Draft Statement of Work (SOW)1 – Template2 <COMPANY> I. Company Introduction <Specific Client Company background & background: Provide a brief background of the company, the products you make, the locations you are in, delineate what makes you different and a coveted target for relationship with a potential provider. This introduction can include product/company/industry growth information; safety history; credit status; publically or privately held, etc. Describe you work environment; 5x24; 7x24; shift configurations, number of customer per location. Provide all information that will help the Temporary Labor Provider (TLP) understand your business and your work environment better. The more they know the better job they will be able to do for you.> II. SOW Introduction & Background This document is intended to outline and define the scope of services and the work requirements to be provided by the Temporary Labor Provider (TLP) in support of <COMPANY>’s manufacturing operations at their locations in <LOCATION>. The TLP shall provide a complete on-boarding service for manufacturing direct labor in the interest of achieving the lowest total cost of product manufacturing. This outsourced service shall demonstrate the design, implementation and end-to-end operational capability that best prepares manufacturing workers for a medical products environment. Production labor is a very large part of <COMPANY>’s overall product cost. As such it deserves the assurance of a proven, consistent, effective and sustainable TPL solution. Like any other product or service, the ultimate measure of worth is the total value provided; that is most often the lowest total cost that does not compromise quality or compliance. The TLP shall submit a proposal for services and products that meet the requirements herein. 1 This document is being provided as an aid to medical device & healthcare product manufacturers for the purpose of improving the effectiveness and compliance of their temporary labor procurement process. It shall not be used in part or in whole for any other commercial purpose; nor is it intended for use by any other organization other than a medical device or healthcare product manufacturer. 2 This State-of-Work (SOW) Template is provided as is without any guarantees or warranty. In association with the product, Operon Resource Management makes no warranties of any kind, either express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, of title, or of non-infringement of third party rights. Use of the product by a user is at the user’s risk. Page 1 of 14 III. Scope of Work The scope of work for this <MANAGED SERVICES / ON-SITE MANAGEMENT / OUTSOURCED / END-TO-END / ON-BORADING / CONTINGENT LABOR> service (SERVICES) shall include the process design, planning, execution, and implementation of the necessary elements that ensure the on-going daily delivery of properly prepared contingent (temporary) workers. This shall include the necessary recruitment, screening, training, orientation and workforce management activities to meet the production labor needs of <COMPANY>. A. Program Plan of Implementation & Transition The TLP shall develop a comprehensive Implementation Plan outlining all program elements in a Gantt chart. Milestones completion dates will be delineated for key program elements including, but not limited to: 1. 2. 3. 4. 5. Service Contract fully executed Initial <COMPANY>review and approval of the Implementation Plan Requirements Definition Phase On-Site Facilities Assessment to accommodate On-Site Support Model (delineate any <COMPANY> responsible items) On-Site Operational Readiness Demonstration a. b. c. d. e. f. g. h. i. j. k. l. Recruitment Plan Presented Subcontract Management Plan Presented (if any) Applicant Testing, Screen, Training and/or Orientation Readiness Demonstration Management System Demonstration (how you plan to manage the activity) Key Personnel Acquisition (if any) Time Collection & Reporting System Approach, Implementation & Testing Key Program Metrics: What, when, by whom and how often Program Reporting & Reviews Payroll, Billing/Invoicing Payroll & Payroll System Validation (from Site Location-s) Treatment of Payroll Errors Invoicing Approach with Sample Cycle Other Associate Assignment Pre-Screening Requirements Demonstration (e.g., drug testing, background checks, DMV/RMV Violations, E-Verify, etc.) 7. Transition of the labor from the existing service (see below) 8. Quality Plan Presentation (how are you going to assure quality of the service and product) 9. Safety & Injury Plan Presentation 10. Risk Mitigation/Management Plan 11. Program Progress Meetings Plan 6. Page 2 of 14 For each key milestone listed indicate the person responsible for that task by name (whether TLP, or <COMPANY> after initial review). The TLP shall indicate where each person in the plan is geographically located and how they will assure their tasks completion (e.g., individual contributor at branch location; central corporate function; outside provider, etc.). B. Transition Service Providers In the case of transitioning services (a new TLP replacing an existing one), the transition and implementation of new service shall be accomplished without the interruption or impact to existing production schedules. Moreover, the transition process shall be executed in accordance with the guidelines and spirit of the American Staffing Association’s Code of Ethics (https://americanstaffing.net/asa/asacode-of-ethics/). The scope of these SERVICES shall include, but not necessarily limited to: 1. 