1.0 Table of Contents

Harlan Laboratories, Inc.
Teklad Diets Division Title: Quality Manual Code: Level 1 & 2 Revision: 02 Effective Date: 05/12/11
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Prepared by: QA Coordinator, Teklad Diets Approved by: U.S. Teklad Operations Manager Changes by: QA Coordinator, Teklad Diets
1.0 TABLE OF CONTENTS

Section 1.0 2.0 3.0 4.0 4.1 4.2 5.0 5.1 5.2 5.3 5.4 5.5 5.6 6.0 6.1 6.2 6.3 6.4 7.0 7.1 7.2 7.3 7.4 7.5 7.6 8.0 8.1 8.2 8.3 8.4 8.5 Content Table of Contents Introduction Distribution List Quality Management System General Requirements Documentation Requirements Management Responsibility Management Commitment Customer Focus Quality Policy Planning Administration Management Review Resources Management Provision of Resources Human Resources Infrastructure Work Environment Product Realization Planning of Realization Process Customer Related Process Design and Development Purchasing Control of Production and Service Provision Control of Measuring and Monitoring Devices Measurement, Analysis and Improvement General Measuring and Monitoring Control of Nonconforming Product Analysis of Data Continual Improvement Page 1 2 2 3 3 8 14 14 15 15 15 16 18 20 20 20 23 23 24 24 25 26 26 28 31 32 32 32 34 35 35
Not Valid when printed
Harlan Laboratories, Inc.- Teklad Diets property. Disclosure of this information outside of the company is not permitted.
Harlan Laboratories, Inc. Teklad Diets Division Title: Quality Manual Code: Level 1 & 2 Revision: 02 Effective Date: 05/12/11
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2.0 INTRODUCTION
Harlan Laboratories, Inc. Teklad Diets Division (hereafter referred to in this document as Teklad Diets) developed and implemented a Quality Management System based on a Quality Policy to better satisfy the needs of its customers and improve management of the company. Accomplishment of this Quality Policy is assessed by specific objectives indicated by the U.S. Teklad Operations Manager and documented in the Management Review records. The Quality Management System complies with the ISO 9001:2008, international standard and its technical equivalent ANSI/ISO/ASQ Q9001-2000. The manual is divided into 5 sections corresponding to Quality Management System requirements of the ISO 9001 standard. Each section starts with a general policy statement expressing the commitment to implement the basic principles of the Quality System elements. The general policy statement is followed by specific procedure policies outlining how the general policy should be carried out and referencing the relevant operational procedures. The main purpose of this manual is to define and describe the Quality Management System, define the authorities and responsibilities of the management and to provide general procedures for all activities comprising the Quality Management System. Another purpose of this manual is to present our Quality Management System to our customers and to inform them that specific controls are implemented to assure product quality. Teklad Diets manufacturing facilities (2) are located in Madison, WI with Harlan Laboratories, Inc. Corporate headquarters being located in Indianapolis, IN.
3.0 DISTRIBUTION LIST

This manual (original) is available through electronic media. One Controlled copy (printed) is controlled by the Quality Assurance Coordinator, Teklad Diets.
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4.0 QUALITY MANAGEMENT SYSTEM SECTION 4.1

General Requirements 4.1.1 General Teklad Diets has established a Quality Management System (QMS) which is visualized with the Quality Management System Model (shown on figure 4.1.1). The organization has documented the QMS in this Quality Manual, which is implemented, maintained and continually improved to assure effectiveness in accordance with the requirements of the ISO-9001 (ANSI/ISO/ASQ, Q9001-2000) Standards. The QMS is envisioned as a long-term strategy to reach the Companys objectives throughout the continuous improvement in all aspects of the organization. The QMS is designed to continually improve the effectiveness and efficiency of the organizations performance by considering the needs of the interested parties (Customers, shareholders, suppliers, employees and society). Teklad Diets, as shown in the QMS Model, identifies the necessary inputs from the interested parties to perform the product realization with all the processes that comply. The final products and services are delivered to the interested parties. The efficiency and effectiveness of processes as well as the satisfaction of the interested parties are measured and the information is analyzed by management to define improvement actions based on their responsibilities. Management has the responsibility to take actions according to the quality policy (see section 4.2.1) and ensure the availability of resources and information necessary to support the operation and monitoring of these processes Improvement actions are defined as deemed necessary in the management reviews, internal audits and/or any suggestion of the interested parties to achieve planned results and continual improvement of the processes. With this QMS Model, Teklad Diets searches for an overall continual improvement cycle of the Quality Management System with the participation and involvement of all employees.
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Continual Improvement of the Quality Management System

Management Review, Internal Audits, Corrective, Preventive and Improvement Actions, Teklad Diets Programs, Etc.
Customers
(and other interested parties): -Customer Contact -Customer Requirements -Market Information -Economic Information -Regulations -Suppliers Information -Etc.
Customers Management Responsibility:

-Leadership -Management Commitment -Quality Planning -Quality Policy -Customer Focus t
(and other interested parties): -Customer Complaints -Sales -Profits -Etc.
Resource Management
-Management Reviews -Management Meetings -Human Development -Technology and Equipment - Materials -Internal Audits -Maintenance Programs -Safety -etc.
Measuring, Analysis and Improvement:

-Indicators -Information Systems -Control Systems -Management Information Systems (JD Edwards) -ISO- 9001 Implementation -Continuous Improvement - Internal Audits -etc.
Satisfaction
Product Realization:
-Feed Manufacturing -Delivery -Quality Assurance System -Diet Design -Specifications -Purchasing -Maintenance -etc.
Requirements
Input
Product
Output
Figure 4.1.1: Quality Management System Model

