Wilson-Hurd ATF Quality Manual

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1 Wilson-Hurd ATF Quality Manual Wilson-Hurd Manufacturing Company Advanced Technical Facility (ATF) 311 Winton Street Wausau, WI Rev. Date: 04 May 2017 Pete Dehne Vice President, Operations

2 Table of Contents 1.0 Policies 1.1 Quality Policy 1.2 Environmental Policy 2.0 Scope 2.1 General 2.2 Application 2.3 Exclusions 2.4 Exceptions due to Non-Applicability 3.0 Administration of Manual 3.1 Purpose 3.2 Maintenance 3.3 Authorization 3.4 Distribution 4.0 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 5.0 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority and Communication 5.6 Management Review 6.0 Resource Management 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment 7.0 Product Realization 7.1 Planning of Production Realization 7.2 Customer-Related es 7.3 Design and Development 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Monitoring and Measuring Devices 8.0 Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement 9.0 Revision History 10.0 Index: Standard Operating Procedures

3 1.0 Policies WILSON HURD QUALITY POLICY Quality assurance is a PARTNERSHIP among all Wilson-Hurd people. Quality systems give each person OWNERSHIP of our commitment to continuously improve the quality of Wilson-Hurd s products and services. Quality responsibility includes the AUTHORITY to stop and address a problem when a product or service may not meet the customer s expectation. File: 2239

4 ENVIRONMENTAL POLICY Wilson-Hurd recognizes the importance of conserving natural resources to benefit current and future generations. Our current and long-term business goals are best served through responsible environmental stewardship. We will comply with all applicable regulatory requirements wherever we operate. Our proactive efforts will provide safeguards for the community, the workplace, and the surrounding environment while providing flexibility to meet the needs of our business. Wilson-Hurd is committed to providing a safe, injury-free workplace by integrating safety into our daily business decisions and operational processes. Management will set the example in insuring safe working conditions; however, all employees are responsible for their safety and the safety of those around them. We strive to conserve natural resources through innovative processes and continuous improvement with the goal of reducing, reusing, recycling, and identifying safer material substitutes or alternatives used in our operations. Energy conservation measures will be applied to reduce our overall energy usage. As a responsible member of the communities in which we live and work, we are committed to designing and manufacturing products that are energy efficient, safe to use, and that minimize the impact to the environment. As we expand our knowledge and understanding of the impact upon the environment of our operations and our manufactured items, we will share this knowledge with the broader community. We will expect similar environmental citizenship from all our suppliers. Wherever possible, our suppliers should reduce the impacts of transportation and utilize better recycling of materials and packaging to reduce waste generation. Suppliers should assist our company environmental efforts by making environmentally sensitive choices. Wilson-Hurd will strive to continually improve our environmental performance and to encourage all employees to carry out their day-to-day activities in a safe and environmentally responsible manner.

5 2.0 Scope 2.1 General Wilson-Hurd Advance Technical Facility (ATF) business unit located at 311 Winton Street Wausau, WI 54402, US is a FDA registered manufacturing facility in support of medical device contract manufacturing for OEM (Original Equipment Manufacturers) customers and related Advance Technology devices to meet customer specific requirements. The Quality System is designed to meet the requirements of ISO 13485:2003, FDA 21 CFR 820 and cgmp. 2.2 Application The Quality Management System (QMS) described in this manual is applicable in contractual situations entailing the manufacture of components / devices in accordance with customer specifications. 2.3 Exclusions ISO 13485:2003-Clause 7.3-Design & Development-including all sub-clauses. 21 CFR 820 Subpart C-Design Controls-including all sub-sections. Wilson-Hurd ATF is a contract manufacturer and does not design, develop, test or market its own products/brand(s). All medical components / devices produced by Wilson-Hurd ATF are manufactured in accordance with specifications provided and authorized by our customer. Planning, execution, and control of design and development activities are, therefore, not addressed in this manual and are excluded from the Quality Management System. 2.4 Exceptions due to Non-Applicability ISO 13485:2003-Clause Cleanliness of Product and Contamination Control 21 CFR (c, d) Wilson-Hurd ATF does not manufacture products that are required to be cleaned prior to sterilization and/or its use. ISO 13485:2003-Clause Installation Activities. 21 CFR Installations. Wilson-Hurd ATF does not perform or support any installation activities. Control and verification of installation activities is not applicable to Wilson-Hurd ATF. ISO 13485:2003-Clause Servicing Activities. 21 CFR Servicing. Wilson-Hurd ATF does not perform or support any servicing activities. Control and verification of servicing activities is not applicable to Wilson-Hurd ATF.

