References for NCIMS HACCP System Audit Report
Per 2005 NCIMS Documents
Note: The Section numbers below refer 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*). Page numbers listed apply
to the printed bound versions of the 2005 PMO.
Section 1 A.
Appendix K. II. PRELIMINARY STEPS (pg. 301)
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.
Appendix K. II. HAZARD ANALYSIS (pg. 303)
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.
Appendix K. II. HACCP PLAN (pg. 304)
- 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.
Appendix K. III. TRAINING AND STANDARDIZATION (pg. 309)
- 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 the hazard analysis, including
delineating control measures, as required; Note: 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. Standardization
Note: job experience of the person(s) developing the hazard analysis will be
judged based on the adequacy of the hazard analysis.
Section 1 B.
Appendix K. II. Hazard Analysis (pg. 303)
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.
Section 1 C.
Appendix K. II Verification and Validation (pg. 306)
Editorial Note: If a HACCP plan exists, evaluate under 7C 2.
- 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.
A qualified individual(s) trained in accordance with the
training requirements of this Appendix shall perform the validation.
Section 1 D.
Appendix K. II. Records (pg. 307)
- Required Records: . . . 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:
- 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 . . .
- 3. 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 modifications; and
- (3) Upon verification and validation in accordance with the requirements cited above
Section 2 A.
Appendix K. II. HACCP Plan (pp. 303-304)
- 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. 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.
Appendix K. III. TRAINING AND STANDARDIZATION (pg. 309)
- 2. Industry Personnel: Only industry individuals who have met the requirements of
Part 1 of this Section shall be responsible for the following functions: b.
Developing a HACCP Plan that is appropriate for the specific milk plant,
receiving station or transfer station, in order to meet these requirements;
Note: 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. Standardization
Note: job experience of the person(s) developing the HACCP Plan will be judged
based on the adequacy of the hazard analysis.
Section 2 B.
Appendix K. II. HACCP PLAN (pg. 303)
- 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.
Section 2 C.
Appendix K. II. HACCP Plan (pg. 304)
- 2. Contents of the HACCP Plan: The
HACCP Plan shall, at a minimum:
- . . . b. 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 . . .
- 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.
Section 2 D.
Appendix K. II. Records (pg. 306-307)
- Required Records: 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:
- 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 . . .
- 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 modifications; and
- (3) Upon verification and validation in accordance with the
requirements cited above
Section 3 A. B. and C.
Appendix K.II. HACCP PLAN (pg. 304)
- 2. Contents of the HACCP Plan: The HACCP Plan at a minimum:
- . . . 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;
and . . .
Section 4 A.
Appendix K.II. HACCP PLAN (pg. 304)
- 2. Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
- . . . c. (3) List the CLs that shall be met at each of the CCPs.
Section 4 B.
PMO. Sec 1.Q-7 (pg. 4)
CRITICAL
LIMIT (CL): Critical a maximum or minimum
value to which a biological, chemical or physical parameter must be controlled
at a CCP to prevent, eliminate, or reduce to an acceptable level the occurrence
of a milk or milk product safety hazard.
Section 4 C.
Appendix K.II. HACCP PLAN (pg. 304)
- 2. Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
- . . . 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
Section 4 D.
Appendix K.II. HACCP PLAN (pg. 304)
- 2. Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
- . . . c. (3) List the CLs that shall be met at each of the
CCPs.
Section 5 A.
Appendix K. II. HACCP PLAN (pg. 304)
- 2. Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
- . . . d. List the procedures (standardization note: what, how, whom) 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;
Section 5 B.
Appendix K. II. HACCP PLAN (pg. 304)
- 2. Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
- . . . 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.
Section 5 C.
Appendix K. II. HACCP PLAN (pg. 304)
- 2. Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
- . . . d. List the procedures (standardization
note: what, how, whom) 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;
Section 5 D.
Appendix K. II. HACCP PLAN (pg. 304)
- 2. Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
- . . . 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.
Appendix K. II. RECORDS (pg. 307)
- Required Records: . . .
- 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;
Section 6 A
Appendix K. II. HACCP PLAN (pg. 304)
- 2. Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
- . . . e. 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;
Section 6 A-G
Appendix K. II. CORRECTIVE ACTIONS (pp. 304-305)
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.
Section 7 A
Appendix K. II. HACCP PLAN (pg. 304)
- 2. Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
- . . . 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; and . . .
Section 7 B
Appendix K. II. Verification and Validation (pp. 305-306)
- 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;
- (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; and
- 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 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.
Section 7 C
Editorial Note: Validation of a HACCP plan starts with the flow diagram and hazard analysis
Appendix K. II. Verification and Validation (pg. 306)
- 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:
- 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.
Section 7 D
Standardization Note: Includes PMO required equipment testing.
