The document discusses a plant health management standard and audits. It provides information on the plant health management standard (PHMS) which outlines requirements for businesses to operate responsibly to improve plant health and biosecurity. It discusses the plant healthy website and plant health assurance scheme (PHAS) which are related initiatives. The document also gives an overview of what an audit of the standard would involve, examining the paperwork, site assessment, pest risk analysis, supply chain management, and other areas to check compliance with the PHMS requirements.
Mature products are often still sold in substantial numbers with a widespread global footprint, despite being long past their marketing exclusivity. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Mature products are often still sold in substantial numbers with a widespread global footprint, despite being long past their marketing exclusivity. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
Presentation: Quality risk management issuesTGA Australia
Quality Risk Management (QRM) is a fundamental element of the regulation of medicinal products. Manufacturers and sponsors widely incorporate the elements of ICH Q9 into their QMS systems. Although Annex 20 (Quality Risk Management) is a voluntary Annex, version 13 of the PIC/S guide to GMP for medicinal products has seen a significant increase in the mandated QRM requirements through the general chapters and Annexes. What do organisations need to do to ensure that they understand their obligations to risk.
Pharmacovigilance "Module I" Pharmacovigilance system & their quality systemMohamed Raouf
This Module contains guidance for the establishment and maintenance of quality assured Pharmacovigilance systems for marketing authorization holders (MAHs) and national medicine authorities (NMAs).
Reference:- Guideline on good pharmacovigilance practices (GVP) version no.3
FDA hosted three webinars after the release of the Food Safety Modernization Act (FSMA) Final Rules on Preventive Controls. These rules will set new safety requirements for facilities that manufacture, process, pack or hold human food and animal food.
This Module provides guidance on planning and conducting the legally required audits, the role, context and management of pharmacovigilance audit activity.
The principles in this module are aligned with internationally accepted auditing standards, issued by relevant international auditing standardization organizations and support a risk-based approach to pharmacovigilance audits.
PECB Webinar: Hands on medical devices risk assessmentPECB
The webinar covers:
• Risk assessment in medical device management systems
• Key issues pertaining to ISO 13485
• FMEA model in medical devices management systems
Presenter:
This webinar will be presented by Mohmed EL Mahdy, PECB Certified Trainer who has extensive experience in Lead Auditor ISO 13485.
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Food safety is the utilization of various resources and strategies to ensure that all types of food are properly stored, prepared, and preserved so they are safe for consumption. The EXIM Policy is the Export-Import policies regulating international commerce in India.
Exim Policy is also known as the Foreign Trade Policy.
EXIM policy is import export policy that contains rules and regulations regarding doing imports and exports.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
Presentation: Quality risk management issuesTGA Australia
Quality Risk Management (QRM) is a fundamental element of the regulation of medicinal products. Manufacturers and sponsors widely incorporate the elements of ICH Q9 into their QMS systems. Although Annex 20 (Quality Risk Management) is a voluntary Annex, version 13 of the PIC/S guide to GMP for medicinal products has seen a significant increase in the mandated QRM requirements through the general chapters and Annexes. What do organisations need to do to ensure that they understand their obligations to risk.
Pharmacovigilance "Module I" Pharmacovigilance system & their quality systemMohamed Raouf
This Module contains guidance for the establishment and maintenance of quality assured Pharmacovigilance systems for marketing authorization holders (MAHs) and national medicine authorities (NMAs).
Reference:- Guideline on good pharmacovigilance practices (GVP) version no.3
FDA hosted three webinars after the release of the Food Safety Modernization Act (FSMA) Final Rules on Preventive Controls. These rules will set new safety requirements for facilities that manufacture, process, pack or hold human food and animal food.
This Module provides guidance on planning and conducting the legally required audits, the role, context and management of pharmacovigilance audit activity.
The principles in this module are aligned with internationally accepted auditing standards, issued by relevant international auditing standardization organizations and support a risk-based approach to pharmacovigilance audits.
PECB Webinar: Hands on medical devices risk assessmentPECB
The webinar covers:
• Risk assessment in medical device management systems
• Key issues pertaining to ISO 13485
• FMEA model in medical devices management systems
Presenter:
This webinar will be presented by Mohmed EL Mahdy, PECB Certified Trainer who has extensive experience in Lead Auditor ISO 13485.
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Food safety is the utilization of various resources and strategies to ensure that all types of food are properly stored, prepared, and preserved so they are safe for consumption. The EXIM Policy is the Export-Import policies regulating international commerce in India.