6 ISO 13485:2003-Clause Particular Requirements for Sterile Medical Devices. 21 CFR (e). ISO 13485:2003-Clause Particular Requirements for Sterile Medical Devices. Wilson-Hurd ATF does not manufacture Sterile Medical Devices. Control and verification of sterilization is not applicable to Wilson-Hurd ATF. ISO 13485:2003-Clause Particulare Requirements for Active Implantable Medical Devices and Implantable Medical Devices. 21 CFR ISO 13485:2003-Clause Particular Requirement for Active Implantable Medical Devices and Implantable Medical Devices. Wilson-Hurd ATF does not manufacture Active Implantable Medical Devices and Implantable Medical Devices. Control and verification of Active Implantable Medical Devices and Implantable Medical Devices is not applicable to Wilson-Hurd ATF. 3.0 Administration of the Quality Manual 3.1 Purpose The Quality Manual provides a description of the policies and systems used by Wilson-Hurd ATF to meet the requirements of both the ISO13485:2003 Standard and 21 CFR Part 820 Quality Systems Regulation. 3.2 Maintenance The Quality Manager is responsible for maintaining the Quality Manual as an accurate assessment of current policies and procedures. Customers, suppliers and employees are encouraged to suggest changes to the manual by contacting the Quality Manager. 3.3 Authorization The Quality Manual is authorized for use through the review and approval of the President as indicated by signature on the front cover of the manual. 3.4 Distribution The Quality Manual is a controlled document. Controlled copies are distributed per the Document Control Listing maintained by the Quality department. Uncontrolled copies of the Quality Manual may be issued, but they will not be updated as changes are made.

7 4.0 Quality Management System 4.1 General Requirements Wilson-Hurd ATF has established implemented and maintains a Quality Management System that complies with both the ISO13485:2003 Standard, 21 CFR Part 820 and CGMP. The system is comprised of the Quality Manual, Quality System Procedures, Flow Charts, Training Outlines, Work Instructions, and related forms and support documentation. Wilson-Hurd ATF ensures control over outsourced processes so that the product conforms to customer statutory and regulatory requirements. Outsourced product / processes from other Wilson-Hurd divisions are controlled under the plant specific ISO 9001 certification Map Wilson-Hurd ATF has developed a Map for the facility that illustrates the sequences and interaction of the quality system elements used to support the ISO 13485:2003 standard and 21 CFR Part 820 (e). Wilson-Hurd: Quality Management System - Map ATF Quality Policy Quality Objectives Measurement, Analysis Maintian Quality System Management Responsibility Resource Quality Manual Quality System Procedures ISO Manuals and Work Order Instructions Internal Audit Customer Contract Negotiations Receive Order Purchasing Production Job Review Customer Satisfaction Review Customer and Regulatory Requirements Resolve Questions with Customer If any Enter Order Purchase Requirement Identified Manufacture Product per Opertion Instructions Job Review to Plan Cost Develop Manufacturing and Cost plan Order Acknow to Customer Select Supplier In-process Inspection per Quality Plan Closed Order to stock Preventive Action Signed Contract with Customer Issue PO Final Product Audit Ship Corrective Action Receiving Release Product for Shipment Control of Customer Supplied Property Document & Record Control Calibration