The QMS Model consists of all processes that are interrelated. These processes are explained below: The first process is to determine the needs and expectations of customers and other interested parties (customers, employees, shareholders, suppliers and society) with practices such as: - Customer requirements, customer suggestions, Customer Service Department, etc. - Employee suggestions, etc. - Economic situation of the Company
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Environmental information, Regulations Suppliers Information Customer contact.
With the customers information, Teklad Diets begins establishing the quality policy and quality objectives of the organization such as: Teklad Diets Quality Policy and Quality Objectives Management Commitment
This is based on the quality objectives that are determined and the processes and responsibilities necessary to attain the quality objectives included in the Management responsibility section of the Quality Manual. Once the responsibilities are defined, the next process is to determine and provide the resources necessary to attain the quality objectives. This is achieved based on the yearly budgeting process and in the following sections of the Quality Manual: Resource Management Management reviews Infrastructure
Continuing with the processes, one of the most important processes is the Product Realization in which many areas are involved as described in Figure 4.1.2., from the planning realization process, diet manufacturing, and inspection and testing of diets, to the delivery and post delivery activities. Once the product realization process is established, the next process is to establish methods to measure the effectiveness and efficiency of each process and customer satisfaction and apply those measurements. Some of these methods and measurements are mentioned below: Process Measurements (see section 8.0) Planning for Continual Improvement Customer Complaints Customer Profile System (JD Edwards) Internal and External Audits
By measuring the processes efficiency and effectiveness, information is gathered to determine means of preventing nonconformities and eliminating their cause, some of the processes to achieve this are mentioned below: Production and service operations control
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Control of nonconforming product Management Review Improvement, corrective and preventive actions Internal and external audits of the QMS
In this last process a continuous improvement cycle is closed by establishing and applying a process for continual improvement of the Quality Management System. Management Review Improvement, corrective and preventive actions Internal and external audits of the QMS
Teklad Diets has identified the product realization processes that provide added value to the organization as well as the support processes that influence the effectiveness of the realization processes (see figure 4.1.2). Top Management defines Strategic Objectives that are aligned with the companys quality objectives. The necessary resources to support the organizations strategic plans are allocated by management. Top Management uses recognized methods for measurement of the organizations performance in order to determine whether planned objectives have been achieved. Those methods include financial measurements, measurements of process performance throughout the organization, internal and external benchmarking, third party evaluations and assessment of satisfaction of customers. This information is considered at the management review in order to ensure that continual improvement of the QMS is the driver of performance improvement of the organization. It is the responsibility of the department heads to identify and document requirements of resources in their areas of responsibility for the maintenance and improvement of the Quality Management System. Resource requirements are normally evaluated by the Executive Management during the management review as in section 5.0, Management Responsibility and section 6.2, Management Review, specifically those requirements of work and internal audit activities. It is the responsibility of the U.S. Teklad Operations Manager to document the final decision in the approval of all resources requested. Resource requests are maintained with the management review records.
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4.1.2 Teklad Diets Process Map:
Corporate Finance / Accounting Corporate Marketing
Corporate Sales Corporate Human Resources
Corporate Information Technology Transportation Services
Top Management QMS Standard Diet Manufacturing

