Risk Assessment Study to justify whether metal detection step improves protection of finished products from metal contamination.
Risk Assessment for BRC Global Standards Course Assignment, MAR 2022
Validation & Verification Study for Metal Detection CCP - AG - LinkedIn profi...Adrian Garcia
This project contains an example of a validation and verification study for 3 models of metal detectors posed as an alternative to replace current aging models in current food manufacturing lines.
This is a Validation & Verification for BRC Global Standards Course Assignment, MAR 2022
Process equipment characterization – how standardized extractables data suppo...MilliporeSigma
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Process equipment characterization – how standardized extractables data suppo...Merck Life Sciences
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
The latest version of BRC Food Issue 8 published on August, 2018 and transition from the previous version is ahead. One of the most important steps in the transition process, as well as in the initial implementation, is determining what documents are needed for an effective Food Safety System based on BRC Food Issue 8. This publication designed to understand mandatory BRC documents requirements as per latest standard BRC Food Safety Issue 8.
For more details visit our website: https://www.globalmanagergroup.com/
Detecting physical contaminants in food, such as metal, glass, stone, plastic, and bone is like trying to find a needle in a haystack, especially when the contaminant may be as small as 1 mm in diameter. Metal detectors and X-ray detection systems provide the highest sensitivity so you can find virtually any foreign object in your packaged food products. Learn about the regulations, technology, and equipment for package product quality inspection in the food industry.
More: https://www.thermofisher.com/us/en/home/industrial/food-beverage/food-weighing-inspection.html
Validation & Verification Study for Metal Detection CCP - AG - LinkedIn profi...Adrian Garcia
This project contains an example of a validation and verification study for 3 models of metal detectors posed as an alternative to replace current aging models in current food manufacturing lines.
This is a Validation & Verification for BRC Global Standards Course Assignment, MAR 2022
Process equipment characterization – how standardized extractables data suppo...MilliporeSigma
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Process equipment characterization – how standardized extractables data suppo...Merck Life Sciences
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
The latest version of BRC Food Issue 8 published on August, 2018 and transition from the previous version is ahead. One of the most important steps in the transition process, as well as in the initial implementation, is determining what documents are needed for an effective Food Safety System based on BRC Food Issue 8. This publication designed to understand mandatory BRC documents requirements as per latest standard BRC Food Safety Issue 8.
For more details visit our website: https://www.globalmanagergroup.com/
Detecting physical contaminants in food, such as metal, glass, stone, plastic, and bone is like trying to find a needle in a haystack, especially when the contaminant may be as small as 1 mm in diameter. Metal detectors and X-ray detection systems provide the highest sensitivity so you can find virtually any foreign object in your packaged food products. Learn about the regulations, technology, and equipment for package product quality inspection in the food industry.
More: https://www.thermofisher.com/us/en/home/industrial/food-beverage/food-weighing-inspection.html
Foreign material control is a cornerstone of food safety in the industry. By implementing stringent inspection protocols and utilizing cutting-edge detection methods, we proactively identify and eliminate foreign contaminants from our products. Our commitment to rigorous quality assurance ensures that consumers can trust in the purity and safety of our food, upholding the highest standards of excellence and integrity.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMerck Life Sciences
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
In beverage processing, Quality Control (QC) is vital for ensuring product safety and consistency. Critical Control Points (CCPs) are meticulously identified and monitored to mitigate risks throughout the production process. Through stringent QC protocols and CCP implementation, we uphold the highest standards of quality, guaranteeing that every sip of our beverage delights consumers with unmatched taste and safety assurance.
Considerations to Extractables and Leachables Testing SGS
How to organize Extractables Assessments? FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, and Process Validation, and recently to include failures of manufacturers in Risk Management. The evaluation of extractables and leachables has become an increasingly important aspect in the Quality by Design (QbD) initiative of the FDA in the area of drug product design, including materials used in the drug product production process and container and closure systems used for product packaging. This presentation provides general approaches and practical aspects in E&L testing.
The Impact of BRC Food 7: Most Common Non-ConformitiesTraceGains
The 7th issue of the BRC Global Standard for Food Safety began audits July 1, 2015, and we now have almost 2 months’ worth of results. The information coming back paints a picture of readiness of sites for the changes, and a picture of what they have had to prepare for successful continuation of certification is forming.
The session will cover the most significant changes the 7th issue brought forward, why they were included, what BRC expected, and what impact the changes are actually having on the industry.
Specifically, the session will focus on:
-The top non-conformities seen in issue 7 audits
-Strategies for your operation to learn from these early audits
-What changes have been made, and why they make the BRC Global Standards the leading certification for food safety.
