To root cause? or not to root cause?
Hello all! I am working on Corrective and presentative actions (2.5.3). It states:
"Records of all investigation, root cause analysis, and resolution of non-conformities, their corrections, and the implementation of preventative actions shall be maintained."
My question is "Are root cause analysis required for all investigations?" I understand that it is a great tool to use when you don't know what caused the NC however most of the time, we already know the cause. Therefore, this can be easily stated in the investigation notes. I may be overthinking this, your help is appreciated.
Hi Sjoy,
I would list the cause(s) in root cause analysis, and only findings in investigation notes. I know it can be obvious most of the time, but that's the way to do it.
Do you have a specific NC?
Good luck!
Hi Sjoy,
I would list the cause(s) in root cause analysis, and only findings in investigation notes. I know it can be obvious most of the time, but that's the way to do it.
Do you have a specific NC?
Good luck!
Nothing note worthy. We have a few but nothing major. I will use it for the next one that a rises. THANK YOU!
Plants I've worked with typically only run a full root cause analysis/investigation for issues that directly affected food safety, with smaller corrective actions recorded for minor findings. But when we trend our minor findings and discover a recurring theme, we will escalate it to a full root cause analysis.
Catching someone with ear buds in a production area is the first example that comes to mind. That's a deviation from GMP, we document and warn or otherwise discipline the employee. But if we notice a huge uptick in repeated GMP related issues, it suggests QA needs to investigate and find a new or better way to communicate the policies to employees.
We do a 5-whys (or as many why's as needed) for most findings, even if the root cause is obvious. It's a super quick and easy way to find the root cause.
So like some examples:
Date was wrong on label...why?
Operator did not change date on equipment before starting...why?
Operator was not trained on when to change the date...why?
Management did not ensure that operator was trained before tasking them.
Gloves stored incorrectly...why?
Operator didn't have a designated spot to store them...why?
On-floor storage areas were not created for the operators...why?
It was assumed that the farther away provided storage would be adequate for the employees...why?
Management did not realize that employees would need closer and more accessible storage.
Haha, our consultant advised the same thing - 5 why's.
I personally am not a big fan of all these why's. They don't always lead to anywhere or you can keep adding why's without going anywhere. Or you can simply state in one single why.
Does anyone else feel this way?
Haha, our consultant advised the same thing - 5 why's.
I personally am not a big fan of all these why's. They don't always lead to anywhere or you can keep adding why's without going anywhere. Or you can simply state in one single why.
Does anyone else feel this way?
We do sometimes only have one why - but it's always recommended to dig a little deeper of course haha
Haha, our consultant advised the same thing - 5 why's.
I personally am not a big fan of all these why's. They don't always lead to anywhere or you can keep adding why's without going anywhere. Or you can simply state in one single why.
Does anyone else feel this way?
Not all pegs fit in the round hole. The same can be said for most of these schemes, 5 whys, fishbone, cause maps, etc.
I feel like sometimes answering "why" to get to the next "why" just forces you to make claims that may be not true.
I understand that it is necessary in investigation, but I believe sometimes things just happened/are the way they happened/are.
For example, a food-contact-surface brush found on non-food contact surface. How would one get 5 why's? Someone just put it there, not necessarily due to lack of training or anything.
I feel like sometimes answering "why" to get to the next "why" just forces you to make claims that may be not true.
I understand that it is necessary in investigation, but I believe sometimes things just happened/are the way they happened/are.
For example, a food-contact-surface brush found on non-food contact surface. How would one get 5 why's? Someone just put it there, not necessarily due to lack of training or anything.
To this point is why I differentiate between a correction and corrective/preventive action. Once requires a root cause and is generally an audit finding or severe deviation from the food safety management system. If I find someone who has a hair restraint violation you correct on the spot, document the time and date for trending, and call it a day. Root cause for hair restraint would just end up with lack or ineffective training, which was accomplished when this issue was found.
Hydraulic fluid leaking all over a press belt, different story.
My only caveat is if trending through standard corrections shows a sign of needing to be elevated to a full CAPA, however this would have to be excessive and I just don't allow things like that in my plants.
Hi Sjoynesfoodsafety,
For me the need for root cause would depend on the NC, for example critical and major NC’s normally require full investigation, root cause analysis, appropriate corrective action and possibly preventive action. Minor NCs may only require correction.
I do use the 5 whys technique but I wouldn’t get hung up on getting to 5 as my view is if you feel like you have resolved a NC and taken the corrective action then that is fine. If for some reason the corrective actions taken haven't completely resolved the issue, then this should be picked up on future internal audits (these should include checking previous NC's) and management/KPI review.
Some guidance from SQF in addition to the SQF code requirements:
SQF Corrective & Preventative Action Edition 9 Guidance Document
There are typically three types of actions that should be considered in your problem-solving process:
1. Corrections are considered short term fixes, i.e., a quick action taken to remediate a specific problem or adjustments made to regain immediate control.
2. Corrective actions are long term fixes designed to eliminate the root cause of the problem and to minimize the risk that the situation will occur again.
3. Preventative actions are designed to prevent the same deviation or event from occurring on similar product(s) or process(es).
SQF Root Cause Analysis Edition 9 Guidance Document
When non-compliance with critical food safety limits or a deviation from food safety requirements happen, there may be a tendency to assume the cause. Root cause analysis seeks to move past assumptions to uncover the true cause. This is often accomplished using an investigative tool. Uncovering the root cause allows the site to identify where the process failed so that a corrective action and potentially a preventative action to be implemented. This ultimately improves the sites’ management of food safety and quality.
The process of conducting a root cause analysis typically involves six steps, a pre-step and post process follow up. The steps are:
Pre-step – identify the investigation team.
1. Describe the problem, non-conformance, or deviation event in detail.
2. Gather data associated with the problem, non-conformance, or deviation event.
3. Determine the causes and identify the root cause. In this step an analysis tool such as a fishbone diagram, flowchart, 5 Whys, TRIZ, Is/Is Not can be used.
4. Identify corrections, corrective actions and explore preventative actions.
5. Define and implement the identified solution.
6. Verify the effectiveness of the solution.
Post process – Collect and maintain records associated with the development and use of the process, including reasons for the investigative tool used, any corrections made, corrective actions implemented, and the verification records.
Kind regards,
Tony
THANK you all for your insight! This was super helpful! :spoton: