Quality Manual. This manual complies with the requirements of the ISO 9001:2015 International Standard. AW2 Logistics, Inc Ace Industrial Dr.

Transcription

1 Quality Manual This manual complies with the requirements of the ISO 9001:2015 International Standard. AW2 Logistics, Inc Ace Industrial Dr. Cudahy, WI Quality Manual Rev 3 Page 1 of 30

2 Table of Contents 1 Introduction Management System Approach Quality Manual Structure... 6 SECTION 1: PLAN Context of the Organization Understanding the organization and its context Understanding the needs and expectations of interested parties Determining the scope of the quality management system Quality management system and its processes Leadership Leadership and commitment Customer focus Policy Organizational roles, responsibilities and authorities Planning Actions to address risks and opportunities Quality objectives and planning to achieve them Planning of changes Support General People Infrastructure Environment for the operation of processes Monitoring and measuring resources Measurement Traceability Organizational Knowledge Competence Awareness Communication Documented Information SECTION 2: DO Operation Operational Planning and Control Customer communication Determining the requirements for products and services Quality Manual Rev 3 Page 2 of 30

3 8.2.3 Review of the requirements for products and services Changes to requirements for products and services Design and development Design and development planning Design and development Inputs Design and development controls Design and development outputs Design and development changes Control of externally provided processes, products and services (Purchasing) Type and extent of control Information for external providers Control of production and service provision Identification and traceability Property belonging to customers or external providers Preservation Post-delivery activities Control of changes Release of products and services Control of nonconforming process outputs, products and services SECTION 3: CHECK Performance Evaluation Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation Internal audit Management review SECTION 4: ACT Improvement General Nonconformity and corrective action Continual improvement Distribution Process Flow...27 Packaging and Crating Process Flow...28 SWOT Analysis Quality Manual Rev 3 Page 3 of 30

4 1 Introduction Our Quality Management System Commitment As the President of AW2 Logistics, I am committed to the quality management system, taking full accountability, and supporting other roles of leadership. Management uses the process approach and risk-based thinking to ensure the management system is integrated into our business processes to achieve intended results. I am committed to provide the resources and training needed to ensure an effective quality management system that is necessary for our success and improvement. We provide a work environment that allows our employees to be successful in meeting our customers needs. The Quality Policy is established to be the driving force behind our quality management system, and I will continue to ensure that it remains compatible with the context and strategic direction of our organization. Charles Buddy Harvin AW2 Logistics, Inc. Quality Policy AW2 Logistics, Inc. We are committed to providing products and services that exceed the expectations of our customer requirements through our dedication to continual improvement. By setting and reviewing our quality objectives, we strive for outstanding product preservation and process accuracy; delivered on time, every time Quality Manual Rev 3 Page 4 of 30

5 2 Management System Approach Our approach to our quality management system is based on the Plan, Do, Check, Act cycle (PDCA). The basis of our business beliefs is represented in three pillars: Customer Focus Our customers are the reason we exist. We aim to meet or exceed their needs and expectations to make them successful. We will even try to anticipate their needs and introduce solutions they ve not seen before in the spirit of true partnership. Our success depends upon our customers success. Process Approach To deliver on our commitment to total customer focus we constantly work on our internal processes to maximize their effectiveness and efficiency. We recognize that it takes countless individual activities to deliver our products and services and that the process approach ties them all together. Our business is a process that transforms several inputs (customer requirements, resources, skilled employees, etc.) into an output that meets our customer s needs. Within our business are several key processes that make it all work. Our processes are dependent upon one another and individually need continual attention and improvement. We are constantly challenging ourselves to refine and change how we do things to reduce the time it takes to get something done with the least errors. When errors do occur, we use them as opportunities to learn and improve. We are never satisfied with how things are working now and strive to raise our game every day. Risk-based Thinking Looking ahead to anticipate what could happen is the reason we employ risk-based thinking throughout our organization. At several points in our process we purposely stop and ask two probing questions: What could go wrong? Is there a way to improve? This perspective of constantly watching for risks and opportunities leads us to action which we carefully manage to ensure timely implementation and effective results. This gives us an attitude of being proactive to take advantage of every opportunity to improve. We intend these three basic beliefs to cause our customers to stand up and take notice the difference we provide to them on a daily basis. Our quality management system described in this Quality Manual Rev 3 Page 5 of 30

6 Quality Manual has been carefully crafted to make these three pillars a real part of what makes us work. 3 Quality Manual Structure This Quality Manual is presented in a PDCA manner and describes our approach to the requirements of ISO 9001:2015. The manual is divided into four sections with all applicable sub-clauses represented in each section as below: Quality Manual Rev 3 Page 6 of 30

7 SECTION 1: PLAN With an ever-changing world we are faced with new challenges on a continuing basis. The issues, changes and trends within our industry and the broader economy present us with risks and opportunities from cultural, technological, competitive, regulatory, market, economic and social factors. Not only can these factors affect our business, but there are also other interested parties and organizations that we deal with on a day-to-day basis and these present additional requirements that we must account for. All of these factors may affect our business negatively (risks) or positively (opportunities). The risks may be relevant to us, and have the potential to affect our business or our customers in a negative way. These aspects of our business environment may also create opportunities for us to improve our organization or take advantage of expanded current or new business ventures. Planning other aspects of our organization is also very important. Our planning process also includes people, their knowledge and training, infrastructure, environment, documented information, and communication. All planning efforts are structured, include decision-makers, and are documented when required. Our extensive planning process puts us in the best position possible to forecast these challenges and take actions when necessary. It also establishes the needed foundations for us to provide our products and services. Quality Manual Rev 3 Page 7 of 30

8 4 Context of the Organization 4.1 Understanding the organization and its context The AW2 Approach: Issues (4.1) stemming from trends and changes in our industry may affect our business purpose and strategic direction. Those that present risks and/or opportunities are initially addressed by top management, then monitored and reviewed on an annual basis by our QMS Plan review which occurs during Management Review. 4.2 Understanding the needs and expectations of interested parties The AW2 Approach: Requirements from interested parties (4.2) that impact our ability to meet customer and applicable statutory and regulatory requirements may present risks and/or opportunities. These are reviewed to determine relevance and necessary actions. Subsequently, they are also monitored and reviewed on an annual basis by our QMS Plan review. 4.3 Determining the scope of the quality management system The AW2 Approach: In light of these external and internal issues and requirements, we have established the scope of our quality management system as: Scope This quality management system pertains to processes relating to the storage and shipment of goods; as well as the design and production of packaging and crating products which protects goods during global shipment. This includes operations of AW2 Logistics, Inc. at both Distribution and Packaging and Crating. AW2 Logistics Distribution, is the main distribution facility for the storage, pick, pack, and shipment of GE Healthcare medical equipment. AW2 Logistics Packaging and Crating, designs and produces specialized packaging that meets customer requirements for shipping internationally and domestically. The addresses for AW2 Logistics are as follows: AW2 Logistics Distribution AW2 Logistics Packaging and Crating W160 S6471 Commerce Dr Ace Industrial Dr. Muskego, WI, Cudahy, WI AW2, Logistics Inc. does not have any exclusions from the ISO9001:2015 Quality Manual Rev 3 Page 8 of 30

9 4.4 Quality management system and its processes The AW2 Approach: The processes (4.4) needed to achieve intended outcomes, results and to continually improve our quality management system are identified on the QMS Plan, and are maintained on Process Plans, and reviewed during Management Review. 5 Leadership 5.1 Leadership and commitment The Aw2 Approach: Our top management holds the ultimate responsibility for the quality management system. Our top management is dedicated and committed (5.1) to ensuring that our quality management system is effective, understood and improved. Top management includes the following members: President Director of Packaging and Crating Operations Manager Operations Supervisors Quality Manager Customer focus The AW2 Approach: Top management demonstrates leadership and commitment to ensure that all applicable requirements are met, risks and opportunities are addressed, and maintains the focus on customer satisfaction (5.1.2) through our QMS Plan, Process Plans and Quality Policy. Top management reviews the requirements specified by the customer and resolves any discrepancies found. Top management ensures that the information relating to customer satisfaction is effective with the help of Quality Objectives which are examined to determine whether AW2 Logistics is meeting customers requirements. 5.2 Policy The AW2 Approach: The top-level requirement that directs our entire quality management system is our Quality Policy. The quality policy (5.2) is maintained, available, communicated, reviewed annually during Management Review. Quality Manual Rev 3 Page 9 of 30

10 Quality Policy We are committed to providing products and services that exceed the expectations of our customer requirements through our dedication to continual improvement. By setting and reviewing our quality objectives, we strive for outstanding product preservation and process accuracy; delivered on time, every time 5.3 Organizational roles, responsibilities and authorities Our Approach: Responsibilities and authorities (5.3) for our process owners are assigned, communicated and understood on our Process Plans. The Quality Manager has been appointed as the Management Representative of our QMS. 6 Planning 6.1 Actions to address risks and opportunities The AW2 Approach: We address the risks and opportunities (6.1) identified in the QMS Plan and Process Plans, as well as other situations through the use of an action item list during management reviews. The actions will be integrated into our quality management system process and will be evaluated for effectiveness during reviews. 6.2 Quality objectives and planning to achieve them The AW2 Approach: We establish objectives (6.2) at relevant functions, levels, and processes, and have plans to achieve them on our Measurement Plans. The measureable quality objectives for AW2 are as follows: Daily production and delivery schedule to be met at 100%. Systemic Receiving accuracy to be 99.0% or better. Picking accuracy to be at 99.0% or better. Inventory accuracy to be at 99.0% or better. Sign offs of first-time orders and all changes to be 100%. Product preservation to be less than 5 incidents per year. Quality Manual Rev 3 Page 10 of 30

11 The results of these objectives and plans are reviewed annually and retained on the Management Review Minutes. 6.3 Planning of changes The AW2 Approach: Changes (6.3) that are needed are planned and carried out carefully considering the consequences, the integrity of our QMS, resources and associated responsibilities. The changes are managed and are recorded in the Management Review Minutes. 7 Support General The AW2 Approach: During our Management Reviews, our top management discusses all internal and externally provided resources needed (7.1.1) for maintenance and continual improvement of our quality management system, and ensures that they are provided People The AW2 Approach: During our Management Reviews, our top management determines the persons necessary (7.1.2) for the effective implementation of our QMS and for the operation and control of our processes, and ensures that the resources are provided Infrastructure The AW2 Approach: To ensure that our infrastructure resources remain adequate, they are reviewed and discussed during Management Reviews. Top management determines, provides and maintains the infrastructure needed to achieve product and conformity requirements. Infrastructure includes buildings, work and storage space, hardware and software, process equipment, utilities and support services such as transportation, communications or information systems. QP-10 is in place to define the activities needed to ensure that the material handling equipment used in AW2 Logistics production and service delivery are properly maintained to provide safe and efficient operation for material handling. References: QP-10 Material Handling Equipment Procedure Quality Manual Rev 3 Page 11 of 30

12 7.1.4 Environment for the operation of processes The AW2 Approach: Our top management ensures that our work environment (7.1.4) is sufficient to achieve conformity of our products and services as discussed during Management Reviews. Maintenance of all work areas is recognized as an important prerequisite for quality and achievement of product conformity. All employees are responsible for contributing to the maintenance of the work environment. The manager or delegate regularly surveys the facilities to identify poor conditions, which may affect the work environment. Feedback is incorporated into the QMS planning activities and reviewed during management reviews Monitoring and measuring resources The AW2 Approach: We have determined, and provide the resources needed to monitor and measure ( ) our products and services to ensure that they continue to meet requirements and specifications. We utilize controlled conditions which include quality plans, procedures, work instructions and forms that define the product and service requirements and record that the product or service meets all requirements before releasing for shipment Measurement Traceability The AW2 Approach: Measurement traceability is essential to providing confidence in the validity of the measurement results. We determine the monitoring and measurement to be undertaken and the measuring equipment needed to provide evidence of product conformity. Procedure QP-04, Calibration Procedure, exists to define the calibration process to be used. The procedure ensures that all equipment is properly identified and labelled, periodically calibrated to conform to requirements, handled, maintained and stored in an environment to preserve and validate the calibration results. The procedure also includes the process for handling equipment that is found to be out of tolerance and the action taken to address the problem. The Operations Manager or designee has the responsibility for this process. All employees have the responsibility to follow the procedure and ensure the proper use of measurement equipment. References: QP-04 Calibration Procedure Quality Manual Rev 3 Page 12 of 30