Exim Policy is also known as the Foreign Trade Policy.
EXIM policy is import export policy that contains rules and regulations regarding doing imports and exports.
useful for pharmaceutical quality assurance students, MBA and all people including industry employee to improve knowledge about the quality risk management process
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
Application of food safety risk assessment in identifying effective control m...ILRI
Presented by Kohei Makita, Katsuaki Sugiura and Tsu-Hoong Chua at a regional seminar for OIE national focal points for animal production food safety, Hanoi, Vietnam, 24-26 June 2014.
Arizona Center for Innovation (AzCI) presents: FDA Drug Development 101 - I discovered a drug which will cure the world disease - now what!
This presentation is part of a series developed for a workshop on "How to Navigate the Biotech Regulatory Process"
The Arizona Center for Innovation is an incubator and innovation center and provides resources in support of startups getting to the next level and become successful enterprises.
How can Food Safety Practitioners prepare for the FSMA Regulations?Beth Mitchell
In this article, Erasmo Salazar, LRQA’s Food Safety Technical Manager – Americas, discusses the impacts and implications of the Food Safety Modernization Act (FSMA) for food safety practitioners including Preventive Controls, Foreign Supplier Verification (FSVP) and Qualified Individuals (PCQI)
Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
Spectroscopy is a branch of science dealing the study of interaction of electromagnetic radiation with matter.
Ultraviolet-visible spectroscopy refers to absorption spectroscopy or reflect spectroscopy in the UV-VIS spectral region.
Ultraviolet-visible spectroscopy is an analytical method that can measure the amount of light received by the analyte.
Multi-source connectivity as the driver of solar wind variability in the heli...Sérgio Sacani
The ambient solar wind that flls the heliosphere originates from multiple
sources in the solar corona and is highly structured. It is often described
as high-speed, relatively homogeneous, plasma streams from coronal
holes and slow-speed, highly variable, streams whose source regions are
under debate. A key goal of ESA/NASA’s Solar Orbiter mission is to identify
solar wind sources and understand what drives the complexity seen in the
heliosphere. By combining magnetic feld modelling and spectroscopic
techniques with high-resolution observations and measurements, we show
that the solar wind variability detected in situ by Solar Orbiter in March
2022 is driven by spatio-temporal changes in the magnetic connectivity to
multiple sources in the solar atmosphere. The magnetic feld footpoints
connected to the spacecraft moved from the boundaries of a coronal hole
to one active region (12961) and then across to another region (12957). This
is refected in the in situ measurements, which show the transition from fast
to highly Alfvénic then to slow solar wind that is disrupted by the arrival of
a coronal mass ejection. Our results describe solar wind variability at 0.5 au
but are applicable to near-Earth observatories.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
The increased availability of biomedical data, particularly in the public domain, offers the opportunity to better understand human health and to develop effective therapeutics for a wide range of unmet medical needs. However, data scientists remain stymied by the fact that data remain hard to find and to productively reuse because data and their metadata i) are wholly inaccessible, ii) are in non-standard or incompatible representations, iii) do not conform to community standards, and iv) have unclear or highly restricted terms and conditions that preclude legitimate reuse. These limitations require a rethink on data can be made machine and AI-ready - the key motivation behind the FAIR Guiding Principles. Concurrently, while recent efforts have explored the use of deep learning to fuse disparate data into predictive models for a wide range of biomedical applications, these models often fail even when the correct answer is already known, and fail to explain individual predictions in terms that data scientists can appreciate. These limitations suggest that new methods to produce practical artificial intelligence are still needed.
In this talk, I will discuss our work in (1) building an integrative knowledge infrastructure to prepare FAIR and "AI-ready" data and services along with (2) neurosymbolic AI methods to improve the quality of predictions and to generate plausible explanations. Attention is given to standards, platforms, and methods to wrangle knowledge into simple, but effective semantic and latent representations, and to make these available into standards-compliant and discoverable interfaces that can be used in model building, validation, and explanation. Our work, and those of others in the field, creates a baseline for building trustworthy and easy to deploy AI models in biomedicine.
Bio
Dr. Michel Dumontier is the Distinguished Professor of Data Science at Maastricht University, founder and executive director of the Institute of Data Science, and co-founder of the FAIR (Findable, Accessible, Interoperable and Reusable) data principles. His research explores socio-technological approaches for responsible discovery science, which includes collaborative multi-modal knowledge graphs, privacy-preserving distributed data mining, and AI methods for drug discovery and personalized medicine. His work is supported through the Dutch National Research Agenda, the Netherlands Organisation for Scientific Research, Horizon Europe, the European Open Science Cloud, the US National Institutes of Health, and a Marie-Curie Innovative Training Network. He is the editor-in-chief for the journal Data Science and is internationally recognized for his contributions in bioinformatics, biomedical informatics, and semantic technologies including ontologies and linked data.