BRC is the leading and most recognized of the GFSI benchmarked programs, and is used at manufacturing sites, and by customers as a leading certification around the world. John Kukoly, our presenter, is the head of BRC activities in the Americas.
Introduction to Hazard Studies
CONTENTS
1 INTRODUCTION
2 HAZARD EVALUATION TECHNIQUES
2.1 Hazard Identification and Control
2.2 Selection of Technique
2.3 GBHE Hazard Study Procedure
2.3.1 Study One – Concept stage hazard review
2.3.2 Study two - Front-end engineering design
and project definition
2.3.3 Study three – detailed design hazard study
2.3.4 Study four – construction/ design verification
2.3.5 Study five – pre-commissioning safety review
2.3.6 Study six – project close-out/ post start-up review
2.4 Application of Hazard Study Procedure
2.5 Outcomes from the Process
2.6 the Hazard Study Toolkit
2.7 Change Management/Modifications
3 HAZARD STUDY LEADER CAPABILITY AND APPOINTMENT
REFERENCES
APPENDICES
A THE PROJECT PROCESS
B GBHE HAZARD STUDY TOOLKIT
Quality by design for Pharmaceutical Industries: An introductionCovello Luca
In this presentation, I have attempted to provide a quick introduction into the main concepts behind Pharmaceutical Quality by Design, an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of drugs.
Hotel management involves overseeing all aspects of a hotel's operations to ensure smooth functioning and exceptional guest experiences. This multifaceted role includes tasks such as managing staff, handling reservations, maintaining facilities, overseeing finances, and implementing marketing strategies to attract guests. Effective hotel management requires strong leadership, communication, organizational, and problem-solving skills to navigate the complexities of the hospitality industry and ensure guest satisfaction while maximizing profitability.
More Related Content
Similar to Risk Assessment for metal detection requirement - BRCGS v8 clause 4.10.3.1 - LinkedIn Profile.pdf
Foreign material control is a cornerstone of food safety in the industry. By implementing stringent inspection protocols and utilizing cutting-edge detection methods, we proactively identify and eliminate foreign contaminants from our products. Our commitment to rigorous quality assurance ensures that consumers can trust in the purity and safety of our food, upholding the highest standards of excellence and integrity.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMerck Life Sciences
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
In beverage processing, Quality Control (QC) is vital for ensuring product safety and consistency. Critical Control Points (CCPs) are meticulously identified and monitored to mitigate risks throughout the production process. Through stringent QC protocols and CCP implementation, we uphold the highest standards of quality, guaranteeing that every sip of our beverage delights consumers with unmatched taste and safety assurance.
Considerations to Extractables and Leachables Testing SGS
How to organize Extractables Assessments? FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, and Process Validation, and recently to include failures of manufacturers in Risk Management. The evaluation of extractables and leachables has become an increasingly important aspect in the Quality by Design (QbD) initiative of the FDA in the area of drug product design, including materials used in the drug product production process and container and closure systems used for product packaging. This presentation provides general approaches and practical aspects in E&L testing.
The Impact of BRC Food 7: Most Common Non-ConformitiesTraceGains
The 7th issue of the BRC Global Standard for Food Safety began audits July 1, 2015, and we now have almost 2 months’ worth of results. The information coming back paints a picture of readiness of sites for the changes, and a picture of what they have had to prepare for successful continuation of certification is forming.
The session will cover the most significant changes the 7th issue brought forward, why they were included, what BRC expected, and what impact the changes are actually having on the industry.
Specifically, the session will focus on:
-The top non-conformities seen in issue 7 audits
-Strategies for your operation to learn from these early audits
-What changes have been made, and why they make the BRC Global Standards the leading certification for food safety.
BRC is the leading and most recognized of the GFSI benchmarked programs, and is used at manufacturing sites, and by customers as a leading certification around the world. John Kukoly, our presenter, is the head of BRC activities in the Americas.
Introduction to Hazard Studies
CONTENTS
1 INTRODUCTION
2 HAZARD EVALUATION TECHNIQUES
2.1 Hazard Identification and Control
2.2 Selection of Technique
2.3 GBHE Hazard Study Procedure
2.3.1 Study One – Concept stage hazard review
2.3.2 Study two - Front-end engineering design
and project definition
2.3.3 Study three – detailed design hazard study
2.3.4 Study four – construction/ design verification
2.3.5 Study five – pre-commissioning safety review
2.3.6 Study six – project close-out/ post start-up review
2.4 Application of Hazard Study Procedure
2.5 Outcomes from the Process
2.6 the Hazard Study Toolkit
2.7 Change Management/Modifications
3 HAZARD STUDY LEADER CAPABILITY AND APPOINTMENT
REFERENCES
APPENDICES
A THE PROJECT PROCESS
B GBHE HAZARD STUDY TOOLKIT
Quality by design for Pharmaceutical Industries: An introductionCovello Luca
In this presentation, I have attempted to provide a quick introduction into the main concepts behind Pharmaceutical Quality by Design, an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of drugs.
