Manual. The third tier of the documentation system consists of
manufacturing/testing documents, forms and specifications developed by each operating unit.
Our policies are in conformance with the applicable requirements of the Code of Federal
Regulations (21 CFR) Quality Systems Regulations for Medical Devices; ISO 13485 Standard:
2003, ISO 9001 Standard: 2008, the In Vitro Diagnostic Directive 98/79 EC and the Canadian
Medical Device Regulations.
Sections of the ISO 13485 Standard which do not apply to R&D Systems are as follows:
Section 7.5.1.2.3 - Service activities (Reason: Applicable to equipment)
Section 7.5.1.2.2 - Installation activities (Reason: Applicable to equipment)
Section 7.5.1.3 -
Section 7.5.2.2 -
} Particular requirements for sterile medical devices (Reason: No claim of
Section 7.5.3.2.2 - product sterility)
Section 8.2.4.2 - Particular requirements for active implantable devices (Reason: No
implantable devices)
Related Procedures:
540007 Canadian Medical Device License, Establishment License and Quality System
Certification
540120 Required Standards Listing, Maintenance and Review
541347 Continuous Improvement

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Section Title: Company Profile Section: 1.3
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R&D Systems was founded in 1976 in Minneapolis, MN. It is a wholly owned subsidiary of
TECHNE Corporation (a holding company with no employees). In July 2014, TECHNE was
renamed as Bio-Techne. The stock is traded publicly on NASDAQ’s National Market System
under the “TECH” symbol. Bio-Techne has two operating subsidiaries: R&D Systems, Inc.
(RDSI) and R&D Systems Europe Ltd. (RDSE).
RDSI has two operating divisions: Biotechnology, which manufactures reagents primarily for
the research market, and Clinical Controls, which manufactures controls and calibrators for
chemistry (Bionostics) and hematology (R&D Systems) analyzers. The Bionostics
manufacturing facility, located in Devens, MA is certified to ISO 13485:2003. Their ISO
Certificate number is FM547845.

The Minneapolis manufacturing facility is certified to ISO 9001:2008 and ISO 13485:2003.
Their ISO Certificate numbers are FM547845 and FM547846, respectively.
In 2005, RDSI purchased BiosPacific, which became a wholly owned subsidiary. BiosPacific is
located in Emeryville, CA and consists of a sales force which provides raw materials for
development of immunoassay kits. BiosPacific received ISO 9001:2008 certification in 2011.
Their ISO Certificate number is FM574663.
In 2011, RDSI purchased Boston Biochem in Cambridge, MA. It became a wholly owned
subsidiary.

In 2014, RDSI purchased ProteinSimple and Novus Corp. ProteinSimple manufactures

instruments for running Western blots and Novus manufactures antibodies. Both of these
businesses complement the existing RDSI product lines.
RDSE in Abingdon, England distributes Biotechnology research reagents and is the European
Representative for the Biotech Division. They received ISO 9001:2008 certification in July
2007. Their ISO Certificate number is 951 07 4360. EuroCell Diagnostics, Village de la
Metairie Batiment B, 35131 Chartes de Bretagne is the European Representative for the Clinical
Controls Division.
RDSE acquired Tocris Holdings Limited in April 2011. Tocris Holding Limited is a Bristol, UK
based manufacturer of biologically active chemical reagents. RDSE also has two sales
subsidiaries, R&D Systems GmbH, in Wiesbaden, Germany and R&D Systems France in Lille.
RDSI established a wholly owned subsidiary in the People's Republic of China in May 2007.
R&D Systems China Co. Ltd. (RDSA) opened its Warehouse and Distribution Center in
Shanghai on October 1, 2007 and in Hong Kong in February 2011. RDSA provides products,
marketing and technical support to our Asian distributors and directly to major customers. In
April 2014, RDSA acquired PrimeGene, which manufactures proteins for sale in China.

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Section Title: Company Profile Section: 1.3
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R&D Systems’ physical plant in Minneapolis currently occupies approximately 600,000 square
feet of laboratory, manufacturing, shipping and office space as of July 1, 2014. Bio-Techne
Corporation and subsidiaries had 1293 full- and part-time employees as of July 1, 2014.

