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Процессная модель APQC Life Sciences (Медико-биологическая отрасль)

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Процессная модель APQC Life Sciences

Рисунок 1. Процессы верхнего уровня модели APQC Life Sciences

Перечень процессов модели APQC Life Sciences приведен ниже.

1. Develop Vision and Strategy

    1.1. Define the business concept and long-term vision

      1.1.1. Assess the external environment

        1.1.1.1. Analyze and evaluate competition

        1.1.1.2. Identify economic trends

        1.1.1.3. Identify political and regulatory issues

        1.1.1.4. Identify trends in medicines and medical system regulation

        1.1.1.5. Assess new technology innovations

        1.1.1.6. Analyze demographics

        1.1.1.7. Identify social and cultural changes

        1.1.1.8. Identify ecological concerns

        1.1.1.9. Identify trends in healthcare legislation

        1.1.1.10. Identify trends in healthcare funding

        1.1.1.11. Identify trends in healthcare delivery

        1.1.1.12. Identify trends in healthcare patient engagement

      1.1.2. Survey market and determine customer needs and wants

        1.1.2.1. Conduct qualitative/quantitative assessments

        1.1.2.2. Capture and assess customer needs

      1.1.3. Perform internal analysis

        1.1.3.1. Analyze organizational characteristics

        1.1.3.2. Create baselines for current processes

        1.1.3.3. Analyze systems and technology

        1.1.3.4. Analyze financial positions

        1.1.3.5. Identify enterprise core competencies

      1.1.4. Establish strategic vision

        1.1.4.1. Align stakeholders around strategic vision

        1.1.4.2. Communicate strategic vision to stakeholders

      1.1.5. Evaluate organization restructuring opportunities

        1.1.5.1. Identify restructuring opportunities

        1.1.5.2. Perform due-diligence

        1.1.5.3. Analyze deal options

          1.1.5.3.1. Evaluate acquisition options

          1.1.5.3.2. Evaluate merger options

          1.1.5.3.3. Evaluate de-merger options

          1.1.5.3.4. Evaluate divesture options

    1.2. Develop business strategy

      1.2.1. Develop overall mission statement

        1.2.1.1. Define current business

        1.2.1.2. Formulate mission

        1.2.1.3. Communicate mission

      1.2.2. Evaluate and select strategic initiatives to achieve the objectives

        1.2.2.1. Define strategic options

        1.2.2.2. Assess and analyze impact of each option

        1.2.2.3. Develop sustainability strategy

        1.2.2.4. Develop global support and shared services strategy

        1.2.2.5. Develop lean/continuous improvement strategy

      1.2.3. Coordinate and align functional and process strategies

      1.2.4. Create organizational design (structure, governance, reporting, etc.)

        1.2.4.1. Evaluate breadth and depth of organizational structure

        1.2.4.2. Perform job specific roles mapping and value-add analyses

        1.2.4.3. Develop role activity diagrams to assess hand-off activity

        1.2.4.4. Perform organization redesign workshops

        1.2.4.5. Design the relationships between organizational units

        1.2.4.6. Develop role analysis and activity diagrams for key processes

        1.2.4.7. Assess organizational implication of feasible alternatives

        1.2.4.8. Migrate to new organization

        1.2.4.9. Draft alternative structures

        1.2.4.10. Present recommendations to senior client executives

        1.2.4.11. Adjust migration

      1.2.5. Develop and set organizational goals

      1.2.6. Formulate business unit strategies

    1.3. Execute and measure strategic initiatives

      1.3.1. Develop Over The Counter (OTC) / generic business

      1.3.2. Develop healthcare services business

      1.3.3. Develop integrated technology/medical services business

      1.3.4. Network for new business

      1.3.5. Obtain new business financing

      1.3.6. Structure contracts /milestones /accounting/tax

      1.3.7. Arrange licensing (in/out)

      1.3.8. Develop capitation programs

      1.3.9. Develop joint ventures

      1.3.10. Perform acquisitions

      1.3.11. Establish high-level measures

2. Develop and Manage Products and Services

    2.1. Discover Products

      2.1.1. Manage research

        2.1.1.1. Identify targets

        2.1.1.2. Validate targets

        2.1.1.3. Develop assay

      2.1.2. Perform research/ licensing

        2.1.2.1. Acquire and license research knowledge

        2.1.2.2. Conduct basic research

        2.1.2.3. Manage research technology/information

        2.1.2.4. Target basic research efforts

    2.2. Manage product and service portfolio

      2.2.1. Evaluate performance of existing products/services against market opportunities

      2.2.2. Define product/service development requirements

        2.2.2.1. Identify potential improvements to existing products and services

        2.2.2.2. Identify potential new products and services

      2.2.3. Perform discovery research

        2.2.3.1. Identify new technologies

        2.2.3.2. Develop new technologies

        2.2.3.3. Assess feasibility of integrating new leading technologies into product/service concepts

      2.2.4. Confirm alignment of product/service concepts with business strategy

        2.2.4.1. Plan and develop cost and quality targets

        2.2.4.2. Prioritize and select new product/service concepts

        2.2.4.3. Specify development timing targets

        2.2.4.4. Plan for product/service offering modifications

      2.2.5. Manage product and service life cycle

        2.2.5.1. Introduce new products/services

        2.2.5.2. Retire outdated products/services

        2.2.5.3. Identify and refine performance indicators

        2.2.5.4. Manage product and service master data

    2.3. Develop products and services

      2.3.1. Design, build, and evaluate products and services

        2.3.1.1. Assign resources to product/service project

        2.3.1.2. Prepare high-level business case and technical assessment

        2.3.1.3. Develop product/service design specifications

        2.3.1.4. Document design specifications

        2.3.1.5. Conduct mandatory and elective external reviews (legal, regulatory, standards, internal)

        2.3.1.6. Build prototypes

        2.3.1.7. Eliminate quality and reliability problems

        2.3.1.8. Conduct in-house product/service testing and evaluate feasibility

        2.3.1.9. Identify design/development performance indicators

        2.3.1.10. Collaborate design with suppliers and contract manufacturers

      2.3.2. Test market for new or revised products and services

        2.3.2.1. Prepare detailed market study

        2.3.2.2. Conduct customer tests and interviews

        2.3.2.3. Finalize product/service characteristics and business cases

        2.3.2.4. Finalize technical requirements

        2.3.2.5. Identify requirements for changes to manufacturing/delivery processes

        2.3.2.6. Complete and report large-scale clinical trials

      2.3.3. Prepare for production

        2.3.3.1. Develop and test prototype production and/or service delivery process

        2.3.3.2. Design and obtain necessary materials and equipment

        2.3.3.3. Install and validate production process or methodology

      2.3.4. Compile and submit dossier

        2.3.4.1. Define regulatory strategy and target product profile

        2.3.4.2. Obtain scientific advice and engage regulators

        2.3.4.3. Plan the submission structure and its components

        2.3.4.4. Create standard backbone and component templates

        2.3.4.5. Assemble registration dossiers

        2.3.4.6. Standardize documentation

        2.3.4.7. Optimize submission process

        2.3.4.8. Introduce regulatory review

        2.3.4.9. Monitor speed of approvals

        2.3.4.10. Compile and submit registration dossiers

      2.3.5. Manage regulatory requirements

        2.3.5.1. Train employees on appropriate regulatory requirements

        2.3.5.2. Maintain records for regulatory agencies

        2.3.5.3. File new product process with FDA and receive regulatory approval

        2.3.5.4. Publish the new product process

        2.3.5.5. Manage submission life cycle

3. Market and Sell Products and Services

    3.1. Understand markets, customers and capabilities

      3.1.1. Perform customer and market intelligence analysis

        3.1.1.1. Determine customer focus for research

        3.1.1.2. Conduct customer and market research

        3.1.1.3. Identify market segments

        3.1.1.4. Analyze market and industry trends

        3.1.1.5. Analyze competing organizations, competitive/substitute products

        3.1.1.6. Evaluate existing products/brands

        3.1.1.7. Assess internal and external business environment

      3.1.2. Evaluate and prioritize market opportunities

        3.1.2.1. Quantify market opportunities

        3.1.2.2. Determine target segments

        3.1.2.3. Prioritize opportunities consistent with capabilities and overall business strategy

        3.1.2.4. Validate opportunities

    3.2. Develop marketing strategy

      3.2.1. Define offering and customer's value proposition

        3.2.1.1. Define customer focus for value proposition