13 7.1.6 Organizational Knowledge The AW2 Approach: All current knowledge (7.1.6) sources, requirements, changes, needs and trends are determined by top management, maintained and discussed during Management Reviews. 7.2 Competence The AW2 Approach: We determine the required competencies (7.2) for our employees, whose work may impact the effectiveness and performance of our QMS, which are defined in job descriptions. We hire employees with specific knowledge, skills and education that best fit our needs and provide training to fulfill any missing competencies. Evidence of this process is retained in employee files. 7.3 Awareness The AW2 Approach: People doing work under our control are made aware (7.3) of our quality policy, objectives, how our quality management system works and the implications of not working within our quality management system as defined on the Communication and Awareness Plan, and is reviewed during Management Review. Training or other action is conducted and documented to ensure personnel: Are aware of their quality responsibilities and their contribution to the achievement of the quality objectives and effectiveness of the QMS. Have acquired the necessary skills to perform their job effectively. Understand the consequences, both real and potential, of their work activities. Understand the importance of conformance to the quality policies and procedures. Are competent to perform tasks that may impact product or service quality. Records of employee education, skills, experience and received training are maintained in the employee files. References: QP-07 Training Procedure Quality Manual Rev 3 Page 13 of 30

14 7.4 Communication The AW2 Approach: Communication (7.4) is very important to our operations success. Our communication decisions are maintained on the Communication and Awareness Plan, and is reviewed during Management Review. 7.5 Documented Information The AW2 Approach: We have determined which internal and external documented information (7.5) is necessary for the effectiveness of our quality management system. This documented information is created, approved, and controlled according to applicable requirements primarily through the use of our AW2 Quality Website. Quality Manual Rev 3 Page 14 of 30

15 SECTION 2: DO Providing our customers with products and services that meet their requirements and expectations is why we are in business. This takes planning, reviewing, as well as execution of these processes to ensure that all requirements are identified and met. In this section of the handbook, we will be describing our methods for conforming to the operational planning, requirements determination and review, design and development, purchasing, product and service provision, post-delivery activities, and what we do when something doesn t go quite as we expected. 8 Operation 8.1 Operational Planning and Control The AW2 Approach: The processes, including outsourced processes that affect our products and services are controlled (8.1). The details and evidence of our processes are maintained within the QMS Plan and Process Plans. Work instructions cover the processes of receiving customer orders. Changes to orders are identified and reviewed with the documentation updated with the relevant information. Work instructions cover the extent of communication with the customer regarding service information and inquiries while Procedure QP-05 covers feedback received from the customer in terms of both positive and negative feedback. QP-01, Document Control Procedure covers the process for customer requested changes or additions to the QMS and how they are approved. The President is responsible for the on-going distribution contract, including periodic reviews of performance. References: QP-01 Document Control Procedure QP-05 Customer Feedback Procedure Customer communication Our Approach: Open, and efficient communication with our customers (8.2.1) is very important for communicating information relevant to products and services, contract information, customer complaints, changes, property, requirements and contingency actions. We determine and implement effective arrangements for communicating with customers relative to product and service information, contracts, order handling and customer feedback. Work instructions define the communication process for customer orders and order handling while Procedure QP- 05 defines the process for customer feedback. Quality Manual Rev 3 Page 15 of 30

16 References: QP-05 Customer Feedback Procedure Determining the requirements for products and services The AW2 Approach: Through the use of a formalized statement of work (SOW), phone calls and s, we determine the requirements (8.2.2) for our current or new products and services to ensure that all applicable customer, organizational, regulatory and statutory requirements are identified to ensure that we have the ability to meet the claims and requirements Review of the requirements for products and services The AW2 Approach: After the requirements are determined, the President or Director of Packaging and Crating reviews all requirements (8.2.3) to ensure that we have the ability to meet the product and service requirements prior to offering the product or service. If our customer does not provide us with any requirements, we will confirm requirements prior to acceptance. Requirements generated from the product or service, the organization, statutory, regulatory and requirements that are differing from previous ones are reviewed. Customer requirements are reviewed by the General Manager and Director of Packaging and Crating and the results are retained in the Customer Project folder Changes to requirements for products and services The AW2 Approach: When the requirements for products and services are changed (8.2.4), the Quality Manager ensures that relevant documented information is amended and that relevant personnel are made aware of the changed requirements. 8.3 Design and development The AW2 Approach: We maintain a design and development process that is appropriate to the products and services that we offer. Our design and development process is performed in controlled stages for: inputs, controls, outputs, and changes Quality Manual Rev 3 Page 16 of 30

