Regulation .08 Hazard Analysis and Risk-Based Preventive Controls.
Regulation .08 Hazard Analysis and Risk-Based Preventive Controls.LinkCopy Citation
The person-in-charge:
A.
Is exempt from this regulation if:
(1)
They meet the definition of a qualified facility in 21 CFR §117.3; or
(2)
They meet the qualifications defined in:
(a)
21 CFR §§117.5—117.8;
(b)
21 CFR §117.201;
(c)
21 CFR §§117.251—117.287; and
(d)
21 CFR §117.315(a)(2);
B.
Shall ensure that a food safety plan:
(1)
Is prepared, implemented, and managed by one or more individuals qualified in preventative controls;
(2)
Is signed and dated by the owner, operator, or agent in charge:
(a)
Upon initial completion;
(b)
When any modification takes place; and
(c)
At least once every 3 years;
(3)
Includes a written hazard analysis that identifies all known and reasonably likely to occur biological, chemical, and physical hazards associated with each type of food manufactured in the plant;
(4)
Includes written procedures for:
(a)
Preventive controls;
(b)
Process controls with parameters and values;
(c)
Allergen controls;
(d)
Sanitation controls;
(e)
Other controls necessary as identified in the hazard analysis;
(f)
Monitoring and record keeping for each preventive control identified in the hazard analysis that include an adequate frequency to control the hazard;
(g)
Corrective actions that:
(i)
Identify and correct the problem;
(ii)
Reduce the likelihood the problem will recur;
(iii)
Evaluate all affected food for safety; and
(iv)
Prevent all affected food from entering commerce;
(h)
Verification activities that ensure that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards;
(i)
Validation for process controls;
(j)
A supply chain program that complies with 21 CFR §§117.405—117.475 if the receiving facility has identified a hazard requiring a supply-chain-applied control; and
(k)
A recall plan for a food with a hazard requiring a preventive control, that includes:
(i)
Maintaining accurate records to identify the initial distribution of the food;
(ii)
Direct notification of the consignees of the food being recalled, including how to return or dispose of the affected food;
(iii)
Public notification about any hazard presented by the food when appropriate to protect public health; and
(iv)
Effectiveness checks to account for all products affected;
(5)
Is implemented to prevent, eliminate, or reduce to an acceptable level, all identified hazards;
(6)
Includes records that document implementation of:
(a)
The food safety plan monitoring;
(b)
Corrective actions; and
(c)
Supply chain, verification, validation, and applicable training for the preventive controls qualified individual and the qualified auditor;
(7)
Includes that records of monitoring and corrective actions are reviewed by a preventive controls qualified individual within 7 working days after the records are created, or within a reasonable time frame; and
(8)
Includes that records of verification activities are reviewed within a reasonable time by a preventive controls qualified individual; and
C.
Shall ensure that a processing plant complies with the 21 CFR §§117.136—117.137 and 117.335 if results of the hazard analysis determine the facility is not required to implement preventive controls for a food item.