FAQ for Transitional Facilities: Performance Based Verification 2022 - FAQ Infographic on PBV Sample PBV report
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FAQ
for Transitional Facilities:
Performance Based Verification 2022
This document includes:
• FAQ
• Infographic on PBV
• Sample PBV report
Produced by Border Clearance Services, Biosecurity NZ
Version 1, Feb 2022
1Frequently Asked Questions for Transitional Facilities:
Performance Based Verification (PBV) 2022
Contents
What is Performance-Based Verification (PBV)?........................................................................ 3
Why has Biosecurity NZ (Ministry for Primary Industries) decided to use PBV for Transitional
Facilities? ............................................................................................................................ 3
Is PBV allowed under the Biosecurity Act?................................................................................ 4
Why are we making the shift f rom inspection to verification? ........................................................ 4
How are the Biosecurity Profiles and verification f requencies decided? ......................................... 5
Are the Biosecurity Profiles flexible? ........................................................................................ 6
What is Evidence-based assurance? ....................................................................................... 6
What does PBV mean for my Transitional Facility? .................................................................... 7
What is the cost impact of PBV for my TF? ............................................................................... 7
How will we know what we are supposed to do for a PBV visit? ................................................... 8
What will verification include? ................................................................................................. 9
How will we know what the outcome of a verification visit is? ....................................................... 9
What are verif ication topics and how are they rated? .................................................................10
Will Corrective Actions still be required? ..................................................................................13
When is PBV starting at Transitional Facilities? ........................................................................13
What happens if I don’t agree with the verif ier’s f indings?...........................................................13
Will the TF Operator training include information about PBV? .....................................................14
Where can I find more information? ........................................................................................14
Glossary .............................................................................................................................15
2Q
What is Performance-Based Verification (PBV)?
A
PBV means verification is conducted at a frequency (the time between verification visits)
which is determined by the TF operator’s performance (the effectiveness of your biosecurity
management).
• The PBV programme has defined graduated verification frequencies (PBV steps)
ranging from monthly through to 24 months.
• A business with a proven history of acceptable performance will move up the range
to less frequent verification, whereas a business with unacceptable p erformance will
move down the range to more frequent verification.
• This means greater certainty for TF management that there will be less disruption to
their business due to BNZ intervention and also enables BCS to manage verification
work more efficiently.
Q
Why has Biosecurity NZ (Ministry for Primary Industries) decided to use
PBV for Transitional Facilities?
A
PBV is an alignment of the existing verification programme with other PBV programmes
administered by MPI. The approach has been proven to be a workable model for lifting
regulatory compliance (Animal Products, Food Safety). Biosecurity NZ believes this is the
best approach for achieving the goal of lifting TF national compliance and providing
evidence-based assurance.
This also aligns with the Biosecurity NZ strategic approaches and principles, including:
• Operational excellence; doing the basics well
• Science and evidence based
• Guardians of our way of life
• Ensuring the right regulation, compliance and accountability
• Providing the tools, systems and processes for everyone to play their part
3Q
Is PBV allowed under the Biosecurity Act?
A
Yes. Currently TFGen (The Standard for Transitional Facilities for General Uncleared Risk
Goods) which is issued under the Biosecurity Act 1993, established a performance-based
verification approach. The refreshed PBV programme provides greater transparency and
criteria for decision making and verification frequencies.
Q
Why are we making the shift from inspection to verification?
A
Inspection
The act of examining for the presence of risk.
Verification
The act or process of confirming or checking for accuracy.
The process by which we ensure the TF operators are compliant with the biosecurity
requirements.
• BNZ’s objective is to strengthen the Sea Cargo Pathway. In relation to annual
(current) verification-inspections at TFs this means creating a shift in how Biosecurity
NZ confirms TF and operator compliance. TFs and TF operators are responsible for
effective biosecurity management. Inspection methodology places the onus on the
“inspector” to identify non-conformance/non-compliance and ensure these are
corrected.