        3.2.1.2. Define offering and positioning

        3.2.1.3. Develop value proposition including brand positioning for target segments

        3.2.1.4. Validate value propositionwith target segments

        3.2.1.5. Develop new branding

      3.2.2. Define pricing strategy to align to value proposition

        3.2.2.1. Establish guidelines for applying pricing of products/services

        3.2.2.2. Approve pricing strategies/policies

      3.2.3. Define and manage channel strategy

        3.2.3.1. Evaluate channel attributes and partners

        3.2.3.2. Determine channel fit with target segments

        3.2.3.3. Select channels for target segments

    3.3. Develop sales strategy

      3.3.1. Develop sales forecast

        3.3.1.1. Gather current and historic order information

        3.3.1.2. Analyze sales trends and patterns

        3.3.1.3. Generate sales forecast

        3.3.1.4. Analyze historical and planned promotions and events

        3.3.1.5. Analyze impact of external factors

      3.3.2. Develop sales partner/alliance relationships

        3.3.2.1. Identify alliance opportunities

        3.3.2.2. Design alliance programs and methods for selecting and managing relationships

        3.3.2.3. Select alliances

        3.3.2.4. Develop partner and alliance management strategies

        3.3.2.5. Establish partner and alliance management goals

      3.3.3. Establish customer management goals and strategies

        3.3.3.1. Develop customer account business plan

        3.3.3.2. Develop customer account strategy and customer objectives/targets

        3.3.3.3. Define funding options

        3.3.3.4. Conduct planning activities for major account customers

        3.3.3.5. Collaborate with account customers to create sales and promo plan

        3.3.3.6. Develop promotional and category management calendars (trade marketing calendars)

        3.3.3.7. Create strategic and tactical sales plans by customer account

        3.3.3.8. Communicate planning information to customer account teams

      3.3.4. Establish overall sales budgets

        3.3.4.1. Calculate product unit forecast

        3.3.4.2. Calculate product market share

        3.3.4.3. Calculate product revenue

        3.3.4.4. Determine variable costs

        3.3.4.5. Determine overhead and fixed costs

        3.3.4.6. Calculate net profit

        3.3.4.7. Create budget

      3.3.5. Establish sales goals and measures

      3.3.6. Establish customer management measures

        3.3.6.1. Perform territory analysis and establish composition

        3.3.6.2. Establish sales force incentive program

    3.4. Develop and manage marketing plans

      3.4.1. Establish goals, objectives and metrics for products by channels/segments

      3.4.2. Establish marketing budgets

        3.4.2.1. Confirm marketing alignment to business strategy

        3.4.2.2. Determine costs of marketing

        3.4.2.3. Create marketing budget

        3.4.2.4. Determine projected ROI for marketing investment

      3.4.3. Develop and manage media

        3.4.3.1. Define media objectives

        3.4.3.2. Develop marketing messages

        3.4.3.3. Define target audience

        3.4.3.4. Engage media provider

        3.4.3.5. Develop and execute advertising

        3.4.3.6. Develop and execute other marketing campaigns/programs

        3.4.3.7. Assess brand/product marketing plan performance

      3.4.4. Develop and manage pricing

        3.4.4.1. Determine pricing based on volume/unit forecast

        3.4.4.2. Execute pricing plan

        3.4.4.3. Evaluate pricing performance

        3.4.4.4. Implement promotional pricing programs

        3.4.4.5. Implement other retail pricing programs

        3.4.4.6. Communicate and implement price changes

        3.4.4.7. Achieve regulatory approval for pricing

        3.4.4.8. Develop pricing schemes for managed care organizations

        3.4.4.9. Refine pricing as needed

        3.4.4.10. Develop and execute pharmacoeconomics

      3.4.5. Develop and manage promotional activities

        3.4.5.1. Define promotional concepts

        3.4.5.2. Plan and test promotional activities

        3.4.5.3. Execute promotional activities

        3.4.5.4. Evaluate promotional performance metrics

        3.4.5.5. Refine promotional performance metrics

        3.4.5.6. Incorporate learning into future/planned consumer promotions

      3.4.6. Track customer management measures

        3.4.6.1. Determine customer loyalty/lifetime value

        3.4.6.2. Analyze customer revenue trend

        3.4.6.3. Analyze customer attrition and retention rates

        3.4.6.4. Analyze customer metrics

        3.4.6.5. Revise customer strategies, objectives and plans based on metrics

      3.4.7. Develop and manage packaging strategy

        3.4.7.1. Plan packaging strategy

        3.4.7.2. Test packaging options

        3.4.7.3. Execute packaging strategy

        3.4.7.4. Refine packaging

    3.5. Develop and manage sales plans

      3.5.1. Generate leads

        3.5.1.1. Identify potential customers

        3.5.1.2. Identify leads

      3.5.2. Bid and proposal development

        3.5.2.1. Refine customer requirements

        3.5.2.2. Verify match with strategic / tactical plans

        3.5.2.3. Perform competitive analysis

        3.5.2.4. Develop pricing and scheduling estimates

        3.5.2.5. Conduct profitability analysis

        3.5.2.6. Submit bid

        3.5.2.7. Receive notification

      3.5.3. Manage customers and accounts

        3.5.3.1. Develop sales/key account plan

        3.5.3.2. Manage customer relationships

        3.5.3.3. Manage customer master data

      3.5.4. Manage customer sales

        3.5.4.1. Perform sales calls

        3.5.4.2. Perform pre-sales activities

        3.5.4.3. Close the sale

        3.5.4.4. Record outcome of sales process

      3.5.5. Manage sales orders

        3.5.5.1. Accept and validate sales orders

        3.5.5.2. Collect and maintain customer account information

        3.5.5.3. Determine availability

        3.5.5.4. Determine fulfillment process

        3.5.5.5. Enter orders into system and identify/perform cross-sell/up-sell activity

        3.5.5.6. Process back orders and updates

        3.5.5.7. Handle order inquiries including post-order fulfillment transactions

      3.5.6. Manage sales force

        3.5.6.1. Determine sales resource allocation

        3.5.6.2. Establish sales force incentive plan

        3.5.6.3. Manage master territory master data

        3.5.6.4. Manage roster master data

        3.5.6.5. Manage alignment of product and master territory master data

      3.5.7. Manage sales partners and alliances

        3.5.7.1. Provide sales and product training to sales partners/alliances

        3.5.7.2. Develop sales forecast by partner/alliance

        3.5.7.3. Agree on partner and alliance commissions

        3.5.7.4. Evaluate partner/alliance results

        3.5.7.5. Manage channel partner master data

4. Deliver Products and Services

    4.1. Plan for and align supply chain resources

      4.1.1. Review production, distribution and materials strategies

        4.1.1.1. Define manufacturing goals

        4.1.1.2. Define labor and materials policies

        4.1.1.3. Define outsourcing policies

        4.1.1.4. Define manufacturing capital expense policies

        4.1.1.5. Define capacities

        4.1.1.6. Define production network and supply constraints

        4.1.1.7. Review distribution network

        4.1.1.8. Define production process

        4.1.1.9. Define production workplace layout and infrastructure

      4.1.2. Manage demand for products and services

        4.1.2.1. Develop baseline forecasts

        4.1.2.2. Align with population disease dynamics

        4.1.2.3. Develop consensus forecast

        4.1.2.4. Determine available to promise

        4.1.2.5. Monitor activity against forecast and revise forecast

        4.1.2.6. Evaluate and revise forecasting approach

        4.1.2.7. Measure forecast accuracy

      4.1.3. Create materials plan

        4.1.3.1. Create unconstrained plan

        4.1.3.2. Collaborate with supplier and contract manufacturers

        4.1.3.3. Identify critical materials and supplier capacity

        4.1.3.4. Monitor material specifications

        4.1.3.5. Generate constrained plan

        4.1.3.6. Define production balance and control

      4.1.4. Create and manage master production schedule

        4.1.4.1. Create site level plan and schedule

        4.1.4.2. Manage work-in-progress inventory

        4.1.4.3. Collaborate with suppliers

        4.1.4.4. Execute site- level production plan and schedule

        4.1.4.5. Monitor master production schedule and plan

      4.1.5. Plan distribution requirements

        4.1.5.1. Maintain master data

        4.1.5.2. Determine finished goods inventory requirements at destination

        4.1.5.3. Calculate requirements at destination

        4.1.5.4. Calculate consolidation at source

        4.1.5.5. Manage collaborative replenishment planning

        4.1.5.6. Manage requirements for partners

        4.1.5.7. Calculate destination dispatch plan

        4.1.5.8. Manage dispatch plan attainment

        4.1.5.9. Calculate destination load plans

        4.1.5.10. Manage partner load plan

        4.1.5.11. Manage the cost of supply