Internal Audits
Teklad Diets
Quality Assurance
Custom Research Diet Manufacturing
Teklad Diets
Customer Service Center
Teklad Diets
Design / Development
Teklad Diets
Raw Materials Purchasing
Teklad Diets
Engineering / Maintenance
Packaging & Shipping Warehouse & Distribution
Customer
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The planning process for the interrelation of each department with all departments shown on figure 4.1.2 is presented. The interrelation of each department shows all the inputs (from all departments or its own department), information generated and used within the department, the output generated by the process to the other departments or customers and the measurements and monitoring devices of the process. 4.1.2 Outsourcing At present, the processes diagramed in the blue field of figure 4.1.2 are outsourced by Teklad Diets. These include: Finance / Accounting Information Technology Sales Marketing Human Resources Transportation In all cases, these outsourced processes are provided by Harlan Laboratories, Inc. corporate office or other divisions within Harlan Laboratories, Inc. Outsourced processes are audited at least annually.
SECTION 4.2
Documentation Requirements 4.2.1 General The quality policy of Teklad Diets is defined in Section of 5.3. Teklad Diets quality objectives are defined in Section 5.4.1. Harlan Laboratories, Inc. Teklad Diets is committed to meeting or exceeding our customers stated and implied needs, through the production and supply of laboratory animal diets, associated products and services which consistently meet with the requirements and specifications of the customer. We are committed to continually improving our Quality Management System and enhancing customer satisfaction. We will demonstrate our commitment to quality by: a. The achievement and maintenance of registration to the appropriate parts of the ISO9000 series of quality standards;
Not Valid when printed Harlan Laboratories, Inc.- Teklad Diets property. Disclosure of this information outside of the company is not permitted.
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b. The creation of Quality Objectives as stated in the Annual Quality Plan; c. Measuring key performance indicators to improve and expand our business. This policy was formulated by the Top Management of Teklad Diets. The effectiveness and accomplishment of this quality policy are assessed by Teklad Diets Management during the Management Review of the Quality Management System. Quality objectives are established to lead the organization to performance improvement. The quality objectives are documented on section 5.4.1 of this Quality manual. The policy has been explained and discussed at the general orientation training given to all current employees, and during the induction training provided to the new employees. The policy is also posted in noticeable locations throughout the company facilities and disclosed in various documents.
4.2.2 Quality Manual
The scope of the Quality Management System is the design, manufacture, sale and distribution of laboratory animal diets. The Design and Development of Animal Diet is accomplished at the Madison, WI facilities, in accordance with section 7.3. Teklad Diets maintains a documented Quality Management System, designed and implemented to fulfill ISO-9001 (ANSI/ISO/ASQ, Q9004-2000) requirements. These documented quality procedures and related documents, create a framework that provides our customers with confidence that the manufacturing and distribution of products are performed in a well-defined and controlled environment. Teklad Diets Quality Management System is defined in the following sequence of documents.
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Document Level Level 1 & 2
Documents Quality Manual, Quality Procedures
Content
Level 3
Level 4
Company Policies for the Quality System, Procedures to meet the ISO-9001 Standard requirements, defining responsibilities and guidelines Work Instructions, Job Documents needed by Teklad Descriptions, Specifications Diets to ensure effective planning, operation and control of its processes Quality Records and Data Records required by the Quality Manual
The correlation between the ISO-9001:2008 Standard and Teklad Diets level 1 & 2 documentation is shown in the following table: ISO-9001: 2008 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement, Analysis and Improvement 4.2.3 Control of Documents 4.2.3.1 General Policy Documented procedures have been established and maintained to control all documents and data related with the requirements of the Teklad Diets Quality System and the ISO-9001 International Standard. 4.2.3.2 Document and Data Approval and Issue Documents and data may be initiated by anyone in the organization, but must be reviewed and approved by authorized personnel prior to issue. The authorized individuals and the rules governing approval and issue of documents are defined in section 4.2.3 Control of Documents, section 4.2.3.7.3 Responsibility. 4.2.3.3 Document and Data Changes
Level 1 & 2 Section 4.0 Quality Management System Section 5.0 Management Responsibility Section 6.0 Resource Management Section 7.0 Product Realization Section 8.0 Measurement, Analysis and Improvement
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Document changes are reviewed and authorized by the same function that reviewed and approved the original document. When new documents are approved, the electronic document is updated and obsolete documents are removed and segregated as appropriate. A revision is performed as needed by the same function that reviewed and approved the original document. 4.2.3.4 Document and Data Control The Quality Manual and Procedures are controlled via electronic document in the system and when printed the document is valid only for the date(s) stated. Control of the identification and current revision status of level 3 and 4 documents are maintained by the means of a Core Document Summary. All documents are identified by Title, Code and Effective Date as a unique identification to prevent the use of invalid and/or obsolete documents. Documents of external origin are identified and controlled. To ensure that documents remain legible and readily identifiable staff is advised to notify the person responsible of preparation of the document when the document is not legible or readily identifiable for him/her to replace, immediately. 4.2.3.5 Document Distribution and Location Documents are distributed to personnel and/or locations where they are used. The Quality Manual and Procedures are available for all users by electronic media, in a read only mode. Controlled copies for level 3 are distributed as appropriate by the site managers, and are available to all users by electronic media, in a read only mode or hard copy where needed. These documents are controlled by the means of the Core Document Summary. 4.2.3.6 Obsolete Documents Invalid and/or obsolete documents are removed promptly from all points of issue or use and destroyed to avoid accidental use by the means indicated in accordance with section 4.2 of the Quality Manual. Controlled copies of obsolete documents may be kept for relevant historical reference and shall be clearly marked as Obsolete. 4.2.3.7 Document Development 4.2.3.7.1 Structure 1. - Index 2. - Introduction 3. - Distribution List 4. - Numbered sections 4.2.3.7.2 Codification Level 1 & 2 documents contain 1 characters code. The character represents the level of the document; example (1, 2, 3 or 4) Level 3 documents contain 13 characters code. Ex: AAA-BBBB-CCC-DDD
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The AAA is a 3-7 character alpha/numeric code which represents the site within Teklad Diets to which the core document applies. Approved codes are provided in Location Code Register, which is held by the Quality Assurance Coordinator. (HTEK, HSTD, HTRD, etc.) BBBB is a 3-4 character code which represents the document type. Document type codes are WORK, QREC, Etc. CCC is a 3 character code which represents the area to which the document applies. ADM - Administrative CUS - Customer Related ENG - Engineering GEN - General Use PRD - Production PUR - Purchasing QCN - Quality Control QST - Quality System SHP - Shipping STO - Stores TRG Training DDD is a document number in the range of 001 to 999.
4.2.3.7.3 Responsibility Review and Approval of level 1 & 2 document by: U.S. Teklad Operations Manager Control by: Quality Assurance Coordinator Review and Approval of level 3 & 4 documents: Operations Managers Control by: Quality Assurance Coordinator 4.2.3.7.4 Distribution and Media The level 1 & 2 documents are available only in electronic form (original) to all personnel through the corporate computer network. The Quality Assurance Coordinator may maintain one printed copy for auditing purposes only. Any other printed documents will be valid only for printed date(s). Information on changes, other than minor (see note below) will be sent via e-mail and kept by issuer. The Quality Assurance Coordinator controls access to electronic documents for all Teklad Diets employees. Anyone requiring access must send a request via e-mail to the Quality Assurance Coordinator. The IT Department provides access to electronic documents, after receiving an authorization via e-mail from the Quality Assurance Coordinator. Recommended changes to level 1 & 2 electronic documents must
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be sent, via e-mail, to the Quality Assurance Coordinator for review. After review the will enter the change into the electronic system. 4.2.3.7.5 Forms Forms are controlled through the electronic system, anyone requiring a change to a form, shall submit the provisional form to appropriate Operations Manager for review and approval. Upon approval by the Operational Manager the provisional form will be sent via email to the Quality Assurance Coordinator for review and entry into the electronic system. 4.2.4 Control of Records Quality records are established and maintained to provide evidence of the conformity to requirements and of the effective operation of the Quality Management System. Records will remain legible, readily identifiable and retrievable. The records are identified, indexed, and stored in a suitable environment to minimize deterioration. Records are stored by the department that is responsible for their establishment. Retention period for quality records is three (3) years unless otherwise defined in a work instruction. Retention period is determined by the department that established and maintains the records on the basis of contractual obligation, useful life of products, legal consideration. The Core Document Summary identifies the documents and the retention period. All records are identified by the title, code, and date of issue. These records may be in formats such as forms, reports, memos, and computer files or databases where is applicable. Computer files and databases used in the quality management system, such as customer lists, contracts, vendor lists, etc. and all affected or supporting data will reside in the servers or PC hard drives with the appropriate backups. Stored records are grouped in file folders, binders, etc., to facilitate their retrieval. These records should be filed and preserved by the same department that initially established the record according to the Core Document Summary. Current, or frequently-retrieved records are normally stored in filing cabinets or similar storage devices; however, they are to be clearly labeled to identify their contents. Historical records may be retained for preservation of knowledge, legal, fiscal or tax policies or other requirements. These records are clearly labeled and dated to display the age of the records. The issuing department is responsible for the storage of these records; they should be stored separately from active records.
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Obsolete records are records whose retention is complete. Each department shall be responsible to ensure that obsolete records are promptly removed from their storage location and destroyed. 4.2.4.1 Establishment of Records Records are usually established by the personnel directly involved with the task, operation or activity whose results need to be recorded. Records identify the product, person, or event to which they pertain; provide the relevant facts and data. Records should be established and maintained in electronic media (computer files or data bases). If records cannot be maintained electronically, then paper files may be maintained, these files must be signed and dated by the person who establishes the record. Specific record formats are given by the procedures that call for their establishment. These can be forms, reports, and minutes of meetings, sign-ups or stamps placed on other documents.
5.0 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment The Global Management Team is committed to the development and implementation of the Quality Management System and to continually improve its efficiency and effectiveness. Teklad Diets communicates to all employees the importance of meeting customers as well as statutory and regulatory requirements, the quality policy and company values via e-mails, notices on bulletin boards and meetings. The Quality Management System is designed to enable management to obtain feedback directly on the effectiveness and efficiency of the Quality Management System and to create an environment that encourages the involvement and development of employees. It is the responsibility of the Management Representative to update this procedure. It is responsibility of top management and department managers to communicate to the Quality Assurance Coordinator, in a documented manner, any modifications in the departmental structure affecting the current organizational charts. Operational Managers are responsible for providing quality system performance information to the Quality Assurance Coordinator for presentation to top management during management review. Operational Managers are responsible to prepare documented procedures consistent with the requirements of ANSI and Teklad Diets policies and implement those procedures in the quality system.
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SECTION 5.2
Customer Focus Teklad Diets aims to meet the needs and expectations of their Customers, Employees, Shareholders, Suppliers and Society by understanding and satisfying the current and future needs and expectations of present and potential customers and all of the interested parties. Customer information and requirements are listed in the JD Edwards database. Additional customer requirements for customer related processes are gathered in accordance with section 7.2 of this manual. When necessary, Teklad Diets employees have access to JD Edwardss database and the QMS. Shareholders and society are provided information by Teklad Diets Management.
SECTION 5.3
Quality Policy Teklad Diets uses the quality policy as a means of leading the organization toward improvement of its performance. The Quality Policy is consistent with overall organizations policies, strategies, values and vision and mission. The quality policy of Teklad Diets is listed in section 4.2.1.
SECTION 5.4
Planning 5.4.1 Quality Objectives Top management has established Quality Objectives in accordance with the Quality Policy. These objectives are measurable in order to facilitate an effective and efficient review by management. 5.4.1.1 Annual Quality Plan The Quality Objectives for Teklad Diets are delineated in the Annual Quality Plan. These objectives are reviewed and set down by Top Management each year. Top management considered several issues when establishing the Quality Objectives, among those issues are: Current and future needs of the interested parties, current product and process performance, levels of satisfaction of interested parties, self-assessments, competitor analysis and resources needed to meet the objectives.
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5.4.2 Quality Management System Planning The Quality Manual defines how Teklad Diets meets the requirements for quality. These documents are considered as the Teklad Diets quality planning, and comply with the applicable requirements for section 5.4.2 of the standard ISO 9001 (ANSI/ISO/ASQ Q9001: 2000). The identification and acquisition of controls, processes, resources and training requirements are covered in this Quality Manual (see sections 4, 5, 6, and 7). The compatibility between the production process and the Inspection and Testing procedures is ensured by the identification of the quality characteristics to be monitored and controlled. The Quality Assurance Coordinator is responsible for identifying and updating quality control techniques or measurement requirements that exceed current procedures or equipment. When required, these will be presented as a resource requirement to the executive management as described in this Quality Manual. Suitable verification of the product is performed during the processing phase. Product release is based on final verification of product as specified in this Quality Manual. Acceptable standards for the product are defined in In-Process Specifications and Packing Specifications. The QMS has been designed to maintain its integrity when changes to the QMS are planned and implemented. Managers are responsible for following all procedures ensuring the integrity of the QMS is maintained, reporting and make appropriate changes to QMS procedures and ensuring the system is capable of permanently maintaining its integrity. Corrective and Preventive Actions and Improvements are assessed and solutions are verified in order to prevent reoccurring problems, as described in section 8.0. Quality records are maintained and identified in accordance with section 4.0.
SECTION 5.5
Administration 5.5.1 Responsibility and Authority
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The responsibility, authority and the interrelation of personnel who manage, perform, and verify work affecting quality is defined in the Teklad Diets organizational chart. (Each facility maintains a current copy of their organizational chart). In general Top Management, Managers, Auditors or any personnel who manage, perform, and verify work affecting quality have organizational freedom and authority to: a) Initiate action to prevent the occurrence of non-conformities relating to product, process and quality system. b) Identify and record any problems relating to the product, process, and quality system. c) Initiate, recommend, or provide solutions through designated channels. d) Verify the implementation of solutions. e) Control further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected. Responsibilities and authorities are communicated through the communications channels defined in section 5.5.3. When temporary absences (vacations, sick leave, etc) occur, individuals will provide management with the name of their temporary replacement. 5.5.2 Management Representative The Quality Assurance Coordinator has been appointed as the Management Representative by the U.S. Teklad Operations Manager. He/she has the authority and responsibility to ensure that the Quality Management System is established, implemented and maintained. He/she also has the responsibility and authority to report to top management the following; performance of the QMS, any needs for improvement and to ensure the awareness promotion of customer requirements throughout the organization. The Management Representative must ensure that the QMS efficiency is continuously measured for improvement as determined during the Management Reviews of the Quality Management System. The Management Representative must ensure that the system complies with the requirements of the ISO-9001 standard.
5.5.3 Internal Communication Teklad Diets has established an effective and efficient process for communicating the quality policy, quality objectives, accomplishments as well as all the information needed to aid in the organizations performance improvement and directly involve everyone in the achievement of quality objectives. Providing this information encourages feedback and communication within in the organization increasing involvement.
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The following list shows the different communication channels which could be used to convey relevant information between management and employees. Management Meetings Pocket Catalogs Management-led communication in work areas Wall-Papers Quality Bulletin Paycheck attachments Posters E-mails Internal Newsletter Suggestions Program Management Open Door Policy Harlan Intranet
SECTION 5.6
Management Review 5.6.1. General Teklad Diets Top Management reviews the Quality Management System (QMS) in conjunction with other participating departments, at minimum of semi-annually. The purpose of the review is to ensure the continuing suitability, adequacy and effectiveness of the QMS. Management Review assesses opportunities for improvement and any need for changes to the QMS including the Quality Policy and Quality Objectives. All the records necessary for management review are maintained as defined in section 4.0 of this Quality Manual. 5.6.1.1 Attendance The Teklad Diets Management Review Team is comprised of representatives of management, quality, production, customer service and technical services departments. The Management Review meeting is chaired by the Global Vice President, Business Development or, in his absence, U.S. Teklad Operations Manager. 5.6.1.2 Agenda As a minimum, the agenda is comprised of the following topics: Assessment of continuing suitability and effectiveness of the Quality Management System by the means of: 1. Results of audits (Internal and External) 2. Status of Corrective/Preventive Action Requests 3. Customer Feedback a. Customer Complaints b. Customer Service Department concerns
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4. Process Performance and Product Conformity a. Production Concerns b. Process Indicators 5. Follow up Action for Previous Management Reviews 6. Changes that Could Affect the Quality Management System 7. Recommendations for Improvements
5.6.2. Review Input Management Reviews include information on the following aspects: a) Results of internal and external audits b) Corrective, Preventive and Improvement Actions c) Customer Complaints d) Process Measurements (Indicators) e) Follow up actions from Previous Management Reviews f) Changes that affect the Quality Management System g) Recommendations for Improvement and/or Resources Needed Management Reviews actions for improvement and resources needed are documented in the meeting minutes which include the issue, action to be taken, responsibilities and dates. The output from management reviews is communicated to the appropriate departments and levels of the organization by the communication means mentioned in the Quality Manual. 5.6.3. Review Output The output from management review includes: a) Corrective, Preventive and Improvement Actions b) Improvement of the effectiveness of the QMS and its processes c) Improvement of product related to customer requirements d) Resources Needed 5.6.3.1 Assessment of Quality Management System Suitability The required information to comprise the topics to assess suitability shall be prepared by the Management Representative and/or involved Department Heads to be presented during the review. 5.6.3.2 Resources requirements Resources requirements that are established during the Quality Management review meeting are recorded and submitted to Harlan Laboratories, Inc. Top Management for approval.
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6.0 RESOURCE MANAGEMENT