2. 3. 4. 5. C. The testing, evaluation, screening and qualification of applicants to specific <COMPANY> position requirements. The training of qualified applicants in the basic process elements for the medical products industry <AND OTHER SELECT ELEMENTS OF THE INDUSTRY – E.G., THE PLASTICS INJECTION MOLDING ENVIRONMENT; OR FILL-FINISH & PACKAGING ENVIRONMENT, ETC.> at <COMPANY>. The orientation of qualified applicants to the unique culture, policies, procedures and other nuances of the <COMPANY> corporate & production environment. The reporting and reviewing of key performance metrics and user feedback on a regular basis. The TLP shall outline other services that are a part of their standard business model or value proposition; and are a part of this offering. If these other services are not part of the offering as presented by the TLP’s proposal, it shall be clearly identified as such. Work Requirements The difference between a highly effective and a moderately effective TLP’s system can results in significant avoidable costs. As such, and as a premise to work requirements, the TLP shall show objective evidence of certain demonstrated capability. This shall include, but not be limited to: 1. 2. 3. Demonstration of specific <COMPANY> requirement definition processes that draws-out all relevant needs of the account/client. <For On-Site Applications> Demonstration of specific account set-up processes that ensure a well-defined, smooth, timely and effective site setup of staff, facilities, operational and support system and their integration into <CLIENT’S> environment. Demonstration of specific design processes that ensure the effective development of a consistent <COMPANY> tailored screening, training & Page 3 of 14 4. 5. 6. 7. orientation processes that optimize the elements of labor cost, product quality and system compliance. Demonstration of the management tools and processes to ensure an effective, timely and controlled implementation of such a program; and delivery of optimally prepared labor where and when required. Demonstration of the (on-site) management system & tools necessary to consistently and reliably execute these processes on a daily, weekly, monthly, yearly basis. Demonstration of the management reporting and review processes that provide meaningful metrics and user feedback; to provide this information in the spirit of driving out cost and improving product quality/system’s compliance. Demonstration of internal / organizational processes, systems and controls to ensure the overall & continued effectiveness and sustainability of the TLP’s program. In addition, the Work Requirements shall include: 8. 9. Recruitment: The TLP shall describe their total recruitment strategy and plan to assure the availability of production workers as defined by <COMPANY> (herein). Qualification: The TLP shall outline their methodology and tools necessary to ensure the skills, aptitude and behaviors of assigned workers. The TLP shall also demonstrate how this objective data will be retained and made available to support <COMPANY> internal audits as well as their customer’s, quality management system audits. These skills, aptitude and behavior validations shall include but not be limited to the following: a. Reading Comprehension: To ensure that assigned workers have the ability to read and understand production document to include Shop Work Instructions (SWI’s), Device Master Records (DMR’s), Maintenance Manuals, Material Safety Data Sheets (MSDS) and the like. To ensure that assigned workers have the ability to accurately and completely collect data on Run Sheets, Inspection Logs and the like. And to ensure proper operation of equipment in accordance with directions. b. Basic Math Skills: To ensure that assigned workers have the ability to perform basic math functions such as adding, subtracting, multiplying, and dividing; the ability to work with fractions, decimals and read a rule. c. Decision Making / Critical Thinking Skills: To ensure that workers assigned to more responsible positions have the ability/aptitude to make good decisions. d. Attention-to-Detail: To ensure that workers assigned to positions requiring the ability to accurately distinguish between very similar objects. e. Visual Acuity: To ensure that assigned workers can effectively read work documents, safety materials and other documentation necessary to perform their job properly and safely. To ensure that assigned workers have the necessary visual acuity, or corrective eyewear, to identify product defects as part of their job scope. Page 4 of 14 f. Manual Dexterity: To ensure that assigned workers can effectively handle and productively assemble small intricate parts (if applicable). g. Work Ethic/Attitude/Quality/Dependability: Thru professional or supervisory reference checking, and/or other tools that the TLP may possess or acquire, verify that a candidate has the necessary qualities and character to meet reasonable work requirements. 