QUALITY MANUAL
QUALITY MANUAL
Authorized By:
________________________________________________ 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
Date: __________________________ __________________________ __________________________ __________________________ __________________________
QUALITY MANUAL
Number: 540308 Revision: 15 Supersedes:540308.14 Section: 1.1 Page: 1 of 1 Revision Date: 7/28/14
SECTION TITLE:
CONTENTS
Section 1 1.1
1.2
1.3
Page 1 Page 2 Page 3, 4
TABLE OF CONTENTS
Table of Contents Quality Policy 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
Page 1 of 22
QUALITY MANUAL Section Title: Quality Policy
Number: 540308 Revision: 15 Supersedes: 540308.14 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
Page 2 of 22
QUALITY MANUAL Section Title: Company Profile
Number: 540308 Revision: 15 Supersedes: 540308.14 Section: 1.3 Page: 2 of 2 Revision Date: 7/28/14
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.
Page 3 of 22
QUALITY MANUAL Section Title: Company Profile
Number: 540308 Revision: 15 Supersedes: 540308.14 Section: 1.3 Page: 2 of 2 Revision Date: 7/28/14
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
Bio-Techne Corporation (TECH)
Minneapolis, MN No Employees
R&D Systems, Inc. Minneapolis, MN 680 Employees
Novus Biologicals Littleton, CO 75 Employees
ProteinSimple Santa Clara, CA 208 Employees
R&D Systems. Europe Abingdon, UK 67 Employees
Tocris Bioscience Bristol, UK 55 Eployees
RDS Asia Shanghai, PRC 31 Employees
Bionostics, Inc, Devena, MA
102 Employees
Boston Biochem Cambridge, MA 11 Employees
BiosPacific Emeryville, CA 7 Employees
RDS GmbH Wiesbaden, DE 10 Employees
RDS France Lille, FR
2 Employees
PrimeGene Shanghai, PRC 45 Employees
This Quality Manual applies to the manufacturing and distribution operations at RDSI in Minneapolis, MN.
Page 4 of 22
QUALITY MANUAL Section Title: Management Responsibilities
Number: 540308 Revision: 15 Supersedes: 540308.14 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 541138 541614
Management Quality Systems Review Procedure Quality Assurance Organization Quality Planning
Page 5 of 22
QUALITY MANUAL Section Title: Management Responsibilities
Quality Systems Flow Chart
Number: 540308 Revision: 15 Supersedes: 540308.14 Section: 2.1 Page: 2 of 3 Revision Date: 7/28/14
Continual improvement of the quality management system
Customers Requirements
Input
Management responsibility
Resource management
Measurement analysis and improvement
Customer Feedback
Product Realization
Product
Quality Control
Output
Manufacturing Operations
Research and Development
Page 6 of 22
QUALITY MANUAL Section Title: Management Responsibilities
R&D SYSTEMS, INC. Department Organization
Chief Executive Officer/ President
Number: 540308 Revision: 15 Supersedes: 540308.14 Section: 2.1 Page: 3 of 3 Revision Date: 7/28/14
Sr. VP Clinical Controls Division
VP Finance & Chief Financial Officer
VP of Sales & Marketing
Business Development
Quality Control Laboratory
Shipping
Hematology Research
Raw Material Manufacturing
Manufacturing
Product Finishing
Facilities IT
Accounting
Marketing/Sales
Biotech Marketing
Biotech Sales
Technical Service
Technical Service BiosPacific
Sr.Director, Quality and Regulatory
Affairs
(Management Representative)
Sr Director Human
Resources
Sr.VP Biotech Division
Cell Culture Development
Antibody Technology
Bioassay Safety
QA/RA
QC/ Microbiology
Cell Culture
Antibody Development
Antibody and Data Operations
Enzymes
Protein Development
Protein Purification Development
New Technologies Molecular Biology
DuoSet/Multi-Plex Development Conjugation
Stem Cell
Product Support
Biomarker Testing Service
Product Finishing
Farm
Manufacturing Shipping
Effective 7/1/14
Page 7 of 22
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