Subparts
Which Subpart(s) cover Preventive Controls?
What are Subparts C and G?
If a facility concludes that there are no hazards requiring a preventive control, must it document that conclusion?
Yes, the hazard analysis must be written, regardless of the conclusion
In general, records required by Part 117 must be retained for at least how long?
What is 2 years?
During an inspection, you notice some product residue on a process line that the firm also notices. The firm immediately cleans the line prior to start of production. Would this be a correction or a corrective action?
Correction – no product was affected (cleaned before production began)
In lieu of having a food safety plan, qualified facilities must do what?
What is submit an attestation stating it is a qualified facility, and an attestation that the facility is controlling the hazards or that it is in compliance with State, local, county, tribal, or other applicable non-Federal food safety laws
Name the preventive controls specified in the rule (not including “other”)
What are Process, Allergen, Sanitation, Supply-chain, Recall Plan?
Which type of preventive control requires validation?
What are process controls?
Process preventive controls are subject to which preventive control management components?
What are monitoring, corrective actions, verification?
As part of the FDA culture change, investigators and regulators are being taught to practice this type of thinking when assessing a facility against Part 117
What is systems thinking?
If a facility identifies a hazard requiring a preventive control but does not implement a preventive control because it is relying on a downstream customer to control the hazard, what must the facility do?
Disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]”
Subpart E describes administrative procedures pertaining to this
What is the withdrawal of the qualified facility exemption?
When is a facility required to have a recall plan?
When the facility identifies a hazard requiring a preventive control
Which records must be reviewed within 7 working days?
What are records of monitoring and corrective actions?
Name two reasons why a facility might request copies of the facility’s records?
What are: 1) to support documented deficiencies; 2) to provide information for agency review
A fresh-cut salad manufacturer receives lettuce from a broker who sources lettuce from a farm. For the purposes of the supply-chain program, who is the supplier of the lettuce?
Who is the farm that grows the lettuce?
A farm mixed-type facility solely engaged in making baked goods from milled grain products and is not a small or very small business must comply with which subparts of 21 CFR Part 117?
What are subparts A, B, C, F, and G?
This individual must sign the Food Safety Plan
Who is the owner, operator, or agent in charge of a facility?
The supply-chain program is subject to which preventive control management components?
What are corrective actions and corrections, review of records, and reanalysis?
If a facility does not identify a hazard requiring a preventive control when there is a hazard requiring a preventive control, and the facility is not implementing any controls, what should the investigator do?
What is cite the firm for not identifying the hazard requiring a preventive control and support the cite with the investigator’s observations of the lack of controls
What is the expected supplier verification activity when the hazard requiring a preventive control is one that has the potential to cause serious adverse health consequences or death to humans?
What is an annual onsite audit?
A facility making juice products subject to and in compliance with the Juice HACCP regulation is exempt from which parts of Part 117?
What are Subparts C and G?
Name three components of the food safety plan
What are: 1) Written hazard analysis; 2) Written preventive controls; 3) written supply-chain; 4) written recall plan; 5) written procedures for monitoring, corrective actions, and verification
Name 3 types of implementation records required by Part 117
What are: 1) Monitoring records; 2) corrective action records; 3) verification records; 4) supply-chain records; 5) PCQI and training records
If an investigator is unable to observe monitoring procedures during an inspection, what should he or she do?
What is ask the firm to describe its procedures?
Which chapter of the Hazards and Controls guidance contains information on potential biological, chemical, and physical hazards?
What is Chapter 3?