• Verification shifts and resets the onus to identify non-conformance/non-compliance
and correct these onto the TF and TF Operator. The verification methodology seeks
objective evidence from the TF Operator of effective biosecurity management since
the last verification. Corrective actions have a focus on improving and strengthening
the operator processes and practices to prevent recurrence.
• This will provide a clear reminder that biosecurity management is the operator
responsibility and Biosecurity NZ’s role is to verify the effectiveness of the operator
biosecurity management.
• Verification will also require the operator to develop a corrective action plan for
correcting and improving programmes & processes where non-conformance/non-
compliance are identified during PBV. [From a quality management perspective,
inspection typically is designed to identify one off defects as opposed to verification
(which is part of an assurance programme) designed to strengthen and improve a
product or service, not just separate good from bad]
4Q
How are the Biosecurity Profiles and verification frequencies decided?
A
Biosecurity Profiles are an improved approach to TFs risk assessment, which previously was
based only on Tiers 1-3 (commodities a TF is approved to receive). Biosecurity Profiles
(BPs) place each TF on a scale from high complexity and high biosecurity risk through to low
complexity and low biosecurity risk.
This enables a true resource to risk approach and as the profiles are dynamic, a TF profile
may change over time according to changes in a TF’s complexity and risk.
A Biosecurity Profile is calculated f or each Transitional Facility based on the following criteria
over a 12-month period:
• consignment type
• container number
• consignment number
• country of import
• the PBV history
• 100% container reporting
• and moderated by BCS with local knowledge.
There are four profiles, each of which sets the maximum PBV f requency a business may
attain e.g.
• Profile 1 = PBV step 6 (6 months)
• profile 2 = PBV step 7 (12 months)
• profile 3 = PBV step 8 (18 months)
• profile 4 = PBV step 9 (24 months).
The Biosecurity Profile sets the maximum verification period a TF business may attain.
Businesses move up and down the PBV steps based on their performance.
The following table details the PBV steps, the verification intervals, the change in verification
frequency based on PBV outcome and the maximum verification frequency achievable
based on the TF biosecurity profile. For example, for a TF with Biosecurity Profile 3, the
verification steps applicable to that facility would be a PBV step 0 through to a maximum of
PBV step 8.
PBV step Verification interval Number of consecutive Number of
acceptable outcomes to unacceptable
move up to next step outcomes to move
down to next step
Step 0 Direct Biosecurity As determined by Biosecurity -
Oversight NZ on a case-by-case basis
Step 1 2 weekly Two One
Step 2 1 monthly Two One
Step 3 6 weekly Two One
5Step 4 2 monthly Two One
Step 5 3 monthly Two One
Step 6 6 monthly Two One
Step 7 1 yearly Two One
Step 8 18 monthly Two One
Step 9 2 yearly Two One
Q
Are the Biosecurity Profiles flexible?
A
Biosecurity NZ determines a PBV ceiling for each facility based on their biosecurity profile.
This profile is determined based on several criteria which consider biosecurity risk and
complexity of operations at the facility in the preceding 12 months.
The purpose is to determine a maximum verification interval that provides an acceptable
level of protection i.e., each of the four biosecurity profiles have a corresponding PBV
ceiling. The profiles are updated monthly based on the facilities transactions and this may
change a facilities profile e.g., if high risk commodities or consignments from high-risk
countries arrive at a facility when previously they did not.
Verification frequency based on performance
A facility receiving an unacceptable PBV outcome will drop a PBV step which will result in
more frequent verification. To advance up a PBV step to receive less frequent verification, a
facility must achieve two consecutive acceptable PBV outcomes. Facilities may move up the
PBV steps until they reach the PBV ceiling as determined by their biosecurity profile.
Q
What is Evidence-based assurance?
A
Able to prove through objective evidence an assurance statement is truthful.