Appendix K. II. Verification and Validation (pg. 306)
- Verification . . .
- 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.
Section 7 E
Standardization Note: Required Pasteurizer Charts Evaluated here
Appendix K. II. Verification and Validation (pp. 305-306)
- a. (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; and
- 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
plant's, receiving station's or transfer station's written procedures. These
reviews shall occur within a reasonable time after the records are made.
Section 7 F
Appendix K. II. Verification and Validation (pp. 305-306)
- a. (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; and
- 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 plant's, receiving station's or transfer station's
written procedures. These reviews shall occur within a reasonable time after
the records are made.
Section 7 G
Appendix K. II. Verification and Validation (pp. 305-306)
- a. (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; and
- 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
plant's, receiving station's or transfer station's written procedures. These
reviews shall occur within a reasonable time after the records are made.
Section 7 H
Appendix K. II. Verification and Validation (pp. 305-306)
- 1.a. (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; and
- 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 plant's, receiving station's or transfer station's
written procedures. These reviews shall occur within a reasonable time after
the records are made.
Section 8 A.
Appendix K. II. RECORDS (pg. 307)
- Required Records: . . . d. 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;
- 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; and
- (4) Plan validation dates.
- h. 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
- 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.
Section 8 B.
Appendix K. II. RECORDS (pg. 307)
- 2. General Requirements: Records required by this Section shall include: d. . . . Processing and other information shall be entered on records at the time that
it is observed. . . .
Section 8 C.
Appendix K. II. RECORDS (pg. 307)
- 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.
Section 8 D.
Appendix K. II. RECORDS (pp. 307-308)
- 4. Record Retention 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.
Section 8 E.
Appendix K. II. RECORDS (pp. 307-308)
- 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.
- 4. Record Retention 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.
Section 8 F
Appendix K. II. RECORDS
(applies to all records required under Appendix K)
Section 9 A.
Appendix K. II. PREREQUISITE PROGRAM (pg. 302)
- 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.
Section 9 A. 1
Appendix K .II. PREREQUISITE PROGRAM (pg. 302)
- Required PPs: . . . The PPs shall address:
- Safety of the water that comes into
contact with milk or milk products or product-contact surfaces, including steam
and ice; . . .
Section 9 A. 2
Appendix K. II. PREREQUISITE PROGRAM (pg. 302)
- Required PPs: . . . The PPs shall address:
- b. Condition and cleanliness of
equipment product-contact surface;
Section 9 A. 3
Appendix K. II. PREREQUISITE PROGRAM (pg. 302)
- Required PPs: . . . The PPs shall address:
- 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;
Section 9 A. 4
Appendix K. II. PREREQUISITE PROGRAM (pg. 302)
- Required PPs: . . . The PPs shall address:
- d. Maintenance of handwashing, hand sanitizing, and toilet
facilities;
Section 9 A. 5
Appendix K. II. PREREQUISITE PROGRAM (pg. 302)
- Required PPs: . . . The PPs shall address:
- 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;
Section 9 A. 6
Appendix K. II. PREREQUISITE PROGRAM (pg. 302)
- Required PPs: . . . The PPs shall address:
- f. Proper labeling, storage, and use of toxic compounds;
Section 9 A. 7
Appendix K. II. PREREQUISITE PROGRAM (pg. 302)
- Required PPs: . . . The PPs shall address:
- 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; and
Section 9 A. 8
Appendix K. II. PREREQUISITE PROGRAM (pg. 302)
- Required PPs: . . . The PPs shall address:
- h. Pest exclusion from the milk plant.
Section 9 B.
Appendix K. II. Prerequisite Program (pg. 302)
- Required PPs: . . . 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.
Section 9 C.
Appendix K. II. Prerequisite Program (pg. 302-303)
- 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.
Section 9 D.
Appendix K. II. Prerequisite Program (pg. 302-303)
- 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.
Section 9 E.
Appendix K. II. Prerequisite Program (pg. 302-303)
- 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.
Section 9 F.
Appendix K. II. Prerequisite Program (pg. 302 third paragraph in
introductory text)
. . . The exact set of PPs
will vary . . . 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. . . .
Section 9 G.
Appendix K. II. RECORDS (pg. 307)
- 2. General Requirements: Records required by this Section shall include: d. . . . The
records shall contain the actual values and observations obtained during
monitoring.
Section 9 H
Appendix K. II. Records (pp. 306-307)
- Required Records: . . . 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:
- 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 . . .
- 3. 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:
- (4) Upon initial acceptance;
- (5) Upon any modifications; and
- (6) Upon verification and validation in
accordance with the requirements cited above.
Section 10 A.
See PMO Section 11
Section 10 B.