8 4.2 Documentation Requirements Documentation System To ensure that all documents and records that are required by the Quality Management System or any other national or regional regulations are reviewed, approved and controlled. The document system is tiered as shown. Level 1 documents are the quality policy, corporate statements and quality manual. Level 2 documents are the Standard Operating Procedures (SOP) and quality objectives. These documents are either required by the ISO13485:2003 Standard or essential to the effective planning, operation, control and function of the Quality System. Level 3 documents are the operational specific documents to given areas and/or processes such as process flow charts, training outlines, work instructions, job tickets and prints, etc. Level 4 are documents used to support and validate the quality system such as forms, records and support documents Quality Manual Wilson-Hurd ATF maintains a Quality Manual that describes the quality management system as it is defined by Wilson-Hurd ATF and as it relates to the ISO 13485:2003 Standard, 21 CFR Part 820 and cgmp Control of Documents Wilson-Hurd ATF maintains a list of Standard Operating Procedures (SOP) in Appendix 1 of the Quality Manual. Wilson-Hurd ATF maintains a Document/Record Control Procedure, to ensure controlled documents are maintained where necessary to ensure the effective operation of the quality system and provide consistent quality products and service to the customer. The procedure applies to both internal documents generated by Wilson-Hurd ATF and external documents received from the customer or other sources.

9 4.2.4 Control of Records Wilson-Hurd ATF maintains a Document/Record Control Procedure, to ensure records are maintained where necessary to demonstrate the effective operation of the quality system and provide support information as service to customers. Device Master Record (DMR) - Wilson-Hurd ATF maintains a device master record for each medical device manufactured. The DMR is a compilation of records containing or pointing to the procedures and specifications for finished devices. Device History Record (DHR) Wilson-Hurd ATF maintains a device history record for each lot of medical device manufactured. The DHR is a compilation of records containing the production history of a particular finished device. Change Control Procedure - The change control procedure is used to ensure changes that could affect product quality or regulatory compliance are made under a controlled condition, will ensure that the change is suitably documented and reviewed / are approved by competent personnel, and will follow-up the complementary actions related to the change. Change control ensures that all planned changes are fully evaluated by competent personnel for their effect on product quality or validated status, and authorized before their implementation. 5.0 Management Responsibility 5.1 Management Commitment Wilson-Hurd management team is committed to the development and implementation of the quality management system. This includes maintaining the Quality System and communicating the importance of meeting customer, statutory and regulatory requirements to all ATF team members. The management team reviews the quality management system and resources needs throughout the year. The importance of meeting customer as well as statutory and regulatory requirements are communicated to the organization through various methods such as department and plant meetings, the job jackets information and process specific operation instructions. 5.2 Customer Focus Wilson-Hurd s Management Team is committed to ensuring that customer requirements are met to enhance customer satisfaction. Customer requirements are reviewed and determined before acceptance of a contract. Customer satisfaction trends are monitored and reported to management at management review meetings to demonstrate Wilson-Hurd ATF is meeting our customer s expectations.

10 5.3 Quality Policy Wilson-Hurd ATF has established and implemented a Quality Policy, (section 1.0 above). The quality policy has been communicated to all personnel. The Quality Policy provides a framework for operation of the business, establishing quality objectives and fosters an atmosphere of commitment to comply with requirements and maintain the effectiveness of the quality system throughout the ATF business unit. During the Management Review process the Quality Policy is reviewed for continuing suitability. 5.4 Planning Quality Objectives The management team established quality objectives as part of the Management Review process. Once established, the quality objectives are communicated throughout the organization Quality Management System Planning The quality system defined in the Map (4.1.1), and the Quality Objectives make up an integral part of the quality planning process. When changes are made to the quality management system, the Change Control Procedure is followed to ensure that the integrity of the quality management system has not been compromised.

11 5.5 Responsibility, Authority and Communication Wilson-Hurd Mfg. Co ATF Organizational Chart Top Management: Management Team: President, V.P. of Operations Top Management, WH Finance Controller, Quality Systems Manager President The President has overall responsibility and authority for the content and implementation of the Quality Management System. This includes final authority over the quality of product and customer service provided. The President has delegated to the Management Team the authority and responsibility to develop, maintain, manage and improve the Quality System. Management meetings, reports and meetings with the Quality Manager are used to review the status of the Quality System with the President Finance Controller The Finance Controller has responsibility and authority for Accounting, Payroll, Credit, and Collections.