• Evidence-based assurance is in relation to regulatory assurances provided by BCS
to the BNZ Leadership team, stakeholders, and government. These assurances must
be supported with traceable, truthful, and accurate objective evidence i.e. , if an
assurance is challenged, BCS can easily prove its validity.
• Effective operator biosecurity management at Transitional Facilities is critical to the
performance of the biosecurity system. The PBV programme will enable BCS
management to provide assurance to government, BNZ leadership and stakeholders
that transitional facilities are operating in compliance with the biosecurity
6requirements. Those facilities that aren’t have been identified and appropriate
controls are in place.
• This assurance will be proven through verifier competency and proficiency,
consistency of PBV decisions, accurate, trusted data, truthful information, and ability
to withstand external scrutiny when challenged or audited.
Q
What does PBV mean for my Transitional Facility?
A
• PBV will allow a move from “one size fits all” to providing choice for TFs to utilise
their own individual TF operator quality biosecurity programmes.
• More useful, new style PBV report produced for TF Operators at conclusion of each
PBV, of a quality suitable for use at board room level and which provides a clear
picture on the facility performance and compliance with regulatory requirements
• Assurance your TF operator programme is being effectively implemented
• Better recognition of the crucial role of Accredited Person & Approved Operator
appointed under the Biosecurity Act have within the biosecurity system
• Good compliance can result in less verification visits
• Proactive management ensures acceptable outcomes to avoid more frequent
verification
Q
What is the cost impact of PBV for my TF?
A
Facilities participating in the trial were not invoiced for Biosecurity NZ time.
A cost recovery review process is in place and this section will be updated once completed.
Facilities receiving an unacceptable PBV outcome will incur more cost due to more frequent
verification. Additional costs may also be incurred if the verifier needs to visit the facility to
verify corrective action plans have been completed as agreed.
The overall verification time is influenced by the preparedness of the operator in terms of
availability during the PBV and access to required documentation and records.
7Q
How will we know what we are supposed to do for a PBV visit?
A
• Start-up meeting
A Start Up meeting is held with each business before the first Performance
Based Verification (PBV) to discuss rules, roles and responsibilities. Operators
are provided with an information pack at time of booking and clarification is
available on request. An explanation for why this change is occurring will also be
given.
• Entry meeting
Before each verification the biosecurity verifier will explain how the verification will
work. They will explain the objective of the day, work through any health and
safety requirements and give any updates from Biosecurity NZ.
• Exit meeting
At the end of the PBV, the verifier will hold an exit meeting to explain the outcome
of the verification, as well as any aspects of the operator biosecurity management
which are performing well, could be improved or require formal corrective actions.
• PBV report
Following each PBV, the verifier will email a PBV report to the operator. This will
formalize details discussed at the exit meeting, including any corrective action
plans. Effective management to prevent recurrence of the reported issues will be
verified at the next PBV.
• PBV scope
The verifier may inform the operator of the verification plan (scope) prior to the
next scheduled verification. PBV seeks evidence of conformance and compliance
throughout the year, not just on the day. Operator identification and management
of issues through-out the year has a strong weighting on determining the PBV
outcome.
8Q
What will verification include?
A
At the commencement of each verification visit, the verifier will advise the operator of the
scope of verification, which should include:
a. follow up verification to previous reported non-conformance and/or non-
compliance
b. the planned verification topics, including any “must do topics” notified by
national programmes
c. an assessment of the operator’s internal verification activities, including day
to day monitoring, supervision, recording, reporting and corrective actions;
and
d. an assessment of any records relating to those activities; and
e. a physical verification of the operating environment and relevant biosecurity
activities occurring on site at the time of the verification; and
f. the expected duration of the verification
Note: The verifier may notify the operator of the planned scope prior to the
day of PBV occurring.
(2) Despite advising the scope, the verifier is not restricted to that scope during the
verification visit.
(3) The operator is provided the opportunity to respond to any identified compliance
issues and their response is taken into consideration when determining the verification
outcome.