17 8.3.2 Design and development planning The AW2 Approach: We have determined the stages and controls for our design and development process (8.3.2). The Design Plan and Schedule controls all stages of the design and development process. The Design Plan and Schedule identifies the important stages of each new project by calling out design requirements, verification, validation, and release. The documented information is retained in the appropriate customer file Design and development Inputs The AW2 Approach: We determine our requirements taking into consideration all input elements. Our design and development inputs (8.3.3) are included within the Design Plan and Schedule Design and development controls The AW2 Approach: We apply controls (8.3.4) to our design and development process to ensure that we: achieve defined results; review and evaluate our D/D requirements; ensure that outputs meet input requirements; meet requirements for application or intended use; resolve problems that may arise during design and development retain documented information in appropriate customer files. Our design and development controls include the Design Plan and Schedule Design and development outputs The AW2 Approach: Our design and development outputs (8.3.5) are adequate, and include essential information needed to ensure that all input requirements are met. The design and development outputs are retained on the Design Plan and Schedule Design and development changes The AW2 Approach: Any changes (8.3.6) that are made during the design and development stages of the products and services are controlled and identified. We retain documented information of the changes, reviews, authorizations and adverse impact actions through Design Change Request Form. Quality Manual Rev 3 Page 17 of 30

18 8.4 Control of externally provided processes, products and services (Purchasing) The AW2 Approach: We ensure that all of our suppliers of processes, products and services (8.4) conform to all applicable requirements. We apply sufficient controls to any provider of products or services that: are directly incorporated into our products or services; are provided directly to the customer on our behalf; or provide a process, or part of a process requested by us. Our criteria for selection, evaluation, performance and re-evaluation practices, is described in the table below: Criteria Selection Evaluation/Re-evaluation Customer specified supplier X Technical specifications X X Price and availability X X Product quality X X On time delivery X Any adverse effect on QMS X X The Director of Packaging and Crating is responsible for controlling the purchasing process and for maintaining appropriate records. Approved suppliers are listed in our Accounting software and on the Approved Supplier List. External providers are evaluated during our Management Reviews. As of the initial release of this document, all current suppliers in good standing are considered to be approved. Quality Manual Rev 3 Page 18 of 30

19 8.4.2 Type and extent of control The AW2 Approach: The controls (8.4.2) that we decide to apply to our external providers are decided on an individual basis. We ensure all suppliers remain in control our quality management system and apply other controls as necessary by product, service or situation Information for external providers The AW2 Approach: Prior to communicating with suppliers, we ensure that all applicable requirements are clearly identified. These may include requirements relating to products, services, supplier processes, certifications or personnel, and any verification or validation that the supplier provides at their premises. The purchasing information (8.4.3) is communicated to suppliers via Purchase Order Control of production and service provision The AW2 Approach: We control all phases of our product or service realization (8.5.1). These controls may include; documented characteristics, monitoring and measurement, validations or reviews of products and/or processes, and release and post-delivery activities. The Director of Packaging and Crating is responsible for controlling all phases of product and service provision for packaging and crating, the General Manager is responsible for controlling all phases of product and service provision for distribution, including processing customer orders and maintaining appropriate records Identification and traceability The AW2 Approach: We will identify the product by suitable means throughout service realization and will identify the product status with respect to monitoring and measurement requirements throughout product realization. Work instructions define the methods used to identify the product through all phases of receipt, storage, picking, packing and shipping processes. The Manager or delegate is responsible for ensuring adequate identification is maintained on all items and work in process or inventory. When contracted, traceability is accomplished by linking the unique part number to the device serial number. Quality Manual Rev 3 Page 19 of 30

20 8.5.3 Property belonging to customers or external providers The AW2 Approach: We will exercise care with customer property while it is under the organization s control. Customer property being used or incorporated into final product is identified, verified, protected and safeguarded while in the care of AW2 Logistics. Work instructions will identify how customer property will be handled if non-conformances are found. In the rare occurrence of customer or provider s property becoming lost, damaged or unusable, the General Manager or delegate will contact the provider and determine course of action. References: QP-08 Non-conforming Material Procedure Preservation The AW2 Approach: We use methods necessary to ensure that our product or service maintains conformance to the requirements. We preserve the product and its constituent parts during all receipt, storage and delivery in order to maintain conformity requirements. Work instructions exist that ensure the product conformity is preserved during all stages of receipt, storage, handling, picking, packing and shipping. The manager or delegate is responsible to implement this process. All employees handling or processing product are responsible to preserve the product integrity Post-delivery activities The AW2 Approach: Post-delivery activities (8.5.5) including, customer complaints, surveys and periodic sales and marketing visits are made considering applicable requirements, product/service use, customer feedback and potential risks Control of changes The AW2 Approach: Any changes (8.5.6) that occur during our product or service provision are controlled by, the General Manager or Director of Packaging and Crating, and recorded in the customer file. Quality Manual Rev 3 Page 20 of 30