12 Vice President of Operations The Vice President of Operations has responsibility and authority for the manufacturing and delivery of products in accordance to plan and customer requirements, Human Resources, Information Systems, and Training Administration. This includes establishing processes that meet the quality requirements for production throughout the manufacturing cycle. Quality requirements are conveyed to personnel through various means such as production job ticket, work instructions and support documents. Under the direction of the Vice President of Operations the Business Development is responsible for order & job entry and communicating delivery requirements to the manufacturing team. The manufacturing team is responsible for production of parts to plan and customer requirements including verifying product quality throughout the production cycle. When questions concerning quality arise beyond manufacturing s scope of understanding, Quality and/or Sales may be called upon to obtain clarification from the customer Quality Systems Manager The Quality Systems Manager oversees the Quality Management system. When the quality of product is in question, the quality department has the authority to determine final disposition. This includes the authority and duty to interpret and revise standards as needed to meet the needs of the customer. The quality department has final authority to release product for shipment. The Quality Systems Manager has the responsibility and authority for quality system audits and the CAPA system. Quality system audits verify the effectiveness of the quality system. The CAPA system is used to eliminate the cause of actual or potential nonconformities. This includes making accept/reject decisions on an ongoing basis as product is produced and released for shipment Management Representative The Quality Systems Manager is the designated ISO representative and FDA liaison for Wilson-Hurd ATF. As ISO representative, the Quality Manager is the liaison between the company and the ISO Register, register s authorized agents or FDA Inspector. The Quality Systems Manager has the responsibility and authority for establishing and implementing the quality management system, system assessment and for reporting system performance to the Executive Management team. The Quality Manager with support from the Executive Management team has primary responsibility and authority to promote awareness of quality systems and customer requirements throughout the organization.

13 5.5.3 Internal Communication Executive Management ensures that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. Communication processes include the ERP system, department and plant meetings, support documents, Operation Instructions and one on one contact. 5.6 Management Review General The status of the Quality Management System is reviewed per the Management Review Procedure to ensure the Quality System s continued suitability, adequacy and effectiveness. Records of management review activity are maintained per the Quality Record Listing. 6.0 Resource Management 6.1 Provision of resources Wilson-Hurd ATF Executive Management determines and provides manufacturing facilities, capital and trained personnel to produce products for customers. Resources are provided to implement and maintain the effectiveness of the Quality Management System that insures that customer and regulatory requirements are defined and achieved. 6.2 Human Resources Necessary competence for personnel performing work is defined per the Employee Staffing and Training Procedure using product specific Operation Instructions. Records of training are maintained per the Quality Record Listing. 6.3 Infrastructure Wilson-Hurd ATF provides and maintains the building, equipment and services that are needed to produce conforming product to satisfy customer and regulatory requirements per the Building Maintenance Procedure. 6.4 Work Environment Wilson-Hurd ATF provides a safe, clean and well-lit work environment that is appropriate to satisfy customer and regulatory requirements per the Environmental Control and Safety Procedures.

14 7.0 Product Realization 7.1 Planning of product realization The Map (Section 4.1.1) illustrates the basic elements of the product realization plan. Wilson-Hurd ATF maintains a Control Procedure to review potential product orders for manufacturability. A risk analysis is then completed on the Manufacturing. This information is then used to define the information on a job ticket, which is used to route the order through the production operation. Upon completion of the order the job ticket and appropriate support information is maintained as a record per the Quality Record Listing. 7.2 Customer-related processes Determination of requirements related to the product Upon receiving a request from the customer, Executive Management determines customer requirements as part of the contract negotiation. Through this negotiation, Wilson-Hurd ATF works with the customer to identify stated, non-stated, statutory and regulatory product requirements. Executive Management reviews the requirements and addresses any additional requirements needed to produce the product for the customer. If Wilson-Hurd ATF takes exception to any customer requirements, the exceptions are communicated to the customer Review of requirements related to the product Before acknowledging an order, the order requirements are reviewed to insure adherence to the contract. During order review the part, quantity, price, and delivery are reviewed. Any items that Wilson-Hurd ATF cannot comply with, or differ from the agreed upon contract, are resolved with the customer prior to releasing the order for production. Business Development maintains records of the order review process per the Quality Record Listing Customer communication Primary customer communication is through the Executive Management, Business Development and Quality departments. Communication methods include , mail, fax, telephone, sales call, etc. Feedback from the customer concerning product provided by Wilson-Hurd is routed through The Quality Department to start the Event. 7.3 Design and development Wilson-Hurd ATF is a contract manufacturer and does not design, develop, test or market its own products/brand(s). All medical components / devices produced by Wilson-Hurd ATF are manufactured in accordance with specifications provided and authorized by our customer. Planning, execution, and control of design and development activities are, therefore, not addressed in this manual and are excluded from the Quality Management System.

