Equipment verification and validation

During our audit for ISO 22k, auditor has asked me a few question which were surprising.


DO you have validated your equipment for hygiene design?
How do you assure that material of construction is appropriate to your product?
What are your standards for equipment design and lay out for food handling parts?


Auditor was of the view that while we should have included technical standards for engineering in our food safety system and their should be some validation/proof of meeting those standards. He said (actually was right) that this will help during installation of new line.

As I am agree with his point, I want to know:

What is your opinion?
From where can I get these standards for hygiene design/material of construction/compatibility?

Regards,RIzwan

Dear Rizwan Ali,

It may well depend on yr kind of business/process/equipment

Some (USA) guidelines for the meat industry, various of which also have general application are here -

http://www.foodsafet...d=3324&sub=sub1

The AMI checklist referred is probably -

Sanitary Design Fact Sheet.pdf   54.77KB   366 downloads

Equipment construction requirements are also discussed in great detail in most textbooks on food processing sanitation, eg by Marriott, Lelieveld respectively.

Rgds / Charles.C

Hi Ali,

See attachment which is of some standards.

During our audit for ISO 22k, auditor has asked me a few question which were surprising.


DO you have validated your equipment for hygiene design?
How do you assure that material of construction is appropriate to your product?
What are your standards for equipment design and lay out for food handling parts?


Auditor was of the view that while we should have included technical standards for engineering in our food safety system and their should be some validation/proof of meeting those standards. He said (actually was right) that this will help during installation of new line.

As I am agree with his point, I want to know:

What is your opinion?
From where can I get these standards for hygiene design/material of construction/compatibility?

Regards,RIzwan

Here are a few more articles, as well as AMI's sanitary facilty construction principles. There is obviously some duplication...

AMI (11) Sanitary Design Principles for Facilities.pdf   131.29KB   182 downloadsDesigned for Sanitation.pdf   130.1KB   174 downloadsGMA Sanitation Checklist Spreadsheet.xls   67KB   251 downloadsGMA Equip Design Checklist.pdf   259.05KB   275 downloadsSanitary Design - A Competitive Advantage.pdf   152.06KB   163 downloads

Dear Rizwan Ali,

For equipment from a European perspective -

The European Hygienic Engineering & Design Group (EHEDG) is a consortium of equipment manufacturers, food industries, research institutes as well as public health authorities and was founded in 1989 with the aim to promote hygiene during the processing and packing of food products.
The principal goal of EHEDG is the promotion of safe food by improving hygienic engineering and design in all aspects of food manufacture.
EHEDG actively supports European legislation, which requires that handling, preparation processing and packaging of food is done hygienically using hygienic machinery and in hygienic premises (EC Directive 2006/42/EC for Machinery, EN 1672-2 and EN ISO 14159 Hygiene requirement).

+ a 4 min.video

http://www.ehedg.org/

An earlier sampler (ca 2004) of above activities here -
EHEDG - Hygienic Equipment design criteria.pdf   134.12KB   212 downloads

Rgds / Charles.C