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Understand the ISO process approach by using 1980’s pop-culture
Three of my skills in this world include medical device development, teaching, and 1980’s pop culture. This article combines all three, using pop culture to illustrate concepts behind medical device quality system regulations that require a “process-based approach.” It’s starts with this, which will either confuse you or make you chuckle:
Was that a process?
Before I give my answer I’ll share the background of MC Hammer, Vanilla Ice, and the Process Approach to quality control so that everyone can make an informed decision.
MC Hammer was famous in the 80’s, especially for the lyrics, “Stop! Hammer Time!” His video for “Can’t Touch This” has been viewed 500 million times.
Vanilla Ice was famous in the 80’s, especially for the lyrics, “Stop! Collaborate & Listen!” His video for “Ice Ice Baby” has been viewed 250 million times.
If you knew hip-hop music from the late 1980’s and 1990’s, answering questions on the first diagram would make you either Stop! and Hammertime; or Stop! Collaborate, and listen.
International Standards Organization (ISO)
Medical device companies must have an approved quality system to sell their products. The international standards for quality systems is ISO 13485, which was updated to emphasize risk-driven processes. ISO 13485 training videos have, collectively, been viewed a few thousand times, but impact the lives of billions of people.
500,000 million people know about MC Hammer, but only a few understand the process approach to quality control of medical devices, which affects billions of people. 44% of medical device recalls could have been prevented by process controls, and healthcare mistakes lead to 250,000 deaths in the United States each year. The process approach could save more lives and make the world a healthier place.
The process approach
The international standard for quality management, ISO 9001, defines a process in clause 3.4.1 as:
“… a set of interrelated or interacting activities that transforms inputs into outputs.”
Inputs and outputs could be things, such as drawings or parts, or information, such as documents or test results.ISO 13485:2016, which is based on ISO 9001 but focused on medical devices, defines a process as:
“Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process.”
and the process approach as:
“…the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
with a goal of:
“…improving processes based on objective measurement.”
Clause 8.2.5 of the standards adds that all processes:
“…should be monitored and improved for effectiveness.”
In other words, all processes should be controlled by an overall process of continuous improvement. But, that still doesn’t tell us what is and what is not a process.
Is this a process?
The first example leads you through a series of choices that result in a a decision, either to “Hammertime” or “Collaborate – Listen.”
Is this a process as defined by the ISO process approach? Why or why not?
I’ll provide space before my answer with lyrics from MC Hammer’s 1989 hit song, “U Can’t Touch This”:
Every time you see me that Hammer’s just so hype I’m dope on the floor and I’m magic on the mic Now why would I ever stop doing this With others makin’ records that just don’t hit I toured around the world from London to the bank It’s Hammer go Hammer It’s a Hammer yo Hammer and the rest go and play
You can’t touch this (oh-oh oh oh-oh-oh) You can’t touch this (oh-oh oh oh-oh-oh) Can’t touch this (oh-oh oh-oh-oh) Yeah u can’t touch this I told you u can’t touch this (oh-oh oh-oh-oh) Too hype can’t touch this Get me outta here u can’t touch this (Oh-oh-oh-oh-oh-oh-oh-oh-oh-oh-oh-oh)
Here’s my answer: The example is not an ISO process according to the process approach.
It’s a flow chart, and useful way to choose “Hammertime” or “Collaborate and Listen”that could be used within a process to help visualize written instructions, but it’s not a process in the context of ISO 13485 because it doesn’t use inputs to produce outputs.
Someone may perceive that it has implied inputs and outputs, but it’s unclear how implied outputs could be used as inputs for other processes that would be linked in a cycle of continuous improvement.
Let’s look at another example from Devo’s 1980 song, “Whip It.” I encourage you to listen to the video while reading the example. Crank up the volume so that everyone in your office can jam with you.
Is this an ISO process-approach? Why or why not?
I’ll provide space before my answer with lyrics from Devo’s 1980 hit song, “Whip It!”