15 7.4 Purchasing Purchasing process Wilson-Hurd ATF maintains a purchasing system that ensures purchased product conforms to specified requirements. Purchasing oversee the selection of supplier based upon supplier history. New suppliers are selected based upon their ability to supply product to Wilson-Hurd s requirements. Vendor tracking records, which monitor supplier performance, are maintained by Purchasing per the Quality Record Listing Purchasing information Purchase orders are used to purchase materials, supplies, tooling and equipment. When required the appropriate description, drawings, specifications, certifications, qualifications are referenced on the purchase order. Purchased orders are reviewed for accuracy prior to being sent to the supplier Verification of purchased product Wilson-Hurd ATF maintains a receiving verification system for purchased products. As part of the standard PO, Wilson-Hurd ATF has reserved the right to inspect or allow our customer to inspect product at the supplier s location. 7.5 Production and service provision Control of production and service provision The manufacturing controls production activity for a part. This includes developing and maintaining a bill of material to manufacture the part and controlling production activity through the manufacturing system. From the bill of material, Wilson-Hurd ATF maintains a job ticket as the main method of communicating the description and sequence of manufacturing operations to process an order through production. This includes routing the order to the appropriate machine center for production activity. The job ticket references relevant drawings and production support documentation needed to produce the order. In addition to the job ticket, each work center is supported by Operation Instructions that support a specific process. This includes measurement devices needed within the work center to support production. Production activity is verified per established quality reference standards or as specified on the job ticket or support information. As work is completed through a work center, product is released to the next operation by either signing off on the job ticket operation or appropriate inspection record. Prior to releasing an order for shipment all operations are verified to be complete. To support the production process, Wilson-Hurd ATF maintains an Equipment and Maintenance procedure to ensure the plant and equipment is maintained for production. Wilson-Hurd ATF does not perform or support any installation activities. Control and verification of installation activities is not applicable to Wilson-Hurd ATF.

16 7.5.2 Validation of processes for production and service provision Wilson-Hurd ATF is responsible for establishing procedures that will validate processes that cannot be fully verified during routine production by inspection and/or testing. This includes any processes where deficiencies become apparent only after the product is in use. Wilson-Hurd ATF is responsible for establishing procedures that will validate computer software for its intended use. For both and Computer validations the Validation Master Plan Procedure will be followed. Wilson-Hurd ATF does not perform or support any servicing activities. Control and verification of servicing activities is not applicable to Wilson-Hurd ATF Identification and traceability Wilson-Hurd ATF maintains identification of materials and parts during all stages of production through the inventory and job ticket system. If a specific customer requires traceability, a plan is established with the customer to satisfy its requirements. Once a plan has been established with the customer, the plan is integrated into the existing quality system. Appropriate records are maintained to document the traceability system per the Quality Record Listing Customer property Wilson-Hurd ATF maintains systems for the identification, verification, storage and maintenance of customer-supplied materials. Customer supplied materials are received as normal product but identified for a specific customer s use per the requirements of Control of Customer Property. Any such product that is lost, damaged, or is otherwise unsuitable for use is recorded and reported to the customer. Records are maintained per the Quality Record Listing Preservation of product Wilson-Hurd ATF maintains procedures for the identification, handling, packing, storage and preservation of products. 7.6 Control of monitoring and measuring devices The Quality department works with Manufacturing to determine the type of measurement equipment needed to verify conformance of product quality. Measurement devices are made available where needed to support production activity. The Quality department maintains a calibration system for the control and verification and/or calibration of measurement devices. This includes a unique identifier and status on the device. If the accuracy of a measuring device is in question, personnel are instructed to notify Quality to verify its accuracy prior to use. If the device is found to be out of verification and/or calibration, manufacturing is notified so appropriate action can be taken. Measurement devices are verified and/or calibrated to the appropriate standards. Verification / Calibration records are maintained electronically for each piece of

