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March 25, 2005
2005 PMO Appendix K. HACCP Program
PMO references not in Appendix K can be found in the
References for NCIMS HACCP Audit Form per 2005 NCIMS Documents
I. The HACCP System Introduction
History of HACCP: The use of the
HACCP System is not new to the dairy industry. HACCP is a logical,
simple, effective, but highly structured system
of food safety control.
The HACCP System was introduced to the food industry as a spin-off of
the space program during the 1960"s. The National Aeronautics and
Space Administration (NASA) used HACCP to provide assurance of
the highest quality available for components of space vehicles.
This program, to develop assurance of product reliability, was
carried over into the development of foods for astronauts.
The U.S. Army Natick Laboratories, in conjunction with NASA, began to develop the foods needed for
manned space exploration. They contracted with the Pillsbury Company to design
and produce the first foods used in space. While Pillsbury struggled with
certain problems, such as how to keep food from crumbling in zero gravity, they
also undertook the task to come as close as possible to 100% assurance that the foods
they produced would be free of bacterial or viral pathogens.
Using traditional quality control
methods for the food industry was soon proven to be unworkable for the task
Pillsbury had undertaken. The degree of safety desired was not provided by the
current programs, and the product sampling necessary to provide an adequate
degree of safety would have been prohibitive to commercialization of space
foods. Pillsbury discarded its standard quality control methods and began an
extensive evaluation, in conjunction with NASA and Natick Labs, to evaluate
food safety. They soon realized that to be successful they would have
to have control over their process, raw materials, environment, and their
people. In 1971, they introduced HACCP as a preventive system that enables
manufacturers to produce foods with a high degree of assurance that the foods
were produced safely.
Background: HACCP is a management tool
that provides a structured and scientific approach to the control of identified
hazards. HACCP is a logical basis for better decision-making with respect to
product safety. HACCP has international recognition as an effective means of
controlling food safety hazards and is endorsed as such by the joint Food and
Agriculture Organization of the World Health Organization (FAO)/World Health
Organization (WHO) Codex Alimentarius Commission. The U.S. National Advisory
Committee on Microbiological Criteria for Foods (NACMCF) has also endorsed it.
The HACCP concept will
enable those operating under and regulating under a HACCP Plan to move to a
preventive approach, whereby potential hazards are identified and controlled in
the manufacturing environment, i.e., prevention of product failure. HACCP
allows for a preventive, systematic approach to food safety.
Voluntary Participation: This Appendix describes a
voluntary, NCIMS HACCP Program alternative to the traditional inspection
system. No milk plant,
receiving station or transfer station may participate in the voluntary NCIMS
HACCP Program unless the Regulatory Agency responsible for the oversight of the
facility agrees to participate with the dairy plant(s), receiving station(s)
and transfer station(s) in the NCIMS HACCP Program. Both parties must provide
written commitment to each other that the necessary resources to support
participation in the NCIMS HACCP Program will be made available. Management
responsible for both the State and dairy plant, receiving
station or transfer station must be willing to provide the resources needed to
develop and implement a successful HACCP System.
HACCP Principles: Following are the seven (7) HACCP principles to be included in a HACCP Plan:
- Conduct a hazard analysis;
- Determine the critical
control points;
- Establish critical limits;
- Establish monitoring
procedures;
- Establish corrective actions;
- Establish verification
procedures; and
- Establish record-keeping and
documentation procedures.
Prerequisite Programs (PPs): Prior to the implementation of a HACCP Plan, there is a
requirement for dairy plants, receiving stations and transfer stations to
develop, document and implement written PPs. PPs provide the basic environment
and operating conditions that are necessary for the production of safe,
wholesome food. Many of the conditions and practices are specified in Federal
and State regulations and guidelines.
PPs, and the HACCP System in
total, address public health concerns such as those identified in 21 CFR Part
7, Recalls; Part 110, Good Manufacturing Practices (GMPs); Part 113, Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Part 131,
Milk and Cream; the Grade "A" PMO; and the current edition of the NACMCF
HACCP Principles and Application Guidelines.