        4.1.5.12. Manage capacity utilization

      4.1.6. Establish distribution planning constraints

        4.1.6.1. Establish distribution center layout constraints

        4.1.6.2. Establish inventory management constraints

        4.1.6.3. Establish transportation management constraints

      4.1.7. Review distribution planning policies

        4.1.7.1. Establish sourcing relationships

        4.1.7.2. Establish dynamic deployment policies

      4.1.8. Assess distribution planning performance

        4.1.8.1. Establish appropriate performance indicators (metrics)

        4.1.8.2. Establish monitoring frequency

        4.1.8.3. Calculate performance measures

        4.1.8.4. Identify performance trends

        4.1.8.5. Analyze performance benchmark gaps

        4.1.8.6. Prepare appropriate reports

        4.1.8.7. Develop performance improvement plan

      4.1.9. Develop quality standards and procedures

        4.1.9.1. Establish quality targets

        4.1.9.2. Develop standard testing procedures

        4.1.9.3. Communicate quality specifications

    4.2. Plan and Manage Regulatory Approval

      4.2.1. Plan and initiate validation

        4.2.1.1. Define ownership and responsibility

        4.2.1.2. Develop master validation plan

        4.2.1.3. Review/Approve master validation plan

      4.2.2. Develop validation/ qualification protocols

        4.2.2.1. Develop Installation Qualification (IQ) protocol

        4.2.2.2. Develop Operational/Performance Qualification (OQ/PQ) protocol

        4.2.2.3. Review and approve protocols

      4.2.3. Execute validation/ qualification Protocols

        4.2.3.1. Train participants

        4.2.3.2. Execute validation/qualification protocols

        4.2.3.3. Evaluate results

        4.2.3.4. Prepare validation report

        4.2.3.5. Review and approve validation report

        4.2.3.6. Release and use

      4.2.4. Maintain validation program documentation

        4.2.4.1. Maintain documentation

        4.2.4.2. Review documentation

      4.2.5. Develop revalidation maintenance plans

        4.2.5.1. Maintain a change control plan

        4.2.5.2. Conduct periodic reviews of the validated system

    4.3. Procure materials and services

      4.3.1. Develop sourcing strategies

        4.3.1.1. Develop procurement plan

        4.3.1.2. Clarify purchasing requirements

        4.3.1.3. Develop inventory strategy

        4.3.1.4. Match needs to supply capabilities

        4.3.1.5. Analyze company’s spend profile

        4.3.1.6. Seek opportunities to improve efficiency and value

        4.3.1.7. Collaborate with suppliers to identify sourcing opportunities

      4.3.2. Select suppliers and develop/maintain contracts

        4.3.2.1. Select suppliers

        4.3.2.2. Certify and validate suppliers

        4.3.2.3. Negotiate and establish contracts

        4.3.2.4. Manage contracts

      4.3.3. Order materials and services

        4.3.3.1. Process/Review requisitions

        4.3.3.2. Approve requisitions

        4.3.3.3. Solicit/Track vendor quotes

        4.3.3.4. Create/Distribute purchase orders

        4.3.3.5. Expedite orders and satisfy inquiries

        4.3.3.6. Record receipt of goods

        4.3.3.7. Research/Resolve exceptions

      4.3.4. Manage suppliers

        4.3.4.1. Monitor/Manage supplier information

        4.3.4.2. Prepare/Analyze procurement and vendor performance

        4.3.4.3. Support inventory and production processes

        4.3.4.4. Monitor quality of product delivered

    4.4. Produce/Manufacture/Deliver product

      4.4.1. Schedule production

        4.4.1.1. Generate line level plan

        4.4.1.2. Generate detailed schedule

        4.4.1.3. Schedule production orders and create lots

        4.4.1.4. Schedule preventive (planned) maintenance (preventive maintenance orders)

        4.4.1.5. Schedule requested (unplanned) maintenance (work order cycle)

        4.4.1.6. Release production orders and release create lots

        4.4.1.7. Develop campaign schedule

        4.4.1.8. Develop production schedule

      4.4.2. Produce product

        4.4.2.1. Manage raw material inventory

        4.4.2.2. Execute detailed line schedule

        4.4.2.3. Report maintenance issues

        4.4.2.4. Rerun defective items

        4.4.2.5. Assess production performance

        4.4.2.6. Process order release

        4.4.2.7. Release to EBR

        4.4.2.8. Report

      4.4.3. Test Product

        4.4.3.1. Test and release bulk

        4.4.3.2. Test and release intermediate product

        4.4.3.3. Test and release finished packaged products

      4.4.4. Perform quality testing

        4.4.4.1. Calibrate test equipment

        4.4.4.2. Perform testing using the standard testing procedure

        4.4.4.3. Record test results

        4.4.4.4. Track and analyze non-conformance trends

        4.4.4.5. Identify root cause of quality issues

      4.4.5. Maintain production records and manage lot traceability

        4.4.5.1. Determine lot numbering system

        4.4.5.2. Determine lot usage

    4.5. Deliver service to customer

      4.5.1. Confirm specific service requirements for individual customer

        4.5.1.1. Process customer request

        4.5.1.2. Create customer profile

        4.5.1.3. Generate service order

      4.5.2. Identify and schedule resources to meet service requirements

        4.5.2.1. Create resourcing plan and schedule

        4.5.2.2. Create service order fulfillment schedule

        4.5.2.3. Develop service order

      4.5.3. Provide the service to specific customers

        4.5.3.1. Organize daily service order fulfillment schedule

        4.5.3.2. Dispatch resources

        4.5.3.3. Manage order fulfillment progress

        4.5.3.4. Validate order fulfillment block completion

      4.5.4. Ensure quality of service

        4.5.4.1. Identify completed orders for feedback

        4.5.4.2. Identify incomplete orders and service failures

        4.5.4.3. Solicit customer feedback on services delivered

        4.5.4.4. Process customer feedback on services delivered

    4.6. Manage logistics and warehousing

      4.6.1. Define logistics strategy

        4.6.1.1. Translate customer service requirements into logistics requirements

        4.6.1.2. Design logistics network

        4.6.1.3. Communicate outsourcing needs

        4.6.1.4. Develop and maintain delivery service policy

        4.6.1.5. Optimize transportation schedules and costs

        4.6.1.6. Define key performance measures

      4.6.2. Plan and manage inbound material flow

        4.6.2.1. Plan inbound material receipts

        4.6.2.2. Manage inbound material flow

        4.6.2.3. Monitor inbound delivery performance

        4.6.2.4. Manage flow of returned products

      4.6.3. Operate warehousing

        4.6.3.1. Track inventory deployment

        4.6.3.2. Receive, inspect, and store inbound deliveries

        4.6.3.3. Track product availability

        4.6.3.4. Pick, pack, and ship product for delivery

        4.6.3.5. Track inventory accuracy

        4.6.3.6. Track third-party logistics storage and shipping performance

        4.6.3.7. Manage physical finished goods inventory

      4.6.4. Operate outbound transportation

        4.6.4.1. Plan, transport, and deliver outbound product

        4.6.4.2. Track carrier delivery performance

        4.6.4.3. Manage transportation fleet

        4.6.4.4. Process and audit carrier invoices and documents

      4.6.5. Manage returns; manage reverse logistics

        4.6.5.1. Authorize and process returns

        4.6.5.2. Perform reverse logistics

        4.6.5.3. Perform salvage activities

        4.6.5.4. Manage and process warranty claims

        4.6.5.5. Manage repair/refurbishment and return to customer/stock

        4.6.5.6. Verify the authorization of the process returns

        4.6.5.7. Receive returned product

        4.6.5.8. Determine the disposition of the returned product

        4.6.5.9. Perform the destruction of the returned products

        4.6.5.10. File the destruction with appropriate agency

        4.6.5.11. Manage and process warranty claims

    4.7. Manage Quality Assurance/Quality Control

      4.7.1. Develop and maintain quality management system

      4.7.2. Develop quality standards and sampling procedures

        4.7.2.1. Receive sample batch quantity

        4.7.2.2. Develop standard testing procedures for all materials

        4.7.2.3. Communicate quality specifications

      4.7.3. Conduct stability and validating tests and maintain test results

        4.7.3.1. Perform testing using the standard testing procedure

        4.7.3.2. Record test results

      4.7.4. Maintain batch records and manage lot traceability

        4.7.4.1. Determine batch numbering system

        4.7.4.2. Perform goods issue

        4.7.4.3. Determine batch usage

    4.8. Develop Sample Program and Requirements

      4.8.1. Develop Sample Delivery Tracking Program

        4.8.1.1. Define requirements and business procedures for sample tracking, distribution, feedback, and reporting

        4.8.1.2. Define systems requirements for sample tracking

        4.8.1.3. "Define systems requirements for sample distribution

        4.8.1.4. "Define systems requirements for feedback and reporting on sample distribution

