Inspection Protocol – Onsite | Inspection Protocol – Virtual | Submittal Policies
Eligibility
Upon applying for the program, you should read the entire Hygienically Clean Food Service Standard. This will clarify the textiles that require testing. To become eligible for Hygienically Clean Food Service certification, you must pass two consecutive sequences of microbiological testing of textiles indicating that your processes are producing Hygienically Clean Food Service linens and garments and negligible presence of harmful bacteria.
Microbiological Sample Testing Process
All testing is done by a Hygienically Clean-approved laboratory accredited by an accreditation body recognized under the ILAC MRA (Mutual Recognition Arrangement) or recognized by federal or state agencies for microbiological testing. Examples of acceptable third-party accreditation bodies include the International Accreditation Service (IAS), American Association of Laboratory Accreditation (A2LA), and ANSI-ASQ National Accreditation Board doing business as ACLASS. Laboratories recognized by federal or state agencies such as EPA, FDA, Department of Agriculture, CDC, CPSC, and OSHA are also approved. All samples must be submitted on the correct Chain of Custody (COC) form provided by the approved laboratory.
Click here to get more information on submitting samples for testing for eligibility.
Use the links below to download forms as required for one of the approved labs:
USP 62 and RODAC Test COC Form
Quality Assurance Manual
Your facility must have a Quality Assurance (QA) Manual to ensure that BMPs are documented and followed as outlined in the Quality Assurance Program of the Standard. The Standard provides you with a guide to documenting the policies and procedures your facility follows to produce Hygienically Clean textiles. Your QA Manual must include the following policies and procedures:
Best Management Practices (BMPs)
- Plant Facilities
- Housekeeping
- Laundry Process
- Hazard Analysis Critical Control Points (as applicable)
- Compliance with OSHA Regulations
Audit Process
Hygienically Clean certification requires your facility to pass an independent, third-party audit that confirms your dedication to compliance and processing using BMPs as outlined in the Hygienically Clean Standard. The focal point of the audit is the evaluation of your Standard Operating Procedures (SOPs) and demonstration of BMPs and HACCP principles as described in your QA Manual that minimize risk. Audits also evaluate practices relevant to handling and processing textile products used in food manufacturing/processing establishments for adherence to U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) directives.
The audit confirms essential evidence that:
- Employees are properly trained and protected
- Managers understand legal requirements
- OSHA-compliant
- Facility operates effectively
Hazard Analysis and Critical Control Points (HACCP) practices are examined, including your facility’s techniques for:
- Conducting hazard analysis
- Determining CCPs, monitoring their control, correcting them if not under control
- Validating and verifying HACCP system effectiveness
- Documenting and record-keeping to show ongoing conformance
The Audit process consists of two parts:
- Initial review of your QA Manual conducted by the Auditor prior to your Audit.
- Comprehensive audit of your facility focusing on the demonstration of your SOPs as outlined in the QA Manual and the Hygienically Clean standard.
Click here to learn more about the Audit Process