10. Pre-Hire Screening: The TLP shall demonstrate how they plan to provide pre- assignment screening / testing for assigned temporary labor Associates. The TLP shall also delineate any costs associated with ensuring or providing these services. The specific services required include: <LIST REQUIREMENTS HERE WITH VERY SPECIFIC PARAMETERS, E.G., DRUG TESTING, BACKGROUND CHECKS, VISION TESTING, EDUCATIONAL VERIFICATION, PROFESSIONAL REFERENCE VERIFICATION; OTHER SPECIFIC APTITUDES OR SKILLS VERIFIED.> 11. Training: As part of the overall screening process the TLP shall ensure the applicants basic understanding and ability to comprehend, internalize and retain key process and systems elements of <COMPANY>’s manufacturing environment. The TLP shall also demonstrate how this objective data will be retained and made available to support <COMPANY> quality system audits. These training elements shall include (as applicable to <COMPANY>, but are not limited to: a. Management Systems Overview Introduce the concept and content of management systems to the new hire. Outline the scope of ISO 9000, ISO 13485; ISO 14000 (as applicable) and the 21 CFR, Part 820 cGMP's as mandated by the FDA. Illustrate how all these come together to form <COMPANY>’s Quality System and what the new Associate must do to help maintain compliance to that system. Also introduces the hierarchy of documentation that makes up a typical management system putting emphasis on level-three documentation, like shop work instructions & device master records as the primary manufacturing documents they will be using. b. cGMP Requirement Overview Provide more comprehensive overview of the applicable elements of the cGMP/QS requirements. As mandated requirements of the Food & Drug Administration (FDA), expand upon the guidance elements of Current Good Manufacturing Practices (cGMP’s) for workers in performing their job in this medical products environment. The scope of the overview shall address documentation requirements, traceability requirements, record keeping, labeling, housekeeping & hygiene requirements as well as insect and pest control practices. c. Gowning & Clean Room Protocol Page 5 of 14 To ensure facility, systems and regulatory requirements, for all workers entering a clean room, outline the essential gowning & clean room protocol requirements to preclude contamination and to ensure safety. This overview shall be framed around the requirements of ISO 14644, Part-5 yet structured to meet the specific facility needs of <COMPANY>. d. Terminology & Visual Defects In an effort to integrate the worker quickly into the <COMPANY> production environment, and ensure a higher level of initial productivity, this overview shall introduce some of the most commonly used terms and language in <COMPANY>’s production environment. The overview shall also introduce the typical defect conditions found in <COMPANY> production environment for purpose of identifying product non-compliances. e. Process Documentation Introduce the process / instructional documentation used in <COMPANY> production environment to the new hire. At <COMPANY> this is commonly referred to as a <WORK INSTRUCTION (W/I) / DEVICE MASTER RECORD (DMR) / OTHER>. f. i. If a Work Instruction (W/I): Ensure the understanding of the document, its purpose & its structure, how the applicant determines responsibility for a particular work instruction and where the new temporary Associates finds instructional guidance to aid them in the manufacture, inspection, labeling and/or packaging of the product. ii. If a Device Master Record (DMR): Ensure the understanding of the document, its purpose & its structure; and the nature of its Federal mandate via the Food & Drug Administration (FDA). Ensure awareness that the DMR is the primary guidance document for the production of a medical device at <COMPANY>. The DMR, which <COMPANY> has adopted as their primary product specification and guidance tool, is a compilation of records organized into a single document (or binder) containing the routine procedures and specifications required to manufacture a finished medical device. The DMR is an essential document in that it will best ensure that <COMPANY> consistently meets company or customer requirements. This overview shall also address the Device History Record or DHR to the extent that the manufacturing operator/assembler understands the whole-of-the documentation process at <COMPANY> to best supports its requirements. Electrostatic Discharge (ESD) Protection For those workers involved