Similar to Risk Assessment for metal detection requirement - BRCGS v8 clause 4.10.3.1 - LinkedIn Profile.pdf (20)
Hotel management involves overseeing all aspects of a hotel's operations to ensure smooth functioning and exceptional guest experiences. This multifaceted role includes tasks such as managing staff, handling reservations, maintaining facilities, overseeing finances, and implementing marketing strategies to attract guests. Effective hotel management requires strong leadership, communication, organizational, and problem-solving skills to navigate the complexities of the hospitality industry and ensure guest satisfaction while maximizing profitability.
Hamdard Laboratories (India), is a Unani pharmaceutical company in India (following the independence of India from Britain, "Hamdard" Unani branches were established in Bangladesh (erstwhile East Pakistan) and Pakistan). It was established in 1906 by Hakeem Hafiz Abdul Majeed in Delhi, and became
a waqf (non-profitable trust) in 1948. It is associated with Hamdard Foundation, a charitable educational trust.
Hamdard' is a compound word derived from Persian, which combines the words 'hum' (used in the sense of 'companion') and 'dard' (meaning 'pain'). 'Hamdard' thus means 'a companion in pain' and 'sympathizer in suffering'.
The goals of Hamdard were lofty; easing the suffering of the sick with healing herbs. With a simple tenet that no one has ever become poor by giving, Hakeem Abdul Majeed let the whole world find compassion in him.
They had always maintained that working in old, traditional ways would not be entirely fruitful. A broader outlook was essential for a continued and meaningful existence. their effective team at Hamdard helped the system gain its pride of place and thus they made an entry into an expansive world of discovery and research.
Hamdard Laboratories was founded in 1906 in Delhi by Hakeem Hafiz Abdul Majeed and Ansarullah Tabani, a Unani practitioner. The name Hamdard means "companion in suffering" in Urdu language.(itself borrowed from Persian) Hakim Hafiz Abdul Majeed was born in Pilibhit City UP, India in 1883 to Sheikh Rahim Bakhsh. He is said to have learnt the complete Quran Sharif by heart. He also studied the origin of Urdu and Persian languages. Subsequently, he acquired the highest degree in the unani system of medicine.
Hakim Hafiz Abdul Majeed got in touch with Hakim Zamal Khan, who had a keen interest in herbs and was famous for identifying medicinal plants. Having consulted with his wife, Abdul Majeed set up a herbal shop at Hauz Qazi in Delhi in 1906 and started to produce herbal medicine there. In 1920 the small herbal shop turned into a full-fledged production house.
Hamdard Foundation was created in 1964 to disburse the profits of the company to promote the interests of the society. All the profits of the company go to the foundation.
After Abdul Majeed's death, his son Hakeem Abdul Hameed took over the administration of Hamdard Laboratories at the age of fourteen.
Even with humble beginnings, the goals of Hamdard were lofty; easing the suffering of the sick with healing herbs. With a simple tenet that no one has ever become poor by giving, Hakeem Abdul Majeed let the whole world find compassion in him. Unfortunately, he passed away quite early but his wife, Rabia Begum, with the support of her son, Hakeem Abdul Hameed, not only kept the institution in existence but also expanded it. As he grew up, Hakeem Abdul Hameed took on all responsibilities. After helping with his younger brother's upbringing and education, he included him in running the institution. Both brothers Hakeem Abdul Hameed and Hakim Mohammed
Vietnam Mushroom Market Growth, Demand and Challenges of the Key Industry Pla...IMARC Group
The Vietnam mushroom market size is projected to exhibit a growth rate (CAGR) of 6.52% during 2024-2032.
More Info:- https://www.imarcgroup.com/vietnam-mushroom-market
Vietnam Mushroom Market Growth, Demand and Challenges of the Key Industry Pla...
Risk Assessment for metal detection requirement - BRCGS v8 clause 4.10.3.1 - LinkedIn Profile.pdf
1. 2022
Adrian Garcia
Risk Assessment for BRC Global Standards
Course Assignment
28/03/2022
RISK ASSESSMENT REPORT FOR
METAL DETECTION REQUIREMENT
2. RISK ASSESSMENT FOR METAL DETECTION REQUIREMENT
BRCGS FOR FOOD SAFETY ISSUE 8:
CLAUSE 4.10.3.1
Page 1 of 6 Prepared by: AG // Reviewed by: AD // Authorised By: LA Technical Dept.
