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EVM for Biotech and Pharma – Part I Implementation and Training

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Updated December 13, 2017

 

EVM for Biotech and PharmaAs you know, the Earned Value Management System (EVMS) is a management process with characteristics that are absolutely logical to manage projects whether there is an external customer or not. The EVMS is also required by the Federal Government on DOD, DOE, FAA, NSA, DOT, DOJ, NASA, etc. contracts over $20M.

With the phasing in of the Affordable Health Care Act and recent funding for research and preparation in the event of bio-terrorism, other branches of the Government, such as Health and Human Services (HHS) and Biomedical Advanced Research and Development Authority (BARDA), are becoming more involved in the healthcare sector. Implementing and using EVMS is a baseline requirement for biotech and pharmaceutical firms awarded large contracts by the Federal Government.

This will require companies and universities that receive funding to understand and implement Earned Value Management and that key project personnel, including management and executives, will require high quality Earned Value Training.

Why EVM and Government Contracts

Earned Value Management has been used since the 1960’s and has become the standard by which the Government measures and evaluates the management and reporting processes on projects awarded to contractors. Initially, it was implemented on projects; such as the development of satellites, long-range missiles, fighter aircraft, etc., but has become the US Government’s gold standard to manage the technical, schedule and cost progress of projects and to identify and manage risk and opportunities.

In order for defense contractors to be eligible for large contracts, they are required to follow the 32 Guidelines of the EIA-748-C which can entail system design and development and a substantial learning curve. Earned Value Management company-wide training and proper implementation becomes critical for project efficiency, future funding and to meet Government requirements.

Integral to EVM are the uses of the Integrated Master Plan (IMP)/Integrated Master Schedule (IMS) and risk and opportunity management.  The Integrated Master Schedule is the basis for developing the Performance Measurement Baseline (PMB) which in turn, is the basis for measuring performance on a project.   Measurement of progress against the baseline provides early identification of problems and helps to identify and mitigate costs and risks, while also identifying opportunities, by implementation of appropriate corrective actions.

Earned Value Management Systems for Project Management

The basic concept of the Earned Value Management System is more than a unique project management technique.  The EIA-748-C contains 32 Guidelines that define a set of requirements that a contractor’s management system must meet. The objectives of an EVMS are:

  •  Relate time phased budgets to specific contract tasks and/or statements of work
  • Relate technical, schedule and cost performance information
  • Furnish valid, timely and auditable data/information for proactive management action and decision making
  • Provide the basis to capture work progress assessments against the baseline plan to facilitate realistic project costs and completion dates
  • Supply managers with a practical level of summarization for effective decision making

Once a contractor’s EVM System is designed and implemented, there are significant benefits to the contractor and to the customer:

  • Contractor benefits include increased visibility and control to quickly and proactively respond to issues which makes it easier to meet project technical, schedule, and cost objectives
  • Customer benefits include confidence in the contractor’s ability to manage the project, early problem identification, and objective rather than subjective contract cost and schedule status

Earned Value Management Training

Experienced project managers will tell you that understanding the scope, schedule and costs of a project is essential to its success. The primary objective of the EVMS is to ensure that all elements of a project are planned, authorized, managed, and controlled in a consistent and cost-effective manner.  There is an increasing demand for training for organizations beyond the traditional aerospace and defense related construction, software, research and development, and production environment to now include non-defense companies to implement and use the Earned Value Management System.

EVM for Biotech and Pharma

Biotech and Pharma companies are not strangers to dealing with government regulations and requirements. Most have gone through rigorous Food and Drug Administration (FDA) processes to receive approval of compounds and/or devices. Nonetheless, learning how to design and use an EVM system can take a considerable investment of time and money, but is an essential requirement for initial and ongoing funding.

In addition to the EIA-748-C, there are numerous documents that give direction regarding the implementation and use of an EVM system.  Some of these are the National Defense Industrial Association (NDIA) Integrated Program Management Division (IPMD) EIA-748 Intent Guide, Cost Accounting Standards (CAS), Data Item Descriptions (DID), Military Standards (MIL-STD) such as MIL-STD-881, the Earned Value Management System Interpretation Guide (EVMSIG), and many others.  We have helped many organizations to ensure that they do not overkill or underkill based on their desired management system characteristics.  H&A personnel understand the requirements and are able to “size” those requirements to meet company and customer requirements.

