Building Value in Your Company for the Professional Packaging Staff

Transcription

1 1:45 p.m. 2:30 p.m. Building Value in Your Company for the Professional Packaging Staff Tim Mlsna R&D Director Packaging Technology Boston Scientific Corporation March 2-4,

2 About My Experience My Background R&D Packaging Engineering Director at Boston Scientific Corporation, Maple Grove, MN. B.S. in Industrial Technology, concentration in Packaging Engineering, from University of Wisconsin-Stout. Currently responsible for BSC s R&D Packaging Engineering, Labeling Engineering, and Sterilization functions at our Cardiovascular division in Maple Grove, MN. Chair of both Cardiovascular Technology Investment Board and BSC Packaging Council. Executive Council of the Institute of Packaging Professionals (IoPP). Advisory Board for Packaging Engineering Program at UW- Stout.

3 Presentation Overview Core Messages Packaging isn t just packaging. There are many elements to consider before you define what packaging will be for you. Core Lessons How to identify and set up what you need for your packaging department. How to communicate to management that it s necessary and valuable.

4 Presentation Overview Business Needs Business Plan Short- and Long-Term Goals Value for Company Existing Gaps Area(s) of Focus People Management Current Strengths, Weaknesses, Opportunities, and Threats R&D, Sterilization, Operations, Sustaining, Manufacturing, Labeling Definition of Roles Scope of Responsibilities Support and Buy-in Clearly Established Roles / Expectations Systems / Processes Developing Effective Systems + Processes Clearly Defined Requirements

5 Business Needs Value for Company Business Needs Existing Gaps Area(s) of Focus People Management Systems / Processes Accurately assess your current and desired future states. Create a thorough and well-developed business plan. Clearly define your shortand long-term goals. Understand your company s focus. Define and map your company s vision.

6 Business Needs Your Current and Future States Where Is Your Company? Startup Small Medium Large Products / technologies remain undefined. Which key technology to pursue? Products and technologies are defined. How to pursue growth and market share? Product portfolio is well-developed. How to increase market share? Products and portfolios well-established. How to grow both internally and through acquisitions?

7 Business Needs Your Plan and Goals Developing a Business Plan Well-developed and thorough; intended to focus development of packaging for your company. Key elements include: A clear assessment of current and future organizational needs Detailed plans for achieving key objectives Clear delineation of responsibilities and expectations: manufacturing and development responsibilities, other functional tie-ins (labeling, sterilization, etc.) Defining Short- and Long-Term Goals Where are you now? Where do you want to be? How will you get there? Are your existing systems and processes adequate? What gaps must you overcome? How will you overcome those gaps?

8 Business Needs Your Focus Where Will You Focus? R&D Technology Development Operations / Mfg Packaging Engineering Others? Labeling Sterilization

9 Business Needs Defining and Mapping Your Vision for Packaging Define Your Vision for Packaging for example Appropriate resources for all project work. Leadership to drive high-level performance. Development of a test lab (or relationship with a test lab) to support all project testing. Deliver high-quality package designs on schedule. Focus on project execution and continuous improvement Full project team support for packaging requirements Create a structure that encourages leveraging packaging resources to maximize efficiency

10 Business Needs Defining and Mapping Your Vision for Packaging Define Your Vision for Packaging Defining your vision isn t just saying that you want a stateof-the-art test lab to support all projects. Support your vision with details! for example Goal: Equip an internal, full service, packaging engineering test lab at [X] location, capable of performing all required new product testing (per SOP , Packaging Test Method Requirements). Benefits: Reduced project timelines (7-14 day reduction), reduced risk to projects, increase in early testing (due to accessibility of equipment), more accurate testing and data. Required Equipment: Random Vibration System, Swing-Arm Drop Tester, Environmental Conditioning Chamber, Walk-in Aging Chamber Cost: $X including technical support

11 Business Needs Defining and Mapping Your Vision Business for Packaging Needs Map Your Vision for example Packaging Engineering Department Labeling New Technologies Test Methods Test Labs Materials Systems New OEM Projects New Device Development Sustaining for Existing Devices Device / Product Names Device / Product Names

12 Existing Gaps Value for Company Business Needs Existing Gaps Area(s) of Focus People Management Systems / Processes Perform a SWOT Analysis to determine the current state of your company. Use the SWOT Analysis to establish practical goals. Understand the value of standardization. Understand the variables that impact standardization and gaps.

13 Existing Gaps SWOT Analysis SWOT Analysis SWOT is a tool for analyzing your company s Strengths, Weaknesses, Opportunities, and Threats. Allows you to see where improvements are needed and opportunities exist. Provides a realistic perspective about your company s present situation and future potential.

14 Existing Gaps SWOT Analysis / Practical Goals Use SWOT Analysis to Establish Practical Goals. for example Draft resource plans to develop new technologies, create new products, maintain existing products, and support manufacturing. Improve communication between Pkg and internal customers. Clearly define roles and activities relating to packaging deliverables. Increase Packaging Design Engineering experience. Strengthen Packaging Engineering functional design reviews. Identify and drive future packaging technology.

