Risk Management

Risk management and design controls

Risk Management is a practice with processes, methods, and tools for managing risks in a project, it encompasses identification, mitigation, and continuous tracking, and control procedures that feedback through the program assessment process to decision authorities focusing on building the right product, project performance, managing change, innovation, and uncertainty. It is intended to be a framework within which experience, insight, and judgment are applied to successfully manage risk. It is included in this article because of its effect on the design process.

Risk management begins with the development of the design input requirements. As the design evolves, new risks may become evident. To systematically identify and, when necessary, reduce these risks. The risk management process is integrated into the design process. In this way, unacceptable risks can be identified and managed earlier in the design process when changes are easier to make and less costly.

An example of this is an exposure control system for a general purpose x-ray system. The control function was allocated to software. Late in the development process, risk analysis of the system uncovered several failure modes that could result in overexposure to the patient. Because the problem was not identified until the design was near completion, an expensive, independent, back-up timer had to be added to monitor exposure times.

Key terms and Definitions:

Risk analysis:

It is a process consisting of three components: risk evaluation, risk management and control and risk communication. Is the systematic use of information to estimate risk.

Risk evaluation:

Risk which is determined acceptable has been achieved in a given context based on the current values of society. Risk evaluation is concerned with assessing probability and impact of individual risks, taking into account any interdependencies or other factors outside the immediate scope under investigation. Probability is the evaluated likelihood of a particular outcome actually happening (including a consideration of the frequency with which the outcome may arise.)

Risk control:

This is a Process in which decision reaches and protective measures are implemented to eliminate risk, reduce risk or maintain risk. Risk Control is the process of identifying and prioritizing risks, then introducing measures that would reduce, if not eliminate adverse events from occurring, is one of the most important disciplines within the risk management process.

Risk management:

Risk Management is first and foremost a systematic application management tool. Organizations should be developing their risk arrangements for the real and demonstrable benefit of the organization.

The Quality system and design controls.

In addition to procedures and work instructions necessary for the implementation of design controls, policies and procedures may also be needed for other determinants of device quality that should be considered during the design process. Design control is the consistent execution of a planned program, structured to ensure that the designs are correct and appropriate for the application, the need for policies and procedures for these factors is dependent upon the types of engineered devices manufactured by a company and the risks associated with their use. In other words, design control is the consistent execution of a planned program, structured to ensure that the designs are correct and appropriate for the application, is a key element of the quality system.  Every company needs to know how to implement Design Control and Design Reviews that shorten the development cycle rather than waste time and create internal friction. The Pareto principle is applicable here, where 80% of the results are achieved in the first 20% of the meeting and the 20% of the participants provides 80% of the results.

Design reviews are formal reviews conducted during the development of a product to assure that the requirements, concept, product or process satisfies the requirements of that stage of development, the issues are understood, the risks are being managed, and there is a good business case for development.

Monte Carlo Simulation in Statistics Monte Carlo simulation is a methodology or tool for understanding the properties of a model or statistic under certain conditions. A Monte Carlo study is recommended to support the theoretical results, and an analysis of the data exchange to demonstrate the empirical usefulness of the reviewers.  It is my experience and strong belief that to make better models we need a better understanding of one's data result from focused data analysis.

Flowcharts will be created to assist with modeling of Design Control procedures and the implementation of an efficient Design Control program that involves a system of checks and balances that guide the Design and Development process throughout the product life-cycle. A team with executive responsibilities has the responsibility for determining what is needed based on variables significance level.

Examples of topics for which policies and procedures may be appropriate are:

risk management

device reliability

device durability

device maintainability

device serviceability

human factors engineering

use of standards

configuration management

compliance with regulatory requirements

document controls

use of subcontractors

use of company historical data

For instance, ISO13485 and the FDA have specific and compatible requirements for Design Control of Medical Devices. 

Points to consider:

Poor Design Control costs time and money, and its effects magnify exponentially as a project moves forward.

Design control is a quality system issue that engineers must perform in a development setting, not in an office automation setting.  Successful design control investments improve device quality, streamline project management, and increase the company's profitability. 

The essential quality aspects and the regulatory requirements, such as safety, performance, and dependability of a product (whether hardware, software, services, or processed materials) are established during the design and development phase. Deficient design can be a major cause of quality problems.

The context within which product design is to be carried out should be set by the Company’s Senior Design Team, integrated by a Customer liaison an Industrial Designer a Mechanical Engineer and manufacturing representatives. It is their responsibility to establish an accurate design intent and development plan which sets the targets to be met. This plan defines the constraints within which the design is to be implemented.

The quality system requirements do not dictate the types of design process that any company must use. A company should use processes best suited to their needs. However, whatever the processes may be, it is important that the design controls are applied in an appropriate manner. This article contains examples of how this might be achieved in a variety of situations.

It is important to note that the design function may apply to various facets of the operation having differing styles and time scales. Such facets are related to products, including service, as well as to their manufacturing processes.

Senior management needs to decide how the design function is to be managed and by whom. Senior management should also ensure that internal policies are established for design issues such as:

assessing new ideas to be applied on current designs

training and retraining of design managers and design staff

evaluation of the design process

product evaluation, including third party product approvals

patenting or other means of design protection

It is for senior management to ensure that adequate resources are available to carry out the design in the required time. This may involve reinforcing the skills and equipment available internally and/or obtaining external resources.

If design controls are a quality system regulation requirement, and design activities occur as part of product development, then a company’s product development system is most effective when integrated with the quality system.

Product development is not a democracy; product development is about using technology to manage change at the most flexible and cost effective point in the process of discovery.  Improving product development is a significant challenge for many companies, yet, it also represents a significant opportunity.