Bio-Techne Organization
RDS Asia PrimeGene
Shanghai, PRC Shanghai, PRC
31 Employees 45 Employees

Bionostics, Inc,
Devena, MA
102 Employees
R&D Systems, Inc.
Minneapolis, MN
680 Employees
Boston Biochem
Cambridge, MA
11 Employees
Novus Biologicals
Littleton, CO
75 Employees
BiosPacific
Emeryville, CA
Bio-Techne Corporation 7 Employees
ProteinSimple
(TECH)
Santa Clara, CA
Minneapolis, MN
208 Employees RDS GmbH
No Employees
Wiesbaden, DE
10 Employees
R&D Systems. Europe
Abingdon, UK
67 Employees
RDS France
Lille, FR
2 Employees
Tocris Bioscience
Bristol, UK
55 Eployees

This Quality Manual applies to the manufacturing and distribution operations at RDSI in
Minneapolis, MN.

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Section Title: Management Responsibilities Section: 2.1
Page: 1 of 3
Revision Date: 7/28/14

Quality is the responsibility of each employee throughout our organization.

Management is responsible for communicating our Quality Policy to all employees and for ensuring full
understanding of, and commitment to, quality.
• The CEO has executive responsibility for the Quality System and is responsible for creating an
atmosphere where quality is the highest priority.
• The Vice-Presidents are responsible for overseeing the development, implementation and
maintenance of the Quality System.
• The Director of Quality and Regulatory Affairs (QC/QA/RA) has been appointed as the
Management Representative by the company president and has responsibility for ensuring that
quality requirements are effectively established and maintained in accordance with the appropriate
regulations and for reporting on the Quality System to upper Management.
• The Director of QC/QA/RA, the Vice-Presidents CCD and Biotech, and the Quality Assurance (QA)
staff are responsible for ensuring that our Quality System is fully maintained and implemented.
• Each director, manager and supervisor is responsible for ensuring that Quality Systems are followed
in his or her area.
• Each employee is responsible for following quality systems guidelines and for the quality of his or
her work.
Two groups are dedicated exclusively to Quality:
1. Quality Assurance (QA) assists operating departments in the development of quality systems and
conducts periodic audits to ensure that those systems are implemented faithfully and effectively.
Quality Assurance has the responsibility to:
• identify and evaluate quality-related problems;
• recommend solutions to quality problems and verify that any problems have been resolved
(corrective actions);
• initiate actions to prevent the occurrence of quality problems (preventive actions);
• control non-conforming products until corrective action has been taken;
• set quality goals and objectives for the company and develop plans to meet those goals and
objectives;
• report to Management on quality-related issues.
The Quality Assurance Department is responsible for quality systems, but implementation of these
systems and quality per se is the responsibility of each director, manager, supervisor and employee.

2. Quality Control (QC) inspects and tests products at all stages of the manufacturing process, from raw
materials to finished goods. QC Management has responsibility for product release against
predetermined specifications. The Biotech QC Departments report to the Director of QC/QA/RA.
The following charts describe the organizational and functional structure of the Company. While the
structure and organization of the Quality function varies between the two divisions of R&D Systems,
their goals are identical.
Related Procedures:
540009 Management Quality Systems Review Procedure
541138 Quality Assurance Organization
541614 Quality Planning

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Quality Systems Flow Chart

Continual improvement of the quality management system

Management
responsibility
Customers Customer

Measurement
Resource analysis and
Requirements management Feedback
improvement

Product Realization Product

Input Output

Quality Control

Manufacturing
Operations

Research and
Development

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R&D SYSTEMS, INC.