17 measurement equipment. External documents are maintained when necessary as support to the electronic records. 8.0 Measurement, analysis and improvement 8.1 General Wilson-Hurd ATF maintains an active measurement, analysis and improvement system in all areas of business activity to demonstrate conformance of product quality and the effective implementation of the quality management system. Information is reviewed at the management meeting, quality management system review meetings and the annual planning process. This information provides the basis for improvement activity at Wilson- Hurd ATF. 8.2 Monitoring and measurement Customer satisfaction The Quality department maintains information relating to customer satisfaction as it relates to performance and meeting customer requirements. This information includes data from complaints and general customer feedback. Events are the early warning feedback system from customer complaints, which are addressed in the EVENT system. Customer performance information is reported and discussed during management meetings Internal audits Wilson-Hurd ATF has an Internal Audit Procedure for planning and implementing internal quality audits to determine the effectiveness of the quality system. Internal quality audits are performed on the basis of the status and importance of the activity and carried out by personnel independent of those having direct responsibility for the activity being audited. The results of the audits are recorded and brought to the attention of the personnel having responsibility in the area audited. The management personnel responsible for the area takes timely corrective action on deficiencies found during the audit per the corrective action. Internal audit results are reviewed with the management team during Management Review Meetings. Records of internal audits are maintained per the Quality Record Listing Monitoring and measurement of processes Wilson-Hurd ATF monitors processes using various methods including but not limited to process capability studies, analysis of production reports, job cost analysis, etc. If a process is not performing to expectations, the situation is reviewed by manufacturing, quality or management and if required actions are taken for improvement.

18 8.2.4 Monitoring and measurement of product Wilson-Hurd ATF maintains inspection and testing activities as required in order to verify that the specified requirements for product are met. Where required, records of the test results are maintained per the Quality Record Listing. Incoming parts or materials are not used until they have been verified as conforming to the purchase order requirements. Inspection of specific material is in accordance with documented instructions per the Receiving Instructions. In-process parts are inspected and tested as required by the appropriate instructions on the job ticket or support documents. When an operation is completed, the operators initials and dates are placed on the appropriate production documentation. This indicates that required inspections and tests have been successfully completed for that operation or lot of material. Product that does not pass in-process inspection or testing follows the Nonconforming Product. Final inspection and testing is performed according to the appropriate instructions to ensure compliance with customer requirements. Prior to releasing the order for shipment, the production documentation is reviewed for signoff to verify all operational inspection and test activity are complete. Product is not released for shipment until all operations have been signed off. Records for inspection and test are maintained per the requirements specified on the job ticket or product release documents. The records provide evidence that the product has been inspected and/or tested successfully. These records show whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria. When necessary, where the product fails to pass any inspection and/or test, the procedures for control of nonconforming product apply. Sign-off on the inspection operation by a qualified inspector is authority to release the order for shipment. 8.3 Control of nonconforming product Wilson-Hurd ATF has Nonconforming Material Procedures to prevent nonconforming product from being used or shipped to the customer. The procedure defines how nonconforming product is identified, documented, evaluated and dispositioned. This includes notification of the appropriate function and, if necessary, the customer. If required by the customer, rework of nonconforming parts is reported to the customer for approval. The description of the rework is recorded as part of the production documentation and retained as a record per the Quality Record Listing. Reworked parts are inspected to the same criteria as the original parts. 8.4 Analysis of data Wilson-Hurd ATF uses the Statistical Techniques & Data Analysis Procedure to show evidence that the quality management system is working and identify areas for continual improvement. This includes data from customer satisfaction including customer complaints, process information including internal nonconforming material reports and supplier performance information, quality system performance including internal audit results.