(4) On completion of the verification and assessment of objective evidence obtained
during verification, the verifier must rate each of the topics verified and assign an
overall outcome for the verification.
Q
How will we know what the outcome of a verification visit is?
A
A report will be sent to Transitional Facilities from the verifier, after b eing peer-reviewed
within Biosecurity NZ. This will include ratings on verification topics and the PBV outcome.
Verified topics will be rated as either, performing, conforming, non -conforming, non-
complying or critical non-complying .
The PBV outcome will be either:
a. an acceptable outcome; or
b. an unacceptable outcome.
9Acceptable outcome means
a) that the operator is substantially complying with applicable regulatory
requirements; and
b) where there have been any departures from requirements, the operato r’s corrective
and preventive actions have been, or are being applied appropriately and are effective.
Unacceptable outcome means the verifier has determined that the operator is not in
substantial compliance with applicable regulatory requirements.
Q
What are verification topics and how are they rated?
A
Verification Topics
Verification topics correspond with topics in TFGEN. The intention is to focus on operator
management which ensures the outcome, and the specific requirements of the standard are
being achieved.
10Verification Topic Results
Classifying the performance status of verification topics helps form a picture of how well a
business entity / operator is managing their biosecurity responsibilities and achieving the
expected biosecurity outcomes.
Under the previous verification model, individual issues were rated as minor, major and
critical. The new verification programme will rate the topic rather than individual issues.
The intention is to strengthen operator procedures and practices relating to the verification
topic rather than focus solely on correcting the issue i.e. under the hygiene topic, fixing
cracks in a container pad alone will not strengthen the operator programme. Improving the
operator hygiene management procedure to ensure early detection of cracks and timely
corrective action by the operator occurs is the aim of PBV.
Based on verification results, each topic is classed as either performing, conforming, non -
conforming, non-complying or critical non-compliance
Performing
A verification topic should be classed as performing when:
• The operator is fully meeting applicable requirements of the Biosecurity Act 1991 and
regulatory requirements relevant to their approval. The operator can demonstrate sound
knowledge of the applicable requirements of the Act, the conditions of approval, legal
duties and how to meet these; and
• There are systems and procedures in place that are documented where required; and
• Procedures are routinely followed; and
• Full records are available where required; and
• The operator identifies departures from requirements, implements timely corrective and
preventive actions and follows up to ensure these are effective.
Conforming
A verification topic can be classed as conforming when:
• Observations made during verification indicate the potential for a current activity to
deteriorate into non-conformance if it continues uncorrected; or
• The operator identifies departures from requirements, effectively implements corrective
and preventive actions and follows up to ensure these are effective.
• Systems and procedures require slight updates or amendments.
• Recording sheets/systems are in place with minimal gaps in recording.
Non-conforming
A verification topic can be classed as non-conforming when:
• Applicable requirements of the Act and regulatory requirements relevant to their approval
are not fully met by the operator, but the departure from requirements is not reasonably
likely to have adverse effect on biosecurity; or
• The operator is not ensuring departures from requirements are identified in a timely
manner or ensuring the corrective, preventive and follow up actions are effective.
• There is a definite need for improvement in systems and procedures; or
11• There are isolated or sporadic lapses in implementation of procedures; or
• There is a consistent failure to keep adequate records.
Non-complying and Critical non-compliance
A verification topic can be classed as non-complying when:
• Applicable requirements of the Act and regulatory requirements relevant to their approval
are not met and findings can be referenced to an offence under the Act; or
• Applicable requirements of the Act and regulatory requirements relevant to their approval
are not met and/or the findings require the verifier to apply a compliance action; or
• A significant failure to manage biosecurity risks or comply with an applicable requirement
of the Act or regulatory requirements relevant to their approval is evident to the extent
that it is reasonably likely to have an adverse effect on biosecurity in the future if
improvements aren’t made. If biosecurity is threatened immediately, then this is Critical
non-compliance; or
• The operator is not ensuring departures from requirements are identified in a timely
manner. Corrective, preventive and follow up actions have not occurred or are
ineffective.