Department Organization

Chief Executive Officer/

President

Sr.Director, Sr Director Sr.VP Biotech

Sr. VP Clinical VP Finance & Chief VP of Sales & Business Quality and Human Division
Controls Division Financial Officer Marketing Development Regulatory Resources
Affairs
Cell Culture Antibody
(Management
Facilities Development Technology
Quality Raw Material Biotech Technical Representative)
Control Manufacturing Marketing Service
IT Cell Culture Protein Purification
Technical Bioassay QA/RA
Laboratory Manufacturing
Accounting Biotech Service Antibody Development
Sales QC/ Development
Product BiosPacific Safety
Shipping Microbiology New Technologies
Finishing
Antibody and Data
Hematology Operations Molecular Biology
Marketing/Sales
Research
Enzymes
DuoSet/Multi-Plex
Protein Development
Development
Conjugation
Stem Cell
Product Support
Biomarker Testing
Service Product Finishing

Manufacturing
Farm
Shipping

Effective 7/1/14

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Section Title: Quality Audits Section: 2.2
Page: 1 of 1
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Periodic audits ensure adherence to our Quality System and identify areas for continuous
improvement.

Internal Quality System audits are performed by the Quality Assurance staff or by other trained
personnel under the guidance of Quality Assurance. Results of audits are reported to the CEO,
the Director of QC/QA/RA, the appropriate Vice President, and the operating units involved. It
is the responsibility of those units to develop corrective actions, to correct deficiencies and to
present evidence of correction.

Vendor audits are performed by Quality Assurance staff on an as-needed basis.

Other Quality System effectiveness checks are made by department managers and senior
management, through periodic review of product complaints, non-conforming material
tracking/trending and material review board meeting minutes.

To ensure that the Quality System is effective and relevant, it is reviewed annually by the Senior
Management Team, the Director of QA/RA, the Regulatory Affairs Manager and other
managers, as appropriate. The agenda for the meeting is written by Quality Assurance based
upon audit results and other outstanding issues related to the Quality System and product quality.
Minutes from the meetings are distributed to those present at the meeting as well as any
designees who are absent from the meeting. A copy of the agenda and meeting minutes are
maintained on file in Quality Assurance.

Related Procedures:

Corporate
540009 Management Quality Systems Review Procedure
541131 Quality Meetings
540167 FDA Inspection Procedure
540291 Internal Audit Procedure
540335 Vendor Audit Procedure
540552 Corrective and Preventive Action
541347 Continuous Improvement
Biotechnology
540135 Customer Feedback System, Biotech
540259 Material Review Board Responsibility Procedure
540550 Quality Assurance Role in the RDS-BTS Laboratory
CCD
6016 Material Review Board Procedure
8034 Technical Service Protocol/Complaints

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Section Title: Personnel Section: 2.3
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It is our policy to hire only qualified personnel and to ensure that they are trained in all aspects of
their jobs.

Copies of job descriptions, job applications, resumes and annual performance reviews are kept
on file in the Human Resources Department.

The Company has a Quality System training program (including the applicable requirements of
ISO 9001, ISO 13485 and 21 CFR 820), conducted by Quality Assurance, which all employees
are required to complete. Upon satisfactory completion of this training by an employee, a
certificate of completion is given to the employee’s supervisor. Quality Assurance maintains a
master log of all certificates of completion issued. Ongoing training, as necessary, ensures
personnel are familiar with applicable requirements.

The Company has provided ISO 13485/CMDR, cGMP and risk analysis training to Managers
and Directors responsible for the manufacture and testing of our products. It is the responsibility
of these trained employees to ensure that all of their employees are familiar with the pertinent
aspects of these regulations.

Regulatory Affairs ensures that the latest revisions all pertinent Standards are available. When
revisions are available, this is communicated to Quality Assurance and other pertinent personnel
so that we can keep up-to-date on the latest regulations and Standards.

Each department maintains job-specific training records for its employees. Supervisors are
responsible for job-specific training, for training on new or revised documents, for ensuring that
training is effective and for maintaining training records. Notification of document changes is
issued as a trigger for training.

Related procedures:

540189 Personnel Training Procedure

540816 Procedure for Generating Personnel Training Reports
540120 Required Standards Listing, Maintenance and Review

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Section Title: Design Controls Section 2.4
Page: 1 of 1
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We have different Design Controls for different types of products. In general, they cover the
following points.

1. Approval of the design goals (Design Input)

2. Review of feasibility studies (Design Review)
3. Approval of the product description (Design Output)
4. Review of process development and preparation of manufacturing documents (Design
Verification Review)
5. Review and approval of product validation (Final Design Review/Data Review)
6. Transfer to manufacturing

The specific procedures for the different product lines are referenced below.