Summary: The seven (7) principles of
HACCP are also called the HACCP Plan. When combined with the PPs, they
constitute a HACCP System. The NCIMS HACCP Program described in this Appendix
includes the HACCP System and other prescribed Grade "A" PMO criteria,
such as drug residue testing and traceback; use of milk only from supplies that
have been awarded a milk sanitation compliance rating of 90% or better or from
an acceptable IMS HACCP listed source; and the labeling requirements of Section
4. When properly implemented, the HACCP program described in this Appendix will
provide assurance of milk and milk product safety that is equivalent to that
provided under the traditional inspection system.
II. Implementation of a HACCP System
Note: The superscripted section numbers appearing below are linked to PMO text that applies to Sections of the Milk Plant, Receiving Station, or Transfer Station NCIMS HACCP System Audit Report,
Form FDA 2359m
(also available in
PDF [*]
and
compressed Word [*]).
(1A)Preliminary Steps: Preliminary steps as listed in the NACMCF
document should be followed when producing a HACCP Plan. Complete, up-to-date
process flow diagrams are required for all milk and milk products manufactured.
Flow diagrams may be combined when processes, products and hazards are similar.
(1A)
Prerequisite Program: HACCP is not a stand-alone program,
but is part of a larger control system. PPs are the universal procedures used
to control the conditions of the milk plant environment that contribute to the
overall safety of the milk or milk product. They represent the sum of
programs, practices and procedures that must be applied to produce and
distribute safe milk and milk products in a clean, sanitary environment. They
differ from CCPs in that they are basic sanitation programs that
reduce the potential occurrence of a milk or milk product safety hazard.
Frequently, both HACCP Plan CCPs and PPs control measures are necessary to control
a food safety hazard.
(10I)HACCP may be
implemented only in a facility that is constructed and operated to provide a
sanitary environment. Milk plant, receiving station or transfer station
premises, building construction, maintenance, and housekeeping shall be
maintained in a manner sufficient to provide such an environment. These factors
shall be controlled by effective milk plant, receiving station or transfer
station programs or by PPs, as the milk plant, receiving station or transfer
station chooses.(10I)
(9F)The exact set of PPs will vary since their
application is milk or milk product and process specific. The existence and
effectiveness of PPs should be assessed during the design and implementation of
each HACCP Plan. PPs should be documented and regularly audited. An audit
review consists of verifying that the company has a program implemented that
indicates how the company monitors and controls each of the PPs.(9F) PPs
are established and managed separately from the HACCP Plan.
- (9A)Required PPs: The following required PPs shall have
a brief written description or checklist that the PPs can be audited against to ensure compliance.
PPs shall include procedures that can be monitored; records that
specify what is monitored; and how often it will be monitored.
Each milk plant, receiving station or transfer station shall have and implement PPs that
address conditions and practices before, during, and after processing. The PPs
shall address:(9A)
- (9A1)Safety of the water that
comes into contact with milk or milk products or product-contact surfaces,
including steam and ice; (9A1)
- (9A2)Condition and
cleanliness of equipment product-contact surface; (9A2)
- (9A3) Prevention of
cross-contamination from insanitary objects and or practices to milk or milk
products or product-contact surfaces, packaging material and other food-contact
surfaces, including utensils, gloves, outer garments, etc., and from raw
product to processed product; (9A3)
- (9A4)Maintenance of handwashing,
hand sanitizing, and toilet facilities;
(9A4)
- (9A5)Protection of milk or
milk product, packaging material, and product-contact surfaces from
adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing
agents, condensate and other chemical, physical and biological contaminants;
(9A5)
- (9A6)Proper labeling, storage,
and use of toxic compounds; (9A6)
- (9A7)Control of employee
health conditions, including employee exposure to high risk situations, that
could result in the microbiological contamination of milk or milk products,
packaging materials, and product-contact surfaces;
(9A7) and
- (9A8)Pest exclusion from
the milk plant.(9A8)
(9B)In addition to the
required PPs specified above, any other PPs that are being relied upon in the
Hazard Analysis to reduce the likelihood of hazards such that they are not
reasonably likely to occur, shall also be monitored, audited, and documented as
required PPs.(9B)
- (9C,
9D, 9E)
Monitoring and Correction: The milk plant, receiving station or transfer
station shall monitor the conditions and practices of all required PPs with
sufficient frequency to ensure conformance with those conditions and that are
appropriate both to the milk plant, receiving
station or transfer station and to the safety of the milk or milk product being
processed. Each milk
plant, receiving station or transfer station shall document the correction of
those conditions and practices that are not in conformance. Devices, such as
indicating and recording thermometers that are used to monitor PPs shall be
calibrated to assure accuracy at a frequency determined by the milk plant,
receiving station, or transfer station.