• Procedures and management systems that directly impact biosecurity are absent or
insufficient to manage biosecurity requirements and risks; or
• Procedures and management systems are not followed, and this constitutes a
direct/immediate risk to biosecurity; or
• Several non-conformances against an applicable requirement of the Act, regulatory
requirements relevant to their approval exist or there is repeated non-conformance of a
single requirement over successive verifications.
12Q
Will Corrective Actions still be required?
A
Corrective Action Plans (CAPS) replace the current Corrective Action Requests (CARS) in
use. A CAP would typically be issued for a topic that was rated non-compliant or for a topic
that had several non-conformances.
For topics rating conforming or non-conforming a CAP may not be issued but actions will be
agreed by the operator to address and manage internally through their own corrective action
process and provide evidence of this at the next PBV.
CAPS will have an agreed timeframe for the operator to supply the evidence of completion to
Biosecurity NZ.
Q
When is PBV starting at Transitional Facilities?
A
• The intention is to commence phase-in of PBV at certain profile levels from February
2022.
• Prior to the phase-in, report testing and PBV was conducted at selected TFs.
• Feedback is an integral part of the phase-in period, and will be sought from TF
Operators as part of this process.
Q
What happens if I don’t agree with the verifier’s findings?
A
Requesting a decision review
(1) An operator who is not in agreement with a verifier decision may seek a review of that
decision by emailing their request along with supporting information to
bcs.pbv@mpi.govt.nz.
(2) Border Clearance Services National Programmes unit will conduct a fact-based
assessment of the request and aim to respond to the submitter within 10 working days.
The submitter will be provided details of how to escalate their request should they be
dissatisfied with the initial response.
(3) National programmes will maintain a national register of all requests for a decision
review and associated correspondence.
13Q
Will the TF Operator training include information about PBV?
A
The TF operator training is currently being updated to include information on PBV, this will
include the information on the Biosecurity Profiles, the PBV audit and Corrective Action
Plans.
Q
Where can I find more information?
A
Prior to your first verification, your verifier will provide you with an information pack
containing: a copy of the PBV report template, an infographic on the PBV journey and this
FAQ document.
Your verifier will be able to provide clarification on the day of your PBV.
Alternatively, you may seek further information or clarification by contacting Biosecurity New
Zealand, National Programmes by email BCS.PBV@mpi.govt.nz; or
Visiting the Biosecurity New Zealand, Sea Cargo Pathways Programme, internet site
14Glossary
Acceptable outcome means
a) that the operator is substantially complying with applicable regulatory requirements and
delivering the intended outcomes; and
b) where there have been any departures from requirements, the operator’s corrective and
preventive actions have been, or are being applied appropriately and are effective.
Biosecurity profile: Biosecurity NZ determines a biosecurity profile for each TF by
assessing their previous 12 months biosecurity activities against several criteria
(consignment types received, number of consignments, number of shipping containers,
country of import, PBV history, 100% container reporting). The purpose is to determine an
appropriate maximum verification interval (PBV ceiling) appropriate for each TF that is
commensurate to the level of complexity and biosecurity risk associated with the TF.
CAP corrective action plan. A document notifying the operator of identified non-
conformance or non-compliance which requires the operator to plan appropriate corrective
and preventive actions.
Compliance action means a standard regulatory action/intervention which Biosecurity
New Zealand requires to be taken when a specific operator non-compliance is identified
during PBV.
External verification is verification conducted by a person who is independent to the
business and processes being verified/audited. External verification focuses on the
effectiveness of an operator’s management control and supervision of their programme for
delivering the required regulatory outcomes. PBV conducted by Biosecurity NZ is external
verification.