Related Procedures:

Biotechnology
540045 Definition of Product Design Goals for Assay Development
540323 Design Control, Protein Products
540266 Validation Master Plan
540215 Specific Immunoassay Validation Procedures (i.e., Linearity, Precision, etc.)
540217 through 540221, 540223, 540235 - 540238, 540288, 540337, 540409, 540729,
540804, 541002 and 541273

CCD
6009 Procedural Elements in a Validation
6009A Testing Protocol Request
3421 Procedure for Developing Operational Procedures
6015 Product Introduction/Product Improvement Procedure
6015A Design Control and Transfer Worksheet
6039 Product Development Request Form
6026 Design Input
6027 Design Output
6040 Design Review Procedure

Corporate
540819 Risk Management
540325 Design Control

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Section Title: Document Controls Section: 2.5
Page: 1 of 1
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To ensure consistent quality, we use written, approved procedures for all operations. The
Document Control and Quality Assurance departments or their designee(s) are responsible for
controlling the issue, distribution, revision and archiving of these procedures.
The documents that must be controlled include:
The Quality Manual and Quality Systems SOPs
Device Master Records
Internal Audit Reports
Standard Operating Procedures
Manufacturing Procedures
Testing/Inspection Procedures and Specifications
Calibration and Maintenance Records
Device History Records
Design Control Records
Forms
Data from BTS Studies
Essential Requirements and Technical Document Indexes
Biotechnology uses a formal Document Change Request (DCR) procedure for creating new
documents and revising existing documents. It involves review and approval by multiple
departments generally including a technical department, the affected department and the Quality
Assurance department. The Clinical Controls Division initiates formal Document Control in
each Department. The Department Supervisor reviews a draft with assistance from designated
individuals.
Related Procedures:
Corporate
540643 Standard Operating Procedure (SOP) Review Procedure
540578 Record Keeping Guidelines
540146 Creating a Document
540748 MasterControl™ Electronic Documentation System
540750 MasterControl™ Functions
Biotechnology
540205 Document Change Request (DCR) Procedure
540382 Preparation & Maintenance of Document Master Files
540532 Data Management: General Procedures & Definitions (BTS Lab)

CCD
3007 New and Updated Procedure Protocols
3008 Manufacturing Procedure Format
6005 Document Organization (Document Control)
3421 Procedure for Developing Operational Procedures
6006 Updating the Device Master Record (DMR)
6030 Format for "Product Description/Device Specifications" Documents
6031 Format for "Product Type" Documents

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Section Title: Purchasing Controls Section: 2.6
Page: 1 of 1
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Consistent quality of raw materials and contracted services is a key part of our Quality System.

Purchasing Control covers the following areas:

• Specifications: Requirements for raw materials are stated in written specifications available
to all personnel doing purchasing and receiving activities.

• Vendors: Qualified vendors are listed on each raw material specification. Document 540000,
Vendor Qualification and Monitoring, describes how to qualify new vendors in the Biotech
and CCD divisions, including outsourced services and processes, and how our vendors are
monitored for quality and on-time delivery of goods and services. Vendor performance is
tracked, with Key Providers and vendors with quality-related returns receiving Vendor
Scorecards. Vendors who do not perform well may be disqualified and replaced.

• Purchasing: The purchase order includes our part number and a request for a Certificate of
Analysis and/or Certificate of Origin where appropriate. All materials used in the
manufacture of products are verified against the purchase order. Purchasing interacts with
suppliers regarding non-conforming or damaged materials.

• Contracts and Supply Agreements: Purchasing, Sales, Legal or Business Development is

responsible to ensure customer contracts and supply agreements are in place when required.
Intellectual property contracts, customer contracts and supply agreements are managed by
Legal or Business Development.