        4.8.1.5. Monitor sample stock levels

5. Manage Customer Service

    5.1. Develop customer care/customer service strategy

      5.1.1. Develop customer service segmentation/prioritization (e.g., tiers)

        5.1.1.1. Analyze existing customers

        5.1.1.2. Analyze feedback of customer's needs

      5.1.2. Define customer service policies and procedures

      5.1.3. Establish service levels for customers

      5.1.4. Establish and manage plans to comply with HIPAA and other customer regulations

    5.2. Plan and manage customer service operations

      5.2.1. Plan and manage customer service work force

        5.2.1.1. Forecast volume of customer service contacts

        5.2.1.2. Schedule customer service work force

        5.2.1.3. Track work force utilization

        5.2.1.4. Monitor and evaluate quality of customer interactions with customer service representatives

      5.2.2. Manage customer service requests/inquiries

        5.2.2.1. Receive customer requests/inquiries

        5.2.2.2. Route customer requests/inquiries

        5.2.2.3. Respond to customer requests/inquiries

      5.2.3. Report Incidents, Adverse Events and Corrective Action Preventive Action (CAPA)

        5.2.3.1. Identify incidents and adverse events

        5.2.3.2. Investigate incidents and adverse events

        5.2.3.3. Resolve incidents and adverse events

        5.2.3.4. Report Corrective Action Preventive Action (CAPA)

        5.2.3.5. Capture and report adverse events

        5.2.3.6. Perform and report trending analytics

      5.2.4. Manage medical inquiries

        5.2.4.1. Receive medical inquiry

        5.2.4.2. Assign medical inquiry

        5.2.4.3. Track medical inquiry

        5.2.4.4. Respond to medical inquiry

      5.2.5. Authorize and manage product returns

        5.2.5.1. Receive return request

        5.2.5.2. Authorize return

        5.2.5.3. Submit return authorization to customer

        5.2.5.4. Verify receipt of return goods

    5.3. Measure and evaluate customer service operations

      5.3.1. Measure customer satisfaction with customer requests/inquiries handling

        5.3.1.1. Gather and solicit post-sale customer feedback on products and services

        5.3.1.2. Solicit post-sale customer feedback on ad effectiveness

        5.3.1.3. Analyze product and service satisfaction data and identify improvement opportunities

        5.3.1.4. Provide customer feedback to product management on products and services

      5.3.2. Measure customer satisfaction with customer-complaint handling and resolution

        5.3.2.1. Solicit customer feedback on complaint handling and resolution

        5.3.2.2. Analyze customer complaint data and identify improvement opportunities

      5.3.3. Measure customer satisfaction with products and services

        5.3.3.1. Gather and solicit post-sale customer feedback on products and services

        5.3.3.2. Solicit post-sale customer feedback on ad effectiveness

        5.3.3.3. Analyze product and service satisfaction data and identify improvement opportunities

        5.3.3.4. Provide customer feedback to product management on products and services

        5.3.3.5. Manage post marketing clinical trials

6. Develop and Manage Human Capital

    6.1. Develop and manage human resources (HR) planning, policies, and strategies

      6.1.1. Develop human resources strategy

        6.1.1.1. Identify strategic HR needs

        6.1.1.2. Define HR and business function roles and accountability

        6.1.1.3. Determine HR costs

        6.1.1.4. Establish HR measures

        6.1.1.5. Communicate HR strategies

        6.1.1.6. Develop strategy for HR systems/technologies/tools

      6.1.2. Develop and implement workforce strategy and policies

        6.1.2.1. Gather skill requirements according to corporate strategy and market environment

        6.1.2.2. Plan employee resourcing requirements per unit/organization

        6.1.2.3. Develop compensation plan

        6.1.2.4. Develop succession plan

        6.1.2.5. Develop employee diversity plan

        6.1.2.6. Develop other HR programs

        6.1.2.7. Develop HR policies

        6.1.2.8. Administer HR policies

        6.1.2.9. Plan employee benefits

        6.1.2.10. Develop workforce strategy models

      6.1.3. Monitor and update strategy, plans and policies

        6.1.3.1. Measure realization of objectives

        6.1.3.2. Measure contribution to business strategy

        6.1.3.3. Communicate plans and provide updates to stakeholders

        6.1.3.4. Review and revise HR plans

      6.1.4. Develop competency management models

    6.2. Recruit, source, and select employees

      6.2.1. Manage employee requisitions

        6.2.1.1. Align staffing plan to workforce plan and business unit strategies/resource needs

        6.2.1.2. Develop and open job requisition

        6.2.1.3. Develop job descriptions

        6.2.1.4. Post requisitions

        6.2.1.5. Manage internal/external job posting Web sites

        6.2.1.6. Modify requisitions

        6.2.1.7. Notify hiring manager

        6.2.1.8. Manage requisition dates

      6.2.2. Recruit/Source candidates

        6.2.2.1. Determine recruitment methods

        6.2.2.2. Perform recruiting activities/events

        6.2.2.3. Manage recruitment vendors

        6.2.2.4. Manage employee referral programs

        6.2.2.5. Monitor recruitment channels

      6.2.3. Screen and select candidates

        6.2.3.1. Identify and deploy candidate selection tools

        6.2.3.2. Interview candidates

        6.2.3.3. Test candidates

        6.2.3.4. Select and reject candidates

        6.2.3.5. Obtain candidate background information

      6.2.4. Manage new hire/re-hire

        6.2.4.1. Draw up and make offer

        6.2.4.2. Negotiate offer

        6.2.4.3. Hire candidate

      6.2.5. Manage applicant information

        6.2.5.1. Create applicant record

        6.2.5.2. Manage/track applicant data

        6.2.5.3. Archive and retain records of non-hires

    6.3. Develop and counsel employees

      6.3.1. Manage employee orientation and deployment

        6.3.1.1. Create/maintain employee on-boarding program

        6.3.1.2. Evaluate the effectiveness of the employee on-boarding program

        6.3.1.3. Execute onboarding program

      6.3.2. Manage employee performance

        6.3.2.1. Define performance objectives

        6.3.2.2. Review, appraise, and manage employee performance

        6.3.2.3. Evaluate and review performance program

      6.3.3. Manage employee development

        6.3.3.1. Define employee development guidelines

        6.3.3.2. Develop employee career plans

        6.3.3.3. Manage employee skills development

      6.3.4. Develop and train employees

        6.3.4.1. Align employee and organization development needs

        6.3.4.2. Align learning programs with competencies