Although Biotech and Pharma are relatively recent industries to use EVM, Humphreys & Associates (H&A) has been providing Earned Value Management training and implementation services for over 35 years. H&A provides self-paced online, classroom and private training courses, and can assist in all aspects of Earned Value Management Implementation.

For more information about EVM training or support, or with questions about your company’s requirements, please contact the Humphreys & Associates corporate office.

EVM for Biotech and Pharma – Part I Implementation and Training Read Post »

DFARS 252.234-7001 – “Thou Shalt Do Earned Value”

Overview

Earned Value Management (EVM) have become increasingly relevant for industries like Biotech and Pharma.

Hypothetically, your organization has received a Request for Proposal (RFP) and wishes to bid for the work.  The RFP includes the clause DFARS 252.234-7001 if the cost to the government is anticipated to be in excess of $20M.  What choices does a company have?  First, the clause could be ignored and the bid made as Firm Fixed Price (FFP). However, this places the entire cost risk on the company and unless the scope is well known and routinely achievable, this risk may be unacceptable.

Otherwise, with any other kind of contract, be it incentive or cost plus, it will require the company to comply with the Earned Value Management Systems (EVMS) clause.  Assume that the proposal is anticipated to be in excess of $50M (as this is the most stringent requirement), your company does not have an EVMS, and it is decided to bid and include a plan to reach compliance.

The subject DFARS Clause requires that a contract be managed with a fully compliant Earned Value Management System as defined in EIA-748 (the latest revision is “C” dated March 2013).  If a system has not been validated, meaning accepted by the Government, the company must include in its proposal how validation will be achieved.

This includes a description of the system proposed to be used including an annotated checklist which addresses each of the 162 management system characteristics, proposed changes to the current system, resumes of the personnel who will design and implement a compliant system, how the Guideline requirements will be met, subcontractor compliance, and a time-phased plan to achieve EVMS compliance.

What is the Extent of the Requirement?

The answer to this question is the object of the first steps towards full Earned Value Management (EVM) system design, implementation, operation, and acceptance.

Step 1: Familiarize company management with the EIA-748 Guideline requirements.  This is usually done with a two to four hour presentation to management conducted by experienced EVMS personnel.  The single most important outcome from this presentation, leading to a successful EVMS implementation and acceptance by the customer, is senior management’s commitment in fully supporting the steps that follow.

Step 2: Review the current management control systems including existing software and identify which of these fully support the earned value requirements.  This information is then used to develop an implementation plan of the necessary tasks, their associated schedule as well as the costs of needed changes.

Step 3:  This significant step helps senior management to:

    1. Review the cost benefit of the EVMS and either change the proposal strategy to a Firm Fixed Price (FFP) bid and stopping the EVMS process without significant investment
    2. Decide to implement the system a step at a time and proceed with the design and subsequent implementation and maintenance of the EVMS; or
    3. Simply not bid

The Choice – Proceed to Implement

Assuming the answer is to proceed, the question becomes what are the next steps?

First, the management system is divided into the required subsystems such as:  work definition and assignment, planning and scheduling, budgeting, work authorization, accounting, material and subcontract management, data analysis and reporting, and change control.  Next, pertinent existing information and materials (forms, documents, reports, etc.) are gathered that support these same subsystems. Interviews are also conducted to determine the “real” needs.  After collecting the existing system documentation and understanding the processes from interviews conducted, the  system documents  are placed in sequence on wall flow charts, commonly called storyboards, which allow the identification of system/subsystem “holes” and/or “gaps and overlaps” versus the EVMS requirements.  New forms, procedures, software modifications and other additions can then be identified and developed to fill these holes.

At this point in the process, the final management system design should be developed and a revised implementation plan/schedule presented to senior management for approval.  Upon approval, the first step is now accomplished.

Second, is to develop an EVMS compliant System Description, procedures and associated desk top instructions.  The System Description is a document that defines the management system much like the operator’s manual to your automobile.  It is a “what to do” document and includes definition of the processes, depicts forms and reports used in and produced by the system, and describes how the system meets the requirements of the EIA-748 Guideline requirements. This is typically organized by the Nine Process Groups of organizing, scheduling, etc.  The procedures and desk top instructions define how to do it and support the requirements outlined in the System Description.  Procedures and desk top instructions define the detailed steps necessary for all requirements and what organizations are responsible for those steps.   With the system documentation in place, and upon its presentation and acceptance by management, the second step is now complete. You could say that you have now designed and built a new automobile and it is time to train people how to drive.