- Required Records: Each
milk plant, receiving station or transfer station shall maintain records that
document the monitoring and corrections required by this Appendix. These
records are subject to the record keeping requirements of this Appendix.
(9C, 9E)
(1A)Hazard Analysis: Each
milk plant, receiving station or transfer
station shall develop, or have developed for it, a written hazard analysis to determine whether there are milk or milk product hazards that are reasonably
likely to occur for each type of milk or milk product processed or
handled by the milk plant, receiving station or transfer station and to
identify the control measures that the milk plant, receiving station or
transfer station can apply to control those hazards.(1A)
(1B)The hazard analysis shall include hazards that can be
introduced both within and outside the milk plant, receiving station or transfer station
environment, including hazards that can occur during handling, transportation,
processing and distribution.
A hazard that is reasonably
likely to occur is one for which a prudent milk plant, receiving station or
transfer station operator would establish controls because experience, illness
data, scientific reports, or other information provide a basis to conclude that
there is a reasonable possibility that, in the absence of these controls, the
hazard will occur in the particular type of milk or milk product being
processed. The hazard analysis shall be developed by an individual(s) trained
in accordance with this Appendix and shall be subject to the record keeping
requirements as described in this Appendix.
- In evaluating what milk or
milk product hazards are reasonably likely to occur, at a minimum,
consideration should be given to the following:
- Microbiological contamination;
- Parasites;
- Chemical contamination;
- Unlawful drug and pesticide residues;
- Natural toxins;
- Unapproved use of food or color additives;
- Presence of undeclared ingredients that may be allergens; and
- Physical hazards.
- Milk plant, receiving
station or transfer station operators should evaluate product ingredients,
processing procedures, packaging, storage, and intended use; facility and
equipment function and design; and milk plant sanitation, including employee hygiene, to
determine the potential effect of each on the safety of the finished milk or
milk product for the intended consumer.(1B)
HACCP Plan:
- (2A, 2B)
HACCP Plan: Every milk plant,
receiving station or transfer station shall have and implement a written HACCP
Plan whenever a hazard analysis reveals one (1) or more hazards that are
reasonably likely to occur.(2B) The HACCP Plan shall be developed by an
individual(s) who has been trained and
shall be subject to record keeping requirements in accordance with this
Appendix. A HACCP Plan shall be
specific to each location and milk or milk product. The plan may group similar
types of milk and milk products together, or similar types of production
methods together, if the hazards, CCPs, CLs, and procedures required to be
identified and performed by 2. of this Section are essentially identical,
provided that any required features of the plan that are unique to a specific
milk or milk product or method are clearly delineated in the plan and are
observed in practice.(2A)
- (1A)Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
- Include complete up-to-date process flow diagrams for all milk and milk products
manufactured. Flow diagrams may be combined when processes, milk and milk products and hazards are similar.
(1A)
- (2C)List all hazards that are
reasonably likely to occur as identified in the hazard analysis specified above,
and that must be controlled for each type of milk or milk product.(2C)
- (3A,
3B, 3C)
List the CCPs for each of the identified hazards, including the appropriate:
- (1) CCPs designed to control hazards that could occur or could be introduced in the milk plant,
receiving station or transfer station environment;
- (2) CCPs designed to control hazards introduced outside the milk plant, receiving
station or transfer station environment, including hazards that occur before arriving at the milk plant,
receiving station and/or transfer station;(
3A, 3B, 3C) and
- (4A, 4D)
(3) List the CLs that shall be
met at each of the CCPs.(4A,
4D)
- (4C, 5A)
List the procedures and the frequency with which they are to
be performed that will be used to monitor each of the CCPs to ensure
compliance with the CLs;(
4C, 5A)
- (6A)Include any corrective action
plans that have been developed in accordance with the corrective action
requirements as described in this Appendix, and that are to be followed in
response to deviations from CLs at CCPs;(6A)
- (7A)List the verification and
validation procedures, and the frequency with which they are to be performed,
that the milk plant, receiving station or transfer station will use in
accordance with verification and validation requirements as described in this
Appendix;(7A) and
- (
5D, 5B)Provide a record keeping system that documents
the monitoring of the CCPs in accordance with the record requirements as described
in this Appendix. The records shall contain the actual values and
observations obtained during monitoring.(
5D, 5B)
- (2C)Sanitation: Sanitation controls may be
included in the HACCP Plan. However, to the extent that they are monitored in
accordance with the PPs, they need not be included in the
HACCP Plan.(2C)
(6A-6G)Corrective Actions: Whenever a deviation from a CL
occurs, a milk plant, receiving station or transfer station shall take
corrective action by following the procedures set forth in 1. or 2. of this Section.