First verification frequency means the verification frequency assigned to a facility
following their first PBV, being either a new facility or an existing facility transitioning to PBV.
Must do verification topics are verification topics notified to verifiers by Biosecurity NZ’s
National Programmes, Border Clearance Services, and which must be included in the PBV
scope.
Regulatory requirement means any requirement of the Biosecurity Act 1993, associated
regulations, notices, and standards that apply to facilities.
Regulatory observations mean observations made by a Biosecurity Officer while
conducting activities other than PBV at a biosecurity business.
PBV Performance based verification. Businesses achieving acceptable PBV outcomes at
conclusion of their verification will receive less frequent verification (u p to the PBV ceiling for
the business). Businesses achieving an unacceptable PBV outcome will receive more
frequent verification.
PBV steps means a range of graduated verification frequencies (steps) e.g., from step 1,
fortnightly verification, through to step 9, 24 monthly verification.
PBV ceiling means the longest interval between verification visits that a facility may attain
and maintain through achieving acceptable PBV outcomes.
Unacceptable outcome means the verifier has determined that the operator is not in
substantial compliance with applicable regulatory requirements.
15Unannounced verification means a verification visit that has minimal or no prior
notification to the business, other than that necessary to ensure safe access and availability
of required staff.
Unscheduled verification means a visit that is notified to the business in a shorter
timeframe than would be expected for a scheduled visit (e.g., notified approximately a
week in advance of the visit).
Verification topic means a regulatory subject verified during PBV e.g., when verifying a
TF operator, a verification topic may be “Hygiene Management”.
Rating a verification topic means the rating applied to a verification topic on completion
of the PBV. Ratings reflect the effectiveness of the operator biosecurity management of
the verification topic.
Verifier means a Biosecurity New Zealand employee deemed through their management
system to have met verifier competency and proficiency requirements and has been
authorised to perform verification activities at specific businesses. Note (i) verifiers may
also be an Inspector appointed under section 103 of the Biosecurity Act 1993; and (ii)
some verifiers may also be Biosecurity Auditors appointed under section 105B of the
Biosecurity Act 1993.
16Performance-Based Verification Report
Company Name Thank you for commitment to
protecting NZ from harmful pest and
disease through good biosecurity
TF Unique Identifier practices at your facility
On commencement of the revised
Biosecurity New Zealand verification
programme, known as performance-
based verification (PBV) you will be
emailed a report like this a few days
after your verification has been
completed. This will now be a
paperless process.
Report Status The new report layout and key
changes are explained on the following
pages.
Final report date Your verifier will answer any questions
you may have prior to commencing
PBV.
Peer reviewedReport scope
Issued to The operators name will appear here
This section records Biosecurity NZ
Issued by The verifiers name will appear here and Facility personnel who
Biosecurity New Zealand regional office participated in the PBV.
PBV Scope: Biosecurity Act 1993, TFGEN, IHS
Performance Based Verification Summary
Verification Date:
This section provides information on the verification frequency,
Type of verification: the outcome of the PBV and when the next PBV is due.
Biosecurity Profile:
Each PBV will be rated as either acceptable or unacceptable, as
PBV Outcome: per the rating criteria (see last section of this document). The
outcome will determine when your next PBV will be due.
Current PBV Step:
New PBV Step:
Next PBV due by:
The introduction section provides an
Is the facility a Biosecurity Business Pledge partner? overview of the report and process for
managing corrective actions.
1. Introduction
This report relates to the performance-based verification of your transitional facility. The
purpose of the verification was to determine your biosecurity management practices for
ensuring conformance with your TF operator manual and compliance with the Biosecurity Act
1993, Facility Standard: Standard for Transitional Facilities for General Uncleared Risk
Goods and other biosecurity standards appliable to your TF and Operator approval. The
verification was a sampling exercise and therefore this report is based on the observations
made during the verification.
Each verification topic in this report is assigned a performance rating as either performing,
conforming, non-conforming, non-complying or critical non-complying.