The third step is to train all levels of management in the operation and use of the EVM System.  This can be accomplished in groups (functional management, control account managers (CAM), IPT Leads, senior management, etc.), and/or by one-on-one training.

Fourth, once all of the above has been accomplished, the company is ready to apply and operate the EVM system on a project.  Ideally the project that was proposed has now been won, and it is the one with which the system will be implemented—and used.  It is much easier to put the system in place and begin to operate it on a new project/contract than it is to try and retrofit it onto an existing project.  This entails following the definition, planning, and authorization subsystem steps defined in the approved Management System Description, procedures and associated desk top instructions, and then producing the required data for analysis and reporting to management and the customer.  Generally speaking, three months of system data and reports are required by the customer before the next step can be undertaken.

Fifth, the next major step is the customer’s review of the EVM system and its subsequent acceptance and validation.  Once system operation has begun, at least one visit will be conducted by the customer’s EVMS representative (in the case of DOD contracts it is the Defense Contract Management Agency (DCMA)).  The visit(s) is conducted to assess the progress against the plan that was submitted in the original proposal.  The visit(s) is usually two to three days in length and conducted by three or four well qualified government representatives.

Once an organization conducts a self assessment and informs the reviewing agency that it is ready for their review, that agency reviews the documentation provided by the organization to determine readiness for a Validation Review.  This review will then be scheduled with the company.  It may be quite some time in the future, as there are very few DCMA representatives available and there are many companies requiring reviews of one kind or another.  A “data call” will occur which is a request for information such as 12 months of Contract Performance Reports (CPRs) or Integrated Program Management Reports (IPMR), the baseline logs from the beginning of the program, etc. When the review does occur, the program team should plan on 15 to 20 reviewers for at least two weeks. The company will need to provide all of the support the review team requires. This will include work rooms, computers, printers, and other elements that will be specified in the review notification.  Other preparations will include development of in-briefings, construction/updates of storyboards, and conduct of mock interviews with project and management personnel to prepare them for their government interviews.

The company cannot expect to complete the Validation Review without action items being assigned.  The DCMA will create Discrepancy Report(s) which will lead to Corrective Action Reports (CARs) that are rated by the degree of severity from 1 to 4. These system discrepancies will each require a Corrective Action Plan (CAP) to be developed and accepted by the DCMA, monitored, and progress reported to the DCMA.  Once the DCMA has accepted all of the responses, the company can expect to receive a formal “System Acceptance Letter,” but it should not heave a sigh of relief – there is still one more step to be accomplished.

The On-Going Process

This last step is Surveillance, the development and execution of a plan that ensures continued system operation in accordance with the EIA-748 Guidelines.  History has proven over the past 46 years that EVM Systems’ operation tends to degrade over time.  This occurs because of taking short cuts, lack of continued management commitment and emphasis, degrading system use, a “we are too big to be failed” attitude, and an occasional laissez-faire attitude.

While all of the steps except this last one can usually be accomplished in nine months to a year, the last one, Surveillance, will need continued operational discipline as long as a validated EVM system is required.

If you have questions on the DFARS clause 252.234-7001 or would like to explore EVM training options, please feel free to contact Humphreys & Associates.

DFARS 252.234-7001 – “Thou Shalt Do Earned Value” Read Post »

IPMR DID Change – Office of Secretary of Defense Publishes New Procedure

Office of Secretary of Defense (OSD) Publishes the Integrated Program Management Report (IPMR) Data Item Description (DID)

This is important, new information for companies with U.S. Department of Defense EVMS contractual requirements.

The Department of Defense Integrated Program Management Report (IPMR), Data Item Description (DID), DI-MGMT-81861, replaces the Contract Performance Report (CPR) DID, DI-MGMT-81466A, and the Integrated Master Schedule (IMS) DID, DI-MGMT-81650.

The IPMR DID can be downloaded from the ASSIST database:  IPMR ASSIST document

The IPMR DID will apply to new contracts and may be applied to follow on contracts, subject to negotiation with the government customer.