RISK ASSESSMENT FOR: BRCGS for Food Safety issue 8, Clause 4.10.3.11
SUBJECT: Risk Assessment Study to justify whether metal detection step improves protection of finished products
from metal contamination.
HAZARDS CONSIDERED: for the purpose of this risk assessment the main category of hazard considered is the
PRESENCE OF PHYSICAL CONTAMINATION (METAL DETECTABLE -MD- FOREIGN BODIES) in the finished product.
PROCESS REVIEW: for the elaboration of this risk assessment, the HACCP team which comprises experienced,
competent, minimum HACCP level 3 trained professionals from Technical Dept., Supply Chain Dept., Engineering Dept.,
Production Dept. & NPD Dept., adjoined by a HACCP-trained Senior Operator and the most experienced of the QCs in
the shop floor, gathered to take part in the creation of this RA.
Prior to the RA meeting, each team involved obtained the following information for hazard characterisation:
▪ NPD Dept. reviewed packaging specifications and agreed packaging requirements to ensure all packaging
types would be considered in the assessment.
▪ Production Dept. reviewed the different production lines and types of products produced in each by creating
a list to ensure none are missed from the assessment.
▪ Engineering Dept. reviewed key elements of the process to provide insight in any improvements necessary to
reduce FB risk upstream the process so metal detection can be ruled out as CCP or even removed. Also collated
and reviewed technical specifications of MD currently available in the process, as well as alternatives in the
market for metal detection step.
▪ Supply Chain Dept. reviewed production scheduling and the forecast to ensure production capacity of certain
product types is not affected by any changes to process so customers are not shorted, and provided insight in
specific supply agreements that could be decisive in the outcome of the risk assessment depending on the
product type.
▪ Technical Dept. reviewed legal and standard requirements to ensure outcome of the risk assessment is
compliant, and provided the working method for the assessment and its documentation. Reviewed HACCP to
ensure all foreign body control steps were considered as well as the intended use of all product types. In
addition, collated trend information from both NC and customer complaints per product type for further
insight, including latest product validation for each product type. Also, contacted MD supplier for insight on
price of current technology MD as well as price for added units into the current service contract to understand
the overhead costs of current MD service frequency. Reference texts such as “BRCGS for food safety issue 8
interpretation guideline” as well as Campden BRI’s “Guideline G5/2 Foreign bodies in foods - guidelines for
their prevention, control and detection” were used, as well as the internal HACCP risk assessment.
METHODOLOGY CHOSEN:
To determine whether the presence of a MD step was necessary if it would not improve protection of the finished
goods and hence increase risk, the assembled team decided to use the decision tree for metal detection from BRC
Global Standard for Food Safety Issue 8 - Interpretation guideline (page 103). REASON:
▪ It is readily available from the Standard’s Interpretation Guideline.
▪ It was as suggested by external auditor trainer during conversion from BRC 7 to 8 training course.
▪ Once reviewed, it covers what needs to be considered for this RA.
▪ It is simple to use.
As approach for the RA, it was decided to consider each main product type in the company’s HACCP as per the intended
use (derived from the packing line itself). Namely:
▪ Roasted Coffee Beans (produced in the pillow pack type packing lines -1kg packs, 500g packs-, as well as in the
stabilo pack type retail packing lines -454g packs, 227g packs-). Coffee is packed inside a metallised laminated
PET/PP film and consumed directly from the pack, then ground, finally brewed on the customer end.
▪ Roasted & Ground Coffee (produced in the stabilo pack type retail packing lines -454g packs, 227g packs-).
Coffee is packed inside a metallised laminated PET/PP film and consumed directly from the pack, brewed on
the customer end.
1
Contained within BRCGS for Food Safety issue 8, section 4.10 Foreign-Body Detection and Removal Equipment, subsection 4.10.3 Metal
Detectors and X-Ray Equipment (page 34).
3. RISK ASSESSMENT FOR METAL DETECTION REQUIREMENT
BRCGS FOR FOOD SAFETY ISSUE 8:
CLAUSE 4.10.3.1
Page 2 of 6 Prepared by: AG // Reviewed by: AD // Authorised By: LA Technical Dept.
▪ Coffee Bags (produced in the coffee bag lines). Product is firstly packed inside a soft filter paper pouch, and
then inside a metallised laminated PET/PP film sleeve. Coffee is consumed inside the filter paper bag, brewed
on the customer end.