As discussed at the exit meeting the TF operator is responsible for addressing all reported
non-conformances and non-compliances through your corrective action process and to keep
records to demonstrate completion.
The last section of this report details any specific corrective action plans required to be
completed by agreed clearance dates.
All details of this report were discussed with the operator during the exit meeting.
If you have concerns about the technical findings of the report, or clearance of corrective
action plans (CAPs), that cannot be resolved between you and the verifier, you may raise
your concerns by contacting Biosecurity NZ, National programmes at bcs.pbv@mpi.govt.nz
In-Confidence Page 2 of 62. Executive Summary
The verifier will provide a high-level summary of the
PBV, summarising the PBV outcome, positive
reinforcement of good biosecurity practices, any
significant non-compliance or non-conformance and
any corrective action plans which may be required
3. Verification Topics completed this PBV
3.1 Physical and Structural Requirements
Section three of the PBV report is designed to align
TF Security with TFGEN andTFGEN Performingto operator
2.1 easy correlation
facilitate
Narrative on operator management of each
Topic will be provided, including manuals.
examples of Objective evidence
Verification topics e.g., TF security, will each have a
observed.
short narrative along with a rating as per the rating
Leased TFs criteria (see last section
TFGEN of this report
2.1.1 for details).
Performing
TF location The verification narrative
TFGEN 2.2 and ratings relate to
Performing
operator biosecurity management e.g., conformance
Official TF signage TFGEN 2.3 Performing
with the operator manual & procedures and
compliance with TFGEN and other regulatory
3.2 Operational Requirements
requirements applicable to the facility.
Approved TF Operator TFGEN 3.1 Performing
Verification results will enable Biosecurity NZ to
provide industry with high level compliance trends
TF Manual which may beTFGEN
used by3.2operators to review and
Performing
strengthen their own procedures and practices.
Manual structure and Information TFGEN 3.2.1 Performing
Receipt and management of uncleared risk goods TFGEN 3.3.1 Performing
Transfer of topics
Verification uncleared risk
will be goods
rated as performing, conforming, TFGEN 3.3.2 Performing
non-conforming, non-complying and critical non-complying.
Unclaimed uncleared risk goods authorised to TFs TFGEN 3.3.3 Conforming
The scale enables clear separation of less serious though to
TF
veryaccess
seriousand security of uncleared risk goods
issues. TFGEN 3.4 Non-
conforming
Segregation of uncleared risk goods TFGEN 3.5 Critical non-
compliance
Record keeping High resolution photos may be TFGEN 3.6 Not verified
included where useful to do so.
Hygiene Management TFGEN 3.7 Non-
complying
The operator had not ensured
shipping containers were placed
appropriately before opening. The
two photos show placement on
gravel and incorrect spacing plus
another on grass and too close to
trees presents a biosecurity risk and non-conformance with the operator manual and non-
compliance with requirements.
In-Confidence Page 3 of 6Pests, other organisms, vermin and weed control TFGEN 3.8 Not
applicable
Internal audits of TF activities TFGEN 3.9 Performing
Inspection of uncleared risk goods at TFs TFGEN 3.10 Performing
Contingency plans TFGEN 3.11 Performing
Staff training TFGEN 3.12 Performing
MPI Verification TFGEN 3.13 Performing
High risk facilities will be reported in the
3.3 to 3.8 High Risk same manner as in section 3.2 above.
3.3 High Risk Biosecurity TF Is the facility approved for this function? No
3.4 Biosecurity Refuse TF Is the facility approved for this function? No
3.5 Biosecurity Treatment TF Is the facility approved for this function? No
3.6 Decontamination TF Is the facility approved for this function? No
3.7 Incineration or sterilisation TF Is the facility approved for this function? No
3.8 Holding non-compliant farm animals at TF or POFA Is the facility approved
for this function? No
4. What do I need to do now?
• Manage all reported non-conformances and non-compliances through your corrective
action process and to keep records to demonstrate completion.