- Milk plants, receiving
stations or transfer stations may develop written corrective action plans,
which become a part of their HACCP Plan(s), in accordance with this Appendix.
These corrective action plans may predetermine the corrective actions that milk
plants, receiving stations and transfer stations will take whenever there is a
deviation from a CL. A corrective action plan that is appropriate for a
particular deviation is one (1) that describes the steps to be taken and
assigns responsibility for taking those steps, to ensure that:
- No milk or milk product is allowed to enter commerce that is either injurious to health or
is otherwise adulterated as a result of the deviation; or
- If such milk or milk product has entered commerce, it is expeditiously removed; and
- The cause of the deviation is corrected.
- When a deviation from a CL occurs, and the milk plant, receiving station or transfer station does not have
a corrective action plan that is appropriate for that deviation, the milk
plant, receiving station or transfer station shall:
- Segregate and hold the affected milk or milk product, at least until the requirements of
paragraphs 2.b and 2.c of this Section are met;
- Perform or obtain a review to determine the acceptability of the affected milk or milk product
for distribution. The review shall be performed by an individual or individuals qualified by
training or experience to perform such a review;
- Take corrective action, when necessary, with respect to the affected milk or milk
product to ensure that no milk or milk product is allowed to enter commerce
that is either injurious to health or is otherwise adulterated as a result of
the deviation;
- Take corrective action, when necessary, to correct the cause of the deviation; and
- Perform or obtain timely validation by a qualified individual(s), as required in
this Appendix, to determine whether modification of the HACCP Plan is required
to reduce the risk of recurrence of the deviation, and modify the HACCP Plan as
necessary.
- All corrective actions taken
in accordance with this Section shall be fully documented in records that are
subject to verification.(6A-6G)
Verification and Validation:
- (7B)Verification: Every milk plant, receiving
station or transfer station shall verify that the HACCP System is being
implemented according to design, except that critical factors for aseptically
processed Grade "A" milk and milk products, as determined by the process
authority and listed on the scheduled process under 21 CFR 113 shall be managed
separately from the NCIMS HACCP System, even if identified as a CCP in the
hazard analysis. Critical factors shall be monitored under the operating
supervision of an individual who has successfully completed an approved course
of instruction in low-acid canned foods as required under 21 CFR 108.35.
Compliance with the provisions of 21 CFR 113 shall satisfy the requirements of
this Section, regardless of whether a critical factor has also been designated
as a CCP.
- Verification activities shall include:
- (1) The calibration of CCP process-monitoring instruments, i.e., pasteurization
tests, etc.;
- (2) At the option of the milk plant, receiving station or transfer station, the
performance of periodic end-product or in-process testing;
- (7H, 11C)(3)A review, including signing and dating, by an individual who has
been trained in accordance with the training requirements of this Appendix, of the records
that document:(7H, 11C)
- (7E)The Monitoring of CCPs: The
purpose of this review shall be, at a minimum,
to ensure that the records are complete and to verify that
the recorded document values are within the CLs.
This review shall occur at a frequency that is appropriate to the importance of
the record and as specified in the HACCP Plan;(7E)
- (7F)The Taking of Corrective
Action: The purpose of this review shall be, at a minimum, to ensure that the
records are complete and to verify that appropriate corrective action(s) was
taken in accordance with the corrective action requirements cited
before. This review shall occur at a frequency that is appropriate to the
importance of the record. A centralized deviation log is required;(7F) and
- (7G)The calibrating of any process monitoring instruments used at CCPs
and the performance of any periodic
end-product or in-process testing that is part of the milk plant,
receiving station or transfer station's verification activities.