Introduction:
RNA interference (RNAi) or Post-Transcriptional Gene Silencing (PTGS) is an important biological process for modulating eukaryotic gene expression.
It is highly conserved process of posttranscriptional gene silencing by which double stranded RNA (dsRNA) causes sequence-specific degradation of mRNA sequences.
dsRNA-induced gene silencing (RNAi) is reported in a wide range of eukaryotes ranging from worms, insects, mammals and plants.
This process mediates resistance to both endogenous parasitic and exogenous pathogenic nucleic acids, and regulates the expression of protein-coding genes.
What are small ncRNAs?
micro RNA (miRNA)
short interfering RNA (siRNA)
Properties of small non-coding RNA:
Involved in silencing mRNA transcripts.
Called “small” because they are usually only about 21-24 nucleotides long.
Synthesized by first cutting up longer precursor sequences (like the 61nt one that Lee discovered).
Silence an mRNA by base pairing with some sequence on the mRNA.
Discovery of siRNA?
The first small RNA:
In 1993 Rosalind Lee (Victor Ambros lab) was studying a non- coding gene in C. elegans, lin-4, that was involved in silencing of another gene, lin-14, at the appropriate time in the
development of the worm C. elegans.
Two small transcripts of lin-4 (22nt and 61nt) were found to be complementary to a sequence in the 3' UTR of lin-14.
Because lin-4 encoded no protein, she deduced that it must be these transcripts that are causing the silencing by RNA-RNA interactions.
Types of RNAi ( non coding RNA)
MiRNA
Length (23-25 nt)
Trans acting
Binds with target MRNA in mismatch
Translation inhibition
Si RNA
Length 21 nt.
Cis acting
Bind with target Mrna in perfect complementary sequence
Piwi-RNA
Length ; 25 to 36 nt.
Expressed in Germ Cells
Regulates trnasposomes activity
MECHANISM OF RNAI:
First the double-stranded RNA teams up with a protein complex named Dicer, which cuts the long RNA into short pieces.
Then another protein complex called RISC (RNA-induced silencing complex) discards one of the two RNA strands.
The RISC-docked, single-stranded RNA then pairs with the homologous mRNA and destroys it.
THE RISC COMPLEX:
RISC is large(>500kD) RNA multi- protein Binding complex which triggers MRNA degradation in response to MRNA
Unwinding of double stranded Si RNA by ATP independent Helicase
Active component of RISC is Ago proteins( ENDONUCLEASE) which cleave target MRNA.
DICER: endonuclease (RNase Family III)
Argonaute: Central Component of the RNA-Induced Silencing Complex (RISC)
One strand of the dsRNA produced by Dicer is retained in the RISC complex in association with Argonaute
ARGONAUTE PROTEIN :
1.PAZ(PIWI/Argonaute/ Zwille)- Recognition of target MRNA
2.PIWI (p-element induced wimpy Testis)- breaks Phosphodiester bond of mRNA.)RNAse H activity.
MiRNA:
The Double-stranded RNAs are naturally produced in eukaryotic cells during development, and they have a key role in regulating gene expression .
