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HACCP

HARPCCombine your plan step-by-step

First Edition

Kassy Marsh

HACCP

HARPCCombine your plan step-by-step

i © Techni-K Consulting Ltd

KASSY MARSH

COMBINE YOUR HACCP & HARPC PLAN

A PRACTICAL STEP-BY-STEP GUIDE

© Techni-K Consulting Ltd ii

Combine your HACCP & HARPC Plan Kassy Marsh

Published by Techni-K Consulting Ltd

Copyright © May 2016 Kassy MarshISBN: 978-0-9954552-0-7

G5 Cavendish House, Welbeck, Nottingham, S80 3LL, UK

www.techni-k.co.uk

All reasonable care has been taken in the compilation, preparation and issue of this publication, but it is provided without liability in its application and use. The information contained in this publication must not be reproduced without the permission of the publisher.

The information and views set out in this publication are those of the author and do not necessarily reflect the official opinion of the Food & Drug Administration, Codex, The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) or the British Retail Consortium (BRC).

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Contents PageAbout the Author v

Preface vi

Executive Summary vii

Abbreviations viii

Glossary ix

The Need for a Combined Approach x

How to Use This Book xi

The Stages Involved in Carrying Out a Combined HACCP & HARPC Plan xii

CHAPTER 1: COMPARING THE STANDARDS 1 Comparing the Standards 2

The HACCP team 2

Scope 3

Pre-requisite programmes (PRPs) 3

Describe the product 4

Information sources 5

Intended use & intended user 5

Process flow diagram 6

Hazard analysis 7

Determine CCPs 8

Establish critical limits 9

Establish monitoring 10

Establish corrective actions 11

Establish verification procedures 11

Documentation & record keeping 12

CHAPTER 2: PREPARATORY STAGES 15Preparatory Stages 16

Obtain Senior Management Commitment 17

Establish the Team 19

Define the Scope of the Study 25

Define the Pre-requisites (Good Manufacturing Practices) 30

CHAPTER 3: EXTRACTION STAGES 37Extraction Stages 38

Define the Product & Extract the Hazards 40

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Define the Intended Use, Intended User & Extract the Hazards 46

Construct the Process Flow Diagram, Describe the Process & Extract the Hazards 50

Define the Hazards 61

CHAPTER 4: ASSESSMENT STAGES 65Assessment Stages 66

Assess Severity 67

Assess Likelihood 71

Establish Significance 75

Define Pre-requisite Controls & Preventive Controls 79

Establish CCPs 84

Identify CCPs 86

Carry Out Validation or Justification of PCs & CCPs 90

CHAPTER 5: CONTINUATION STAGES 95Continuation Stages 96

Documentation & Record Keeping 97

Review 100

Maintain the System 103

References 105

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About the Author

Kassy started her career in the food manufacturing industry in 1998 and has developed an exceptional ability to implement simple and practical solutions, which can be effectively implemented into the factory environment. With a background of NPD, process control, compliance, auditing and technical management, she has a wealth of experience in effectively meeting the required standards. She is well known for her best practice risk assessments and specializes in food safety principles.

In 2015 she co-authored the book ‘Assessing Threat Vulnerability for Food Defence. This pioneering methodology is now one of the leading risk

assessment tools in use for the assessment of food threats.

To meet the increasing demand for a methodology to assess food integrity, in early 2016 Kassy developed and co-authored her second publication ‘Assessing Error Vulnerability for Food Integrity’. This system is now used by a leading UK retailer as a training tool for their supply base.

Since starting her own consultancy business in 2012, she has become well regarded in the field of food safety risk assessment for her ability to provide simple, practical and easily understood step-by-step solutions.

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Preface

HARPC (Hazard Analysis & Risk-Based Preventive Controls) is a relatively new term; an acronym developed to suit the new Food & Drug Administration's (FDA) Hazard Analysis and Risk-Based Preventive Controls Rule for Human Food, which is part of the new Food Safety Modernization Act (FSMA).

The term HARPC (Hazard analysis and risk-based preventive controls) has been developed as an abbreviation to meet the FSMA rule – Preventive Controls Rule for Human Food.

When I first heard of the term HARPC (pronounced harp-see), as a specialist in risk assessment and HACCP, I was intrigued. Keeping up to date with the latest risk assessment systems and food safety laws is an important part of my role as a food safety consultant, in order for me to be able to provide the food industry with the best possible advice.

So, I spent some time researching HARPC and the FSMA preventive controls rule, to try to firstly understand, how this new methodology worked, and secondly, how it should be incorporated with our current HACCP principles. Unfortunately, I couldn't find the answers I was looking for. The FDA have provided a lot of guidance information with regard to the requirements of a HARPC plan, but there was little detailed advice as to how you should actually go about carrying out a HARPC assessment. There was even less guidance available for facility’s who already had a HACCP plan, on how they could adapt their current food safety systems to meet the new HARPC requirements.

