Hygiene Facilities Question - ISO/TS 22002-1
Our ISO auditor has taken issue with TS-13.2 which states that, "Establishments shall have employee hygiene facilities that do not open directly on to production, packing or storage areas."
Full disclosure: this audit is my first experience with the ISO GFSI standard, and I'd like to understand if this year's auditor is being too harsh with her interpretation or if previous auditors simply overlooked the issue, inattention or otherwise. I did my best to mock up an example of the layout (attached). Understanding that this specific layout wouldn't be ideal for the design of a new plant, I don't get the impression that our restrooms open directly into production areas, and it seems unnecessary to spend the significant amount of capital required to create another vestibule separating plant restrooms from the rest of the plant when EMP trends and internal audits prove that the risk is being managed effectively. Are there other options, or is the requirement as cut-and-dry as the auditor has made it out to be?
Some relevant info:
- Hot-fill-hold renders product sterile
- Product is filled and sterilized in orange rooms which contain zones 1, 2, and 3. There are no physical doors into these rooms; rather, each room has a large opening measuring ~10ft leading to the main corridor.
- A vestibule separates the production and green office area
- Restrooms for plant associates are blue
- Smock hangers are outside the restrooms to prevent cross contamination
- After using the restroom or upon entering the plant through the vestibule, employees are required to use foot baths located along the wall between the vestibule and restrooms
- The red line is approximately 15 feet. If an employee had not used a foot bath after leaving the restroom, this is the shortest distance they could walk (in full view of their co-workers) before entering a production room.
Any insight would be greatly appreciated!
Attached Files
Do Auditors miss things?.., yes. It happens, I was an Auditor, but I missed stuff now and then.
The catch is, it is the facility personnel that should be fully up to speed on the infrastructure requirements. If you or the people responsible for same were up to speed, this may have been eliminated with a documented risk analysis, etc.
As it is, I agree with the Auditor.
I'd be running a risk analysis/assessment that may or may not be accepted, if not - re-construction will be needed.
Our ISO auditor has taken issue with TS-13.2 which states that, "Establishments shall have employee hygiene facilities that do not open directly on to production, packing or storage areas."
Full disclosure: this audit is my first experience with the ISO GFSI standard, and I'd like to understand if this year's auditor is being too harsh with her interpretation or if previous auditors simply overlooked the issue, inattention or otherwise. I did my best to mock up an example of the layout (attached). Understanding that this specific layout wouldn't be ideal for the design of a new plant, I don't get the impression that our restrooms open directly into production areas, and it seems unnecessary to spend the significant amount of capital required to create another vestibule separating plant restrooms from the rest of the plant when EMP trends and internal audits prove that the risk is being managed effectively. Are there other options, or is the requirement as cut-and-dry as the auditor has made it out to be?
Some relevant info:
- Hot-fill-hold renders product sterile
- Product is filled and sterilized in orange rooms which contain zones 1, 2, and 3. There are no physical doors into these rooms; rather, each room has a large opening measuring ~10ft leading to the main corridor.
- A vestibule separates the production and green office area
- Restrooms for plant associates are blue
- Smock hangers are outside the restrooms to prevent cross contamination
- After using the restroom or upon entering the plant through the vestibule, employees are required to use foot baths located along the wall between the vestibule and restrooms
- The red line is approximately 15 feet. If an employee had not used a foot bath after leaving the restroom, this is the shortest distance they could walk (in full view of their co-workers) before entering a production room.
Any insight would be greatly appreciated!
Hi Bartholamew,
Attachment is undetailed but yr toilets appear to open directly into the entire operational area ?.
If so, IMEX, this would be auditorially unacceptable.
Charles,
The layout doesn't quite do the situation justice, but you're correct in the sense that employees only go through one door when transitioning from the restroom to the plant floor. In my experience with SQF, this requirement was applicable to processing areas, an apparently important distinction. Many of the facilities I've worked in or audited would be non-compliant with the strictest definition of "opening directly on to production, packing, or storage areas". I've found that plants generally consider production to be any area that isn't administrative.
For this ISO requirement specifically, is construction of a vestibule my only option to achieve compliance? Would a railing that forced employees to transition past the foot baths be sufficient if I could prove negative pressure in the restrooms?
Charles,
The layout doesn't quite do the situation justice, but you're correct in the sense that employees only go through one door when transitioning from the restroom to the plant floor. In my experience with SQF, this requirement was applicable to processing areas, an apparently important distinction. Many of the facilities I've worked in or audited would be non-compliant with the strictest definition of "opening directly on to production, packing, or storage areas". I've found that plants generally consider production to be any area that isn't administrative.
For this ISO requirement specifically, is construction of a vestibule my only option to achieve compliance? Would a railing that forced employees to transition past the foot baths be sufficient if I could prove negative pressure in the restrooms?
Hi Bartholamew,
Sorry but I am not familiar with the application of the terminology "vestibule" in a manufacturing context.
Yr Product/Process/employee flowcharts not known but I attach an, IMO, more acceptable alternative for a Low Risk scenario.
layout2a.PNG 80.4KB 4 downloads
We were required to build air-locks for our restroom facilities to eliminate this and we are a packaging manufacturer. I would be surprised if you did not also have to unless you build a wall with access to production areas through a door / passage way. Bathrooms opening into the vestibule and the access to production from the vestibule controlled should suffice.