Related Procedures:

540687 Purchasing Procedure, R&D Systems

540192 Receiving Procedure, R&D Systems
540000 Vendor Qualification and Monitoring
540335 Vendor Audit Procedure
540876 Quarantined Product Procedure
540805 Policy Regarding Contracts and Supply Agreements
640xxx Non-biological Raw Materials Specifications (Biotech)
645xxx Biological Raw Material Specifications (Biotech)
54xx, 55xx Biological Raw Material Specifications (CCD)
56xx, 57xx Non-biological Raw Materials Specifications (CCD)

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Section Title: Identification and Traceability Section: 2.7
Page: 1 of 1
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The ability to trace each lot of product back to the raw materials used in its manufacture and to
trace any lot of raw material to products into which it became incorporated is an essential feature
of our Quality System.

A part number and lot number (or receiving number) control all materials used to manufacture
products. This provides complete traceability from receipt of raw materials through final
shipment to the customer. In Biotechnology, part numbers are assigned by Document Control or
through the Product Development Project Tracking (PDPT) database. An MRP System (RenCS)
is in place in the kit manufacturing area which is used to track inventory, assign job (lot)
numbers and plan the production of the kit products. Lot numbers for all other products may be
sequentially assigned from the Document Change Request (DCR) Database or PDPT, or are
assigned at the time of bottling.

The Vice President of CCD assigns final product lot numbers for CCD products.

Receiving departments are responsible for assigning receiving numbers to incoming raw
materials.

Related Procedures:

540153 Part Number Assignment (Biotech)

540206 Assigning Lot Numbers
540540 Receiving, Entering and Labeling of Samples for RDS-BTS Lab
540831 RenCS, Add and Maintain Part Records
8862 Assigning Final Product Lot Numbers (CCD)
6019 Identification and Traceability (CCD)

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Section Title: Production and Process Control Section: 2.8
Page: 1 of 2
Revision Date: 7/28/14

We design quality into our products. Areas of the manufacturing process that require control are
identified during the development of a product and the effects of variables and appropriate limits
are established.
Process Control is accomplished through planning, written procedures, inspection, calibration,
training, supervisory oversight and employee awareness. Changes to the manufacturing process,
if required, are controlled, qualified and validated.
• Written procedures provide bills of materials, instructions for production, equipment
required, working environment, filling and labeling instructions, record sheets, expiration
dating, in-process testing, and acceptance criteria.
• Monitoring of product manufacture is accomplished through the use of Batch Records
(Device History Records) containing the current revisions of the documents required for the
manufacture of a product. Manufacturing and Quality Control departments print official
copies of their documents from MasterControl™. In CCD, Operations assembles the batch
records. Quality Control verifies compliance through review and approval of completed
batch records prior to final product release.
• The Specification Deviation Procedure handles both planned and unplanned deviations from
the written procedures.
• All new inspection, measuring and test equipment is inspected and validated, when
appropriate, against manufacturer’s specifications and is identified with a permanent
preventive maintenance (PM) number. Equipment is calibrated on a regular schedule.
Improperly maintained or calibrated equipment will not be used. Records of calibration and
maintenance are maintained by the Facilities Department. Quality Assurance audits
equipment periodically, to ensure that calibration is proceeding according to schedule.
• The supervisor or lead personnel contributes to quality through training employees, assisting
employees with new or specialized processes, interpreting instructions for and
communicating process changes to employees.

Related Procedures:

Corporate
540126 Deviation Procedure
540142 Procedure for Documentation of Equipment Maintenance and/or Calibration
540310 Software Validation
540133 Internal Notification Procedure: Receipt of New Equipment

Biotechnology
540781 Planning Guidelines, Immunoassay Manufacturing
540834 RenCS, Recipe Authorization
540833 RenCS, Add, Copy and Maintain a Process Specification

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540832 RenCS, Adding and Copying a Recipe

540207 Label Control, Product Finishing
540072 Filling Operations Procedure
540267 Preparation, Completion and Approval of Batch Records
540278 Bottling Procedure for Cytokines and Antibodies Designated for Retail Sale
540256 Labeling Procedure for Cytokines and Antibodies Designated for Retail Sale
540134 Incoming Equipment Validation Procedure

CCD
9090 Product Finishing Label Control
9054 Bottling Procedure
8812 Finished Device Inspection Procedure
8813 Guidelines for Determining Assay Ranges
8006 Bottled Product Release
8809 Assay Sheet Printing and Release
6009A Testing Protocol Request
6017 Product Type, Product Type Revision, Product Change Notification

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Section Title: Acceptance Activities Section: 2.9
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Acceptance/inspection activities are critical to the manufacture of quality products.