(7G)
The purpose of these reviews shall be, at a minimum, to ensure that the records are complete
and that these activities occurred in accordance with the milk plant's,
receiving station's or transfer station's written procedures. These reviews
shall occur within a reasonable time after the records are made.
- (4) The taking of corrective action procedures whenever any verification procedure establishes
the need to take a corrective action.(7B)
- (7D)The calibration of CCP process-monitoring
instruments, and the performance of any periodic end-product and in-process
testing, in accordance with 1.a.(3)ii) and 1.a.(3)iii) of this Section, shall
be documented in records that are subject to the record keeping requirements in
this Appendix.(7D)
- (7C) Validation of the HACCP Plan: Every milk
plant, receiving station or transfer station shall validate that the HACCP Plan
is adequate to control hazards that are reasonably likely to occur. This
validation shall occur at least once within twelve (12) months after
implementation and at least annually thereafter or whenever any changes in the
process occur that could affect the hazard analysis or alter the HACCP Plan.
Such changes may include changes in the following:
- Raw materials or source of raw materials; product formulation; processing methods
or systems, including computers and their software; packaging; finished product
distribution systems; or the intended use or intended consumers of the finished
product and consumer complaints.
(11B)The validation shall be performed by a qualified
individual(s) trained in accordance with the requirements described in this
Appendix and shall be subject to the record keeping requirements cited below.
(11B)The HACCP Plan
shall be modified immediately whenever a validation reveals that the plan is no
longer adequate to fully meet the requirements of this document.(7C)
- (1C) Validation of the Hazard Analysis: Whenever
a milk plant, receiving station or transfer station does not have a
HACCP Plan, because a hazard analysis has revealed no hazards that are
reasonably likely to occur, the milk plant, receiving station or transfer
station shall reassess the adequacy of the hazard analysis whenever
there are any changes in the process that could reasonably affect whether a
hazard exists. Such changes may include changes in the following:
- Raw materials or source of raw materials;
- Product formulation;
- Processing methods or systems, including computers and their software;
- Packaging;
- Finished product distribution systems; or
- The intended use or intended consumers of the finished product; and
- Consumer complaints.
(11B)A qualified individual(s) trained in accordance with
the training requirements of this Appendix shall perform the validation.
(1C) (11B)
Records:
- (1D), (2D), (
9H), (8E)Required Records: It is essential that milk plants,
receiving stations and transfer stations use consistent terminology to identify
each piece of equipment, record, document, or other program throughout their
written HACCP System. A milk plant, receiving station or transfer
station shall maintain the following records documenting the milk plant, receiving station or transfer
station's HACCP System:(8E)
- Records documenting the ongoing application of the PP, including a brief written
description, monitoring and correction records;
- The written hazard analysis;
- The written HACCP Plan;(1D), (2D)
, (9H)
- (8A)Required HACCP documents and
forms specified in 1.a. through c. of this Section shall be dated or identified
with a version number. Each page shall be marked with a new date or version
number whenever that page is updated;
- A Table of Contents and centralized list of the HACCP program records, by title,
documenting the ongoing application of the HACCP System shall be maintained and
provided for review;
- A document change log;
- Records documenting the ongoing application of the HACCP Plan that include:
- (5D)(1) Monitoring of
CCPs and their CLs, including the recording of actual times, temperatures, or
other measurements, as prescribed in the milk plant's, receiving station's or transfer station's
HACCP Plan;(5D)
- (2) Corrective actions, including all actions taken in response to a deviation;
- (3) A centralized deviation log is required; and
- (4) Plan validation dates.
- Records documenting verification and validation of the HACCP System, including the
HACCP Plan, hazard analysis and PPs.
- General Requirements: Records required by this Section shall include:
- The identity and location of the milk plant, receiving station or transfer station;
- The date and time of the activity that the record reflects;
- The signature or initials of the person(s) performing the operation or creating the
record; and
- (8B, 9G)
Where appropriate, the identity of the milk or milk product and the
production code, if any. Processing and other information shall be entered on records at the time that
it is observed. The records shall contain the actual values and observations
obtained during monitoring.(8A) (8B,
9G)
- (1D, 2D),
(9H)Documentation:
- The records in paragraphs 1.a. through c. of this Section shall be signed and dated
by the most responsible individual onsite at the milk plant, receiving station
or transfer station. This signature shall signify that these records have been
accepted by the firm.
