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07.11

Application of Risk Management During Project Definition

 By Paul Kostek

Why care about risk management? We all do risk management whether we realize it or not. We make decisions on insurance for ourselves and our possessions, determining the amount we buy based on the amount of risk we face. As part of projects, we’ll do trade studies and pick the solution with the best payoff for the least risk. Today, more and more companies are looking at enterprise-level risk. For most engineers, the application of risk management will be at the project level. In two of the most regulated markets — aerospace and medical — the operating authorities (FAA and FDA) are levying requirements for the performance and documentation of risk management, including allocating risk down to the subcontractor/supplier level.

At the project level, we want to address risk at the beginning of the project to ensure that our user needs/system requirements address known/identified risks, determine the appropriate system response to failure, and limit the amount of rework on requirements/design.

How do most of us start off a new project? We look at material (requirements/design) from previous projects that might be applicable/reusable. We may have a specification from the customer outlining their needs, or a marketing needs document. We then begin work on developing a set of user needs. These needs must consider potential risks and identify trade-offs/mitigations.

Following are steps involved in a creating a risk management plan:

  • Identifying Risk — part of user needs/system specification development. Use lessons learned, requirements analysis, risk checklists and brainstorming to identify known or new risks.

  • Analyzing Risk – determine likelihood of risk occurring and impact; categorization of risk — technical, cost, schedule, risk level — high, moderate, low.

As shown in Figure 1, items in green are low risk, requiring no additional analysis. Items identified as moderate risk (yellow) need to be assessed to determine if any mitigations are required that could move them into the green (low-risk area). High-risk items require assessment to determine what mitigations can be done to lessen the risk and whether these steps make financial/schedule/technical sense. ALARP — As Low As Reasonably Possible comes into play here. We don’t want to create mitigations that result in the product being too costly or difficult to field; with ALARP, a decision is made to proceed after reasonable steps are taken and documented.


Figure 1 Risk Assessment Process
(Source: FAA Air Traffic Organization – Capt Bill Yantiss TASS 11/9/2009)

Assessing Risk

  • Avoidance – redefine plans, requirements, technical approach

  • Transfer – move to group/organization/supplier to address

  • Assume – accept risk based on cost/benefit analysis

  • Mitigation – plans/actions to reduce likelihood or lower consequence of risk

Risk Mitigation – add requirements to specification, change design, usage. These need to be assessed and verified as the design progresses.

After completing these stages, a risk management plan (aka a safety risk management plan) can be produced. This document is then used as part of planned phased reviews of the project. It should include any risk management activities performed by suppliers. This plan will serve as the guideline for engineers and project management as the project moves through the design cycle.

For example, in FDA-regulated industries, international standard IEC 60601-1 3rd edition provides guidance and the requirements for the risk management plan, including risk management work undertaken by suppliers. This can be a challenge because many smaller suppliers have not had to deal with this requirement in the past and may need guidance from the end user. Designers may be required to provide direction, review and approve the work done by suppliers. This should be a clearly stated task within the supplier’s SOW. Another useful resource for designers working on the medical technology industry is IS0 14971 Risk Management of Medical Devices Ensuring Safety and Efficacy.        

Track and Modify Risk

As the project moves through the design phases, track the identified risks to ensure all are addressed, modify if necessary and identify any new risks that may emerge during the design process. The initial tracking should be done when the product requirements are first reviewed. Tracking can be done with a checklist or as part of the risk management plan. New risks must be assessed to ensure that they are valid before any changes are made.

Implementing a risk management plan at the beginning of a project can help to remove some of the possible problems that can appear during the project’s lifecycle. There is no guarantee that all problems will be identified early or avoided, but reviewing lessons learned and previous problems can limit the number of requirement and design changes. All this is essential in a marketplace where time to market is critical, and for regulated industries where demonstrating that risk was considered early on, documented and assessed throughout the design process.

In addition to internal standards for Risk Management activities, good resources include the INCOSE Systems Engineering Handbook (v 3.2) and the Project Management Institute’s PMBOK (Project Management Book of Knowledge).

Successfully managing risk is a joint effort of management and engineering, and requires a commitment to identifying, managing and mitigating risk. Remember that the objective of risk management is to balance the allocation of resources in such a way that the minimum amount of resources achieves the greatest risk mitigation benefits.

IEEE-USA's six-part webinar series on risk management continues on 17 August July with a presentation by Paul Kostek on Application of Risk Management During Project Definition.

Speaker: Paul Kostek
When: 17 August 2011, 12:00-1:00 PM ET

About: This IEEE-USA webiar will provide an overview of Risk Management and its application on a project. What you’ll learn:

  • Difference between Enterprise and Project Risk Management
  • FDA and FAA risk management requirements
  • Essentials of the Risk Management process and some aids
  • Impact of risk management on project definition and design
  • Integrating risk management input from suppliers.
Rates
IEEE Members $19 for individual webinar; $89 for series
Non-Members $38 for individual webinar; $189 for series

 

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Paul Kostek is a Principal of Air Direct Solutions a systems engineering/project management firm in Seattle, Washington. He works with companies in the aerospace, avionics and medical device industries. Paul was President of IEEE-USA in 1999, President of the Aerospace and Electronics Systems Society 2000-01, Chaired the IEEE Intelligent Transportation Systems Conference in 2004 and the AIAA/IEEE Digital Avionics Systems Conference in 2006. He is the Chair of the 2011 IEEE Global Humanitarian Technology Conference.

Comments may be submitted to todaysengineer@ieee.org.


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