21 8.6 Release of products and services The AW2 Approach: The release of our product/service (8.6) is indicated by means of packaging inspection (Packaging and Inspection Form), and does not occur until all planned arrangements have been completed, and is only released by authorized persons. 8.7 Control of nonconforming process outputs, products and services The AW2 Approach: We will ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. Procedure QP-08, Non-conforming Material Procedure, exists to define the process for non-conforming product, how to properly disposition the non-conforming product and the responsibilities for these actions. The procedure defines the documentation and control of this material. NCR s will be reviewed on a periodic basis to assess the impact of nonconformity and appropriate action will be taken to eliminate the cause of the non-conformance. References: QP-08 Non-conforming Material procedure Quality Manual Rev 3 Page 21 of 30

22 SECTION 3: CHECK We make great efforts to be data-driven decision makers. This can only be accomplished by ensuring that we maintain accurate data and that the data is properly interpreted. We take the time to analyze data from various areas that supplies us with data on: customer satisfaction; process effectiveness; product/service conformity; effectiveness of our QMS; external providers; our planning efforts; external providers; and the associated risks and opportunities. Our thorough checking process allows us to have confidence in our quality management system and identify improvement areas. 9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation The AW2 Approach: Our method of monitoring, measurement, analysis and evaluation is maintained within our Measurement Plans. The review of this plan is retained in our management review minutes Customer satisfaction The AW2 Approach: We monitor the information relating to customer satisfaction as to whether the organization has met the customer requirements, as well as continuously monitoring customer feedback. Procedure QP-05, Customer Feedback Procedure, is in place to define the process for collection and analyzing customer feedback data that determines the measure of customer satisfaction. Quality Manual Rev 3 Page 22 of 30

23 Data from product returns and process performance metrics are also reviewed on a monthly basis to determine needs for improvement. The data analysis and action taken is reported to management as part of the management review and is communicated to the customer on a periodic basis. References: QP-05 Customer Feedback Procedure Analysis and evaluation The AW2 Approach: Our sources and evaluations (9.1.3) are described within our Measurement Plans. We determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made. The management team determines the data to be collected and performs the analysis to ensure QMS objectives are met. AW2 Logistics personnel may be required to collect and report the data to be analyzed. 9.2 Internal audit The AW2 Approach: We conduct internal audits on an annual basis to determine whether the QMS conforms to planned arrangements of the international standard and is effectively implemented and maintained. Procedure QP-03, Internal Audit Procedure, exists to define the planning, scheduling, conducting and documenting of the internal audit process. The procedure defines the management responsibility and requirements for planning and conducting the audits, reporting the results and ensuring the actions are taken on a timely basis to eliminate detected nonconformities. Records of the audits and their results shall be maintained and action taken will be documented and reviewed as part of the management review. The Management Representative is responsible to oversee the internal auditing system and for retaining appropriate documented information. References: QP-03 Internal Audit Procedure Quality Manual Rev 3 Page 23 of 30

24 9.3 Management review The AW2 Approach: To ensure the continuing adequacy, suitability, and effectiveness of the QMS, the management team members will review the QMS in a management review at least annually. The number of reviews may be more frequent based on the performance and results of the system. At a minimum, these reviews are attended by President Director of Packaging and Crating Management Representative Other Members of Management The management team has the responsibility to participate and take appropriate action based on the results of the Management Review. The agenda for the review meetings is prepared by the management representative or delegate and is distributed to other participants prior to the meeting. Outputs from our Management Reviews include the actions and decisions relating to any opportunities for improvement, needed changes to the QMS and resource needs. Outputs are also retained on the Management Review meeting minutes. Quality Manual Rev 3 Page 24 of 30

