“Never Events” and Product Recalls

Vince Shiers Ph.D., Managing Director, RQA Group.
 
Applying the “Never Event” Principle to the Food Manufacturing Sector.
Allergen related recalls are almost always due to cross-contamination of allergens or using incorrect packaging or errors on the label being applied. In the first two months of 2019, there were 26 allergen alerts issued by the UK Food Standards Agency. Of those, at least 5 were due to using incorrect packaging. In the US, in the same period, there were 7 FDA enforcement notices for products that were packed in the completely wrong packaging or had errors on the label plus a further 53 products that were recalled due to either cross-contamination of allergens or an error on the packaging. I propose that packing food products in the wrong packaging or with errors on the label should be classed as a “Never Event” because these sorts of errors are totally avoidable and should never happen.
 
 
But what is a “Never Event”?
“Never Events” are defined by the National Health Service England (NHS) as a particular type of serious incident that meets all the following criteria:
1. They are wholly preventable
 
2. Each “Never Event” type has the potential to cause serious patient harm or death
 
3. The category of “Never Event” has occurred in the past… and risk of recurrence remains
 
4. The occurrence of the “Never Event” is easily recognised and clearly defined.
 
Examples of a “Never Event” in the health sector include a surgical intervention performed on the wrong patient or wrong site (for example wrong knee, wrong eye). It can be seen that putting the wrong label on a food product resulting in allergen safety risks could meet all the above criteria.
 
 
How do “Never Events” help the Health Service?
In the words of the NHS: “Learning lessons from incidents requires timely incident reporting, which in turn requires a fair, open, and just culture that rejects blame as a tool. In part, this is because: “…a patient safety incident cannot simply be linked to the actions of the individual healthcare staff involved. All incidents are also linked to the system in which the individuals were working. Looking at what was wrong in the system helps organisations to learn lessons that can prevent the incident from recurring.”
 
So “Never Events” are not simply the result of an error of an individual but can be linked to failures in the system where the individual works. Improving the system will help a company to learn lessons and prevent reoccurrence. The success of systems in businesses relies on employees following them, all of the time. This is only achieved by senior management developing a culture of identifying, investigating and correcting failures in the system with an open, evidence-based decision making and fair approach that encourages zero tolerance for “Never Events”.
 
 
What is a “Never Event” in Food Manufacturing?
This is clearly open to discussion and I welcome a debate on this, but a first draft goes like this:
1. They are wholly preventable
 
2. Each “Never Event” type has the potential to cause serious harm or death to consumers
 
3. The category of “Never Event” has occurred in the past… and risk of recurrence remains
 
4. The occurrence of the “Never Event” is easily detected at the time of manufacture and clearly defined
 
 
How Does That Apply to Food Manufacture?
There are already many controls in food manufacture including pre-requisite programmes and HACCP but the frequency of serious and avoidable product recalls is still high and increasing. So perhaps an additional approach is required using principles learnt from the health care industry. If the wrong label is put on a food product do we believe that blaming the operator responsible will prevent the same issue happening again? Probably not. Using the “Never Event” principle we need to look holistically at the system within which the operator is working and identify gaps in that system that enabled the error to occur. This may involve re-training, but it should also require senior management to look at their responsibilities to see if they have engendered an environment that allows “Never Events”. Much of this will already happen, but there is a need for a new focus to ensure the company culture prevents serious incidents rather than allowing them to occur. For example, is there too much pressure on production targets that passively encourage short cuts. Is there an environment where basic training of operators is seen as optional when budgets are stretched? In short, Senior management must see themselves as responsible for the actions of their employees, even if those employees are many levels of seniority below them. So, the occurrence of a “Never Event” in a food factory is therefore much more than an error at operator level; it is a failure of senior management and ultimately the culture they have developed in their company.
 
 
“Never Events” and Food Safety Culture
Food Safety Culture is the phrase of the moment with organisations such as the Global Food Safety Initiative and BRC. For “Never Events”, food safety culture gets to the heart of the issue. Classifying specific food safety incidents as “Never Events” and senior management providing leadership to identifying and eliminating these events reinforces the Food Safety Culture throughout the organisation.
 
 
12 Steps to Implement “Never Events” Principle
1. Look back at previous incidents in your company and your sector. Agree “Never Events” for your company.
 
2. Include “Never Events” in the senior management meeting agenda.
 
3. Identify gaps in current systems that allow “Never Events” to occur.
 
4. Develop a policy that reinforces senior management commitment to creating a culture where “Never Events” are understood and will always be prevented.
 
5. Allow a culture of unfettered reporting of “Never Events” including whistleblowing.
 
6. Develop a plan that covers identifying, investigating, responding and managing “Never Events”. Include senior management responsibilities and the approach required for investigating and managing an event. This may link into existing policies and plans but should be given extra emphasis.
 
7. Introduce steps to reduce the possibility of “Never Events” to an absolute minimum.
 
8. Ensure training is provided specifically addressing causes and prevention of “Never Events”. (This is not just aimed at operators).
 
9. Include in induction training. Include “Never Event” elimination steps in the internal audit programme to ensure ongoing system compliance.
 
10. Seek external challenge of your “Never Events” to ensure the elimination steps are robust.
 
11. Introduce governance mechanisms with respect to regular reporting on “Never Events” and “near misses”1 at senior management meetings. Include reporting at company level as well as site level.
 
12. Once principle is embedded, review the “Never Event” list annually and consider including other areas of the business, such as health and safety.
 
 
Finally…
Ultimately by applying the “Never Event” principle, changes can be made to reduce the occurrence of product recalls caused by careless and unnecessary errors. After all, “Never Events”, should never happen…