1. Plant Healthy
Plant Health Management Standard & Audits
Phyto-threats Workshop 13th November 2019
Helen Bentley-Fox & Amanda Calvert
2. Plant health management & audits
• Background to Plant Health Management Standard (PHMS)
- History
- What next
• Plant healthy
- Website
- Assurance scheme
• What to expect at audit
- Auditor’s viewpoint of the standard’s requirements
• Discussion and questions
3. Plant Healthy
Plant Health Management Standard (PHMS)
Plant Healthy – online self assessment
Plant Health Assurance Scheme (PHAS)
Plant Health Alliance Steering Group
4. Plant Healthy
Plant Health Management Standard
Plant Healthy – online self assessment
Plant Health Assurance Scheme (PHAS)
Plant Health Alliance Steering Group
Plant Health Assurance Scheme test audit
5. Plant Healthy
Membership organisations
Trade Associations
Government
Plant Health Biosecurity Steering Group
Chair - Sir Nicholas Bacon
Governing Body for PHAS
Plant Health Management Standard (PHMS)
Plant Healthy – online self assessment
Plant Health Assurance Scheme (PHAS)
Plant Health Alliance Steering Group
6. Plant Healthy
Plant Health Management Standard (PHMS)
Plant Healthy – online self assessment
Plant Health Assurance Scheme (PHAS)
Plant Health Alliance Steering Group
7. Plant Health Management Standard (PHMS)
A list of requirements that
demonstrates a business
or organisation is operating
responsibly
23 requirements to improve
the health of the plants we
buy and sell & enhance
biosecurity
Other certification schemes The standard behind the Plant Health Assurance Scheme
8. To prescribe, or not to prescribe: that is the question
Plant Health Management Standard (PHMS)
10. Plant Health Management Standard (PHMS)
To prescribe, or not to prescribe: that is the question
The insect proof facilities
should have a double door
entrance. Dimensions of this
entrance should be
compatible with the size of
the largest machinery to be
used (the two doors should
never be open at the same
time)
11. Plant Health Management Standard (PHMS)
To prescribe, or not to prescribe: that is the question
‘The organization shall
maintain biosecurity’.
12. Plant Health Management Standard (PHMS)
To prescribe, or not to prescribe: that is the question
Requirements
must be
applicable to a
range of business
types
Guidance – can
then offer
examples on how
to achieve the
requirements
Intuitive and adoptable requirements that cover businesses within the plant supply chain
13. PHMS – Plant Supply Chain
Propagation
material
Trade & movement of
propagation material
Propagation
facility
Growing of
plants
Trade and
movement of
plants
Plants in the
landscape guidance documents
14. Two key concepts:
(1) Appropriate Level of Protection (ALOP) – World Trade Organisation
(2) Pest risk analysis (PRA) – International Plant Protection Convention
These are normally applied at the national level…
Risk based approach – Needed to be flexible yet robust. External and internal
influences unique to each business or organisation.
Principles of ALOP and PRA have been adapted for the purposes of a ‘site’ to enable a
joined up approach
Aim is to map pest pathways and prevent new pest introductions into a defined area
Plant Health Management Standard (PHMS)
15. Stages adapted from the
International Plant Protection
Convention’s framework for
pest risk analysis. For the
purposes of applying the
principles at the site level.
Pest Risk
Analysis
Unmitigated
risk The level of risk to the business /
organisation and environment if
appropriate controls are NOT in place –
see - UK Plant Health Risk Register
(2) Pest Risk Assessment
Site
[Host]
Plants
Identify
pests
Map pest
pathways
List plants handled by a business (run
through this process with specifications of
plant and new species handled)
Pests that can infest plants
handled by business – see
Plant Health Risk Register
How the pests can arrive,
proliferate and be transferred
from the site (e.g. through
trade, visitors or natural
processes).
Define site boundaries (nursery, garden
centre, landscapers yard, garden)(1) Initiation
Controls
Managed
risk
Appropriate Level
of Protection
(ALOP)
The husbandry and housekeeping
measures available to control pests
The level of risk to the business /
organisation and environment if
suitable controls and management
systems are in place.
Define ALOP for site and
demonstrate that the
level of risk is acceptable
Monitoring
linked to the pest risk
assessment (unmitigated risk)
for specific pests –
demonstrates effectiveness of
controls and management
systems
(3) Pest Risk Management
Note – the term ‘Pests’ includes diseases
and ‘infest’ includes ‘infect’
20. planthealthy.org.uk
Next steps
Plant Health Biosecurity Steering Group
Approve the business plan
Funding
Certification Bodies
Certification process
Launch(es) to all sectors
Launch to public
23. The Audit Process
Paperwork and
Site assessment
Business description
• The location
• Size of the business
• Number of employees
• Type of business
24. Legal requirements
The company should be able to
provide records/evidence to
illustrate that any statutory
requirements imposed have been
fulfilled and discharged.
Plant Passports,
Phytosanitary Certificates
and Forest Reproductive
Material regulations
25. Plant Health Policy
The business’ approach to plant health
A plant health policy statement is a company-
level document that sets out commitment
and prescribes acceptable methods or
behaviours relating to plant health rules and
objectives within the business, a set of
expectations put in place to manage
employee behaviour.
Policies are different from procedures and
standard operating procedures because they
are applicable to an entire organisation and
are primarily intended to set direction.
The policy must be signed and dated by a
senior responsible person and reviewed as
part of a continual improvement process at
least annually.