        6.3.4.3. Establish training needs by analysis of required and available skills

        6.3.4.4. Develop, conduct, and manage employee and/or management training programs

    6.4. Manage employee relations

      6.4.1. Manage labor relations

      6.4.2. Manage collective bargaining process

      6.4.3. Manage labor management partnerships

      6.4.4. Manage employee grievances

    6.5. Reward and retain employees

      6.5.1. Develop and manage reward, recognition, and motivation programs

        6.5.1.1. Develop salary/compensation structure and plan

        6.5.1.2. Develop benefits and reward plan

        6.5.1.3. Perform competitive analysis of benefit and rewards

        6.5.1.4. Identify compensation requirements based on financial, benefits, and HR policies

        6.5.1.5. Administer compensation and rewards to employees

        6.5.1.6. Reward and motivate employees

        6.5.1.7. Deliver programs to support work/life balance for employees

      6.5.2. Manage and administer benefits

        6.5.2.1. Deliver employee benefits program

        6.5.2.2. Administer benefit enrollment

        6.5.2.3. Process claims

        6.5.2.4. Perform benefit reconciliation

      6.5.3. Manage employee assistance and retention

      6.5.4. Administer Payroll

    6.6. Re-deploy and retire employees

      6.6.1. Manage promotion and demotion process

      6.6.2. Manage separation

      6.6.3. Manage retirement

      6.6.4. Manage leave of absence

      6.6.5. Develop and implement employee outplacement

      6.6.6. Manage deployment of personnel

      6.6.7. Relocate employees and manage assignments

      6.6.8. Manage expatriates

    6.7. Manage employee information and analytics

      6.7.1. Manage reporting processes

      6.7.2. Manage employee inquiry process

      6.7.3. Manage and maintain employee data

      6.7.4. Manage human resource information systems (HRIS)

      6.7.5. Develop and manage employee metrics

      6.7.6. Develop and manage time and attendance systems

      6.7.7. Review retention and motivation indicators

      6.7.8. Manage/Collect employee suggestions and perform employee research

    6.8. Manage employee communication

      6.8.1. Develop employee communication plan

      6.8.2. Deliver employee communications

    6.9. Manage union relations

      6.9.1. Evaluate union relations internally

      6.9.2. Evaluate union relations externally

      6.9.3. Optimize relations

      6.9.4. Monitor relations

7. Manage Information Technology

    7.1. Manage the business of information technology

      7.1.1. Develop the enterprise IT strategy

        7.1.1.1. Build strategic intelligence

        7.1.1.2. Identify long-term IT needs of the enterprise in collaboration with stakeholders

        7.1.1.3. Define strategic standards, guidelines and principles

        7.1.1.4. Define and establish IT architecture and development standards

        7.1.1.5. Define strategic vendors for IT components

        7.1.1.6. Establish IT governance organization and processes

        7.1.1.7. Build strategic Roadmap to develop IT capabilities in support of business objectives

      7.1.2. Define the enterprise architecture

        7.1.2.1. Establish the current and future enterprise architecture definition

        7.1.2.2. Confirm enterprise architecture maintenance approach

        7.1.2.3. Maintain the relevance of the enterprise architecture

        7.1.2.4. Act as clearinghouse for IT research and innovation

        7.1.2.5. Govern the enterprise architecture

      7.1.3. Manage the IT portfolio

        7.1.3.1. Establish the IT portfolio

        7.1.3.2. Analyze and evaluate the value of the IT portfolio for the enterprise

        7.1.3.3. Provision resources in accordance with strategic priorities

      7.1.4. Perform IT research and innovation

        7.1.4.1. Research technologies to innovate IT services and solutions

        7.1.4.2. Transition viable technologies for IT services and solutions development

      7.1.5. Evaluate and communicate IT business value and performance

        7.1.5.1. Establish and monitor key performance indicators

        7.1.5.2. Evaluate IT plan performance

        7.1.5.3. Communicate IT value

    7.2. Develop and manage IT customer relationships

      7.2.1. Develop IT services and solutions strategy

        7.2.1.1. Research IT services and solutions to address business and user requirements

        7.2.1.2. Translate business and user requirements into IT services and solutions requirements

        7.2.1.3. Formulate IT services and solutions strategic initiatives

        7.2.1.4. Coordinate strategies with internal stakeholders to ensure alignment

        7.2.1.5. Evaluate and select IT services and solutions strategic initiatives

      7.2.2. Develop and manage IT service levels

        7.2.2.1. Create and maintain the IT services and solutions catalog

        7.2.2.2. Establish and maintain business and IT service level agreements

        7.2.2.3. Evaluate and report service level attainment results

        7.2.2.4. Communicate business and IT service level improvement opportunities

      7.2.3. Perform demand side management (DSM) for IT services

        7.2.3.1. Analyze IT services and solutions consumption and usage

        7.2.3.2. Develop and implement incentive programs that improve consumption efficiency

        7.2.3.3. Develop volume/unit forecast for IT services and solutions

      7.2.4. Manage IT customer satisfaction

        7.2.4.1. Capture and analyze customer satisfaction

        7.2.4.2. Assess and communicate customer satisfaction patterns

        7.2.4.3. Initiate improvements based on customer satisfaction patterns

      7.2.5. Market IT services and solutions

        7.2.5.1. Develop IT services and solutions marketing strategy

        7.2.5.2. Develop and manage IT customer strategy

        7.2.5.3. Manage IT services and solutions advertising and promotional campaigns

        7.2.5.4. Process and track IT services and solutions orders

    7.3. Develop and implement security, privacy, and data protection controls

      7.3.1. Establish information security, privacy, and data protection strategies and levels

      7.3.2. Test, evaluate, and implement information security and privacy and data protection controls

    7.4. Manage enterprise information

      7.4.1. Develop information and content management strategies

        7.4.1.1. Understand information and content management needs and the role of IT services for executing the business strategy

        7.4.1.2. Assess the information and content management implications of new technologies

        7.4.1.3. Identify and prioritize information and content management actions

      7.4.2. Define the enterprise information architecture

        7.4.2.1. Define information elements, composite structure, logical relationships and constraints, taxonomy, and derivation rules