in specific assembly applications whose product content includes the use of integrated circuits and other static sensitive components, Electrostatic Discharge (ESD) Protection training shall be administered. Assigned temporary workers shall be provided an overview of ESD and the importance of personnel grounding, continuous monitoring, static Page 6 of 14 control garments, and controlling static charges. It also addresses handling, packaging and transportation of electrostatic-sensitive products. g. Warehouse & Distribution Center Orientation For those temporary workers that are involved with the internal logistics / supply chain process, (e.g., receiving, receiving inspection, staging, warehousing, shipping or related material handling activity), an overview shall be provided that outlines the typical flow of materials. The scope of the overview shall address the process from raw material receipt to finished product shipment. It shall identify and integrate all typical in-house supply chain activity that interfaces with the production process. It shall provide a new entry-level temporary logistics worker a “big-picture” introduction so they can assimilate the job requirements more effectively and come down the learning curve more rapidly. h. General Safety Training A general industrial safety overview shall be provided to each temporary worker that is assigned to <COMPANY>. It shall address precautions and practices to preclude personal injury. The scope of this overview shall include, but not be limited to: Personal Protective Equipment (PPE), Trips & Falls, Back Injuries, Blood Borne Pathogens, Hazard Communications (and related MSDS), Logout/Tagout and Fire Safety. The successful completion of this program will be required for every assigned temporary worker, prior to starting work. i. Forklift Qualification Although <COMPANY>is responsible for ensuring the proper training of personnel using motorized industrial trucks in its facilities, an overview and screening tool shall be provided that ensures a worker’s understanding of proper and safe industrial motorized truck operation. This overview/screening tool shall be an adjunct pre-requisite to the <COMPANY>’s related Forklift Certification Program as mandated by OHSA. The intent of the overview is to best insure a well suited and pre-qualified candidate. This will 1) reduce the possible need to “retrain” due to candidate fall-out and 2) to optimize the worker’s learning ensuring a higher level of initial productivity. j. Lean Six-Sigma An overview shall be provided that introduces Lean Manufacturing & Six Sigma to new temporary workers. The overview shall further introduce 1) the concept of 5-S’s and 2) the principals of the 7-Wastes. The intent of this overview is to ensure a basic understanding of these principals, and to ensure more effective & more rapid integration into <COMPANY>’s Lean Culture. For each training element the TLP shall demonstrate how they plan to ensure this level of knowledge or retention of this information. 12. <COMPANY>Orientation: The TLP shall, working with <COMPANY>’s management team, define and tailor a new hire orientation program for temporary workers. The TLP shall also Page 7 of 14 demonstrate the process by which evidence of this orientation process will be completed for each temporary worker. The TLP shall also demonstrate how objective data will be developed, retained and made available to support <COMPANY> quality system audits. This orientation program shall include, but not be limited to the communication of: a. <COMPANY> Work Ethic Expectations b. Work days and shift times c. Job content & expectations d. Employee Entrance locations e. Dress code requirements f. Parking requirements g. Building access protocols; especially on off-shifts h. How and where do they register their time worked i. Whom do they report to and how to contact that supervisor j. How they should contact the TLP (24/7 support) k. Where do they report; especially on their first day l. What their break and lunch times are; and where can they take their breaks m. Safety requirements and PPE n. Building security requirements o. Building evacuation procedures p. What do they do if they are injured q. Who and when to call if they are going to be late or absent r. No-Call/No-Show (NCNS) & Attendance Policies s. Other key rules they need to follow t. What behaviors & conduct are not tolerated in work environment u. Overtime policies and procedures v. How and when do they get paid w. Communication of how & where do they secure healthcare benefits x. How do they pursue direct employment with the client y. Requirements for legal documentation (W4, I9, Felony Convictions) z. The need to verify write-to-work in the US via Confirmation of Employment Eligibility (E-Verify) Page 8 of 14 13. Management & Measurement a. b. c. d. Communication of Staffing Requirements: The TLP shall participate in Operational/Production Planning activity to stay abreast of current, pending or future labor