27. Pest Risk Analysis
Areas of plant health risk shall be identified
and assessed, and specific plans shall be in
place to reduce these risks to an Appropriate
Level of Protection
• The extent of site
• Susceptible host plants
• Significant pests
• Pathways of pests
• Potential or level of risk
• Current or planned mitigation
• Risk following mitigation
• Monitoring of the site
• Evidence of review
28. Supply chain management
As part of the pest risk analysis, the business shall risk-assess their suppliers and approve those that they
deem to have met their plant health requirements.
What level of biosecurity do suppliers have in place?
29. Plant health hygiene and housekeeping
Rules and practices, that have been
assessed and developed through the
pest risk analysis processes.
• General housekeeping -
• Growing media and soil
• Weed management
• Water
• Cleaning
• Waste treatment and disposal
• Visitors
30. Plant health controls
• Goods in
• Traceability
• Treatment and mitigation
• Dispatch
• Complaints
31. Monitoring and ongoing health assessment
• Ongoing monitoring
• Self-assessment, review and continual
development
32. Training and recognition
• Plant health competencies
• Legislation and keeping up to date
• Information sharing
• Other relevant training
HBF and I work for GiB as the technical manager for the grown in Britain standards
a technical expert for a couple of standard committees in the British standards Institute,
feeding into a number of international standards.
PHMS with Alistair Yeomans from the HTA who is unable to attend today.
I’ll let Amanda introduce herself as we are doing a bit of a double act just to keep you interested.
talk about the scheme and how it has developed. What you can do today and what you need to make sure you are Plant Healthy ready in 2020. Amanda will then go into what you should expect at audit in more detail. If we could have questions at the end.
PHMS long time in the making,
some of you may already be aware of but please bear with me.
The overarching aim of Plant health management standard is to provide a checklist that will enable you to improve your plant health management systems as part of the plant supply chain. It is based on the International Plant Protection Convention’s framework for pest risk analysis and using this checklist and periodic reviews to continually improve your plant health management.
The assurance scheme is overarches the implementation of the PHMS and allows businesses to sign up to the scheme, be audited against the standard and publicise that they are part of the scheme. The scheme details how companies are audited, by whom, how often and how they will be regulated using the logo and finally awarded a certificate.
This is the group that owns the standard. They are borne out of the Highgrove meeting a year and a half ago and chosen to hold the standard to ensure that it is not influenced by any particular trade body to demonstrate independence of the scheme and support throughout the sector.
On line Plant healthy assessment… I will go into this later on in my presentation but suffice to say it is an online self assessment tool to help a business identify where they could improve their biosecurity.
The PHMS is a list of just 23 requirements to improve the health of the plants we buy and sell thereby enhancing biosecurity.
You are probably familiar with these logos, Red Tractor, FSC and Fairtrade. Behind certification schemes there are standards just like the PHMS. Once a company is audited against these standards they are permitted to use the logo and certification mark within the scheme restrictions.
The standard was quite a few years in the making as you are probably aware. It went from generic to prescriptive and back again, and again and again…. and finally settled as the standard that you can view on the Plant Healthy website.
Many of you are probably familiar with Iso standards such as 9001. As you know the ISO standards are quite generic and when you are audited it includes only what you write in the scope. For example, ISO9001 is a quality management system for your plants, but if you choose to leave out plant health in your scope of what you see as quality your definition of quality is the plants must be of a certain height in a certain pot, you can still attain 9001 certification.
So the trick was to write the phms in a generic enough way that it could cover all types of businesses but specific enough that it is effective.
So prescribing or not prescribing becomes a balancing act.
Highly prescriptive descriptions such as this with a double door entrance, never open at the same time.
Overly generic and the company won’t know where to start or what the auditor will need to see. Also, for the auditor this is impossible to audit as the auditor will not know when the requirements have been met.
Guidance provides examples of different ways or approaches to meet the requirements of the standard. Wording of each requirement had to be tested to see if it was applicable to a range of business types and that it would allow for different scales of operation and different business models to meet the requirements in a way that is practical to each business.
The outcome is the same
The knowledge of why and how must run throughout the business
So now we think we have a standard that covers the whole plant supply chain.
Rather than reinvent the wheel we took two internationally recognised concepts ALOP and PRA developed by international experts.
appropriate level of protection (ALOP) is the level of protection deemed appropriate by the company establishing a sanitary or phytosanitary measure to protect, human, animal or plant life or health within its territory. This concept is also referred to as the acceptable level of risk.
pest risk analysis is the process of evaluating biological or other scientific and economic evidence to determine whether an organism is a pest, whether it should be regulated (or in the case of this standard should be managed by the individual business), and the strength of any phytosanitary measures to be taken against it.