15 Existing Gaps Existing Standardization Gaps Understand the Value of Standardization. Components. More standardization = less confusion / frustration / time / cost (e.g., how is work that s transferred around the world validated effectively under different conditions? More testing, more cost, more time!) Test methods, standard policies, procedures, etc. gives you a consistent approach for regulatory agencies, suppliers, customers, international peers, and others Caution! Don t standardize at the expense of good design and meeting your customer s requirements

16 Area(s) of Focus Value for Company Business Needs Existing Gaps Area(s) of Focus People Management Systems / Processes As it relates to Packaging Engineering Beyond Packaging Engineering, determine other functional and technical areas where packaging function can add value for your organization. R&D / Design Ops / Mfg Sterilization Labeling Others?

17 Area(s) of Focus Packaging Engineering Questions for Consideration: Will Packaging Engineering organization be focused on R&D / Development only? Operations and Manufacturing only? Both? R&D / Development Focus Support R&D s packaging needs Work with teams to develop designs for new products Understand complexities of supporting distant locations Research new technologies for your industry and organization Manufacturing / Operations Focus Support Ops/Mfg packaging engineering needs Consider complexities of multiple sites and lines Drive toward standardization Focus on cost reductions

18 Area(s) of Focus Packaging Engineering Questions for Consideration: Design Focus: Primary pkg design / interaction(s) with device/drug Secondary pkg design / through suppliers Distribution environment Device product considerations: fragility; sensitivity to light, heat, moisture, humidity, etc. Quality every step of the way Ops / Mfg Focus: Sealing, loading, manufacturing efficiencies Automation Cost reduction opportunities Quality every step of the way

19 Area(s) of Focus Beyond Packaging Engineering Questions for Consideration: Labeling? System Design Data Management Graphics Sterilization? Role of Sterilization Ops/Mfg = Validation R&D = Understanding sterilization effect on device & package Type EtO, Ebeam, Gamma, etc. Humidity, Pressure, Temperature, etc.

20 People Value for Company Business Needs Existing Gaps Area(s) of Focus People Management Systems / Processes Assess your current situation. Clearly define proposed roles, expectations, and responsibilities know what you re looking for. Focus on individuals with skills sets and areas of expertise that are wellmatched to your needs. Ensure full management buy-in and support for effective hiring.

21 People Assessing Your Current Situation Assess Your Current Situation If the packaging function is new to your company, identify who s doing the work now. By the time you think about creating a packaging function, people in your business are already performing packaging activities. Who are they? for example R&D / Engineering: creating specs; designing tray, clips, pouches, etc. Mfg Engineering: validating equipment, drafting work instructions, planning future cost reductions DA / Quality: testing packaging robustness Purchasing: qualifying and contracting packaging vendors

22 People Critical Steps Critical Steps New functions are examined and judged critically. First impressions are key so get the right people! As the hiring manager, 2 people will be most critical as you define and develop a Packaging Engineering function: 1. First Person Hired into New Role Must Have: Strong technical packaging knowledge base Project management experience Attention to detail (no significant rework!) Confidence Excellent communication skills continued on next slide

23 People Critical Steps Critical Steps As the hiring manager, 2 people will be most critical as you define and develop a Packaging Engineering function: 2. Your Direct Supervisor Must Have: Ability to influence the organization Confidence in your vision Good understanding of the existing opportunities in your company and how packaging can help Clear expectations for packaging s roles, and responsibilities Strong appreciation for packaging s capabilities: value of the position and its distinctive background in education / experience

24 People Getting Approval and Moving Forward Getting Approval Hold initial discussions with your supervisor. Present your plan clearly: scope of responsibilities, expectations, opportunity, value. Request and obtain approval for position(s). Moving Forward Take time to thoroughly interview candidates. Find the right person for the job. Commit to effective training after employee is hired employees must have the tools and knowledge necessary to succeed.

25 Management Value for Company Business Needs Existing Gaps Area(s) of Focus People Management Systems / Processes Finalize clear expectations regarding employee roles. Establish clear project team responsibilities. Understand that packaging can play a role in many areas. Understand how packaging s role may grow and change with the department.

26 Management / Team Structure Employee Responsibilities Packaging Roles and Responsibilities Roles and responsibilities are customized to your business; Tailored to skills of engineers, technicians, lab managers, etc. Attend project meetings; support product development Regularly communicate issues and status updates with team members and managers, as appropriate. Establish relationships with others not directly involved in packaging project team (Product Design, Ops, Graphics, Labeling, Mfg, Sterilization, Distribution, Receiving, etc.)

