PCQI & Food Safety Plan Support for Japanese Factories
We help Japanese food factories producing for the U.S. prepare for FSMA's preventive controls requirements — in Japanese and English.
What FDA requires
Applies to registered facilities, including foreign ones
Domestic and foreign food facilities that are required to register with FDA must meet the Preventive Controls for Human Food requirements (21 CFR Part 117), unless an exemption applies.
A written food safety plan
The plan includes a hazard analysis, preventive controls, a supply-chain program, a recall plan, and procedures for monitoring, corrective actions and verification.
Prepared or overseen by a PCQI
The food safety plan must be prepared, or its preparation overseen, by a Preventive Controls Qualified Individual (PCQI). The PCQI also does or oversees validation, record review and reanalysis.
How someone becomes a PCQI
Through training at least equivalent to the standardized curriculum recognized by FDA (currently the FSPCA course), or through job experience. The PCQI may be, but does not have to be, an employee of the facility.
The plan must be reanalyzed at least every 3 years, and also when, for example, significant changes create a potential new hazard.
How we support you
- On-site visits to factories anywhere in Japan (process walk-through and interviews; travel and accommodation are billed at actual cost)
- Hearing and gap check against your existing HACCP / ISO 22000 / FSSC 22000 documents
- Documentation support for the food safety plan (hazard analysis, preventive controls, procedures) in Japanese and English
- Guidance on PCQI training (FSPCA courses) and on setting up your internal PCQI arrangements
- Support when U.S. importers or customers ask for your food safety plan or related records
- Support for periodic reanalysis and updates of the plan
About the PCQI's role
The food safety plan must be prepared or overseen by a PCQI. Our service is administrative and documentation support. Please talk to us about the PCQI arrangement that fits your factory (your own PCQI or an external PCQI).
Depending on the facility's size and activities, exemptions or modified requirements may apply. Ask us, or check FDA's information, to see whether your facility is covered.
How it works
- 01
Consultation & site visit
Online or at your factory (anywhere in Japan): tell us about your products, processes and existing food safety documents.
- 02
Gap check & quote
We identify what is needed and send a quote for the scope.
- 03
Documentation
We help prepare and translate the food safety plan and procedures with your team and your PCQI.
- 04
Operation & review
We support records, reanalysis and updates over time.
This is an administrative support service. It is not legal advice and does not constitute FDA approval, certification or endorsement.
Sources (FDA / Code of Federal Regulations)
- FDA – FSMA Final Rule for Preventive Controls for Human Food (opens in a new tab)
- 21 CFR 117.126 – Food safety plan (opens in a new tab)
- 21 CFR 117.180 – Preventive controls qualified individual (opens in a new tab)
- 21 CFR 117.170 – Reanalysis (opens in a new tab)
- FDA – Food Safety Preventive Controls Alliance (FSPCA) (opens in a new tab)
Ask about PCQI support
We help Japanese food factories producing for the U.S. prepare for FSMA's preventive controls requirements — in Japanese and English.