• Incoming materials are received in accordance with documented procedure(s).

• Deliveries are inspected against the purchase order for type, quantity and external transit
damage. Additional inspection may include verification against Certificates of Analysis,
Certificates of Origin, in-house material specifications or incoming testing procedures.

• In-process testing is specified by the manufacturing and/or Quality Control procedures.

Testing may include the recording of physical parameters such as pH and temperature, actual
functionality testing and/or visual inspection.

• Final inspection and testing are completed before any product is released for sale. Quality
Assurance or Quality Control Management sign the product release forms. All
documentation is reviewed and the product is physically inspected before release stickers are
placed on the product and batch record.

All inspections and testing are supported by completed documentation. Release by exception is
documented and approved by the Material Review Board.

Related Procedures:

540192 Receiving Procedure, R&D Systems

540080 Raw Materials Departmental Receiving and Inspection Procedure
540124 Inspection of Assembled Kits
540143 Literature and Label Approval Procedure
550449 Immunoassay Approval/Rejection Criteria
540267 Preparation, Completion and Approval of Batch Records
540526 Receiving OEM Products
540363 Releasing Retail Product
540194 Certificate of Analysis Procedure
541138 Quality Assurance Organization
8812 Finished Device Inspection Procedure (CCD)

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Section Title: Non-Conforming Product Section: 2.10
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Our Quality System provides for the identification, documentation, evaluation, segregation, and
disposition of non-conforming product.
Quality Assurance administers the non-conforming materials system with the participation of the
Material Review Board (MRB). Within departments producing research use only materials,
appropriate technical personnel will review non-conforming material and make decisions
concerning disposition of that material. Any employee with knowledge of non-conforming
material may call for a Material Review Board meeting. Minor non-conformities may be
released by Quality Control with adequate documentation. Disposition of major non-
conformities lies with the MRB. QA is responsible for documenting the activities of the MRB.
The Biotech MRB is composed of representatives from Quality, Manufacturing, and
Development. Additional representatives from Product Support, Marketing, Technical Service
or Sales may also participate as required. All corrective actions must be fully documented.
Minutes from meetings of the MRB are published and maintained in MasterControl™.
In CCD, MRBs are documented using the Material Review Board (MRB) form. Minutes from
meetings of the MRB are published and maintained in MasterControl™. A summary of MRBs is
distributed quarterly to managers for review.
All non-conforming material is clearly marked with Quarantine stickers or labeled appropriately.
In addition, it is physically separated from conforming material until final disposition.
A Specification Deviation is issued for any deviation in the manufacturing procedure even if the
product ultimately meets final release specifications. If a product is reworked, it must undergo all
required inspections and tests as well as any additional inspection or testing required by the
MRB. Reworked material must pass the same release criteria as the original product.
Related Procedures:
Corporate
540126 Deviation Procedure
540552 Corrective and Preventive Action
541214 Corrections, Removals and Recalls for IVD Products
Biotechnology
541089 Antibody Rework Procedure, Dept 378
540259 Material Review Board Responsibility Procedure
540265 Rework Procedure
540835 Quarantining Product in Finished Goods Inventory
550407 Criteria for the Acceptance of Protein Preparations for Sale
550406 Criteria for the Acceptance of Antibody Preparations for Sale
CCD
3009 Adjustment/Replacement of a Finished Product
6016 Material Review Board Procedure
1012 Rework Procedure
3018 Quarantine Procedure
8021 Rejection of a Product, QC Laboratory
10212 CCD Shipping's Inventory Quarantine Procedure
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Section Title: Corrective and Preventive Action Section: 2.11
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We are committed to taking preventive and corrective action to remedy any customer
dissatisfaction or non-conformity that is identified. Whenever appropriate, a root cause analysis
will be done to identify the root cause of the dissatisfaction or non-conformity.