PRA – don’t get confused with pest risk assessment which is the evaluation of the probability of the introduction and spread of a pest and the magnitude of the associated potential economic consequences.
Normally, these are applied at the national level so we adapted them so they applied to a site rather than a country. Same principle but on a much smaller scale. So what does this look like….
Difference between process and the assessment. International standards so that it can be implemented globally.
Blue boxes are assessing what you have ie initiating the pest risk analysis,
the purple is assessing the risk
the green are your actions to try and reduce that identified risk ie manage that risk.
It is a cycle as things change and everything must be constantly reviewed.
This could result in many different risk assessments and outcomes or they could be grouped for example, Pathways could be assessed for area such as water and Phytopthera and the mitigation may be a sand filter.
Underpinning this cycle are a number of extra requirements. They may be external such as statutory requirements (section 4.1 of the standard), or internal such as your company plant health policy (Section 4.2 of the standard), how your company is organised and who is responsible each element of plant health cycle (4.3) and finally how plant health is disseminated within your company and how the company keeps up to date with new stuff (4.9).
So that is what we have done and why. This next bit is about what is ready now. If you haven’t already done so, go to the plant healthy website. There you can find the standard and also a plant healthy checklist to mark where you are now.
From what I understand nearly 200 companies have completed an assessment, showing an appetite for doing something about biosecurity, definitely at the nursery level but this needs to expand to other business sectors.
The checklist is simple and covers each of those items earlier on the cycle and the standard. The checklist asks you if you have done anything or if you think it isn’t applicable to your organisation.
Once completed you get a summary like the one above telling you what your score is. Hopefully it is better than this example.
Tomorrow approve business plan
Secure funding
We two certification bodies
Processes for certification including training of auditors
Launching to sectors Spring 2020 (subject to tomorrow’s meeting and funding) – it may be rolled out different times to different sectors…
Soft launch to public by Summer 2020.
Obviously brand awareness is part of this…
Certify businesses not products… cannot label individual plants because of broken coc.
2017 – 11 audits in total, 10 then 1 in 2019 – Delamere
Informed the development of the standard, guidance, future audit process and documents
Before the audit – background info re the business – website, also talk to directors/managing directors of the business to let them know roughly how long the audit will take, the staff we would like to talk to (to make sure they are there) and the type of things we would like to look at – eg paperwork and a walk around the site/sites
Length of audit depend on the size and type of business and whether is across multiple sites
Check if there are any known risks in the area/region that the nursery is located – e.g. Chalara etc
Arrival on site – Visual check – surroundings – public access – footpaths, gardens, level of exposure. Where you park, the reception area – is it on the actual nursery or in a different area, are we asked to sign a visitor book are we asked to clean our boots – does anyone notice if they are covered in mud? We are auditors and could have been to another nursery that has issues
Then have an initial meeting that always includes the director/manager that has the ultimate responsibility for the nursery/business, and those that run the nursery on a day to day basis. We may also call in other members of staff at this point, again depending on the size of the business and roles within it
How and who manages them
Have they got any processes in place
Who is responsible if an outbreak of a notifiable pest occurs – is there a written process in place?
Have they had any outbreaks –what did they do how was it managed
When walking around the nursery we will look out for incoming stock and then when we go back into the office ask for all documentation relating to it to assess whether the systems work,
Policy statement and underlying processes to enable the business to meet the objectives set out within that policy
Roles all the way down to dispatch, who is responsible for what, how do they know, how do they report who do they report to
How the business manages risk – do they know what they are, have they looked into all areas of risk in depth, RA need to be useable/understandable by staff and easy to update and review – check that the processes/systems they have are fit for purpose will they support reducing and mitigation of risk, what controls are in place and who is responsible, how is this communicated
Procurement processes, due diligence checks
General eg boot washing
More specific – soil – when it arrives – visual assessment
Sterilisation of seed beds – is it done how often, is growing media re-used? What do they do with it after its used
Water – supply, storage, water treatments, testing, drainage across the site
Waste treatment where is it how does it drain, how hot does it get
Wider environment
Goods in – where do they come into – is it in the main nursery area? What sort of checks take place? Do they check the pallets re imported goods etc.
Traceability how is this managed on site from the moment of arrival to sale – then spot check on site take back a reference to the office and follow through
Talk to staff re in all departments and check that the processes described in the office are actually put into practise at each stage.