In summary:

  • The IPMR DID combines the CPR and IMS DIDs into one.  The intent is to emphasize the integration of the schedule and cost data for performance reporting.
  • CPR Formats 1 to 5 are now the IPMR Formats 1 to 5.  There are a few content changes for Formats 1 to 5 which are mostly confined to Format 3.  The Baseline Changes (Block 6.b.) row columns have been opened up for change detail content.
  • The Integrated Master Schedule (IMS) becomes IPMR Format 6.  There are additional schedule data elements that are required including specific data coding details.
  • A new Format 7 has been added for time phased cost data (historical and future time periods).  Format 7 is an annual submission.
  • The electronic data delivery format for the OSD EVM Central Repository is changing from the ANSI X12 standard to the UN/CEFACT XML standard.  Additional information about the XML data submittal instructions is available on the OSD EVM Central Repository website.

We highly recommend being prepared to support the new IPMR DID as it will impact existing EVM Systems.  It will be necessary to reference the old and new terms and forms.  Existing contracts will be against older DID requirements (unless otherwise negotiated with the client) and new contracts will be against the IPMR DID.

Be prepared to update:

  • Training materials to reflect the updated cost Formats 1 to 5 as well as discuss the new Format 6 and 7.
  • System Description and Storyboard text as well as example formats and/or artifacts.
  • Procedures or project directives that specify schedule data coding requirements and related details necessary to produce the required IMS data for submission to the OSD EVM Central Repository.
  • Desktop instructions for producing the cost IPMR Formats 1 to 5 as well as the new Format 7.
  • Software toolset outputs and electronic deliverables.
  • Contractor self-surveillance and subcontractor surveillance materials.

Most cost and schedule software vendors are aware of the IPMR data requirements.  You may want to check with your toolset vendor of choice to see when they plan to have software updates available to support the IPMR DID and the UN/CEFACT XML data submissions to the OSD EVM Central Repository.

Humphreys & Associates is available for consulting on this topic.  Contact us for more information.

IPMR DID Change – Office of Secretary of Defense Publishes New Procedure Read Post »

New Integrated Program Management Report (IPMR) DID

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This coming change, likely to take effect in May 2012, applies to government contractual requirements (CDRLs) on contracts that require Earned Value Management (EVM) by most federal agencies. This is of particular importance to program and project managers, corporate EVM focal points and other staff that maintain a corporate EVM System Description or training materials. In some cases it applies to IT resources responsible for maintaining the schedule and cost toolsets used on projects.

A new Data Item Description (DID) for contract performance reporting and integrated master schedules was recently circulated for public comment.  The new DID, Integrated Program Management Report (IPMR), DI-MGMT-81466B, will replace the current Contract Performance Report (CPR) DID, DI-MGMT-81466A, and the Integrated Master Schedule (IMS) DID, DI-MGMT-81650.

A copy of the draft IPMR DID can be found on the PARCA (Performance Assessments and Root Cause Analyses) website. PARCA is part of the Office of the Assistant Secretary of Defense for Acquisition.  The Earned Value Management Division of PARCA is the DOD focal point for all policy, guidance, and competency relating to EVM.

In summary:

  • The IPMR DID combines the CPR and IMS DIDs into one
  • CPR Formats 1 to 5 become the IPMR Formats 1 to 5
  • The IMS becomes IPMR Format 6
  • There are a few content changes mostly confined to Format 3, which opens up the Baseline Changes (Block 6.b.) row columns
  • It adds a new Format 7, time phased historical data (an annual submission)
  • The electronic data delivery format is changing from the ANSI X12 standard to the UN/CEFACT XML standard

The initial comment period for the IPMR DID closed on January 31, 2012, followed with additional discussions with industry through the NDIA Program Management Systems Committee (PMSC). The likely publication date is early May 2012 but this is dependent on the final formal coordination process within OSD. The new DID will begin being applied on new contracts once the DID is approved.

The new DID does impact current EVM Systems as it will be necessary to reference the old and new terms and forms.  As a result, it may be necessary to update:

  • Training materials
  • System Description and Storyboard text, example formats and/or artifacts
  • Desktop instructions for producing specified formats
  • Software toolset outputs and electronic deliverables
  • Self-surveillance and subcontractor surveillance materials

Most cost and schedule software vendors are aware of the pending changes.  You may want to check with your toolset vendor of choice to see when they plan to have software updates available to support the new DID requirements.

Humphreys & Associates is available to provide resources, consulting and information on this topic. Click here to contact us.

New Integrated Program Management Report (IPMR) DID Read Post »

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