6.1 Provision of Resources Teklad Diets provides resources through the annual budget preparation procedure, based on sales forecasts, budget history, customer requirements, strategic plans, etc. In addition, resources requests may come from, but are not limited to, management reviews, internal and external audits, Corrective, Preventive and Improvement actions, employee suggestions, etc. When resources are needed during the year the following procedures are followed: Personnel Request - Resource requests are issued and documented in the Staffing Requisition Form, by the requesting department manager. This request is presented to the applicable senior manager for evaluation and approval and returned to the manager, who forwards the form to the Harlan laboratories, Inc. Human Resources department for processing upon approval. Resource Requests (other than personnel requests): Are issued and documented in the Capital Expenditure Form, by the requesting department manager. This request is presented to the applicable senior manager for evaluation and approval. Once the request is approved, it is signed and returned to the manager, who forwards the form to the applicable department (Accounting or Purchasing) for processing. Capital Expenditure Forms are used for any resource request that exceed a dollar amount defined in the Form.
SECTION 6.2
Human Resources 6.2 Human Resources Personnel assigned to perform specific tasks that affect product quality are qualified and have the necessary competency through the appropriate education, training, skills and/or experience. Job Descriptions define the necessary or preferred education, training, skills and experience needed for every position. A candidate for an open position has to meet these requirements in order to be considered for the position. If no candidate meets the requirements, the department manager must approve the waiver of any requirement. For a new position, the department manager coordinates with Human Resources in the development of a new Job Description prior to hiring the employee.
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6.2.1 Competence, Awareness and Training Department managers are responsible for determining the necessary competency for each position. A Certificate of Competence is developed, by the appropriate manager, defining the basic skills and competencies requirements for each employee. The training provided by Teklad Diets is divided into five Categories. Orientation Training* Departmental Training Safety Training* Quality training Others
* Not included in the Certificate of Competence
6.2.2.1 Orientation Training is given to all new employees when hired, which covers the following subjects: a) b) c) d) g) Company Policies, Sexual Harassment, Drug Abuse Policy, Employee Orientation Safety Training Good Manufacturing Practices Teklad Diets Quality Policy and Quality Objectives Introduction to ISO-9001
Evidence of this training is recorded on Orientation Training Form. Records of orientation training are maintained by each department in the employee job training folder. 6.2.2.2 Departmental or On-the-Job Training for new employees Training where necessary skills and competencies required in a specific position are acquired by on-the-job training and tutelage from a supervisor, group leader, and senior employee. Departmental/on the job training must be performed upon assignment to a new position, promotion or transfer. The departmental training process occurs during the first 60 days of employment which the employee performs the job under the tutelage of the supervisor or the departments head or designee. The new employees supervisor certify that the employee has exhibited the knowledge, ability, and skills required of the position and is qualified to work in that position. Departmental training requirements per position are documented in the Certificate of Competence. Departmental training also applies to supervisor levels which are trained by their department manager. Departmental training is given to the employee based on the positions procedures and/or work instructions which may include several procedures and/or work instructions. The
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procedures and/or work instruction for the positions are based on the positions Job Description. An employee may be trained to perform several positions. Department managers also follow the procedure mentioned above under the guidance given by senior managers and is documented in the Certificate of Competence. The training given to department managers is comprised of the Quality Manual and procedures. It is the responsibility of the department manager to read and understand the Quality Manual and procedures. 6.2.2.3 Verification of Job Competency Prior to completion of the 90 day probationary period the job competency verification must be performed. The supervisor or the department manager evaluates employee competency by observation or by applying an examination (written or oral). The employees competency is documented on the Certificate of Competence, both the employee and the supervisor must sign this form. If an employee is not competent in an evaluation, the employee may be given the opportunity to be retrained. After the employee has been retrained, the employee competency must be re-evaluated. If an employee is unable to exhibit the required competencies for the position, within the 90 day probationary period, the evaluation will be reviewed with Human Resources for further action. 6.2.2.4 New or Changes in Work Instructions or Procedures When new skills, competencies or tasks are added to the position, the employee must be trained. Training from these changes must be documented on the training documentation verifying that the employee has been trained and determined to be competent. If an employee is not competent in an evaluation, the employee may be given the opportunity to be retrained. After the employee has been retrained, the employee competency must be re-evaluated. If an employee is unable to exhibit the required competencies for the position, within the 90 day probationary period, the evaluation will be reviewed with Human Resources for further action. 6.2.2.5 Safety Training
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The Health & Safety Committee requires that basic safety training be conducted as part of the orientation training. Supervisors and Managers are responsible for ensuring that safety training is completed annually. The Health & Safety Committee is responsible for coordinating training with supervisors and managers. All records are maintained by the Operations Manager. Safety Training complies with all government and OSHA regulations 6.2.2.6 External Training External training may be added to the Certificate of Competence if the employees supervisor considers it necessary. Evidence of/or the certificate of external training is maintained by individual departments.
SECTION 6.3
Infrastructure 6.3 Infrastructure Teklad Diets provides and maintains the infrastructure needed to achieve conformity to product requirements. This includes: Buildings, workspaces, production equipment and associated utilities are being kept in good working order. A documented maintenance program has been established, implemented and maintained as detailed in HTEK-SOP-ENG-001, Equipment Maintenance. Personnel of all departments and levels are required to report to supervisors or managers any problems or deficiencies in infrastructure or to directly issue Work Orders for buildings, workspace, equipment, and associated utilities as needed. Teklad Diets complies with all the Government environmental requirements by ensuring that the management of waste is safe and that the facility is not exceeding the environmental requirements of the local area. Programs to comply with these requirements are defined and records are kept by the responsible Manager of each program.
SECTION 6.4
Work Environment
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6.4 Work Environment Teklad Diets provides and strives to continuously improve the necessary work environment to ensure that this environment has a positive impact on motivation, satisfaction and performance of people in order to achieve conformity to product requirements. Teklad Diets complies with all governmental and statutory regulations as shown on table below: Regulations / Requirements U.S. Department of Labor (FLSA, Polygraph, FMLA,OSHA) Equal Employment Opportunity Commission (ADA, ADEA) Workforce Commission Workers Compensation Commission Immigration and Naturalization (INS) Internal Revenue Service (IRS) Communicated/ Implemented Postings, Company Policies, Trainings Postings, Company Policies Postings, Company Policies Trainings, Postings, Company Policies I-9 forms, trainings, policy Payroll and Accounting processes Responsible Human Resources Human Resources Human Resources Human Resources Human Resources Human Resources Finance
The Health & Safety Committee defines the safety rules and provides guidance on the use of protective equipment. The Operations Manager is responsible to coordinate the Safety Program including safety training, reporting unsafe conditions and ensuring that Teklad Diets meets governmental and regulatory safety requirements. The respective Site Manager maintains all safety records.
7.0 PRODUCT REALIZATION

