I am really impressed with all of the discussion in this forum. It's been very informative.
There is indeed much ambiguity regarding FSMA, so it's good to know that I am not alone! I am hoping that I can start a discussion regarding the state of equipment sanitation/design within the FSMA framework. Also, I am providing information that I have come across.
The previous IFSQN posting titled "FSMA Overview" was particularly useful to me as it lead me the following article (complements to Charles.C):
The article makes the following statement:
"Packaging machinery in the United States is covered by the American National Standards Institute (ANSI)/Packaging Machinery Manufacturers Institute (PMMI) B155.1-2011 standard, “Safety Requirements for Packaging Machinery and Packaging-Related Converting Machinery.” This is a voluntary consensus standard that requires the machinery supplier to build the machine to an acceptable level of risk using the risk assessment process. Sanitary design is a consideration in the standard. The ANSI/PMMI B155.1-2011 standard is harmonized with EN/ISO 12100-2010."
The ANSI/PMMI B155.1-2011 manual that I have looked at makes references to ISO 14159, ISO 21469, EN 1672 part 2, and the American Meat Institute (AMI) principles of sanitary design.
- I was not able to find a full text of the ISO 14159 standard for North America; however, here is the ISO 14159 from Saudi Arabia--the literature mentions that the original ISO 14159 document has been adopted by Saudi standards without any technical changes, so i hope it is relevant for most of us here.
- The AMI principles are quite readily available online.
- As for the other references, I could not find anything extensive.
Although the article states that the standards are voluntary, certifications that are deemed mandatory in order to conduct business (i.e. 3A, SQF, BRC, etc.) have strict sanitary requirements to prevent the buildup of potential contamination that in turn impact the design of equipment. My understanding is that the certain certifications, such as SQF, do not go as in depth as the ISO 14159 standard. For instance, the SQF code does not go into details such as weld types and other design requirements, from what I can gather.
My question or curiosity is if the FSMA will go into such depth as the ISO 14159 standards, or will it continue to be "voluntary consensus" as stated in the article?
Please correct me if I am wrong as I am not familiar with ALL regulations/standards.
I look forward to everyone's thoughts and expertise on this topic!