▪ Coffee Pods (produced in the coffee pod lines). Product is firstly packed inside a hard filter paper pouch, and
then inside a metallised laminated PET/PP film sleeve. Coffee is consumed inside the filter paper pod, brewed
on the customer end.
BRC Global Standard for Food Safety Issue 8 - Interpretation guideline: decision tree for metal detection (page 103).
Contains 4 questions to decide whether level of risk leads to MD required or not for the product (see below):
1)
2)
3)
4)
4. RISK ASSESSMENT FOR METAL DETECTION REQUIREMENT
BRCGS FOR FOOD SAFETY ISSUE 8:
CLAUSE 4.10.3.1
Page 3 of 6 Prepared by: AG // Reviewed by: AD // Authorised By: LA Technical Dept.
WEAKNESS OF THE MODEL: This model will produce a Boolean-type qualitative outcome (required / not compulsory)
and hence the risk cannot be characterised using a quantitative Severity x Likelihood 1-to-3 scoring system for
instance, or an FMEA-type quantitative Severity x Occurrence x Detection 1-to-10 RPN scoring system. Review of the
risk score reduction from before to after the implementation of any corrective actions would be hard.
RISK RATING:
▪ If metal detection is required, then risk rating is HIGH if metal detection is not present in the line. Metal
detection will improve protection of finished products from MD physical hazards.
▪ If metal detection is not compulsory, then risk rating is LOW if metal detection step is not present in the line.
Metal detection will not improve protection of finished products from MD physical hazards.
REVIEW PROCESS: This risk assessment to be reviewed minimum on an annual basis. In addition, to be reviewed upon
product’s format change or relevant modification / change to the production line, increase in FB related complaints,
increase in foreign body related NCs for any production lines rated LOW, or as required either by client standards or
within the HACCP / BRCGS for Food Safety framework.
See page overleaf for Risk Assessment Table.
5. RISK ASSESSMENT FOR METAL DETECTION REQUIREMENT
BRCGS FOR FOOD SAFETY ISSUE 8:
CLAUSE 4.10.3.1
Page 4 of 6 Prepared by: AG // Reviewed by: AD // Authorised By: LA Technical Dept.
Decision Tree for Metal Detection
Question 1 Question 2 Question 3 Question 4 RA Outcome
Finished
Product
Type
(Process)
Hazard
Current Control
Measures for
Physical
Contamination
Q1
Answer
Q1 Rationale
Q2
Answer
Q2 Rationale
Q3
Answer
Q3 Rationale
Q4
Answer
Q4 Rationale
Is Metal
Detection
Required?
Risk Rating
if Metal
Detection
is Not
Present
Evaluation of RA
Outcome
Monitoring
Procedure
Effectiveness
KPI
Corrective Action
with
Responsibilities and
Est. Target
Completion Date
Completion
Date
Completed
By
Roasted
Coffee
Beans
Presence of
metal
detectable
physical
contamination
in the finished
product
1) Green bean
cleaner sieve during
tipping stage to
remove larger
debris and dust.
2) After roasting
stage, a magnet
grate will capture
metallised debris, a
destoner system
will screen out
stones denser than
a roasted coffee
bean.
3) After packing
stage, a metal
detector will detect
and reject packs
with metal
contaminants equal
in size or larger
than Fe 4mm, Non-
Fe 5mm and SS
8mm.
NOTE: For food service
customers using bin-
to-cup machines: the
machine will grind the
coffee and any
physical contaminants
present will remain in
the grinder, consumer
is not exposed.
YES
Retail clients’
contracts require
roasted coffee
beans' products
for their brands
to passed
through a metal
detector.
METAL
DETECTION
REQUIRED
HIGH
In order to ensure
safety of the end
consumer and to
keep costumer
happy:
1) Metal Detector
must remain in
place and in
working condition
2) Operators must
perform metal
checks as
established
3) Metal Detector
must be serviced
and calibrated as
per the frequencies
recommended by
the manufacturer
1) Operators to
monitor Metal
Detector working
condition every
start and end of
shift via failsafe
checks
2) Operators to
perform metal
checks on metal
packs at the
frequency
established in the
procedure
3) These checks
being carried out
and recorded
must be
monitored during
internal audits
(GMP,
documentary
audits, traceability
exercises)
N/A
None at this
moment
N/A N/A
Roasted
&
Ground
Coffee
Presence of
metal
detectable
physical
contamination
in the finished
product
1) Green bean
cleaner sieve during
tipping stage to
remove larger
debris and dust.