7.1 Planning of Product Realization Teklad Diets identifies the processes needed to satisfy the requirements of customers and other interested parties. To ensure product realization, consideration should be given to associated processes as well as desired outputs, process steps, activities flows, control measurements, trainings, equipment, methods, information, materials and other resources. The process for product realization is consistent with the requirements of all the Quality Management System.
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During the product realization planning process the organization ensures that the following elements are defined and understood: a) Quality objectives and requirements of the product b) The need to establish processes, documents, and provide resources specific to the product c) Required verification, validation, monitoring, inspection and test activities applicable to the product and the criteria for product acceptance. d) Records needed to provide evidence that the realization processes and resulting product meets requirements.
SECTION 7.2
Customer Related Processes 7.2.1 Determination of Requirements related to the Product Teklad Diets Sales Department determines the requirements specified by the customer. Delivery and post-delivery activities are accomplished in accordance with established work instructions. These requirements are documented in the Customer Profile section of the JD Edwards system. Sales personnel submit the information to the Customer Service center that enters the information into the system. The requirements not stated by the customer but necessary for specified or intended uses are defined in the Technical Data Sheets/Product Guide. The statutory and regulatory requirements as well as any additional requirements determined by the organization related to the product are listed below: Requirement USDA FDA Responsible Operations Manager Operations Manager How do we Comply Inspections Inspections
7.2.2 Review of requirements related to the product Teklad Diets Customer Service Department reviews the requirements related to the product prior to the organizations commitment to supply a product to the customer, ensuring that product requirements are defined, contract or order requirements differing from those previously expressed are resolved and that the organization has the ability to meet the defined requirements. This process is delineated in HTEK-SOP-CUS-001, Sales Order Processing. 7.2.3 Customer Communication
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Effective communication with customers is key to the success of Teklad Diets. As such, all communication will be conducted in accordance with HTEK-SOP-CUS-002, Customer Communications.
SECTION 7.3
Design and Development 7.3 Design and Development The Design and Development of Animal Diet does apply to Teklad Diets. The Design and Development of Animal Diet is accomplished in Madison, WI according to the following procedures: HSTD-SOP-PRD-001, New Products-Standard Diets or HTRD-SOP-PRD-001, New Products-Custom Diets
SECTION 7.4
Purchasing 7.4.1 Purchasing Process Teklad Diets assesses its suppliers and purchases only from those that can satisfy the companys quality requirements. Purchasing documents clearly describe ordered products, including quality requirements. Purchasing documents are reviewed and approved prior to release. Teklad Diets ensures that purchased product conforms to specific requirements and evaluates and selects suppliers based on their ability to supply product in accordance with the organizations requirements. Selection, evaluation criteria and re-evaluation criteria is defined in this procedure. 7.4.1.1 Diet Manufacture Purchasing Process New suppliers are required to complete and submit the Initial Supplier Approval Questionnaire before they can be considered for approved status. Suppliers are notified by letter of the requirements and performance criteria which they must meet. These requirements and criteria will vary based on the type of raw material, product or service that they supply. All approved suppliers are regularly evaluated to assess their ability to meet the stated criteria. The frequency and method of evaluation has been established for each category of supplier.
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7.4.1.2 Purchasing Materials (i.e. Supplies, ingredients, packaging materials, consulting, and calibrations services). Suppliers shall provide the following documents/items depending on the type of product and/or service required by the applicable department, such as: A. Licenses B. Permits C. Certifications D. Insurance E. Other documents/items as deemed necessary These records are maintained by the purchasing agent. 7.4.1.3 Purchase Request Procedure: Purchase Requisitions are generated in the JD Edwards System by authorized personnel. In case of an emergency, the Purchasing Agent is authorized to create a Purchase Order directly when given verbal approval by an authorized person 7.4.1.4 Purchase Order Processing: The Purchasing Agent creates a Purchase Order referencing the requisition when applicable and edits information when deemed necessary. The purchase order is released according to applicable release strategies in JD Edwards. The Purchase Order is then sent via electronic media, printed, or verbally communicated to the supplier. All Purchase Orders are maintained in the JD Edwards System and may be viewed by authorized personnel when deemed necessary. The report is reviewed on-line or printed by the Purchasing Agent which notifies the applicable Receiving Dept. to verify the order has or has not been received. The Purchasing Agent then expedites, cancels, or modifies orders as deemed necessary. 7.4.1.5 Receiving of Supplies: Supplies are received in accordance with established work instructions. In the event that supplies are received in a damaged, nonconforming, or incorrect condition, it is the responsibility of the applicable receiving department to notify the purchasing department of the situation. The receiving department identifies non-conformities and follows procedures for the Control of Non-Conforming Product. The Purchasing Agent makes arrangements with the supplier to discard, return, or exchange the nonconforming supplies. 7.4.2 Evaluation of suppliers Suppliers are evaluated and selected based on their ability to meet Teklad Diets requirements, including Quality System requirements. Quality capabilities and performance
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of suppliers are assessed by Teklad Diets Quality Committees and authorized Purchasing Personnel. Suppliers showing noncompliance to Teklad Diets requirements are asked to implement corrective actions, and may be notified about the possibility of being discontinued if there is no improvement. 7.4.3 Purchasing Information Purchasing documents are processed by the purchasing departments. The documents clearly describe ordered products or services. They include precise identification of the products, reference applicable standards if any, and state quality requirements if needed. Purchasing Personnel reviews and approves all purchasing documents prior to release.
7.4.4 Verification of purchased Product Teklad Diets has established inspection and other activity requirements to ensure purchased product meets specified purchasing requirements. If specified in the contract, customers may be given authorization to verify purchased product at the suppliers location. Customer verification does not absolve Teklad Diets from the responsibility to deliver a quality product. Teklad Diets currently has no contracts where this requirement applies. If such contracts are accepted in the future, Teklad Diets will document and implement appropriate procedures in compliance with this clause of ISO9001:2008.
SECTION 7.5
Control of production and service provision 7.5 General Policy Production operations are planned and documented in the Production Schedule Planner master. Individual operations are documented in Customer Purchase Orders. Personnel performing process operations are provided with work instructions. Particular processes are controlled and are carried out in accordance with written procedures. Production and process equipment is checked and maintained to ensure continuing process control. Production areas are regularly cleaned to provide a suitable production and working environment. 7.5.1 Control of Production Service Provision The Production Schedule Planner master is prepared by the Production/Purchasing Coordinator in cooperation with Customer Service and Production departments to cover requirements for shipping. Inspections and testing requirements are carried out for process
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adjustment purposes and the inspection and testing of finished product for release and distribution. 7.5.1.1 Calibrations In house calibrations shall be conducted by assigned employees; calibrations will be conducted in accordance with the manufacturers or specific work instructions when applicable. External calibrations will be conducted by approved calibration suppliers. 7.5.1.2 Procedure: Customer purchase orders are received on daily basis. The Customer purchase orders describe the order number, product name, shipping date, number of containers and quantity. Daily orders also specify the packaging requirements and any other customer requirement. The customer purchase orders will be initialed by the person completing the order. If changes to the orders are received, the Customer Service Department will enter the change into the JD Edwards system and a new Customer Purchase order is printed. Production is provided the new Customer Purchase order for processing. 7.5.1.3 Process control Processes are controlled using one or more of the following process control methods: -Written procedures -Operation Training or Certification -Process order information The Customer Purchase orders and process work instructions contain all necessary information to process the order. 7.5.1.4 Production Equipment Processes and equipment, as well as modifications to the existing equipment are approved (after testing and evaluation) by the Operation Managers. All current processes and equipment installed prior to January 1, 2011 are approved based upon their demonstrated capability. The testing of new or modified equipment may be conducted at the manufacturing premises or at Teklad Diets. Approval for use will be carried out with a memorandum signed by the individuals mentioned in the above. Production employees will report to the Group Leader any equipment that is not operating properly. Group Leaders will report problems to Supervisor or maintenance department for repair, using the maintenance request. Maintenance department will make the necessary repairs.
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Maintenance department will perform preventive maintenance to the process equipment to assure the continuity of the operation. 7.5.1.5 Production Environment A clean production environment and proper maintenance of production areas are emphasized by management as an important prerequisite for quality. Production environment is maintained through cleaning of the production areas by employees and regular inspections by the management team. Personnel are encouraged to report conditions (verbally, written, etc.) that may adversely affect performance of their job, the equipment, and/or the quality of the product (lack of illumination, ventilation, etc.). If the conditions of the facility cannot be corrected immediately (such as ceiling leakage, lack of illumination, etc), corrective actions as well as long term actions must be taken and the results of those actions recorded on the work order request form. 7.5.1.6 Criteria for Workmanship For Process Control the only workmanship criteria is contained in process work instructions and the production department makes adjustment to the process based on the results of testing of the product. 7.5.1.7 Product Release and authority to release product Prior to release for sale, all product is inspected and or tested. Test methods and authority to release product is defined in work instructions. 7.5.1.8 Product Delivery In order to prevent damage or deterioration, all products must be loaded in accordance with applicable work instructions. The Shipping department/transportation company is provided with the customers name, location, P.O. number, contact name, telephone number, pickup and delivery date. The transportation company makes an appointment and arranges the delivery of the product to the customer. The transport equipment must be clean, dry, no leaks or holes, free of odors and inspected prior to loading in accordance with applicable work instructions. Results are documented in applicable forms. In order to safeguard the product, all transport equipment (except customer pick up and common carrier) is sealed after loading. 7.5.1.9 Characteristics of the Product Information of the characteristics of the products is available in work instructions. 7.5.2 Validation of Processes for production and service provisions Teklad Diets does not have any processes or services, where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where
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deficiencies become apparent only after the product is in use or the service has been delivered. 7.5.3 Identification and Traceability Ingredients, packaging material, in-process products, and finished products are identified and or traced in accordance with HSTD-SOP-PRD-007, Identification and Traceability and/or applicable work instructions. 7.5.4 Customer Property Teklad Diets will exercise care with customer property, according to HTRD-WORK-PRD101, Receiving in Customer Reserves. Customer property shall be verified to be correct on receipt, according to requirements agreed in product specifications and contracts; stored and maintained in a satisfactory condition according to documented requirements agreed with the customer. 7.5.5 Preservation of Product Methods and means of handling, storage, packaging, preservation and delivery that prevent product damage and deterioration are provided. Receipt and dispatch to and from storage areas are controlled. The condition of stored products is checked regularly. Packaging is specified and controlled. Products are protected prior to and during delivery.
SECTION 7.6
Control of Measuring and Monitoring Devices 7.6.1 General Policy Teklad Diets recognizes the importance of equipment used to measure and monitor product quality. Production and Quality Assurance Coordinator are responsible for defining the appropriate monitoring and measurement devices needed to provide evidence of conformity of product to determined requirements. All measuring and monitoring equipment used for verification of the product quality is maintained in accordance with HTEK-SOP-QCN-001, Calibration. Calibration certificates are maintained. The calibration status of measuring equipment is identified either by Calibration Log, Calibration Certificate, Calibration Sticker, and/or other appropriate means. Adequate safeguards for handling, preservation and storage of equipment as well as environmental conditions are maintained by departments based on equipment or by the calibrating company instructions in order to keep equipment under proper working conditions. 7.6.2 Calibration and Maintenance Responsibilities
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Quality Assurance Coordinator and Production Managers are responsible for calibrating and maintaining the inspection and test equipment. Calibration instruments and standards having known relationship to the nationally recognized standards shall be used. Where no such standard exists equipment shall be calibrated in accordance to applicable work instructions.
8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT SECTION 8.1