        7.4.2.2. Define information access requirements

        7.4.2.3. Establish data custodianship

        7.4.2.4. Manage changes to content data architecture requirements

      7.4.3. Manage information resources

        7.4.3.1. Define the enterprise information/data policies and standards

        7.4.3.2. Develop and implement data and content administration

      7.4.4. Perform enterprise data and content management

        7.4.4.1. Define sources and destinations of content data

        7.4.4.2. Specify and purchase external data sets

        7.4.4.3. Manage technical interfaces to users of content

        7.4.4.4. Manage retention, revision, and retirement of enterprise information

    7.5. Develop and maintain information technology solutions

      7.5.1. Develop the IT development strategy

        7.5.1.1. Establish sourcing strategy for IT development

        7.5.1.2. Define development processes, methodologies, and tools standards

        7.5.1.3. Select development methodologies and tools

      7.5.2. Perform IT services and solutions life cycle planning

        7.5.2.1. Plan development of new requirements

        7.5.2.2. Plan development of feature and functionality enhancement

        7.5.2.3. Develop life cycle plan for IT services and solutions

      7.5.3. Develop and maintain IT services and solutions architecture

        7.5.3.1. Create IT services and solutions architecture

        7.5.3.2. Revise IT services and solutions architecture

        7.5.3.3. Retire IT services and solutions architecture

      7.5.4. Create IT services and solutions

        7.5.4.1. Understand confirmed requirements

        7.5.4.2. Design IT services and solutions

        7.5.4.3. Acquire/Develop IT service/solution components

        7.5.4.4. Train services and solutions resources

        7.5.4.5. Test IT services/solutions

        7.5.4.6. Confirm customer acceptance

      7.5.5. Maintain IT services and solutions

        7.5.5.1. Understand upkeep/enhance requirements and defect analysis

        7.5.5.2. Design change to existing IT service/solution

        7.5.5.3. Acquire/develop changed IT service/solution component

        7.5.5.4. Test IT service/solution change

        7.5.5.5. Retire solutions and services

    7.6. Deploy information technology solutions

      7.6.1. Develop the IT deployment strategy

        7.6.1.1. Establish IT services and solutions change policies

        7.6.1.2. Define deployment process, procedures, and tools standards

        7.6.1.3. Select deployment methodologies and tools

      7.6.2. Plan and implement changes

        7.6.2.1. Plan change deployment

        7.6.2.2. Communicate changes to stakeholders

        7.6.2.3. Administer change schedule

        7.6.2.4. Train impacted users

        7.6.2.5. Distribute and install change

        7.6.2.6. Verify change

      7.6.3. Plan and manage releases

        7.6.3.1. Understand and coordinate release design and acceptance

        7.6.3.2. Plan release rollout

        7.6.3.3. Distribute and install release

        7.6.3.4. Verify release

    7.7. Deliver and support information technology services

      7.7.1. Develop IT services and solution delivery strategy

        7.7.1.1. Establish sourcing strategy for IT delivery

        7.7.1.2. Define delivery processes, procedures, and tools standards

        7.7.1.3. Select delivery methodologies and tools

      7.7.2. Develop IT support strategy

        7.7.2.1. Establish sourcing strategy for IT support

        7.7.2.2. Define IT support services

      7.7.3. Manage IT infrastructure resources

        7.7.3.1. Manage IT inventory and assets

        7.7.3.2. Manage IT resource capacity

      7.7.4. Manage IT infrastructure operations

        7.7.4.1. Deliver IT services and solutions

        7.7.4.2. Perform IT operations support services

      7.7.5. Support IT services and solutions

        7.7.5.1. Manage availability

        7.7.5.2. Manage facilities

        7.7.5.3. Manage backup/recovery

        7.7.5.4. Manage performance and capacity

        7.7.5.5. Manage incidents

        7.7.5.6. Manage problems

        7.7.5.7. Manage inquiries

8. Manage Financial Resources

    8.1. Perform planning and management accounting

      8.1.1. Perform planning/budgeting/forecasting

        8.1.1.1. Develop and maintain budget policies and procedures

        8.1.1.2. Prepare periodic budgets and plans

        8.1.1.3. Prepare periodic financial forecasts

        8.1.1.4. Develop project budgets

      8.1.2. Perform cost accounting and control

        8.1.2.1. Perform inventory accounting

        8.1.2.2. Perform cost of sales analysis

        8.1.2.3. Perform product costing

        8.1.2.4. Perform variance analysis

        8.1.2.5. Report on profitability

      8.1.3. Perform cost management

        8.1.3.1. Determine key cost drivers

        8.1.3.2. Measure cost drivers

        8.1.3.3. Determine critical activities

        8.1.3.4. Manage asset resource deployment and utilization

      8.1.4. Evaluate and manage financial performance

        8.1.4.1. Assess customer and product profitability

        8.1.4.2. Evaluate new products

        8.1.4.3. Perform life cycle costing

        8.1.4.4. Optimize customer and product mix

        8.1.4.5. Track performance of new customer and product strategies

        8.1.4.6. Prepare activity-based performance measures

        8.1.4.7. Manage continuous cost improvement

    8.2. Perform revenue accounting

      8.2.1. Process customer credit

        8.2.1.1. Establish credit policies

        8.2.1.2. Analyze/Approve new account applications

        8.2.1.3. Review existing accounts

        8.2.1.4. Produce credit/collection reports

        8.2.1.5. Reinstate or suspend accounts based on credit policies

      8.2.2. Invoice customer

        8.2.2.1. Maintain customer/product master files

        8.2.2.2. Generate customer billing data

        8.2.2.3. Transmit billing data to customers

        8.2.2.4. Post receivable entries

        8.2.2.5. Resolve customer billing inquiries

      8.2.3. Process accounts receivable (AR)

        8.2.3.1. Establish AR policies

        8.2.3.2. Receive/Deposit customer payments

        8.2.3.3. Apply cash remittances

        8.2.3.4. Prepare AR reports

        8.2.3.5. Post AR activity to the general ledger

      8.2.4. Manage and process collections

        8.2.4.1. Establish policies for delinquent accounts

        8.2.4.2. Analyze delinquent account balances

        8.2.4.3. Correspond/Negotiate with delinquent accounts

        8.2.4.4. Discuss account resolution with internal parties

        8.2.4.5. Process adjustments/write-off balances

      8.2.5. Manage and process adjustments/deductions

        8.2.5.1. Establish policies/procedures for adjustments

        8.2.5.2. Analyze adjustments

        8.2.5.3. Correspond/Negotiate with customer

        8.2.5.4. Discuss resolution with internal parties

        8.2.5.5. Prepare chargeback invoices

        8.2.5.6. Process related entries

    8.3. Perform general accounting and reporting

      8.3.1. Manage policies and procedures

        8.3.1.1. Negotiate service level agreements

        8.3.1.2. Establish accounting policies

        8.3.1.3. Set and enforce approval limits

        8.3.1.4. Establish common financial systems

      8.3.2. Perform general accounting

        8.3.2.1. Maintain chart of accounts

        8.3.2.2. Process journal entries

        8.3.2.3. Process allocations

        8.3.2.4. Process period end adjustments (e.g., accruals, currency conversions, etc.)

        8.3.2.5. Post and reconcile intercompany transactions

        8.3.2.6. Reconcile GL accounts

        8.3.2.7. Perform consolidations and process eliminations

        8.3.2.8. Prepare trial balance

        8.3.2.9. Prepare and post management adjustments

      8.3.3. Perform fixed asset accounting

        8.3.3.1. Establish fixed asset policies and procedures

        8.3.3.2. Maintain fixed asset master data files

        8.3.3.3. Process and record fixed asset additions and retires

        8.3.3.4. Process and record fixed asset adjustments, enhancements, revaluations, and transfers

        8.3.3.5. Process and record fixed asset maintenance and repair expenses

        8.3.3.6. Calculate and record depreciation expense

        8.3.3.7. Reconcile fixed asset ledger

        8.3.3.8. Track fixed assets including physical inventory

        8.3.3.9. Provide fixed asset data to support tax, statutory, and regulatory reporting

      8.3.4. Perform financial reporting

        8.3.4.1. Prepare business unit financial statements

        8.3.4.2. Prepare consolidated financial statements

        8.3.4.3. Perform business unit reporting/review management reports

        8.3.4.4. Perform consolidated reporting/review of cost management reports

        8.3.4.5. Prepare statements for board review

        8.3.4.6. Produce quarterly/annual filings and shareholder reports

        8.3.4.7. Produce regulatory reports

    8.4. Manage fixed asset project accounting

      8.4.1. Perform capital planning and project approval

        8.4.1.1. Develop capital investment policies and procedures

        8.4.1.2. Develop and approve capital expenditure plans and budgets

        8.4.1.3. Review and approve capital projects and fixed asset acquisitions

        8.4.1.4. Conduct financial justification for project approval

      8.4.2. Perform capital project accounting

        8.4.2.1. Create project account codes

        8.4.2.2. Record project-related transactions

        8.4.2.3. Monitor and track capital projects and budget spending

        8.4.2.4. Close/capitalize projects

        8.4.2.5. Measure financial returns on completed capital projects

    8.5. Process payroll

      8.5.1. Report time

        8.5.1.1. Establish policies and procedures

        8.5.1.2. Collect and record employee time worked

        8.5.1.3. Analyze and report paid and unpaid leave

        8.5.1.4. Monitor regular, overtime, and other hours

        8.5.1.5. Analyze and report employee utilization

      8.5.2. Manage pay

        8.5.2.1. Enter employee time worked into payroll system

        8.5.2.2. Maintain and administer employee earnings information

        8.5.2.3. Maintain and administer applicable deductions

        8.5.2.4. Monitor changes in tax status of employees

        8.5.2.5. Process and distribute payments

        8.5.2.6. Process and distribute manual checks

        8.5.2.7. Process period end adjustments

        8.5.2.8. Respond to employee payroll inquiries

      8.5.3. Process payroll taxes

        8.5.3.1. Calculate and pay applicable payroll taxes

        8.5.3.2. Produce and distribute employee annual tax statements

        8.5.3.3. File regulatory payroll tax forms

    8.6. Process accounts payable and expense reimbursements

      8.6.1. Process accounts payable (AP)

        8.6.1.1. Verify AP pay file with purchase order vendor master file

        8.6.1.2. Maintain/manage electronic commerce

        8.6.1.3. Audit invoices and key data in AP system

        8.6.1.4. Approve payments

        8.6.1.5. Process financial accruals and reversals

        8.6.1.6. Process taxes

        8.6.1.7. Research/resolve exceptions

        8.6.1.8. Process payments

        8.6.1.9. Respond to AP inquiries

        8.6.1.10. Retain records

        8.6.1.11. Adjust accounting records

      8.6.2. Process expense reimbursements

        8.6.2.1. Establish and communicate expense reimbursement policies and approval limits

        8.6.2.2. Capture and report relevant tax data

        8.6.2.3. Approve reimbursements and advances

        8.6.2.4. Process reimbursements and advances

        8.6.2.5. Manage personal accounts

    8.7. Manage treasury operations

      8.7.1. Manage treasury policies and procedures

        8.7.1.1. Establish scope and governance of treasury operations

        8.7.1.2. Establish and publish treasury policies

        8.7.1.3. Develop treasury procedures

        8.7.1.4. Monitor treasury procedures

        8.7.1.5. Audit treasury procedures

        8.7.1.6. Revise treasury procedures

        8.7.1.7. Develop and confirm internal controls for treasury

        8.7.1.8. Define system security requirements

      8.7.2. Manage cash

        8.7.2.1. Manage and reconcile cash positions

        8.7.2.2. Manage cash equivalents

        8.7.2.3. Process and oversee electronic fund transfers (EFTs)

        8.7.2.4. Develop cash flow forecasts

        8.7.2.5. Manage cash flows

        8.7.2.6. Produce cash management accounting transactions and reports

        8.7.2.7. Manage and oversee banking relationships

        8.7.2.8. Analyze, negotiate, resolve, and confirm bank fees

      8.7.3. Manage in-house bank accounts

        8.7.3.1. Manage in-house bank accounts for subsidiaries

        8.7.3.2. Manage and facilitate inter-company borrowing transactions

        8.7.3.3. Manage centralized outgoing payments on behalf of subsidiaries

        8.7.3.4. Manage central incoming payments on behalf of subsidiaries

        8.7.3.5. Manage internal payments and netting transactions

        8.7.3.6. Calculate interest and fees for in-house bank accounts

        8.7.3.7. Provide account statements for in-house bank accounts

      8.7.4. Manage debt and investment

        8.7.4.1. Manage financial intermediary relationships

        8.7.4.2. Manage liquidity

        8.7.4.3. Manage issuer exposure

        8.7.4.4. Process and oversee debt and investment transactions

        8.7.4.5. Process and oversee foreign currency transactions

        8.7.4.6. Produce debt and investment accounting transaction reports

        8.7.4.7. Process and oversee interest rate transactions

      8.7.5. Monitor and execute risk and hedging transactions

        8.7.5.1. Manage interest rate risk

        8.7.5.2. Manage foreign exchange risk

        8.7.5.3. Manage exposure risk

        8.7.5.4. Develop and execute hedging transactions

        8.7.5.5. Evaluate and refine hedging positions

        8.7.5.6. Produce hedge accounting transactions and reports

        8.7.5.7. Monitor credit

    8.8. Manage internal controls

      8.8.1. Establish internal controls, policies and procedures

        8.8.1.1. Establish board of directors and audit committee

        8.8.1.2. Define and communicate code of ethics

        8.8.1.3. Assign roles and responsibility for internal controls

        8.8.1.4. Define business process objectives and risks

        8.8.1.5. Define entity/unit risk tolerances

      8.8.2. Operate controls and monitor compliance with internal controls policies and procedures

        8.8.2.1. Design and implement control activities

        8.8.2.2. Monitor control effectiveness

        8.8.2.3. Remediate control deficiencies

        8.8.2.4. Create compliance function

        8.8.2.5. Operate compliance function

        8.8.2.6. Implement and maintain controls-related enabling technologies and tools

      8.8.3. Report on internal controls compliance

        8.8.3.1. Report to external auditors

        8.8.3.2. Report to regulators, share/debt-holders, securities exchanges, etc.

        8.8.3.3. Report to third parties (e.g., business partners)

        8.8.3.4. Report to internal management

    8.9. Manage taxes

      8.9.1. Develop tax strategy and plan

        8.9.1.1. Calculate foreign, national, state and local tax strategy

        8.9.1.2. Consolidate and optimize total tax plan

        8.9.1.3. Maintain tax master data

      8.9.2. Process taxes

        8.9.2.1. Perform tax planning/strategy

        8.9.2.2. Prepare returns

        8.9.2.3. Prepare foreign taxes

        8.9.2.4. Calculate deferred taxes

        8.9.2.5. Account for taxes

        8.9.2.6. Monitor tax compliance

        8.9.2.7. Address tax inquiries

    8.10. Manage international funds/consolidation

      8.10.1. Monitor international rates

      8.10.2. Manage transactions

      8.10.3. Monitor currency exposure/hedge currency

      8.10.4. Report results

    8.11. Perform global trade services

      8.11.1. Screen sanctioned party list

      8.11.2. Control exports and imports

      8.11.3. Classify products

      8.11.4. Calculate duty

      8.11.5. Communicate with customs

      8.11.6. Document trade

      8.11.7. Process trade preferences

      8.11.8. Handle restitution

      8.11.9. Prepare letter of credit

9. Acquire, Construct and Manage Assets

    9.1. Design and construct/acquire non-productive assets

      9.1.1. Develop property strategy and long term vision

        9.1.1.1. Confirm alignment of property requirements with business strategy

        9.1.1.2. Assess the external environment

        9.1.1.3. Determine build or buy decision

      9.1.2. Develop, construct, and modify sites

      9.1.3. Plan facility

        9.1.3.1. Design facility

        9.1.3.2. Analyze budget

        9.1.3.3. Select property

        9.1.3.4. Negotiate terms for facility

        9.1.3.5. Manage construction or modification to building

      9.1.4. Provide workspace and assets

        9.1.4.1. Acquire workspace and assets

        9.1.4.2. Change fit/form/function of workspace and assets

    9.2. Plan maintenance work

      9.2.1. Perform routine maintenance

      9.2.2. Perform corrective maintenance

      9.2.3. Overhaul equipment

      9.2.4. Manage facilities operations

        9.2.4.1. Relocate people

        9.2.4.2. Relocate material and tools

    9.3. Obtain and install assets, equipment, and tools

      9.3.1. Develop ongoing maintenance policies for productive assets

        9.3.1.1. Analyze assets and predict maintenance requirements

        9.3.1.2. Develop approach to integrate preventive maintenance into production schedule

      9.3.2. Obtain and install equipment

        9.3.2.1. Design engineering solution for the manufacturing process

        9.3.2.2. Install and commission equipment

    9.4. Dispose of productive and non-productive assets

      9.4.1. Develop exit strategy

      9.4.2. Perform sale or trade

      9.4.3. Perform abandonment

10. Manage Enterprise Risk, Compliance, Remediation and Resiliency

    10.1. Manage enterprise risk

      10.1.1. Establish the enterprise risk framework and policies

        10.1.1.1. Determine risk tolerance for organization

        10.1.1.2. Develop and maintain enterprise risk policies and procedures

        10.1.1.3. Identify and implement enterprise risk management tools

        10.1.1.4. Coordinate the sharing of risk knowledge across the organization

        10.1.1.5. Prepare and report enterprise risk to executive management and board

      10.1.2. Oversee and coordinate enterprise risk management activities

        10.1.2.1. Identify enterprise level risks

        10.1.2.2. Assess risks to determine which to mitigate

        10.1.2.3. Develop risk mitigation and management strategy, and integrate with existing performance management processes

        10.1.2.4. Verify business unit and functional risk mitigation plans are implemented

        10.1.2.5. Ensure risks and risk mitigation actions are monitored

        10.1.2.6. Report on risk activities

      10.1.3. Coordinate business unit and functional risk management activities

        10.1.3.1. Ensure that each business unit / function follows the enterprise risk management process

        10.1.3.2. Ensure that each business unit/function follows the enterprise risk reporting process

      10.1.4. Manage business unit and function risk

        10.1.4.1. Identify risks

        10.1.4.2. Assess risks using enterprise risk framework policies and procedures

        10.1.4.3. Develop mitigation plans for risks

        10.1.4.4. Implement mitigation plans for risks

        10.1.4.5. Monitor risks

        10.1.4.6. Analyze risk activities and update plans

        10.1.4.7. Report on risk activities

    10.2. Manage compliance

      10.2.1. Establish compliance framework and policies

        10.2.1.1. Develop enterprise compliance policies and procedures

        10.2.1.2. Implement enterprise compliance activities

        10.2.1.3. Manage internal audits

        10.2.1.4. Maintain controls-related technologies and tools

      10.2.2. Manage regulatory compliance

        10.2.2.1. Develop regulatory compliance procedures

        10.2.2.2. Identify applicable regulatory requirements

        10.2.2.3. Monitor the regulatory environment for changing or emerging regulations

        10.2.2.4. Assess current compliance position, and identify weaknesses or shortfalls therein

        10.2.2.5. Implement missing or stronger regulatory compliance controls and policies

        10.2.2.6. Monitor and test, on an ongoing and scheduled basis, regulatory compliance position and existing controls, defining controls that should be added, removed, or modified as required

