Regulations
Recall Plan
Record Keeping
Verification/Validation
Miscellaneous
100
Which part of the code of regulations is the Preventive Controls rule for Human Food: (a) Part 11 (b) Part 110 (c) Part 112 (d) Part 120 Bonus: Identify all 4 Parts
Answer: (d) Part 117 Part 11 - Electronic Records; Electronic signatures Part 110 - current Good Manufacturing Practices Part 112 - Juice HACCP
100
Gone Crackers cracker company concluded in its hazard analysis that there are no hazards requiring a preventive control. Is Gone Crackers required to have a recall plan?
A written recall plan is only required when a business determines that a hazard requires a preventive control.
100
What are corrective action records?
Records that document the root cause and corrective actions taken in response to a deviation from the Food Safety Plan
100
Summarize the difference between Verification and Validation?
Verification demonstrates that the Food Safety Plan is properly implemented Validation demonstrates that the Food Safety Plan will effectively control the hazards
100
When is environmental monitoring required?
Applies to RTE foods exposed to the environment after processing and before packaging. (applies only to facilities subject to Subpart C)
200
Identify the 7 subparts of the PC rule
Subpart: A - General provisions B - Current Good Manufacturing Practices (cGMPs) C - Hazard Analysis & Risk Based Preventive Controls D - Modified Requirements E - Withdrawal of a Qualified Facility Exemption F - Requirements Applying to Records That Must Be Established and Maintained G - Supply Chain Program
200
In the event of a recall, who might you want to contact outside of your company?
- Regulatory agencies (federal, state) - Customers affected (or who may be affected) by the recall - The public (e.g. via website, AP)
200
The temperature in a refrigerated walk-in registers 40 degrees Fahrenheit. The operating limit of 38 degrees. Is a corrective action required? Hint: The critical limit is 40 degrees.
No corrective action is required. However, a correction would be necessary to restore the temperature to a value within the operating limit.
200
Name 1 example of the following: - process verification - allergen verification - Sanitation verification
Process verification: Checking equipment calibration, Record review Allergen verification: Label review, visual inspection Sanitation verification: Visual inspection, environmental monitoring
200
Name the 5 validation exceptions
(1) Food allergen preventive controls (2) Sanitation preventive controls (3) Supply-chain program (4) Recall plan (5) other preventive controls with written justification
300
A distributor stores unexposed, packaged foods that are shelf stable as well as TCS. For points, you must answer the following 2 questions correctly: (a) With what subparts must the distributor comply? (b) Is this distributor considered a receiving facility?
(a) The distributor is exempt from subparts C & G, but must comply with subparts B (cGMPs) and subpart D (modified requirements) (b) No, the distributor's customers would be the receiving facilities. Receiving facility means a facility that is subject to subparts C and G and manufactures/processes a raw material or other ingredient that it receives from a supplier.
300
Name 5 different ways a company could manage recalled product
- Reconditioning - Reworking - Relabeling - Diverting to a use that does not present safety concern - Destruction
300
True or false: records generated by a third party lab must also meet the requirements for records
True *The record obtained from the laboratory (or any 3rd party, e.g. a consultant) is a true, original copy of the record and must be kept on file
300
What is the minimum frequency at which the food safety plan must be validated through re-analysis?
At least every three years. Reanalysis includes: - Verifying that the Food Safety Plan, including the hazard analysis is still accurate - Reviewing records to identify trends and verify that the Food Safety Plan is being followed
300
Give an example of a calibration vs. accuracy check for a: (a) Thermometer OR (b) pH meter
(a) CALIBRATION: A dial thermometer is checked against an NIST standardized thermometer for two or more temperatures ACCURACY CHECK: Thermomter used to monitor cold temperatures measures the correct temperature of an ice slurry (b) CALIBRATION: Meter is adjusted to read between two pH points or buffer standards ACCURACY CHECK: pH of a single standard near that of the product is measured correctly under plant conditions
400
Name the 4 preventive control management components
(1) Monitoring (2) Corrective Actions & Corrections (3) Verification (4) Reveiw of records
400
For points, you must get both of the following correct. True or false: (a) Reanalysis of the Food Safety Plan is required (b) The recall plan must be tested periodically for effectiveness and documented
(a) True May result in: - Modification of the Food Safety Plan - Retraining - Other actions to prevent recurrence (b) False, validation activities are not required for recall plan. It is recommended that a company verify their information and test the recall team through recall simulations.
400
How long must required records be retained? Bonus: Other than the Food Safety Plan, records may be stored offsite IF accessible within _____.
Required records must be retained at least 2 years. Records that must be retained are: - Food Safety Plan - Records on general adequacy of equipment and processes used - Electronic records considered onsite if they can be accessed onsite Bonus: 24 hours
400
Name 3 conditions when validation of the food safety plan would be appropriate/required?
(1) Before the food safety plan is implemented (ideally) (2) Within the first 90 calendar days of production (3) When a change in control measure(s) could impact efficacy (4) When reanalysis indicates the need (5) Within a reasonable timeframe with written justification by the PCQI
400
For points, you must answer the following 2 questions correctly: (1) Who is required to sign and date the Food Safety Plan (2) When must the Food Safety Plan be signed?
(1) Owner, operator or agent-in-charge (2) Upon initial completion and after modifications are made *Intent is to keep management informed of changes
500
Define the following terms and their compliance dates: (1) Very small business (2) Small business
(1) Very small business - A business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee): Three years, except for records to support its status as a very small business (January 1, 2016). (2) Small business: a business with fewer than 500 full-time equivalent employees: 2 years *All other businesses: 1 year **Publication Date of PC rule for human food: 9/17/2015
500
Arrange the following hazards in order of frequency of occurence: L. monocytogenes Salmonella Undeclared allergens
Biological hazards in foods are reported most frequently Undeclared allergens represent about 1/3 of reports (1) Undeclared allerens (36%) (2) Salmonella (33%) (3) L. monocytogenes (18%) (4) Other (13%) Source: Reportable Food Registry Reports 2008-2013
500
Records must be recorded at the time the activity occurred and identify what?
The facility, date, time (as appropriate) and appropriate signatures. *Document control elements are optional (e.g. version number/date, superceded version number/date). **Records must be verified and be accessible upon request by the regulatory authority.
500
All monitoring and corrective action records must be reviewed within ___ working days from he time they were created Bonus: Who is required to perform or oversee verification of record review?
7 working days Bonus: the PCQI
500
Give 3 examples of significant changes that could warrant a re-analysis (and sometimes additional validation).
(1) Changes in raw materials or suppliers (2) Changes in product or process (3) Adverse review findings (4) Recurring deviations (5) New scientific information on hazards or control measures relevant to the product (6) New distribution or consumer handling activities
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