2) After roasting
stage, a magnet
grate will capture
metallised debris, a
destoner system
will screen out
stones denser than
a roasted coffee
bean.
3) After packing
stage, a metal
detector will detect
and reject packs
with metal
contaminants equal
in size or larger
than Fe 3mm, Non-
Fe 4mm and SS
8mm.
YES
Retail clients’
contracts require
roasted &
ground coffee
products for
their brands to
passed through a
metal detector.
METAL
DETECTION
REQUIRED
HIGH
In order to ensure
safety of the end
consumer and to
keep costumer
happy:
1) Metal Detector
must remain in
place and in
working condition
2) Operators must
perform metal
checks as
established
3) Metal Detector
must be serviced
and calibrated as
per the frequencies
recommended by
the manufacturer
1) Operators to
monitor Metal
Detector working
condition every
start and end of
shift via failsafe
checks
2) Operators to
perform metal
checks on metal
packs at the
frequency
established in the
procedure
3) These checks
being carried out
and recorded
must be
monitored during
internal audits
(GMP,
documentary
audits, traceability
exercises)
N/A
None at this
moment
N/A N/A
6. RISK ASSESSMENT FOR METAL DETECTION REQUIREMENT
BRCGS FOR FOOD SAFETY ISSUE 8:
CLAUSE 4.10.3.1
Page 5 of 6 Prepared by: AG // Reviewed by: AD // Authorised By: LA Technical Dept.
Decision Tree for Metal Detection
Question 1 Question 2 Question 3 Question 4 RA Outcome
Finished
Product
Type
(Process)
Hazard
Current Control
Measures for
Physical
Contamination
Q1
Answer
Q1 Rationale
Q2
Answer
Q2 Rationale
Q3
Answer
Q3 Rationale
Q4
Answer
Q4 Rationale
Is Metal
Detection
Required?
Risk Rating
if Metal
Detection
is Not
Present
Evaluation of RA
Outcome
Monitoring
Procedure
Effectiveness
KPI
Corrective Action
with
Responsibilities and
Est. Target
Completion Date
Completion
Date
Completed
By
Coffee
Bag
Presence of
metal
detectable
physical
contamination
in the finished
product
1) Green bean
cleaner sieve during
tipping stage to
remove larger
debris and dust.
2) After roasting
stage, a magnet
grate will capture
metallised debris, a
destoner system
will screen out
stones denser than
a roasted coffee
bean.
3) Before packing
stage, enclosed
inline grinder will
reduce any debris
present to small
dust particles.
4) Coffee grounds
are packed into
sealed filter paper
pouches which are
brewed as is, hence
consumer is not
directly exposed to
any physical
contaminants in the
coffee.
NO
The coffee bag
line only
produces
products for our
own brands only.
NO
1) Raw ingredient -
green coffee beans
are pre-washed,
CLEANED, graded at
source.
2) Any metal/stone
foreign body hazard
in the raw ingredient,
is removed by passing
the green coffee
beans through a
green bean cleaner
(SIEVE and air
separator) at the
tipping point for
removal of foreign
materials larger or
smaller than a coffee
bean in size/shape
and removal of dust
and smaller particles.
3) When the coffee
beans are roasted,
the coffee beans pass
through a MAGNET
grate (11,000 gauss
for the Neotec
roaster / 9,000 gauss
for the Probat
roaster) and then
passed through a
DESTONER to remove
metal and stones
after the roasting
process.
4) The coffee bag
packing line has
inbuilt GRINDER,
grinds the roasted
coffee beans into
espresso fine powder
grounds prior to
packing into a coffee
bag (e.g., tea bag
format) that is fully
sealed.
YES
1) The
production
equipment
processes are
broadly
enclosed, with
a functional
and fully
operational
HACCP system
in place.
2) Daily knife
and needle
checks in place.
3) Daily glass
audits in place.
4) Scheduled
PPM in place,
tools and items
used are
accounted for
and logged into
the PPM
report.
5) There is no
history of
customer
complaints
related to
foreign objects
for products
produced in
this line since
established in
January 2012.
YES
1) Coffee used to manufacture
coffee bags is ground to finely
espresso grounds and
encapsulated inside a sealed filter
paper pouch (similar to the
commercial presentation of tea
bags), that protects the product.
2) When the coffee bags are
brewed, coffee grounds remain
inside encapsulated coffee bag as
the intended use of this product,
and any potential contaminants
are kept hold inside the coffee
bag and would be apparent to the
customer before brewing as they
have to handle the product to
extract the coffee bag from
metallised sachet and place into
cup, during the brewing stage
they would have to stir the coffee
bag in hot water and retrieve the
coffee bag.
3) The chances of any metal
contaminants going into the brew
are very remote, as the coffee bag
filter paper pores size in our dry
filter paper is >75micron (equates
to 0.075mm), the filter papers
hold the coffee ground particles
during brewing stage, and only
allow the coffee extract to be
released into the brew, the coffee
grounds still remain inside the
coffee bag after brewing, posing
no food safety issue to the
consumer and the coffee bag is
removed/disposed prior to
consumer consuming the brew.
4) To date we have received zero
metal complaints of this nature
for the coffee bags line since
established in January 2012,
which indicates chances of any
metal contaminants going into
the brew are very remote.
METAL
DETECTION
NOT
COMPULSORY
LOW
Taking into account
that:
1) Products
produced on this
line are mostly
OWN BRAND
2) There are OTHER
STEPS in the process
that will remove
most of the physical
contaminants
3) There is VERY
LIMITED RISK of
physical
contamination in
the finished product
due to the way the
packing line is set
up
4) There is NO
HISTORY of foreign
body complaints on
this product line
5) Outcome of the
risk assessment is
NOT COMPULSORY
with LOW-risk
rating in case MD is
not present in the
line
6) Adding a MD
would cause the
company a large
upfront COST, plus
overhead ongoing
servicing costs, plus
PRODUCTIVITY LOSS
due to Operators
carrying out &
logging metal
checks
It is considered
redundant to add a
metal detection
step as it will not
improve protection
of finished
products.
1) Glass audits for
this line to be
carried out as per
established
frequencies and
reviewed during
quarterly
documentary
audits.
2) NC trend per
category for this
product line to be
reviewed by
Technical monthly
to verify there is
no trend of
physical
contaminants
appearing.
3) Customer
complaints trend
per category for
this product line
to be reviewed by
Technical monthly
to verify there is
no trend of
physical
contaminants
appearing.
4) PPM reports for
this product line
to be checked by
Technical
quarterly to verify
there is no
adverse foreign
body incident
logged by the
Engineers.
1) Less than 2
foreign body
customer
complaints per
10 million
coffee bags
produced
Monthly KPI
2) No foreign
bodies from this
line in the metal
rejects register
Monthly KPI
1) Technical to
modify PPM records
for this line to add
checks for loose
machinery parts in
close contact with
the forming belt
that seals the filter
paper pouches.
2) Technical to add
verification of glass
audits into the
quarterly
documentary
audits.
3) Technical to add
trending of CC
related to foreign
bodies for this line
as it was not
considered
previously.
Est. Target
Completion Date:
31/03/2022
29/03/2022
AG
(Technical)
7. RISK ASSESSMENT FOR METAL DETECTION REQUIREMENT
BRCGS FOR FOOD SAFETY ISSUE 8:
CLAUSE 4.10.3.1
Page 6 of 6 Prepared by: AG // Reviewed by: AD // Authorised By: LA Technical Dept.
Decision Tree for Metal Detection
Question 1 Question 2 Question 3 Question 4 RA Outcome
Finished
Product
Type
(Process)
Hazard
Current Control
Measures for
Physical
Contamination
Q1
Answer
Q1 Rationale
Q2
Answer
Q2 Rationale
Q3
Answer
Q3 Rationale
Q4
Answer
Q4 Rationale
Is Metal
Detection
Required?
Risk Rating
if Metal
Detection
is Not
Present
Evaluation of RA
Outcome
Monitoring
Procedure
Effectiveness
KPI
Corrective Action
with
Responsibilities and
Est. Target
Completion Date
Completion
Date
Completed
By
Coffee
Pods
Presence of
metal
detectable
physical
contamination
in the finished
product
1) Green bean
cleaner sieve during
tipping stage to
remove larger
debris and dust.
2) After roasting
stage, a magnet
grate will capture
metallised debris, a
destoner system
will screen out
stones denser than
a roasted coffee
bean.
3) Before packing
stage, enclosed
inline grinder will
reduce any debris
present to small
dust particles.
4) Coffee grounds
are packed into
sealed filter paper
pods which are
brewed in a
machine; hence
consumer is not
directly exposed to
any physical
contaminants in the
coffee.
NO
There are no
requirements for
metal detection
for the coffee
pods produced
from our
foodservice
customers or for
our own brands.
NO
1) Raw ingredient -
green coffee beans
are pre-washed,
CLEANED, graded at
source.