- The records in paragraphs 1.a. through c. of this Section shall be signed and dated:
- (1) Upon initial acceptance;
- (2) Upon any modification; and
- (3) Upon verification and validation in accordance with the requirements
cited above.(1D,
2D), (9H)
- (8C)Record Retention:
- All records, required by this Section, shall be retained at the milk plant,
receiving station or transfer station for perishable or refrigerated
products, for at least one (1) year after the date that such products were prepared, and
in the case of frozen, preserved, or shelf-stable products,
for two (2) years after the date that the products were prepared or the shelf-life of the
product, whichever is greater, unless longer retention time is
required by other regulations.(8C)
- (8D)b. Records that relate to the
adequacy of equipment or processes used, such as commissioning or process
validation records, including the results of scientific studies and
evaluations, shall be retained at the milk plant, receiving station or transfer
station facility for at least two (2) years after the date that the milk plant,
receiving station or transfer station last used such equipment or process.
(8D)
- (8E)Off-site storage of
processing records is permitted after six (6) months following the date that
the monitoring occurred, if such records can
be retrieved and provided on-site
within twenty-four (24) hours of a request for official review. Electronic
records are considered to be on-site if
they are accessible from an on-site
location.
- If the processing facility is closed for a prolonged period, the records may be
transferred to some other reasonably accessible location(s) but
shall be immediately returned to the processing facility for official review upon
request.
- Official Review: All records required by
this Section shall be available for official review at reasonable times.
- Records Maintained on Computers: The maintenance of records on computers, in accordance with the
requirements cited above, is acceptable.(8E)
III. Employee Education and Training
(11A, 11D)The success of a HACCP system
depends on educating and training management and employees in the importance
for their role in producing safe milk and milk products. This should also
include information in the control of milk borne hazards related to all stages
of dairy production and processing. Specific training activities should
include working instructions and procedures that outline the tasks of employees
monitoring specific CCPs and PPs. (11A
, 11D)
IV. Training and Standardization
(11A)HACCP training for industry and regulatory
personnel will be based on the current "Hazard Analysis and Critical Control
Point Principles and Application Guidelines" of NACMCF, the current FDA HACCP
recommendations, and the regulatory requirements of this Appendix and related
Sections of this Ordinance.(11A)
Regulatory Agency personnel responsible for the evaluation, licensing and regulatory audits of facilities
using the NCIMS HACCP Program will have equivalent training to the training
required to perform traditional NCIMS functions. They shall also have specialized
training in conducting HACCP System audits.
Industry, State and Federal
regulatory and listing personnel should be trained together.
HACCP Training:
- Core Curriculum: The Dairy HACCP Core Curriculum consists of:
- Basic HACCP training; plus
- An orientation to the requirements of the NCIMS HACCP Program.
Basic HACCP training consists of instruction in the application of the NACMCF Principles of HACCP to
Food Safety. This training includes practical exercises in conducting a hazard
analysis and evaluating potential hazards; in writing a HACCP Plan; and in the
validation of the plan. It should be taught
by experienced instructors.
The orientation component ideally is coupled with the basic HACCP training, but can be taught
separately. The content of the orientation will be conducted under the
guidance of the NCIMS. It is intended to familiarize industry and regulatory
personnel with specific dairy HACCP concerns and the regulatory requirements
under the NCIMS HACCP Program. It is to be taught by instructors experienced
in the application of HACCP under the NCIMS HACCP Program.
The industry individual(s)
performing the functions listed in Part 2 of this Section shall have
successfully completed appropriate training in the application of HACCP
principles to milk and milk product processing at least
equivalent to that received under the Dairy HACCP Core Curriculum.
Alternatively, job experience may qualify an individual to perform these
functions if the experience has provided knowledge at least equivalent to that
provided through the standardized curriculum.