requirements. <COMPANY> Production Control/Master Planners or Production Group Leaders/Supervisors shall provide labor requirements as soon as they are known. These Planners/Managers will endeavor to communicate requirements at least two weeks before start dates. Requirements of Staffing Availability: In urgent situations, the TLP’s labor fulfillment system shall provide resources in such a fashion as they are available with a 24 hour notice. The TLP system should also be capable of supplying emergency labor requirements on shorter notice. This could be as short as 1 hour to support unforeseen TLP or <COMPANY> scheduled “call-outs”. This is the exception rather than the rule. Requirements Fulfillment: The TLP shall demonstrate how its system will be able to support this staffing availability above while ensuring the full screening, training and orientation of assigned workers. Reporting & Reviews: The TLP shall demonstrate its ability to provide weekly usage reports as well as quarterly program reviews. The quarterly program reviews shall outline: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. e. Accomplishment over the past period Injury Reporting Orders Activity (Broken down by department) Fill Rates / Time to Fill Measures Attendance Levels Screening & Training Process Yields (numbers and percentages) Usage Levels (Dollars & Hours by department) Overtime Usage (Dollars & Hours by department) Turnover Levels (Broken down by department) Feedback Summaries (feedback from workers & users) Key Issues Other events/activities bearing on service Future Initiatives to drive continuous improvement & cost take out Key market activities that affect labor and labor related issues. Other Client Requested Reports 1. 2. 3. 4. Weekly Headcount Monthly Total Hours Reports Monthly Temp Usage Reports (including: dollars, headcount, turnover, etc.) Weekly timecard reports (Broken down by Department/Job Shift) Page 9 of 14 IV. Reference The TLP shall provide a minimum of three current-client references that will be able to substantiate the TLP’s claims within their proposal to this solicitation. Each of those three current-client references shall include both the functional department head that the TLP reported through (e.g., HR, Staffing, etc.), as well as the functional department head that the TLP provided most of the support for (e.g., Operations, Manufacturing, etc.). The contact information shall include: Name Title Company Street Address Direct office phone number Mobile number (if possible) Email Address Website Address In the TLP’s proposal, the TLP shall confirm that the references have been contacted by the TLP and that the listed references have agreed to take a reference call from <COMPANY>. V. Quality Management System The TLP shall have & demonstrate effectiveness of a management system -MS (or quality management systems - QMS) that defines processes, defines procedures or work instructions and that provides guidance and controls of such process/procedures. In that <COMPANY>’s production environment is unique in many respects from any other medical device production environment, TLP shall show how such MS or QMS provides adequate definition and control of their business model for <COMPANY>’s application. VI. Period of Performance The period of performance for this TLP support service shall be four years, at which time the period of performance can be extended. The relationship will be defined by a formal service agreement which will outline these terms as well as other terms and conditions of the relationship between <COMPANY> & the TLP. <COMPANY> will entertain the use of the success bidders Service Agreement format. VII. Place of Performance The services herein shall be provided at <COMPANY>’s facilities in <STATE>. The services may also be requested to support <COMPANY>’s operations in <OTHER STATES, COUNTRIES>. Page 10 of 14 To ensure optimal communication and coordination of requirements and support, the services and support processes shall be performed on-site at <COMPANY> facility(s). As such <COMPANY> will provide office space, office furniture, telephone and facilities to execute processing, testing, training and orientation of temporary workers. <COMPANY> will also provide access to their network for Internet access. The TLP shall provide all necessary equipment & supplies (e.g., computers, printers, time clocks/scanners, testing fixtures/tools, and the like). VIII. Acceptance of Services The TLP shall provide conditions of guarantee or assure that service and products quality meets requirements. Approval of weekly temporary worker time reports shall be acceptance by <COMPANY> of TLP service / product, setting aside any additional guarantees offered by TLP. TLP shall clearly delineate any additional terms or conditions in this regard. IX. Rates & Payment Terms The TLP shall clearly delineate its rate structure (Bill Rates) against <COMPANY> provided pay rates per position and per shift. If the TLP has costs other than mark-up over pay-rate, then those costs