Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-3-16 - PRODUCTION, PROCESSING, HANDLING OR DISTRIBUTION OF MILK, MILK PRODUCTS AND FROZEN DESSERTS › APPENDICES › Appendix K - HACCP PROGRAM

Current through Register Vol. 42, No. 9, June 28, 2024
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 1960s. 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 percent 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 (FAO) of the 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 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 NCIMS voluntary HACCP Program alternative to the traditional
				  inspection system. A milk plant, receiving station, or transfer station may not
				  participate in the NCIMS voluntary HACCP Program unless the Health Officer's
				  responsible for the oversight of the facility agrees to participate with the
				  milk plant(s), receiving station(s), and transfer station(s) in the NCIMS
				  voluntary HACCP Program. Both parties shall provide written commitment to each
				  other that the necessary resources to support participation in the NCIMS
				  voluntary HACCP Program shall be made available.
Management responsible for both the Health Officer and the
				  milk plant, receiving station, and/or transfer station shall be willing to
				  provide the resources required to develop and implement a successful HACCP
				  System.
HACCP PRINCIPLES
- Following are the seven (7)
				  HACCP principles to be included in a HACCP Plan:
1. Conduct a hazard analysis.
2. Determine the critical control points.
3. Establish critical limits.
4. Establish monitoring procedures.
5. Establish corrective actions.
6. Establish verification procedures.
7. Establish record-keeping and documentation
				  procedures.
PREREQUISITE PROGRAMS (PPs)
- Prior to the
				  implementation of a HACCP Plan, there is a requirement for milk 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 voluntary HACCP Program described in this Appendix includes
				  the HACCP System and other prescribed
Grade "A" PMO
criteria,
				  such as drug residue testing and trace back; use of milk only from supplies
				  that have been awarded a milk sanitation compliance rating of 90 percent or
				  better or from an acceptable IMS HACCP listed source; and the labeling
				  requirements of Section 4. When properly implemented, the NCIMS voluntary 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
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.
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 shall 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.
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.
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. PPs are established and managed
				  separately from the HACCP Plan.
1. 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:
a. Safety of the water that comes into contact with milk or
				  milk products or product-contact surfaces, including steam and ice.
b. Condition and cleanliness of equipment product-contact
				  surface.
c. 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.
d. Maintenance of handwashing, hand sanitizing, and toilet
				  facilities.
e. 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.
f. Proper labeling, storage, and use of toxic
				  compounds.
g. 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.
h. Pest exclusion from the milk plant.
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.
2. 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.
3. 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.
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.
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.
1. In evaluating what milk or milk product hazards are
				  reasonably likely to occur, at a minimum, consideration should be given to the
				  following:
a. Microbiological contamination.
b. Parasites.
c. Chemical contamination.
d. Unlawful drug and pesticide residues.
e. Natural toxins.
f. Unapproved use of food or color additives.
g. Presence of undeclared ingredients that may be
				  allergens.
h. Physical hazards.
2. 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.
HACCP PLAN
1. 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. 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.
2. Contents of the HACCP Plan - The HACCP Plan shall, at a
				  minimum:
a. 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.
b. List all hazards that are reasonably likely to occur as
				  identified in the hazard analysis specified above, and that shall be controlled
				  for each type of milk or milk product.
c. 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.
(3) List the CLs that shall be met at each of the
				  CCPs.
d. 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.
e. Include any corrective action plans that have been
				  developed in accordance with the corrective action requirements as described in
				  thisaAppendix, and that are to be followed in response to deviations from CLs
				  at CCPs.
f. 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.
g. 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.
3. 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.
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.
a. 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:
b. 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
c. If such milk or milk product has entered commerce, it is
				  expeditiously removed; and
d. The cause of the deviation is corrected.
2. 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:
a. 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.
b. 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.
c. 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.
d. Take corrective action, when necessary, to correct the
				  cause of the deviation.
e. 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.
3. All corrective actions taken in accordance with this
				  section shall be fully documented in records that are subject to
				  verification.
VERIFICATION AND VALIDATION
1. Every milk plant, receiving station, or transfer station
				  shall verify that the HACCP System is being implemented according to design,
				  except that the milk plant's APPS or RPPS, respectively, as defined by these
				  rules, shall be managed separately from the NCIMS HACCP System, even if
				  identified as a CCP in the hazard analysis. The milk plant's APPS or RPPS,
				  respectively, shall be inspected by the FDA, or the state regulatory agency
				  when designated by the FDA, in accordance with the applicable requirements of
				  21 CFR Parts 108, 110, and 113 at a frequency determined by FDA.
a. 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.
(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.
(i) 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.
(ii) 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.
(iii) 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.
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 plants, receiving stations, or transfer stations
				  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.
b. 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.
2.
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:
a. 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.
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.
				  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.
3.
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:
a. Raw materials or source of raw materials.
b. Product formulation.
c. Processing methods or systems, including computers and
				  their software.
d. Packaging.
e. Finished product distribution systems; or
f. The intended use or intended consumers of the finished
				  product.
g. Consumer complaints.
A qualified individual(s) trained in accordance with the
				  training requirements of this appendix shall perform the validation.
RECORDS
1. 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:
a. Records documenting the ongoing application of the PP,
				  including a brief written description, monitoring, and correction
				  records.
b. The written hazard analysis.
c. The written HACCP Plan.
d. Required HACCP documents and forms specified in 1a-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.
e. 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.
f. A document change log.
g. Records documenting the ongoing application of the HACCP
				  Plan that include:
(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.