- Industry Personnel: Only industry
individuals who have met the requirements of Part 1 of this
Section shall be responsible for the following functions:
- (1A)Developing the hazard analysis,
including delineating control measures, as required;(1A)
- (2A)Developing a HACCP Plan that
is appropriate for the specific milk plant, receiving station
or transfer station, in order to meet these requirements;(2A)
- (11B)Validating and modifying the HACCP Plan in accordance
with the corrective action procedures and the
validation activities as specified;(11B) and
- (11C)Performing required HACCP
Plan records reviews. (11C)
- (12C)Regulatory Personnel: Regulatory personnel
performing HACCP audits shall have successfully completed appropriate training
in the application of HACCP principles for milk and milk product processing at
least equivalent to that received under the Dairy HACCP Core Curriculum.
V. HACCP Audits and Follow-up Actions
State Regulatory Audits, Enforcement Audits, Actions and Follow-up: Audits shall be conducted of the milk plant, receiving station, or transfer station facility, and NCIMS HACCP Program to ensure compliance with the HACCP
System and other associated NCIMS regulatory requirements.
The audit may be announced at the discretion of the auditor under certain
circumstances, i.e., initial audit, follow-up audit, new construction,
pasteurizer checks, etc. When unannounced audits are conducted, the audits shall
not be completed until appropriate milk plant personnel have had an opportunity to make all
pertinent records available for review by the auditor.
Auditing Procedures:
- Pre-Audit Management Interview: Review and discuss the milk plant HACCP System including:
- Changes in the management structure;
- The Hazard Analysis - Ensure that all milk or milk product hazards are addressed;
- Changes in the HACCP Plan;
- Changes in the PPs;
- Changes in the flow diagram; and
- Changes in milk or milk products or processes.
- Review past Audit Reports(AR) and corrections of deficiencies and non-conformities, if any;
- n-milk plant review of the implementation and verification of the HACCP System;
- Review records of the HACCPSystem;
- Review compliance with other applicable NCIMS regulatory requirements*;
- Discuss findings and observations;
- Prepare and issue an AR based on findings of deficiencies and non-conformities. The AR shall include
timelines for the correction of all identified deficiencies and
non-conformities; and
- Conduct the exit interview.
*Note: Examples of Other Applicable NCIMS Requirements:
- (10I)Raw Milk Supply Source;
- Labeling Compliance;
- Adulteration;
- Licensing Requirements;
- Drug Residue Testing and Traceback Requirements;
- Regulatory Samples in Compliance;
- Approved Laboratory Utilized for the Required Regulatory Tests; and
- Pasteurization Equipment Design and Installation.(10I)
State Regulatory Enforcement Action/Follow-up: The State Regulatory Agency shall:
- Prepare and issue ARs based
on findings of deficiencies and non-conformities and other NCIMS requirements;
- Review the AR with the milk plant and
establish time lines for the correction of all identified deficiencies and
non-conformities and other NCIMS requirements;
- (12A)Follow-up to ensure corrections are made as a
result of the issuance of the AR;(12A)
- Take immediate action when an imminent health hazard is observed to prevent further movement of milk and milk
products until such hazards have been eliminated and
- (12B)Initiate regulatory enforcement action, such as
permit suspension, revocation, hearings, court actions, and/or other equivalent
measures when the milk plant, receiving station or transfer station has failed to recognize or
correct a deficiency(ies) or nonconformity(ies).(12B)
Audit Timeframes:
Audits | Frequency Minimums |
First Year after Initial Regulatory Audit: |
Initial audit; Next audit in thirty (30) to forty-five (45) days; and four (4) month intervals
thereafter, unless the Regulatory Agency determines that a greater frequency is warranted. |
Subsequent Audits |
Every six (6) months unless the Regulatory Agency determines that a greater frequency is warranted*. |
Compliance Follow-Ups |
Compliance follow-ups shall be made as frequently as necessary to assure that problems
observed by the Regulatory Agency have been resolved. |
*The Regulatory Agency may elect to extend the minimum audit frequency from four (4) to six (6)
months as long as the following conditions exist:
- Item 12b of the MILK PLANT, RECEIVING STATION OR TRANSFER
STATION NCIMS HACCP SYSTEM AUDIT
REPORT is not marked on the
regulatory audit for the current HACCP audit;
- No current two (2) out of four (4) warning letter(s) or three (3) out of five (5)
violation letter(s) for finished milk or milk product, or violative water sample results; and
- No CLEs on the current or prior audit.
Audit Report Form:
Refer to Appendix M of this Ordinance. (12C)
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