General 8.1 General Teklad Diets has defined and implemented monitoring, analysis and improvement processes to demonstrate conformity with the product, ensure conformity of the Quality Management System and continually improve the effectiveness of the Quality Management System. These processes include applicable methods as technical statistics and the extent of their use.
SECTION 8.2
Measuring and Monitoring 8.2.1 Customer Satisfaction Teklad Diets evaluates customer satisfaction and uses this information as an important measurement of performance of the Quality Management System. With this evaluation Teklad Diets assesses customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information are explained in HTEK-SOP-CUS-002, Customer Communications.
8.2.2 Internal Audit 8.2.2.1 General Policy A procedure has been established for the planning and implementation of internal quality audits to verify the effectiveness of the quality management system. 8.2.2.2 Procedures Planning and scheduling is established by the Quality Assurance Coordinator in accordance with HTEK-SOP-QST-001, Internal Quality Audit. The seven Teklad Diets processes identified on figure 4.1.2, along with Standard Diet Manufacturing and Custom Research
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Diet Manufacturing, are audited on an annual basis. Selected activities are audited more frequently, depending on their importance and quality performance history. Further requirements and instruction on conducting Internal Audits are described in HTEKWORK-QST-003, Internal Quality Audit. 8.2.3 Measuring and Monitoring of Processes Teklad Diets applies suitable methods for monitoring and measurement of the Quality Management Systems processes.
Measurement Indicator Internal Audits Audits completed as per schedule Process Quality Assurance Raw Material Sampling and Testing In-process Inspection and Testing Finished Product Inspection and Testing Criteria (method of collection) Number of audits completed as per schedule divided by total number of audits performed Properly log, sample and analyze incoming raw materials, both bulk and bagged. Reduce and control the production of scrap due to moisture, PDI, bulk density or other production issues. Promptly submit and accurately document all production run samples which are scheduled for analysis at an independent laboratory. Measurement Frequency Objective Annually 90% Quarterly Annually Annually 98% < 40 tons 98%
Customer Service Design & Development Raw Materials Purchasing Formula Creation Maintain stocks of materials Proposed new formulas are ordered, produced and monitored Ensure that ample supplies of all standard diet raw materials that meet the specifications of Harlan Laboratories, Inc.Teklad Diets are available so the manufacturing process is not interrupted for more than eight continuous hours Log all occurrences >2.0 hours of production interruption due to equipment service interruption Produce Standard diets per plan. Produce Custom Diets per plan with less than 1% scrap Reduce shipping errors at distribution centers. Annually Annually 75% 98%
Engineering / Maintenance
Minimize loss of production time Volume Volume Order fulfillment
Annually
5.0% of 250 days of production 28,000 tons 218,000 kg 20% reduction
Standard Diet Manufacturing Custom Diet Manufacturing Warehouse / Distribution