27 Management / Team Structure Employee Responsibilities Packaging Roles and Responsibilities, cont d Roles and responsibilities are customized to your business; Tailored to skills of engineers, technicians, lab managers, etc. Ensure all functional work is done well and on time: Specs, Hazard and Failure Mode analyses Labeling + Graphics creation / approval / implementation Work instructions, procedures, change requests Protocols, reports, testing, results Input into regulatory submissions Manage package design deliverables; work with suppliers, R.I., and others to ensure effective packaging implementation

28 Management / Team Structure Employee Responsibilities Packaging Roles and Responsibilities, cont d Within Labeling: Packaging Graphics Create electronic art for pre-printed purchased components Managing the release of labels, DFU, artwork, etc. Process revisions for specified product types Labeling Engineering Design, program, and validate labeling systems Process labeling releases / revisions for specified product types Packaging Engineering Facilitate release of packaging artwork and product labeling

29 Management / Team Structure Employee Systems Responsibilities / Processes Sample Project Team Structure Function Function ETM Labeling Eng, Graphic Design, Purchasing, Drafting, ETM R&D, PD, DA, RI, Operations, Suppliers, etc. Packaging Engineering CTM CTM CTM ETM Function Function ETM CTM Core Team Leader CTM ETM Function ETM CTM CTM CTM ETM Core Team Function Extended Team ETM Function Function

30 Management / Team Structure Packaging s Many Areas Understanding Packaging s Many Roles / Areas Start with Labeling? System design? Data management? Regulations? Packaging Engineering R&D Only? Ops? Both? Technology Development? What to pursue? Dev p costs? Sterilization? Ops / Mfg? Role of sterilization? EtO? Ebeam? Gamma? Multiple sites? Lines? Standardization? Cost reductions? Automation?

31 Management / Team Structure Growth and Change Increasing Visibility / Growing Your Dept. When growth and change happen, you have to help drive and manage it successfully. Key Concepts: Discuss growth / expansion ideas with peer managers. Growth doesn t have to come thru headcount additions ( empire building ). Provide options with your ideas: Transfer employee to maintain neutral headcount Leave structure unchanged, but re-define individual reporting directions to drive standardization and functional excellence within individual areas (Pkg, Labeling, Sterilization, etc). Clearly define how results will be measured and shown: Metrics? Regular management reviews? Other?

32 Systems / Processes Value for Company Business Needs Existing Gaps Area(s) of Focus People Management Systems / Processes Know your existing systems. Develop or improve those systems. Understand the complexities of effective processes. Clearly define all project stages. Understand the requirements and deliverables within each of those stages.

33 Systems / Processes Know Your Systems Development / Production Systems Must be Defined Assess existing system: Does it allow for adequate consideration of pkg? Does it require additional clarity for non-pkg functions?* * Probably. If you don t have an existing system, develop one: Many online resources provide great information. Investigate to learn more. The following slides contain generic examples that illustrate the many complexities involved in effective processes and systems. Understanding the relationships between all project elements is critical for company success.

34 Systems / Processes Project Stages / Processes All projects involve stages of development: Getting Ready / Identifying and Investigating Ideas Defining what product is expected / will be created Engineering / building / creating that product Testing the newly-created product against expectations and requirements Getting the product to customers Whatever you call them, each of these stages involves multiple milestones and reviews, as defined by your company (and, of course, regulations and standards).

35 Systems / Processes Project Stages / Processes What Needs to be Done? Who Will Do It? Endless possibilities for developing project maps and tracking project progress. Project Stage Deliverable Name Function in Charge Person in Charge Guiding SOP Complete? 2 Market Spec Marketing / Reg John Doe JAN Product Spec Device R&D Jane Smith Packaging Spec Packaging R&D Bill Wilson We might not own it all, but if we don t understand it all, we can t make it better!

36 Systems / Processes Project Stages / Processes Have You Considered These? Anything Missing? Who s Responsible? When Does it Need to be Done? Proposals, Plans, Contracts Specifications Market, Product, Packaging, Labeling Hazard and Failure Modes Analyses Prototype and Concept Evaluations Finished Good, Assembly, and Component Drawings Project work plans / schedules Test methods / test method validations Design Reviews Design Verifications Plans, Protocols, and Reports Sterilization Protocols, Reports Work Instructions, SOPs Training programs Clinical database, trial, documents Labeling / Directions for Use / artwork / graphics for packaging Supplier / Vendor Requirements Regulatory Requirements and Submissions Equipment / production flow BOMs, Routings, mfg procedures Scaling Plans

37 Systems / Processes Project Stages / Processes Packaging Involvement Suggestions Initial ( Thinking ) Stages Concepts, prototypes, and evaluations Preliminary packaging design testing, if needed Input into Market and Product specs, hazard and risk analyses Draft of Packaging spec, component and assembly drawings, and material / equipment specs Middle ( Engineering ) Stages Input into sterilization, shelf-life, and other design verification testing protocols Input into regulatory submissions Test method validation; design testing Coordination of DFU, artwork, graphics, and labeling timelines

38 Systems / Processes Project Stages / Processes Packaging Involvement Suggestions Testing Stages Any necessary updates to packaging / material specs or drawings (component and assembly) Further coordination of all labeling activities Analysis of test results Creation of mfg visual aids and inspection procedures Input into design validation End Stages Final review, approval and documentation of all test reports Completion of any late stage changes to labeling Coordination of transfer activities Project close out

39 Conclusions Value for Company Business Needs Existing Gaps Area(s) of Focus People Management Systems / Processes Building Value in Packaging Understand your needs. Identify and correct any gaps. Decide where your focus will be most valuable. Get the right people. Support them and your company s goals with management commitment. Develop and improve your systems and processes.

40 Questions Discussion