Product Safety 101: 0% risk does NOT exist. Life as we know it is full of surprises and endless possibilities. “100% Risk Management” is a wonderful challenge.
Risk and Quality go hand in hand. When you reduce the risk, the product quality will rise. And higher quality triggers stronger brand, lower total costs, and increase in demand. Therefore, proper Quality Management always includes Risk Management. It starts with the suppliers making components and the factory workers assembling the final product, all the way to the end consumers. (Note that the end consumer is not necessarily the person who purchased the product — maybe you bought a product but a child or your grandmother ends up using it).
In order to always ensure Product Safety, Risk Management has a major role to play. Risk Management is part of your Quality Management System whether you purchase food, consumables, durable goods, financial services, or any other commodity.
Classic Risk Management focuses on the severity and the frequency of risk. This information is then translated into a risk matrix that is similar to the EU RAG tool being based upon the RAPEX Guidelines 2010/15/EC.
Now for the challenges. Is your company capable of taking the following steps?
- Identify the risk
- Understand the risk
- Reduce/mitigate the risk
- Implement the Key Learnings in its Quality Management System
These steps are to be followed BEFORE the product is on the market.
That’s why design is the critical starting point of Risk Assessment. The weaknesses (aka “failure modes”) of the product (both each component, and the combination of all components) need to be examined carefully. However, if you make the design of the product hard to reproduce, then inconsistency in production might lead to major risks — or even a product recall.
Once the product hits the market all Customer Complaints need to be categorized according to the risk matrix. This way, the organization can work on a Corrective and Preventive Action plan when necessary. This information should then be stored in the product’s Technical File so it can be used for future reference and guidance.
As market and brand competition has increased, product development has had to speed up. Some retailers have done so successfully. But the downside of going faster is a tendency to make more mistakes. Therefore a preventive, rather then reactive, approach to risk is crucial.
Product Safety is expected by any consumer (including myself) both chemically and mechanically, let it be via design, workmanship or other ways. Remember the brake pedal programming problem that prevented some drivers from stopping while driving on the highway… Nobody wants to be in that position.
Ensuring Chemical Product Safety is pretty straightforward and known in the industry via REACH EC 1907/2007. When it comes to Mechanical Product Safety, tough, strange things start happening.
I hear people say “we all survived in our childhood without these new regulations”, or “a small part is not really dangerous since it can be swallowed”. But what these self acclaimed “experts” do not realize is that one day a small child might be found with an object lodged in the throat. The object cannot be removed by hand. The child is chocking. And the nearest hospital is 10 minutes away…
Statistically these incidents will occur. And so do many other mechanical safety-related problems when you look deeper into available incident data.
Often these incidents are caused by:
- A poor understanding of design related risk
- Poor component quality usage/selection
- Poor quality workmanship when the products are being manufactured
- A poor combination of quality components combined with inappropriate workmanship
Here is an example. A zipper from a reputable brand is sewn into a baby sleeping bag. The zipper train and puller is of the “non end zipper stop” kind, so it can easily be removed when required. These zippers are not suitable for a baby product, since the baby could remove the zipper part by himself when unsupervised in his “safe” cot bed. Then the baby can put it in his mouth and a disaster might happen.
Many people base their decisions on experience. It means scenarios with a low probability are not taken into account. That reliance on “experience” could one day lead to a fatal incident.
A certain airline is THE most unfortunate recent example of the consequences of this approach. “Yes we can take a low risk and fly over a war zone, since nothing ever happened before. They got unlucky and consequences were enormous for EVERYBODY!
Now the precautionary principle of “Safety First” is sound, but Keeping it Simple ( or KIS ) is also needed.
Another example: the “cot bed set” for babies. It has a cot duvet, sometimes with a pillow or a baby sleep bag, in combination with a cot “bumper”. It looks all nice and safe. However, these bumpers designed to “protect” the baby from hitting the head against the cot bed are actually causing CO2 buildup that can cause death.
As nature intended, a baby can bump his head against objects, like the cot bed. That is part of learning and discovering the world around him/her. As harsh as that might seem, the baby will not suffer lasting physical injuries from hitting the cot a couple of times. But he/she will have learned an important lesson in life.
A proper cot bed is designed to achieve a good airflow, to follow measurement standards so the head or any other limb does not get stuck in between pillars, to avoid sharp edges, and so on. Over time babies become more agile, so they might use the cot bumper to stand on and climb out of the “safe” cot bet…
Are some “safety” requirements overdone? In my opinion, some certainly are. They actually increase the risk!
Let’s take a recent example: the tragic airplane crash in France where the cockpit “safety doors” locked the captain out while the plane was going down.
However there is no need to despair. Common sense does go a long way when you need to decide on design and safety requirements in your own company. Even as a consumer, you can do a risk assessment and avoid using nicely decorated cot bumpers if you think it is unsafe.
Here is another recent example. In the UK, a small child stuck his head in the cot bed. Fortunately one parent was keeping an eye on the child on a video monitor and came to the rescue. The lesson is, even parents have some responsibility to watch over their kids!
There is much more to be said and learned on the topic of Product Safety & Risk Management. My aim here is simply to raise awareness on the matter. I do not know everything nor do I pretend to — every day I learn new things. I hope that sharing this knowledge will help prevent further safety indents.