See PMO Section 7 Table 1 and Appendix N
Section 10 C.
See PMO Appendix N
Section 10 D.
See PMO Section 4
Section 10 E.
See PMO Sections 2 & 5
specifically critical processing element violations #1, 2, and 3.
Section 10 F.
See PMO Section 7 Table 1 and
Section 6 specifically: "Each milk plant regulated under the NCIMS HACCP
Program shall adequately document it’s response to each regulatory sample test
result that exceeds any maximum level specified in Section 7 of this
Ordinance."
Section 10 G.
See PMO Section 7 16p, and Appendix H
Section 10 H.
See PMO Section 6. Note: " . . . samples shall be analyzed at
an appropriate official or officially designated laboratory." See Appendix N. III,
Section 10 I.
PMO various and Appendix K. II. PREREQUISITE PROGRAMS (pg. 302)
"HACCP may be implemented only in a facility that is
constructed and operated to provide a sanitary environment. Milk plant,
receiving station or transfer 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 chooses."
Appendix K. IV. HACCP AUDITS AND FOLLOW-UP ACTIONS (pg. 310)
AUDITING PROCEDURES:
*NOTE: Examples of Other Applicable NCIMS Requirements:
- 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.
Section 11 A.
Appendix K. III. TRAINING AND STANDARIZATION (pg. 308)
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.
Appendix K. IV. TRAINING AND STANDARIZATION (pg. 308)
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.
Section 11 B
Appendix K. II. Verification and Validation (pg. 306)
- 2. Validation of the HACCP Plan: . . . 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. . . .
- 3. Validation of the Hazard Analysis: . . . a qualified
individual(s) trained in accordance with the requirements described of this
Appendix and shall perform the validation.
Appendix K . IV. Training and Standardization (pg. 309)
HACCP TRAINING: . . . 2. Industry Personnel: . . . c. Validating and modifying the HACCP Plan
in accordance with the corrective action procedures and the validation
activities as specified; . . .
Section 11 C.
Appendix K. II. Verification and Validation (pg. 305)
- Verification: . . . a. Verification
activities shall include: . . . (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: . . .
Appendix K. IV. Training and Standardization (pg. 309)
HACCP
TRAINING: . . . 2. Industry Personnel: . . . d. Performing required HACCP Plan records
reviews.
Section 11 D.
Appendix K. III. TRAINING AND STANDARIZATION (pg. 308)
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 foodborne hazards related to
all stages of dairy production. Specific training activities should include
working instructions and procedures that outline the tasks of employees
monitoring specific CCPs and PPs.
Section 12 A
Appendix K. IV. HACCP AUDITS AND FOLLOW-UP ACTIONS (pg. 310)
State Regulatory Enforcement Action/Follow-Up: The State
Regulatory Agency shall:
- . . . 3. Follow-up to ensure corrections are made as a result of
the issuance of the AR; . . .
Section 12 B
Appendix K. IV. HACCP AUDITS AND FOLLOW-UP ACTIONS (pg. 310)
State Regulatory Enforcement Action/Follow-Up: The State
Regulatory Agency shall:
- . . . 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 deficiencies(ies) or non-conformity(ies).
Section 12 C
Appendix K. III. TRAINING AND STANDARDIZATION (pg. 309)
HACCP TRAINING:
- 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.
Appendix K. IV. HACCP AUDITS AND FOLLOW-UP ACTIONS (pp. 309-311)
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;
- In-milk
plant review of the implementation and verification of the HACCP System;
- Review
records of the HACCP System;
- 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:
- 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.
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;
- Follow-up
to ensure corrections are made as a result of the issuance of the AR;
- 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
- 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 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.
Section 12 D
PROCEDURES GOVERNING THE COOPERATIVE STATE-PUBLIC HEALTH SERVICE/FOOD
AND DRUG ADMINISTRATION PROGRAM OF THE NATIONAL CONFERENCE ON INTERSTATE MILK
SHIPMENTS, SECTION VIII. PROCEDURES GOVERNING
THE CERTIFICATION OF MILK PLANT, RECEIVING STATION AND TRANSFER STATION NCIMS
HACCP SYSTEMS FOR IMS LISTED SHIPPERS, D. STATE HACCP
RESPONSIBILITIES, 6. Challenges and Remedies, c. Action to be Taken if
the PHS/FDA HACCP Audit Indicates the Listing is Not Justified, 2.) Milk
Plants, Receiving Stations and/or Transfer Stations, C.) Withdrawal of
Certification, ii.) Significant deficiencies involving one (1) or more CLE’s . . .
- 8. HACCP
SYSTEM AUDIT FOLLOW-UP ACTIONS: A series of observations that lead to a finding of a
potential HACCP System failure that is likely to result in a compromise to milk
or milk product safety.