        10.2.2.7. Maintain relationships with regulators as appropriate

    10.3. Manage remediation efforts

      10.3.1. Create remediation plans

      10.3.2. Contact and confer with experts

      10.3.3. Identify/Dedicate resources

      10.3.4. Investigate legal aspects

      10.3.5. Investigate damage cause

      10.3.6. Amend or create policy

    10.4. Manage business resiliency

      10.4.1. Develop the business resilience strategy

      10.4.2. Perform continuous business operations planning

      10.4.3. Test continuous business operations

      10.4.4. Maintain continuous business operations

      10.4.5. Share knowledge of specific risks across other parts of the organization

11. Manage External Relationships

    11.1. Build investor relationships

      11.1.1. Plan, build, and manage lender relations

      11.1.2. Plan, build, and manage analyst relations

      11.1.3. Communicate with shareholders

    11.2. Manage government and industry relationships

      11.2.1. Manage government relations

        11.2.1.1. Assess relationships

        11.2.1.2. Appoint responsible executives

        11.2.1.3. Monitor relationships

        11.2.1.4. Receive input from internal advisors

        11.2.1.5. Receive input from external advisors

        11.2.1.6. Liaise with authorities

      11.2.2. Manage relations with quasi-government bodies

        11.2.2.1. Establish relationships with agencies

        11.2.2.2. Respond to audit inquiries

        11.2.2.3. Maintain documentation of contacts

        11.2.2.4. Plan and manage meetings

      11.2.3. Manage relations with trade or industry groups

        11.2.3.1. Evaluate the requirements for strategic relationships

        11.2.3.2. Monitor the success of the partnerships

        11.2.3.3. Extend or change the relationships

      11.2.4. Manage lobby activities

    11.3. Manage relations with board of directors

      11.3.1. Report results

      11.3.2. Report audit findings

    11.4. Manage legal and ethical issues

      11.4.1. Create ethics policies

      11.4.2. Manage corporate governance policies

      11.4.3. Develop and perform preventative law programs

      11.4.4. Ensure compliance

        11.4.4.1. Plan and initiate compliance program

        11.4.4.2. Execute compliance program

      11.4.5. Manage outside counsel

        11.4.5.1. Assess problem and determine work requirements

        11.4.5.2. Engage/retain outside counsel if necessary

        11.4.5.3. Receive strategy/budget

        11.4.5.4. Receive work product and manage/ monitor case and work performed

        11.4.5.5. Process payment for legal services

        11.4.5.6. Track legal activity/performance

      11.4.6. Protect intellectual property

        11.4.6.1. Manage copyrights and patents

        11.4.6.2. Maintain intellectual property rights and restrictions

        11.4.6.3. Administer licensing terms

        11.4.6.4. Administer options

      11.4.7. Resolve disputes and litigations

      11.4.8. Provide legal advice/counseling

      11.4.9. Negotiate and document agreements/contracts

    11.5. Manage public relations program

      11.5.1. Manage community relations

      11.5.2. Manage media relations

      11.5.3. Promote political stability

      11.5.4. Create press releases

      11.5.5. Issue press releases

12. Develop and Manage Business Capabilities

    12.1. Manage business processes

      12.1.1. Establish and maintain process management governance

        12.1.1.1. Define and manage governance approach

        12.1.1.2. Establish and maintain process tools and templates

        12.1.1.3. Assign and support process ownership

        12.1.1.4. Perform process governance activities

      12.1.2. Define and manage process frameworks

        12.1.2.1. Establish and maintain process framework

        12.1.2.2. Identify cross-functional processes

      12.1.3. Define processes

        12.1.3.1. Scope processes

        12.1.3.2. Analyze processes

        12.1.3.3. Map processes

        12.1.3.4. Publish processes

      12.1.4. Manage process performance

        12.1.4.1. Provide process training

        12.1.4.2. Support process execution

        12.1.4.3. Measure and report process performance

      12.1.5. Improve processes

        12.1.5.1. Identify and select improvement opportunities

        12.1.5.2. Manage improvement projects

        12.1.5.3. Perform continuous improvement activities

    12.2. Manage portfolio, program, and project

      12.2.1. Manage portfolio

        12.2.1.1. Establish portfolio strategy

        12.2.1.2. Define portfolio governance

        12.2.1.3. Monitor and control portfolio

      12.2.2. Manage programs

        12.2.2.1. Establish program structure and approach

        12.2.2.2. Manage program stakeholders and partners

        12.2.2.3. Manage program execution

        12.2.2.4. Review and report program performance

      12.2.3. Manage projects

        12.2.3.1. Establish project scope

        12.2.3.2. Identify project requirements and objectives

        12.2.3.3. Identify project resource requirements

        12.2.3.4. Assess culture and readiness for project management approach

        12.2.3.5. Identify appropriate project management methodologies

        12.2.3.6. Create business case and obtain funding

        12.2.3.7. Develop project measures and indicators

        12.2.3.8. Develop project plans

        12.2.3.9. Define roles and resources

        12.2.3.10. Identify specific IT requirements

        12.2.3.11. Create training and communication plans

        12.2.3.12. Design recognition and reward approaches

        12.2.3.13. Design and plan launch of project

        12.2.3.14. Deploy the project

        12.2.3.15. Execute projects

        12.2.3.16. Evaluate impact of project management (strategy and projects) on measures and outcomes

        12.2.3.17. Report the status of project

        12.2.3.18. Manage project scope

        12.2.3.19. Promote and sustain activity and involvement

        12.2.3.20. Realign and refresh project management strategy and approaches

        12.2.3.21. Review and report project performance

        12.2.3.22. Close projects

    12.3. Manage enterprise quality

      12.3.1. Establish quality requirements

        12.3.1.1. Define critical-to-quality characteristics

        12.3.1.2. Define preventive quality activities

        12.3.1.3. Develop quality controls

          12.3.1.3.1. Define process steps for controls (or integration points)

          12.3.1.3.2. Define sampling plan

          12.3.1.3.3. Identify measurement methods

          12.3.1.3.4. Define required competencies

        12.3.1.4. Prove capability to assess compliance with requirements

        12.3.1.5. Finalize quality plan

      12.3.2. Evaluate performance to requirements

        12.3.2.1. Test against quality plan

          12.3.2.1.1. Conduct test and collect data

          12.3.2.1.2. Record result(s)

          12.3.2.1.3. Determine disposition of result(s)

        12.3.2.2. Assess results of tests

          12.3.2.2.1. Assess sample significance

          12.3.2.2.2. Summarize result(s)

          12.3.2.2.3. Recommend actions

          12.3.2.2.4. Decide next steps

      12.3.3. Manage non-conformance

        12.3.3.1. Assess potential impact

        12.3.3.2. Determine immediate action(s)

        12.3.3.3. Identify root cause(s)

        12.3.3.4. Take corrective or preventitive action

        12.3.3.5. Close non-conformance

      12.3.4. Implement and maintain the enterprise quality management system (EQMS)

        12.3.4.1. Develop regulatory compliance procedures

        12.3.4.2. Plan and deploy the EQMS scope, targets, and goals

        12.3.4.3. Identify core EQMS processes, controls, and metrics

        12.3.4.4. Develop and document EQMS policies, procedures, standards, and measures

        12.3.4.5. Assess the EQMS performance

        12.3.4.6. Create environment and capability for EQMS improvement(s)

          12.3.4.6.1. Reward quality excellence

          12.3.4.6.2. Create and maintain quality partnerships

          12.3.4.6.3. Maintain talent capabilities and competencies

          12.3.4.6.4. Incorporate EQMS messaging into communication channels

          12.3.4.6.5. Assure independent EQMS management access to appropriate authority in the organization

          12.3.4.6.6. Transfer proven EQMS methods

    12.4. Manage change

      12.4.1. Plan for change

        12.4.1.1. Select process improvement methodology

        12.4.1.2. Assess readiness for change

        12.4.1.3. Determine stakeholders

        12.4.1.4. Engage/Identify champion

        12.4.1.5. Form design team

        12.4.1.6. Define scope

        12.4.1.7. Understand current state

        12.4.1.8. Define future state

        12.4.1.9. Conduct organizational risk analysis

        12.4.1.10. Assess cultural issues

        12.4.1.11. Establish accountability for change management

        12.4.1.12. Identify barriers to change

        12.4.1.13. Determine change enablers

        12.4.1.14. Identify resources and develop measures

      12.4.2. Design the change

        12.4.2.1. Assess connection to other initiatives

        12.4.2.2. Develop change management plans

        12.4.2.3. Develop training plan

        12.4.2.4. Develop communication plan

        12.4.2.5. Develop rewards/incentives plan

        12.4.2.6. Establish change adoption metrics

        12.4.2.7. Establish/Clarify new roles

        12.4.2.8. Identify budget/roles

      12.4.3. Implement change

        12.4.3.1. Create commitment for improvement/change

        12.4.3.2. Re-engineer business processes and systems

        12.4.3.3. Support transition to new roles or exit strategies for incumbents

        12.4.3.4. Monitor change

      12.4.4. Sustain improvement

        12.4.4.1. Monitor improved process performance

        12.4.4.2. Capture and reuse lessons learned from change process

        12.4.4.3. Take corrective action as necessary

    12.5. Develop and manage enterprise-wide knowledge management (KM) capability

      12.5.1. Develop KM strategy

        12.5.1.1. Develop governance model

        12.5.1.2. Establish central KM core group

        12.5.1.3. Define roles and accountability of core group versus operating units

        12.5.1.4. Develop funding models

        12.5.1.5. Identify links to key initiatives

        12.5.1.6. Develop core KM methodologies

        12.5.1.7. Assess IT needs and engage IT function

        12.5.1.8. Develop training and communication plans

        12.5.1.9. Develop change management approaches

        12.5.1.10. Develop strategic measures and indicators

      12.5.2. Assess KM capabilities

        12.5.2.1. Assess maturity of existing KM initiatives

        12.5.2.2. Evaluate existing KM approaches

        12.5.2.3. Identify gaps and needs

        12.5.2.4. Enhance/Modify existing KM approaches

        12.5.2.5. Develop new KM approaches

        12.5.2.6. Implement new KM approaches

    12.6. Measure and benchmark

      12.6.1. Create and manage organizational performance strategy

        12.6.1.1. Create enterprise measurement systems model

        12.6.1.2. Measure process productivity

        12.6.1.3. Measure cost effectiveness

        12.6.1.4. Measure staff efficiency

        12.6.1.5. Measure cycle time

      12.6.2. Benchmark performance

        12.6.2.1. Conduct performance assessments

        12.6.2.2. Develop benchmarking capabilities

        12.6.2.3. Conduct internal process and external competitive benchmarking

        12.6.2.4. Conduct gap analysis to understand need for change and degree needed

        12.6.2.5. Establish need for change

    12.7. Manage environmental health and safety (EHS)

      12.7.1. Determine environmental health and safety impacts

        12.7.1.1. Evaluate environmental impact of products, services, and operations

        12.7.1.2. Conduct health and safety and environmental audits

      12.7.2. Develop and execute functional EHS program

        12.7.2.1. Identify regulatory and stakeholder requirements

        12.7.2.2. Assess future risks and opportunities

        12.7.2.3. Create EHS policy

        12.7.2.4. Record and manage ehs events

      12.7.3. Train and educate functional employees

        12.7.3.1. Communicate EHS issues to stakeholders and provide support

      12.7.4. Monitor and manage functional EHS management program

        12.7.4.1. Manage EHS costs and benefits

        12.7.4.2. Measure and report EHS performance

        12.7.4.3. Implement emergency response program

        12.7.4.4. Implement pollution prevention program

        12.7.4.5. Provide employees with EHS support

 

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