A Customer Feedback System is maintained by Quality Assurance using the input from
Technical and Customer Service. All customer complaints are logged and then classified as to
type of complaint (performance, physical, etc.). All complaints are numbered and tracked by QA
from receipt of initial call until closure. A summary report of Biotech complaints is available
monthly for review by appropriate personnel. Weekly and monthly summaries of CCD
complaints are circulated to Management.

In Biotechnology, periodic meetings are held to review performance complaints. Each meeting
is attended by members of the appropriate department(s), MRB members and Technical Service.
In the CCD, complaints are reviewed weekly by members of the MRB and Technical Service.

Corrective action is taken to remedy non-conformities that are identified and to prevent future
recurrences. Preventive action is taken to eliminate the cause of a potential non-conformance.
The Material Review Board reviews non-conformities. An action plan is put together with QA
being responsible for monitoring and documenting the progress of any corrective or preventive
action plan to ensure its completion. A corrective or preventive action that changes approved
documents or processes is handled through the Document Change Request and the Change
Control systems in Biotechnology and through department-level document control in CCD.

Related Procedures:

540775 Medical Device Reporting (MDR) of Injury or Death

540552 Corrective and Preventive Action
540260 Field Notification Procedure
540135 Customer Feedback System, Biotech
540331 Returned Goods Procedure (Biotech)
541231 Change Control Procedure, Biotech
8034 Technical Service Protocol/Complaints (CCD)
8036 Procedure for Investigation of Returned Product (CCD)

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 Number: 540308
Revision: 15
QUALITY MANUAL Supersedes: 540308.14
Section Title: Statistical Techniques Section: 2.12
Page: 1 of 1
Revision Date: 7/28/14

Statistical methods are very powerful tools when used correctly within the quality process. These
methods are selected with care to ensure they suit the application required and will produce an
objective output.

The motivation to use these statistical methods is a desire to improve quality and to meet
customer requirements. The Quality System is subject to variations from components, design
and equipment. Statistical methods can assist with the elimination or minimization of these
variations.

Statistical methods are used whenever possible or applicable to ensure product consistency.

Test and control are implemented to release product, and to improve the knowledge base to allow
for product improvement.

Tools that are used or should be considered are:

Experimental Design - Design of Experiment(s) software is available and is being used
by kit development groups.
Analysis of Variance/Regression Analysis
Risk Analysis
Root Cause Analysis
Statistical Sampling Inspection
Histograms - Plot frequency of events
Pareto diagrams - Assist with sorting crucial problems
Flow charts - Pictorial diagrams of processes or systems

Examples of where Statistical techniques may be applied:

Design Input - Determining requirements and expectations
Design Control - Periodic evaluation to provide assurance of acceptable product
performance
Shelf Life - Determine appropriate dating for products
Process Control - Determine machine or process capabilities, monitor deviations
Defect Analysis - Assist with understanding problems
Data Analysis - Review and understanding of products
Vendor Monitoring - Analysis of non-conforming product and on time delivery
Continuous Improvement - Analysis of audit findings and corrective actions

Related Procedures:

540865 Statistical Methods

540537 Test for Outlier Determination (Grubb's Method)
8043 Detecting Outliers (CCD)

Page 19 of 22
 Number: 540308
Revision: 15
QUALITY MANUAL Supersedes: 540308.14
Section Title: Labeling and Packaging Control Section: 2.13
Page: 1 of 1
Revision Date: 7/28/14

We present to our customers only the highest quality labeling and packaging, and ensure that
they meet all regulatory requirements.

Labels, literature and packaging are subject to incoming inspection.

Label control is the responsibility of the Quality Assurance and Manufacturing departments.
Document Control and our Insert, Certificate of Analysis (ICA) database maintain the Literature
Approval system through which new Biotech label and literature copy is circulated for approval
prior to printing. The variable information on labels is printed in Manufacturing from password
secured files. Each label is assigned a part number and is revision controlled. All labeling
operations require label inspection and reconciliation.

The QA/RA Specialist(s) monitors label control in CCD.

Pre-printed labels are stored in locked cabinets or access-controlled areas.

