Simplifying Quality Management Systems through Intuitive Quality Design

Ryan Hagemeier, QA RA Director of Global Quality Systems, Hill-Rom
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In today’s complex regulatory landscape, navigating through the various regulations and standards can seem like a very daunting task. In order to ensure products are designed, manufactured, marketed, delivered, serviced, etc. in a manner that consistently adheres to these requirements, quality management systems are established. Quality management systems are traditionally comprised of procedures and processes to help coordinate an organization to both meet applicable requirements and incorporate mechanisms to measure and implement continuous improvement activities. However, in many cases, quality management systems are unintentionally designed in a manner where they are too complex to navigate and sometimes impossible to deliver the expected outcome on a regular basis.

Traditional quality management systems are designed with a foundation of a quality manual and a series of procedures and work instructions which prescribe the requirements set by the organization and provide guidance on how to produce objective evidence, demonstrating the applicable requirements are met. This approach relies on the user of the quality process to be effectively trained in a manner where they retain the process requirements and consistently incorporate them into their daily work.

  â€‹Intuitive quality designs can be used to create a quality management system with reduced overall cycle time, improved effectiveness, and elimination of rework and non-value added work  

Since adhering to the numerous governmental regulations and product standards in the industry is a significant financial investment, it is imperative that quality management system processes be done correctly the first time. One method of achieving this is through the use of intuitive quality design. This approach takes the requirements and options out of procedures and work instructions and puts them at the employee’s point of use in forms, tools, and templates.

A great example of using intuitive design to improve a complex and detailed process, is something we experience on an annual basis–filing taxes. Imagine if we were expected to file our taxes every year and the only guidance we were provided was the thick tax code book? Unless you are an accountant, the likelihood of you accurately filing your taxes would be slim at best. To ensure citizens could easily and accurately complete their taxes, the government developed the 1040 form. While it lacks razzle-dazzle, it clearly outlines what steps to follow with instructions embedded in the form. Without having an accounting degree, an average user can complete the form meeting the expectations in a relatively easy manner. Taking it one step to the next level, in recent years, several companies such as TurboTax® and TaxSlayer® have created an engaging and intuitive process where they ask the user a series of questions and the answers are used to create forms which meet federal and state government requirements.

This same, simple and intuitive approach can be applied to the development of a world class quality management system. Imagine that instead of employees sifting through a series of procedures to find guidance, an interactive tool drove them to the expected outcome in an efficient manner each and every time. Intuitive quality designs can be used to create a quality management system with reduced overall cycle time, improved effectiveness, and elimination of rework and non-value added work. By establishing clear expectations of compliance requirements and process outcomes at the point of use, the likelihood of your users meeting your expectations on a consistent basis can be improved exponentially. If you are interested in applying this technique to your quality management system, consider the guidance provided below to develop an intuitive quality system for your organization.

Where to Start

When developing any quality process using intuitive quality design, I recommend taking the following steps:
• Perform a detailed process review
o Locate each direct and indirect requirement
o Understand how people work within your process
• Review recent internal and external audit findings to identify potential compliance traps or areas where your organization has repeated issues. If you have any compliance gaps in your process, it is important to address them in an effective manner prior to modifying your process through intuitive quality design
• Identify where bottlenecks occur in the process through interviews with frequent and infrequent users of the process
• Understand where and why rework exists throughout the process

Building a Framework

Once a thorough understanding of the process is obtained, you can start to outline the framework of the process by taking the following steps:

1. Document every step in your process, large and small
• Leverage existing standard operating procedures, work instructions, job instructions, policies, etc. to ensure you capture every step (formal and informal)
• Be sure to capture requirements used in your local operating mechanisms (reporting, meetings, etc.)
2. Capture the expectation of the output at each step (i.e. “what does good look like”)
3. Anticipate potential unfavorable outcomes at each step (i.e. “what does bad look like”)
4. Determine the preferred sequence of events to maximize efficiency and reduce overall process cycle time (wherever possible).
5. Identify potential scenarios, if multiple paths in your process exist. In many complex processes, there are “if/then” decision points. It is critical that you understand and map each of these potential paths before you start building your process using intuitive quality system design.

Drafting Documents

Once the process is understood
• Develop your style using tables, fonts, colors, etc.
• Start building on “paper”
• Break process into sections
• Utilize functionality of word, excel, etc. to improve usability, where appropriate
• Transform requirements into questions and/or prompts for the user
• Capture guidance to assist user reach desired outcome
• Perform trial runs with frequent users and key stakeholders
Tips and Recommendations
• Be patient, change of this magnitude does not come quickly or easily
• Expect multiple revisions–your users will identify unforeseen scenarios after initial use
• There is no “right way,” be sure to develop the system that works best for your quality system, your company, and your employees
• Don’t assume users understand the requirements
• Anticipate resistance to change
• Get buy-in from upper management
• Communicate the approach to a broader audience
• Be open to feedback from users

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