Annually Annually Annually
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Process
Measurement Indicator
Criteria (method of collection)
Measurement Frequency Objective over prior year Annually < 15
Process Control
Product nonconformity
NCRs resulting from absence of non-human process control of critical process points or a failure of process control of critical process points.
These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved Corrective, Preventive and Improvement actions are taken, as appropriate, to ensure conformity of the process & product. 8.2.4 Measuring and Monitoring of Product Teklad Diets monitors and measures the product characteristics to verify that product requirements are met. Inspection and testing activities are conducted in three areas; purchased materials received, all stages of production, packaging and final inspection prior to shipment. Incoming materials, in-process and finished products are prevented from use if critical conditions are detected in accordance with applicable work instructions. Records of inspections are established and maintained in accordance with section 4.0 of this Quality Manual. Product release is handled in accordance with planned arrangements
SECTION 8.3
Control of Nonconforming Product 8.3 General Policy To ensure that product conforms to product requirements, any/all nonconforming product is identified, documented, evaluated and segregated (when practical) to prevent nonconforming products from being used or shipped. Detailed rules for nonconformity review, for making the disposition decision, and for recording these activities are provided in the procedure Identification and Control of Nonconforming Product and Equipment. 8.3.1 Records Records related to the control of non-conforming product are maintained.
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SECTION 8.4
Analysis of Data Teklad Diets determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the quality management system and evaluates where continual improvement of the effectiveness of the quality management system needs to be made. This includes data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data provides information relating to customer satisfaction, conformity to product requirements, characteristics and trends of processes and products including opportunities for preventive and improvement. The results of analysis are presented in a format suitable for the different levels of the organization. The result of the analysis can be used by Teklad Diets to determine trends, customer satisfaction, satisfaction of other interested parties, effectiveness and efficiency of the processes, supplier contribution, economics of quality, financial and market-related performance benchmarking of performances and competitiveness. Monitoring, measuring and analysis of data for customer satisfaction, conformity to product requirements, characteristics and trends of processes and product including opportunities for preventive action and suppliers are addressed in section 8.2.1, section 7 and 8, section 8 and section 7.4 respectively.
SECTION 8.5
Continual Improvements 8.5.1 Planning for Continual Improvement Teklad Diets continually improves the effectiveness and efficiency of the Quality Management System through the use of the Quality Policy, Quality Objectives, Audit Results, Analysis of Data, Corrective and Preventive Action and Management Review, in which the Quality Cycle model is used. The Quality Cycle model is known as Plan-DoCheck-Act (PDCA) which can be briefly described as follows: 1. Plan - Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization policies 2. Do - Implement the processes 3. Check - Monitor and measure processes and product against policies, objectives and requirements for the product and report results
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4. Act - Take actions to continually improve process performance 8.5.2 Improvement actions As a means of continual improvement; processes, products and/or services, action requests are generated as considered necessary by Top Management team and handled in accordance with section 8.5.3. These improvement actions can be generated from, but not restricted to, the following processes: Management Reviews, Employee Suggestion, Customer Suggestion, Analysis of Data, and Audit Results. 8.5.3 Corrective Action Causes of quality management system non-conformities are investigated, tracked, and documented as delineated in HTEK-SOP-QST-002, Corrective Action. Corrective action implementation may be proposed by any Teklad Diets employee or customer.