Product packaging is designed to protect the product from environmental stress and physical
damage during shipping. The effectiveness of the packaging in protecting the product has been
documented and is monitored on every lot by analyzing data received through the external QC
program and through customer complaints.
Finished products are assembled according to written procedures. Final product packaging is
done so as to protect product integrity through physical separation of different operations. All
packaging areas are cleared prior to the start of the next operation. Quality Control or other
appropriate personnel inspect finished products using statistically valid sampling plans and
release product only after it meets inspection criteria.
Related Procedures:
Corporate
541104 Labeling Guidelines, IVD
Biotechnology
540207 Label Control, Product Finishing
540256 Labeling Procedure for Cytokines and Antibodies Designated for Retail Sale
540143 Literature and Label Approval Procedure
540124 Inspection of Assembled Kits
540467 Line Clearance
541365 Development, Revision and Approval of Protein Inserts using the ICA System
CCD
6029 Clinical Controls Division Labeling Control
6029A Labeling Review Form
9090 Product Finishing Label Control
8809 Assay Sheet Printing and Release
8855 Instruction Sheets – Revising, Printing and Inspecting

Page 20 of 22
 Number: 540308
Revision: 15
QUALITY MANUAL Supersedes: 540308.14
Section Title: Material Handling, Storage and Distribution Section: 2.14
Page: 1 of 1
Revision Date: 7/28/14

It is our goal to minimize damage or deterioration of products throughout manufacturing to

delivery to the customer. Stability studies are conducted during development to validate
recommended storage conditions.

Storage conditions for raw materials, work in process and finished goods are specified in the
appropriate specifications or manufacturing procedures. Storage areas are environmentally
monitored to protect product integrity. Backup generators are available in case of a power
outage. Products are properly identified with part number, lot or receiving number and
acceptance status before they are placed in storage areas.

Materials are handled in a manner to ensure first in-first out use when required. Materials are
marked with an expiration date where appropriate. This date is monitored and outdated product
is removed from stock for appropriate disposal or retesting.

Products are packaged and labeled for distribution to ensure physical and functional integrity
during transportation. The mode of transportation is chosen to protect the quality of the product.

Related Procedures:

541178 International Order Procedure, Biotech Shipping

541252 Domestic Retail Biotech Shipping Procedure
541351 Finished Goods Inventory Cycle Counts, Biotech Shipping
541358 Processing Expired Product in Biotech Shipping
540180 Identification and Breakdown of Expired Product in Inventory
540221 Validation: Stability Testing of Immunoassay Kits
541069 RenCS, Removing Expired Components from Inventory
540281 CCD Shipping Procedures
6100 Storage of Products (CCD)
10211 Closing Out Expired Product (CCD)

Page 21 of 22
 Number: 540308
Revision: 15
QUALITY MANUAL Supersedes: 540308.14
Section Title: Records Section: 2.15
Page: 1 of 1
Revision Date: 7/28/14

We believe that it is essential to maintain quality records not only to conform to the regulations,
but to also aid management in reviewing the effectiveness of our Quality System and making
decisions on how to improve it. The records that are maintained also demonstrate that products
were manufactured to specifications and standards.

The quality records that are maintained include:

• Quality System DOCUMENTATION
• Device Master Records
• Device History Records
• Document Change Requests
• Calibration and Maintenance Records
• Internal Audit Reports and Management Reviews
• Customer Complaints
• Vendor Qualifications
• Purchase Orders
• Customer Orders and Contracts
• Personnel Records/Training records
• Design History Files (Validation Data)
• Field Notifications and Recalls
• BTS Sponsor Notebooks
• Process and Equipment Validations
• MRB Minutes
• Deviations

All of our records are stored in conditions to facilitate their preservation and to allow ready
access by appropriate personnel. The records are retained for at least three years, or as specified
in individual SOPs or customer contracts.

Related Procedures:

541138 Quality Assurance Organization

540008 Quality Record Retention
540539 Archiving Study Documents for the RDS-BTS Laboratory
540534 Computer Servers Back-up Procedures
541303 R&D Systems Server/Application Documentation

Page 22 of 22