Section 1
HAZARD ANALYSIS
-
A. Flow Diagram and Hazard Analysis conducted and written for each kind of group of milk or milk product processed. **
-
- 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)
- 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)
- 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.
-
B. Written Hazard analysis identifies all potential milk or milk product safety hazards & determines those that are reasonably likely to occur (including hazards within & outside the processing plant environment).
- 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.
-
C. Written Hazard analysis reassessed after changes in raw materials, formulations, processing methods/systems, distribution, intended use or consumers.
-
- 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.
-
D. Written Hazard analysis signed and dated as required.
-
- 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 . . .
- 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
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Section 6
HACCP PLAN CORRECTIVE ACTION
-
A. Corrective actions when defined in the HACCP plan were followed when deviations occurred.
- Appendix K. II. HACCP PLAN (pg. 304)
- 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;
- 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.
-
B. Predetermined corrective actions defined in the HACCP plan ensure the cause of the deviation is corrected.
- 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.
-
C. Corrective action taken for products produced during a deviation from CL(s) defined in the HACCP plan. **
- 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.
-
D. Affected milk or milk product produced during the deviation segregated and held, AND a review to determine product acceptability performed, AND corrective action taken to ensure that no adulterated milk and/or milk product that is injurious to health enters commerce.
- 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.
-
E. Cause of deviation was corrected.
- 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.
-
F. Reassessment of HACCP Plan performed and modified accordingly.
- 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.
-
G. Corrective actions documented.
- 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.
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Section 3
HACCP PLAN CRITICAL CONTROL POINTS (CCP)
-
A. HACCP plan lists CCP(s) for each milk or milk product safety hazard identified as reasonably likely to occur.
-
- Appendix K.II. HACCP PLAN (pg. 304)
-
Contents of the HACCP Plan: The HACCP Plan at a minimum: . . .
- 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 . . .
-
B. CCP(s) identified are adequate control measures for the milk or milk product safety hazard(s) identified.
-
- Appendix K.II. HACCP PLAN (pg. 304)
-
Contents of the HACCP Plan: The HACCP Plan at a minimum: . . .
- 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 . . .
-
C. Control measures associated with CCP(s) listed are appropriate at the processing step identified.
-
- Appendix K.II. HACCP PLAN (pg. 304)
-
Contents of the HACCP Plan: The HACCP Plan at a minimum: . . .
- 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 . . .
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Section 7
HACCP PLAN VERIFICATION & VALIDATION
-
A. HACCP plan defines verification procedures, including frequency.
-
- Appendix K. II. HACCP PLAN (pg. 304)
- Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
. . .
- 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 . . .
-
B. Verification activities are conducted & comply with HACCP Plan.
-
- 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.
-
C. Reassessment of HACCP plan conducted annually, OR
-
- Editorial Note: Validation of a HACCP plan starts with the flow diagram and hazard analysis
- Appendix K. II. Verification and Validation (pg. 306)
- 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.
-
1. After changes that could affect the hazard analysis, OR
-
2. After significant changes in the operation including raw materials and/or source, product formulation, processing methods/systems, distribution intended use or intended consumer.
-
D. Calibration of CCP process monitoring instruments performed as required and at the frequency defined in the HACCP plan. **
-
- Standardization Note: Includes PMO required equipment testing.
Appendix K. II. Verification and Validation (pg. 306)
- Verification . . .
- 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.
-
E. CCP monitoring records reviewed and document that values are within CL(s) as required.
-
- 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.
-
F. Corrective action record reviewed as required.
-
- 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.
-
G. Calibration records and end product or in process testing results defined in HACCP Plan reviewed as required.
-
- 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.
-
H. Records reviewed as required - including date and signature.
-
- 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.
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