(2) Corrective actions, including all actions taken in
				  response to a deviation.
(3) A centralized deviation log is required.
(4) Plan validation dates.
h. Records documenting verification and validation of the
				  HACCP System, including the HACCP Plan, hazard analysis, and PPs.
2.
General Requirements
- Records required by
				  this section shall include:
a. The identity and location of the milk plant, receiving
				  station, or transfer station.
b. The date and time of the activity that the record
				  reflects.
c. The signature or initials of the person(s) performing the
				  operation or creating the record.
d. 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.
3.
Documentation
a. The records in paragraphs 1a-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.
b. The records in paragraphs 1a-c. of this section shall be
				  signed and dated:
(1) Upon initial acceptance.
(2) Upon any modification.
(3) Upon verification and validation in accordance with the
				  requirements cited above.
4. Record Retention
a. 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.
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.
c. 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.
d. 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.
5.
Official Review
- All records required by
				  this section shall be available for official review at reasonable times.
6.
Records Maintained on Computers
- The
				  maintenance of records on computers, in accordance with the requirements cited
				  above, is acceptable.
III.
EMPLOYEE EDUCATION AND TRAINING
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.
IV.
TRAINING AND STANDARDIZATION
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 these
				  rules.
The Health Officer personnel responsible for the evaluation,
				  licensing, and regulatory audits of facilities using the NCIMS voluntary HACCP
				  Program shall have equivalent training to the training required to perform
				  traditional NCIMS functions. They shall also have specialized training in
				  conducting HACCP System audits.
Industry, regulatory, rating, and FDA personnel should be
				  trained together.
HACCP TRAINING
1. Core Curriculum - The Dairy HACCP Core Curriculum consists
				  of:
a. Basic HACCP training.
b. An orientation to the requirements of the NCIMS voluntary
				  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 voluntary HACCP
				  Program. It is to be taught by instructors experienced in the application of
				  HACCP under the NCIMS voluntary HACCP Program.
The industry individual(s) performing the functions
				  identified in this Appendix requiring training or 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.
2.
Industry Personnel
- Only industry
				  individuals who have met the requirements of Part 1 of this section shall be
				  responsible for the following functions:
a. Developing PPs.
b. Developing the hazard analysis, including delineating
				  control measures, as required.
c. Developing a HACCP Plan that is appropriate for the
				  specific milk plant, receiving station, or transfer station, in order to meet
				  these requirements.
d. Validating and modifying the HACCP Plan in accordance with
				  the corrective action procedures and the validation activities as
				  specified.
e. Performing required HACCP Plan records reviews.
3.
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
REGULATORY AGENCY AUDITS, ENFORCEMENT AUDITS, ACTIONS
				  AND FOLLOW-UP
- Audits shall be conducted of the milk plant, receiving
				  station, or transfer station facility, and the NCIMS voluntary 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
1. Pre-Audit Management Interview - Review and discuss the
				  milk plant HACCP System including:
a. Changes in the management structure.
b. The Hazard Analysis - Ensure that all milk and/or milk
				  product hazards are addressed.
c. Changes in the HACCP Plan.
d. Changes in the PPs.
e. Changes in the flow diagram.
f. Changes in milk or milk products or processes.
2. Review past Audit Reports (AR) and corrections of
				  deficiencies and non-conformities, if any.
3. In-milk plant review of the implementation and
				  verification of the HACCP System.
4. Review records of the HACCP System.
5. Review compliance with other applicable NCIMS regulatory
				  requirements*.
6. Discuss findings and observations.
7. 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.
8. Conduct the exit interview.
Note:
Examples of Other Applicable NCIMS
				  Requirements:
1. Raw Milk Supply Source.
2. Labeling Compliance.
3. Adulteration.
4. Licensing Requirements.
5. Drug Residue Testing and Trace Back Requirements.
6. Regulatory Samples in Compliance.
7. Approved Laboratory Utilized for the Required Regulatory
				  Tests.
8. Pasteurization Equipment Design and Installation.
THE HEALTH OFFICER ENFORCEMENT
				  ACTION/FOLLOW-UP
The Health Officer shall:
1. Prepare and issue ARs based on findings of deficiencies
				  and non-conformities and other NCIMS requirements.
2. 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.
3. Follow-up to ensure corrections are made as a result of
				  the issuance of the AR.
4. 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.
5. 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).
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
								Health Officer determines that a greater frequency is warranted.
Subsequent Audits
Every six (6) months unless the Health Officer
								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 Health Officer have been
								resolved.
*The Health Officer may elect to extend the minimum audit
				  frequency from four (4) to six (6) months as long as the following conditions
				  exist:
1. Item 12b on FORM FDA 2359m-MILK PLANT, RECEIVING STATION,
				  OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT is not marked on the
				  regulatory audit for the current HACCP audit.
2. No current two (2) out of four (4) warning letter(s) or
				  three (3) out of five (5) violation letter(s) for finished milk and/or milk
				  product, or violative water sample results.
3. No CLEs on the current or prior audit.
Audit Report Form (refer to Appendix M).
Author:
G. M. Gallaspy, Jr.
Statutory Authority:
Code of Ala. 1975,
					 §§
											22-2-2,
					 22-20-7.