25 SECTION 4: ACT This final step within our Plan, Do, Check and Act quality management system serves two purposes. First, it is the step which is used to make the decision of taking or not taking action based on the analysis and evaluations that occur during the check step. Whether we decide to take action or not, the decision will always be metric-driven, and risk-based. The second purpose of the Act step is that it serves as the pivoting step that guides our QMS back to the Plan phase to begin the PDCA cycle and support continual improvement. This last section of our manual covers our approach to improvements and corrective actions. 10 Improvement 10.1 General The AW2 Approach: We select opportunities relating to: improve our products and services; correct, prevent or reduce undesired effects; improve our QMS. We retain the documented information regarding improvements on our Measurement Plans and Corrective Action Forms Nonconformity and corrective action The AW2 Approach: Nonconformities are taken seriously and are reacted to as applicable. We take any actions necessary to ensure that the nonconformity does not recur or occur elsewhere. Nonconformities are documented on our Nonconformance Form and/or Corrective Action Form and discussed during Management Review. Procedure QP-06, CAPA Procedure, defines the corrective and preventive action process. Corrective action may be initiated by, but is not limited to, the result of one or more of the following: Non-conformance reports QMS non-compliance detected during internal audit and external audits Customer complaints Process performance metrics Quality Manual Rev 3 Page 25 of 30

26 References: QP-06 CAPA Procedure 10.3 Continual improvement The AW2 Approach: We consider the results of analysis and evaluation, and the outputs from Management Review, to confirm if there are needs or opportunities to be addresses as part of continual improvement. We will continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, data analysis, corrective and preventative action and management review. Quality Manual Rev 3 Page 26 of 30

27 Distribution Process Flow Customer Requirements Order Entered Order printed & Accepted Yes Items Arrive at Receiving Dock No Can the product be fixed and reused? Receiving Inspection Yes Date Sensitive/ Sterile Product Process NCR/Catalog Returns Process Yes Is the product Damaged? No Is the product Date Sensitive/ Sterile Product Scrapped Physical and Systemic Receiving and Putaway No Yes Daily Cycle Count of Product Receiving Accuracy Inspection Needs Uncrating Yes No System Uncrated Order Release System? No Order Picked Product Internationally Crated Yes Picking Accuracy Inspection Key Processes Quality Needs Crating? Int l International or Domestic Domestic Sales Purchasing No International Order Pack Distribution Key Complete Systemic Processing and Export Release Domestic Order Pack Complete Systemic Processing Start of Process Standard Process Decision Point Order Ships Alternate Process End of Process Quality Manual Rev 3 Page 27 of 30

28 Packaging and Crating Process Flow Quality Manual Rev 3 Page 28 of 30

29 SWOT Analysis STRENGTHS + BRAND ACE WorldWide + Distribution Expertise / Reputation (Supplier of the Year) + Customer Tenure + Skilled Team (Design / Conceptualization +) + Presence of distribution locations + Class A WH Space + Custom Designed Packaging + Reusable Materials + Service Offerings + Real-time Vehicle tracking (transportation) + International Plant Protection Convention (IPPC) standards - packaging OPPORTUNITIES + Create internal remedial training + ERP/WMS deployment, Efficiency gains, Inventory Control, Distribution data storage, picking, moving product. + Cycle time + Optimizing freight spend + Reduce WASTE. (transportation, inventory, material, motion, waiting, overprocessing, defects). + Cudahy Warehouse layout + Additional revenue opportunities based on existing customer (prototyping ) + Better Practices + Domestic Expansion of Distribution Centers + Vendor managed inventory WEAKNESSES - Lack of WMS - Lack of Integrated ERP - Organization structure (inability to deploy CI initiatives or optimize efficiencies due to customer restrictions) - Lack of investment in assets - Warehouse layout / Replenishment strategy THREATS - Increased 3PL competition with more automation / technology capability - Commodity Prices - Reputable Suppliers - Labor availability (semiskilled jobs / lower wage pool) - Pricing - One Primary Customer - Site Selection (New business chooses whose closest to customer) - Capacity - Inventory Management - Customer Expectations (orders faster) Quality Manual Rev 3 Page 29 of 30

30 Rev Date Author Approver Reason for Change 0 09/2016 J Kugler B Harvin Original Issue 1 10/2016 J Kugler B Harvin Added process flow charts and SWOT analysis 2 10/2017 J Kugler B Harvin Update Quality policy 3 11/2017 J Kugler B Harvin Updated Packaging and Crating Process Flow Quality Manual Rev 3 Page 30 of 30