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3.0 DISTRIBUTION LIST

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4.0 QUALITY MANAGEMENT SYSTEM SECTION 4.1

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Continual Improvement of the Quality Management System

Customers Management Responsibility:

(and other interested parties): -Customer Complaints -Sales -Profits -Etc.

Measuring, Analysis and Improvement:

Figure 4.1.1: Quality Management System Model

Environmental information, Regulations Suppliers Information Customer contact.

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4.1.2 Teklad Diets Process Map:

Corporate Finance / Accounting Corporate Marketing

Corporate Sales Corporate Human Resources

Corporate Information Technology Transportation Services

Top Management QMS Standard Diet Manufacturing

Custom Research Diet Manufacturing

Packaging & Shipping Warehouse & Distribution

4.2.2 Quality Manual

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Document Level Level 1 & 2

Documents Quality Manual, Quality Procedures

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5.0 MANAGEMENT RESPONSIBILITY

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6.0 RESOURCE MANAGEMENT

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7.0 PRODUCT REALIZATION

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8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT SECTION 8.1

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Minimize loss of production time Volume Volume Order fulfillment

5.0% of 250 days of production 28,000 tons 218,000 kg 20% reduction

Standard Diet Manufacturing Custom Diet Manufacturing Warehouse / Distribution

Annually Annually Annually

Criteria (method of collection)

Measurement Frequency Objective over prior year Annually < 15

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