• Manage corrective action plan(s) (if issued) and provide evidence
Section 4of&completion to Border
5 details operator corrective
Clearance Services by the agreed clearance date.
actions required as a result of the PBV.
• Contact your Border Clearance Services verifier if you would like clarification on any
aspects of this report or corrective actions. For significant non-conformance or non-
compliance, a corrective action plan
5. Corrective Action Plans (CAP) may be issued.
Total number issued: 0 A corrective action request (CAR)
template will no longer be issued. Rather
Infringement notice issued: No
the operator may determine the method
Intention to suspend notice issued: No which best suits their needs for
Compliance order issued: No documenting the plan. Biosecurity NZ
expectation is the plan will be
documented and include planned
• Some instances were identified where the systems or procedures were not in conformity
corrective action,
or compliance with TF Operator Biosecurity Management Programme and plan to understand why
/ or Biosecurity
the issue has occurred and then take
regulatory requirements which has resulted in the following Corrective Action Plan(s)
(CAP) being issued. appropriate preventive action to reduce
the likelihood of recurrence.
• You are reminded it is your responsibility to provide evidence of satisfactory completion to
the verifier by the agreed clearance date. The operator should complete the CAP by
the date agreed to with Biosecurity NZ
and send evidence of completion.
In-Confidence Page 4 of 6Corrective Action Plan Reference (1)
Verification topic:
Agreed clearance date:
Regulatory requirement and or outcome not achieved
Verifier/Auditor findings
TF Operator Action Required
Using your process for managing corrective actions, I recommend you:
1) Investigate the circumstances that led to the raising of this CAP and provide records
of your conclusions on the cause of the issue to your BNZ verifier for review; and
2) Describe the corrective action you have taken as a result of your investigations, to
correct the issue and prevent recurrence; and
3) Provide evidence of corrective action implementation. This should include copies of
any system changes you have made, and records to demonstrate that your corrective
actions have been implemented and are effective.
Regulatory reminder
1) Operator responsibilities
As a TF operator approved under the Biosecurity Act 1993, section 40 you are
responsible for managing compliance with conditions of the TF and your TF operator
approvals, including compliance with applicable standards and all directions given by
an inspector relating to goods held at your facility.
2) Possible consequence to ineffective management of your corrective action plan
Failure to resolve the issues identified in the agreed operator corrective action plan(s)
may result in further escalation of these issues by BNZ using powers under s126 of
the Biosecurity Act 1993. Possible consequences May include but may not be limited
to; interruption of operations, specific actions on management staff, infringements,
suspension, or cancellation of the facility.
Contact
For enquiries relating to PBV please email BCS.PBV@mpi.govt.nz
Criteria for determining a PBV Outcome
Acceptable PBV outcome means
a) that the operator is substantially complying with applicable regulatory requirements; and
In-Confidence Page 5 of 6b) where there have been any departures from requirements, the operator’s corrective and preventive actions have been, or are being applied appropriately and are effective. Unacceptable PBV outcome means the verifier has determined that the operator is not in substantial compliance with applicable regulatory requirements. Criteria for rating a Verification Topic Performing: TF operator manual fully conforms with requirements and is effectively managed to deliver the required outcomes Conforming: The TF operator manual is effectively managed to deliver the required outcomes however some improvements are required to strengthen processes and procedures Non-Conforming: The TF operator manual is not being managed effectively and improvements are required to strengthen processes and procedures to give assurance the required regulatory outcomes will be met. Non-complying & Critical non-compliance: The TF operator manual is not effectively managed and required regulatory outcomes are not being met. Where the non-compliance has an immediate and significant impact on biosecurity then this is categorised as critical non-compliance. An operator corrective action plan is required to strengthen processes, procedures, and biosecurity management. In-Confidence Page 6 of 6
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