When a good time turns around You must whip it You will never live it down Unless you whip it No one gets away Until they whip it
I say whip it Whip it good I say whip it Whip it good
Crack that whip
Give the past the slip Step on a crack Break your momma’s back
When a problem comes along You must whip it Before the cream sits out too long You must whip it When something’s going wrong You must whip it
The “Whip It!” chart is not the process approach. It’s elaborate and a lot of work went into it, but it’s not monitored for effectiveness. In other words, the song remains the same.
Another way to view this could be to use a term from Systems Engineering, “closed-loop process.” A closed-loop process is also called a “feedback” process because outputs are fed back into the process so that the process improves. Conversely, an open-loop process does not improve.
The Whip It flow chart would always result in the same song, and The MC Hammer flow chart would continue giving two choices but would not improve, would not stay relevant, and would not maintain effectiveness over time. In other words, neither example was a process in the ISO definition of process approach.
This is a process
Let’s look at what ISO considers a process using the
which is based on the process approach.
In the diagram, arrows show the flow of information between departments, which means that each departments processes are linked, and that “Risk Management” is the basis all processes.
is shown to link to all departments, because to monitor and control supply-chains so that things external to our quality system don’t become a weak link in our processes.
The diagram doesn’t show inputs from the external world that are described in the text of ISO standards, which includes inputs for “Design and Development” that come from real-world feedback based on the needs of customers, users, and patients; and international regulatory requirements. These regulatory requirements are continuously improved based on outputs of all medical device companies, such as products and patient outcomes, creating a closed-loop system of continuous improvement for global healthcare.
As an example of a process within a company linked to other processes within that company, consider “Design and Development” and the FDA design-control guidance:
The written descriptions state that Design Input includes:
user needs (shown in the flow-chart)regulatory requirements
post-market surveillance of existing productsfrom outputs of linked processes in Measurement, Analysis, & Improvement
risk management policiesfrom outputs of linked processes overseen by Management.
The work of your design team converts design inputs into Design Output, which can include:
part drawingssoftware codesservices to customers
risk analysis documentsbecome input to Purchasing through linked processes
After verification and validation, Design Output becomes input for other departments, such as manufacturing and purchasing. In this way, each company functions as a process of continuous improvement.
A company’s quality system should monitor effectiveness of it’s products and feed that information back into product design in a process of continuous improvement. ISO summarizes the process approach as:
For an organization to function effectively, it needs to identify and manage numerous linked processes. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
Processes should be linked to form a closed-loop system of inputs and outputs. If an output isn’t used by other processes it could be an unnecessary use of resources. In the words of MC Hammer and Vanilla ice, it’s time to Stop! that process, then Collaborate and Listen! to make team-based decisions on prioritizing value-added steps in a process of continuous improvement.
Process maps aren’t required, but they can help you and your team analyze any part of your quality system to ensure it’s a risk-driven process, or to look for gaps to close. They don’t have to be elaborate; simple process maps can be more effective because a diverse group of people can use them without formal training. Common flowchart symbols are shown here:
CONSULTING & TRAINING
Oriel STAT-A-MATRIX (I consult with Oriel)
MaetricsLNE G-MedMDI Consultants
Me (Jason 🙂
Processes receive inputs and creates outputs that become inputs for other processes, creating a continuous flow of information and actions.A company’s quality system coordinates these processes
If you think this has been entertaining and useful, please link to it or forward it for others who could benefit.
Vanilla Ice wrote at age 16.
I listened to “Ice Ice Baby” at my high school prom. It’s a fun song, but my taste and choices have evolved, especially with haircuts.
Today, I help corporation improve by becoming more efficient and innovative while reducing risk to people. I focus on life-work harmony for employees, and keep the perspective that we can help >7.6 Billion people have healthier, happier lives.
Life, like a quality system, is process of continuous improvement. I wish you well with both.