19 Where required Wilson-Hurd ATF uses statistical techniques to monitor and improve processes or product characteristics. The Quality Manager is responsible for implementing and maintaining improvement activity with support from the management team. 8.5 Improvement Continual improvement As defined in the process map, management is committed to the continual improvement cycle of the quality management system. Any of the sections described in the ATF Quality Manual can be used to identify opportunities for continual improvement. Wilson-Hurd ATF follows the Recall procedure to issue and implementation of any advisory notices Corrective action Wilson-Hurd ATF maintains procedures to address corrective actions by using a modified 8- D approach designed to eliminate the cause of the nonconforming condition. Corrective actions that relates to performance and meeting customer requirements are processed through the CAPA system. Corrective actions associated with internal audit findings are addressed in the CAPA System. Supplier Corrective actions are addressed in the SCAR system. Corrective action taken to eliminate the causes of nonconformities is to a degree appropriate to the magnitude of the problem and commensurate with the risks encountered. Corrective action reports are maintained by Quality per the Quality Record Listing Preventive Action Wilson-Hurd ATF maintains a Preventive Action Procedure, designed to use appropriate sources of information to eliminate potential risks of nonconformities on a process or part specific basis. Records of preventive actions are maintained by Quality per the Quality Record Listing. 9.0 Revision History Reason for Revision Revision Made By Rev. Date Initial Paul Swanborg 06/25/2012 Update to actual practices Yvonne Standridge 04/26/2013 Add exceptions , , and Add Authority to VP of Sales, Operations and Quality Manager. Added procedure name to 8.4. Added Event System to Chris Weed 05/03/2014 Changed Location Address. Added Systems to Quality Systems Manager title Susanne Buchberger 26 Sep 2016 Updated Organizational chart and Section due to Company change in Organizational Structure Susanne Buchberger 15 Feb 2017 Corrected Index 10.0, ATF Quality Manual and SOP Index for previous changes made Susanne Buchberger 04 May 2017

20 10.0 Index ATF Quality Manual and SOP Index Document Number Title Owner Reviewed & Approved By Quality Manual Quality Plan President President SOP 001 Document and Record Control Quality Manager President & VP of Operations SOP 002 Quality Objectives V.P. of Operations President & Quality Manager SOP 003 Creating Standard Operating Procedures Quality Manager President & VP of Operations SOP 004 Management Review Procedure Quality Manager President & VP of Operations SOP 005 Employee Staffing - Training V.P. of Operations President & Quality Manager SOP 006 Maintenance Procedure V.P. of Operations President & Quality Manager SOP 007 Environmental Controls V.P. of Operations President & Quality Manager SOP 008 Safety Procedure V.P. of Operations President & Quality Manager SOP 009 Design Transfer Procedure Quality Manager President & VP of Operations SOP 010 Change Control Procedure Quality Manager President & VP of Operations SOP 011 Purchasing Controls Procedure V.P. of Operations President & Quality Manager SOP 012 Supplier Assessment Procedure V.P. of Operations President & Quality Manager SOP 013 Receiving Inspection Procedure V.P. of Operations President & Quality Manager SOP 015 Control Procedure V.P. of Operations President & Quality Manager SOP 016 Labeling Procedure V.P. of Operations President & Quality Manager SOP 017 Deviation Procedure Quality Manager President & VP of Operations SOP 018 Validation Master Plan Quality Manager President & VP of Operations SOP 019 Identification and Traceability Procedure Quality Manager President & VP of Operations SOP 020 Control of Customer Property Quality Manager President & VP of Operations SOP 021 Handling, Storage, Packing, Preservation & Delivery Quality Manager President & VP of Operations SOP 022 Calibration Procedure Quality Manager President & VP of Operations SOP 023 Statistical Techniques & Data Analysis Quality Manager President & VP of Operations SOP 024 Quality Audit Procedure Quality Manager President & VP of Operations SOP 025 Release of Finished Goods V.P. of Operations President & Quality Manager SOP 027 Non-Conforming Material Quality Manager President & VP of Operations SOP 028 Complaint Handling Procedure Quality Manager President & VP of Operations SOP 030 CAPA Procedure Quality Manager President & VP of Operations SOP 031 Recall Procedure Quality Manager President & VP of Operations SOP 032 Medical Device Reporting Quality Manager President & VP of Operations