2) Any metal/stone
foreign body hazard
in the raw ingredient,
is removed by passing
the green coffee
beans through a
green bean cleaner
(SIEVE and air
separator) at the
tipping point for
removal of foreign
materials larger or
smaller than a coffee
bean in size/shape
and removal of dust
and smaller particles
3) When the coffee
beans are roasted,
the coffee beans pass
through a MAGNET
grate (11,000 gauss
for the Neotec
roaster / 9,000 gauss
for the Probat
roaster) and then
passed through a
DESTONER to remove
metal and stones
after the roasting
process.
4) The coffee bag
packing line has
inbuilt GRINDER,
grinds the roasted
coffee beans into
espresso fine powder
grounds prior to
packing into a hard
coffee pod (e.g., tea
bag format) that is
fully sealed.
YES
1) The
production
equipment
processes are
deemed
enclosed, with
a functional
and fully
operational
HACCP system
in place.
2) Daily knife
and needle
checks in place.
3) Daily glass
audits in place.
4) Scheduled
PPM in place,
tools and items
used are
accounted for
and logged into
the PPM
report.
5) There is no
history of
customer
complaints
related to
foreign objects
for products
produced in
this line since
established in
November
2014.
YES
1) Coffee used to manufacture
coffee pods is ground into finely
espresso grounds and
encapsulated inside sealed, hard
filter paper pouch, that protects
the product.
2) Any metal contamination
would be apparent to the food
service customer as they have to
extract the coffee pod from
individual metallised sachet and
place coffee pod into their filter
holder with espresso filter basket
to attach to a traditional espresso
machine, steam in pressured
through the pod to provide an
espresso brew. Fine coffee
grounds remain inside the
encapsulated filter pod after
coffee extraction. The foodservice
customer espresso filter basket
has spaced pore holes 0.1mm in
diameter as a secondary measure
would capture metal foreign body
larger in size if the filter paper
encapsulating the pod rips.
3) Any potential metal
contaminants are kept hold inside
the coffee pods as the coffee pod
(filter paper) pores size in our dry
filter paper is 75micron (equates
to 0.075mm), the filter papers
hold the coffee ground particles
and will only allow the coffee
extract liquid to be released into
the brew, the coffee grounds
remain inside the coffee pod and
customer filter holder with
espresso filter basket, posing no
food safety issue to the
consumer.
4) To date we have received zero
metal complaints of this nature
for the coffee pod line since
established in November 2014,
which indicates chances of any
metal contaminants going into
the brew are very remote.
METAL
DETECTION
NOT
COMPULSORY
LOW
Taking into account
that:
1) There are OTHER
STEPS in the process
that will remove
most of the physical
contaminants
2) There is VERY
LIMITED RISK of
physical
contamination in
the finished product
due to the way the
packing line is set
up
3) There is NO
HISTORY of foreign
body complaints on
this product line
4) Outcome of the
risk assessment is
NOT COMPULSORY
with LOW-risk
rating in case MD is
not present in the
line
5) Adding a MD
would cause the
company a large
upfront COST, plus
overhead ongoing
servicing costs, plus
PRODUCTIVITY LOSS
due to Operators
carrying out &
logging metal
checks
It is considered
redundant to add a
metal detection
step as it will not
improve protection
of finished
products.
1) Glass audits for
this line to be
carried out as per
established
frequencies and
reviewed during
quarterly
documentary
audits.
2) NC trend per
category for this
product line to be
reviewed by
Technical monthly
to verify there is
no trend of
physical
contaminants
appearing.
3) Customer
complaints trend
per category for
this product line
to be reviewed by
Technical monthly
to verify there is
no trend of
physical
contaminants
appearing.
4) PPM reports for
this product line
to be checked by
Technical
quarterly to verify
there is no
adverse foreign
body incident
logged by the
Engineers.
1) Less than 2
foreign body
customer
complaints per
1 million coffee
pods produced
(slower
production
rate)
Monthly KPI
2) No foreign
bodies from this
line in the metal
rejects register
Monthly KPI
1) Technical to
modify PPM records
for this line to add
checks for loose
machinery parts in
close contact with
the forming belt
that seals the filter
paper pouches.
2) Technical to add
verification of glass
audits into the
quarterly
documentary
audits.
3) Technical to add
trending of CC
related to foreign
bodies for this line
as it was not
considered
previously.
Est. Target
Completion Date:
31/03/2022
29/03/2022
AG
(Technical)
NOTE regarding image copyrights: All rights over the cover image used in this project’s front sheet belong to its author. This document is freely shared non-
profit. Due to the difficulty searching the origin the image used the original author is not included. If you wished to either be credited by the image or request
its removal, please contact me by email at adoriangp@gmail.com. Thank you for your comprehension and please accept my apologies for the inconvenience.