shall be clearly delineated in the TLP response. The TLP shall delineate any other direct or indirect costs associate with this service that would be considered billable to <COMPANY>. Acceptable invoices shall be paid by <COMPANY> on a weekly basis. Payment terms shall be 45 days from date of invoice. X. Conversion Terms The TLP shall clearly delineate the conversion terms and operational procedure for ensuring efficient and smooth conversion from TLP employees to <COMPANY> employment as needed. This is no guarantee that <COMPANY> will hire any or all of TLP’s employees, or hire them at any specified time. XI. Other Offerings The TLP shall clearly and completely delineate any additional offerings related to the work requirements or other provisions, terms or conditions stated herein or otherwise related to the service that the TLP believes adds meaningful value to the process. Page 11 of 14 XII. Insurance The TLP shall provide objective evidence of adequate Workers’ Compensation Insurance that would be applicable to the requirement stated herein <$1,000,000 per accident; per employee>. XIII. Confidentiality As part of the work requirement, <COMPANY> requires a fully executed Confidentiality / NonDisclosure Agreement with the TLP (See Attached Confidentiality Agreement). Moreover, before working temporary employees of the TLP’s start on assignment, they too will need to sign <CLIENT’S> confidentiality agreement. XIV. EEOC Compliance The TLP shall provide a statement of Equal Employment Opportunity Compliance in their proposal. XV. Legal Compliance The TLP shall provide a statement of Federal and State legal compliance, specifically delineating those legal requirements. This could include, but is not limited to workers compensation insurance laws, background checks laws, drug testing laws, healthcare laws, minimum wage laws, overtime and other wage laws, sick leave laws, Bill-of-Rights laws, etc. XVI. Indemnifications The TLP shall provide clear statement of indemnification holding <COMPANY> harmless from losses incurred as a result of worker compensation claims or related law suits. XVII. Relationship The selected TLP shall be the provider of choice to <COMPANY> for requests of temporary or temporary-to-hire labor in the following functional areas: <AREAS>. XVIII. <COMPANY> Support Locations <COMPANY> has work locations as outlined in the attached <TABLE>. The TLP shall indicate which of these locations they presently support (if any) and which they are herein including in their proposal for support. The TLP shall also indicate who the TLP’s points of contact are for each location. Page 12 of 14 Location Matrix Location Description Type Facility (Hqts./Mfg./Office/R&D) Address Size (s.f.) Average Weekly Temp Hours Current OnSite Support (Y/N) Location A Location B Location C XIX. <COMPANY> Usage Data For those who request it, <COMPANY> will provide usage data for the past <NUMBER> of years that includes number of hours recorded 1) by location, 2) by department, 3) by shift, 4) by job title and 5) by salary grade level. This information will be provided in a summary format as well as detailed level down to the weekly reporting periods. XX. <COMPANY>/TLP Information Exchange For those potential TLP respondents who request it, <COMPANY> will accommodate a conferencecall information exchange session to provide the TLP all the available information that they may need to assemble their proposal to <COMPANY>. If the TLP wishes, <COMPANY> will support an on-location session for the same purpose at <CLIENT’S> location. XXI. Proposal Delivery For interested parties, the TLP’s proposal is due in-hand no later than <DATE/TIME>. Both an electronic as well as hard copy shall be sent directly to <NAME, TITLE, COMPANY, ADDRESS, CITY, STATE, ZIP; EMAIL ADDRESS, OFFICE PHONE, MOBILE PHONE> XXII. Post Submittal Presentation <COMPANY> will be accommodating post submittal support presentation of the top (2) two company respondents. Those companies will be selected and notified within <NUMBER> weeks of the submittal date. Dates for on-site presentations at <COMPANY><ADDRESS> will be arranged individually with the selected TLP’s. As an alternative, the TLP may elect to use a remote audio/visual conferencing tool to support their presentations as well. XXIII. Schedule of Events The following table provides a schedule of events for the major elements of the solicitation process: Page 13 of 14 Date XXIV. Event 28 February 2015 Request for Proposals (RFP’s) Released 28 February 2015 Proposals Due 28 February 2015 On-site Presentations 28 February 2015 Proposal Assessment and Evaluation Process Complete 28 February 2015 Notification of Selected Provider 28 February 2015 Post Award Service Agreement Completed 28 February 2015 Contract Signature / Work Begins Service Agreement A service agreement will be developed and agreed upon between the TLP & <COMPANY> that will clearly and completely delineate the services, products, terms and conditions of a pending relationship. Page 14 of 14