The aim of this book is to provide you with step-by-step guidance as to how you can develop your own combined HACCP and HARPC assessment. It is based on the NACMCF and Codex Alimentarius principles of HACCP and incorporates the new requirements of the FDA's preventive control rule. Some aspects of the requirements of HACCP and HARPC contradict one another, so where this is the case I have adapted the typical NACMCF and Codex requirements to allow for compliance with both systems. Where the principles have been amended to comply with both systems, the contradictions and solutions are explained, giving you the necessary understanding to be able to explain this if challenged during an inspection.

The book is laid out in a methodical manner, so you can work through it step-by-step. To help you to use the book as a practical tool, I've also provided exercises for you to try for yourself. The system provided also meets the requirements of the BRC standard, so that facilities who have this certification can ensure that they meet the clauses of the HACCP section.

During my extensive research for this book, it became very clear to me that HARPC requires a totally different mind-set to that of a typical HACCP system. Many of our usual and well-established techniques for assessing risks are turned on their head. As you work through the book try to remember this and maintain an open mind. Although it is a very different approach to assessing food safety, I truly believe there are many benefits to a HARPC system. It encourages food safety to be assessed as a whole, rather than having many risk assessments on a range of topics assessed individually. HACCP, although it has been around for many years now and is well established, in my opinion, is becoming too rigid an approach for today's food manufacturing environment. As HARPC principles develop, as all systems do over time, perhaps the preventive control approach will even become the more recognised way of assessing food safety.

Kassy MarshDirector, Techni-K Consulting Ltd

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Executive Summary

The Food & Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed by Congress on December 21, 2010 and then became law when it was signed by President Obama on January 4, 2011.

The aim of FSMA is to better protect human and animal health by helping to ensure the safety and security of the food and feed supply.

The act is made up of 5 rules to improve food safety, which are:1. Intentional adulteration2. Preventive controls for human food and separately for animal food3. Standards for produce safety4. Imports: The foreign supplier verification program for importers5. Imports: A program for the accreditation of third-party auditors (also known as certification bodies)

It is the preventive controls for human food rule, which requires a hazard analysis and risk-based preventive controls (HARPC) approach.

The preventive controls for human food rule, along with the rule for animal food was the first rule to be published in its final format, on September 17, 2015 and becoming effective from November 16, 2015. There is a staggered approach for compliance to the rule, depending on the business size of the food facility. Businesses other than those that are defined as small or very small must comply within 2 years of the publication, which is September 2016. Small businesses have been given another year after to that to comply (2017) and very small businesses, another 2 years (2018).

The preventive control rule applies to all domestic (USA) processors, packers, or storage facilities which are required to register as a food facility under section 415 of the FD&C Act. It also applies to foreign manufacturers, who import into the United States.

There is therefore no doubt, that the publication of the preventive control rule for human food will change the way we assess food safety across the world, and the introduction of HARPC to meet the requirements of the rule will turn HACCP on its head.

Although at first glance the requirements of HARPC and HACCP look very similar, there are a number of fundamental differences which make compliance to both requirements difficult. For example, the hazard analysis carried out to meet the preventive control rule, must be carried out without taking any controls into consideration. This is contradictory to the NACMCF and Codex principles, where the hazard is assessed taking the controls into account. The consequences of this change are huge, as the number of significant hazards that are taken through to the next stage of the assessment will increase substantially. This leaves us with the problem, of how to handle the number of significant hazards, without producing an over bearing, and probably unfocused number of a CCPs.

Therefore, there is a need for a combined HACCP and HARPC approach, with a structured methodology that meets both requirements.

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Abbreviations

CCP Critical control point

CGMP Current good manufacturing practice

FDA Food & Drug Administration

FSMA Food Safety Modernization Act

GMP Good manufacturing practice

HACCP Hazard analysis and critical control point

HARPC Hazard analysis and risk-based preventive controls

NACMCF National Advisory Committee on Microbiological Criteria for Foods

PRP Pre-requisite programme

PC Preventive control

USDA United States Department of Agriculture

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Glossary

Term Definition Source

Criteria A range of acceptability Developed by the author

Critical limit A minimum value that defines where the food becomes unsafe

Developed by the author

Critical control point (CCP) Procedures, practices and processes designed to eliminate or reduce the hazard to an acceptable level (which is specific to a particular process step)


Facility The production site Developed by the author

Justification Subjective rationale for the effectiveness of the preventive control

Likelihood How likely is the event to occur and cause contamination of the product


NACMCF/ Codex Alimentarius HACCP

A set of principles for controlling food safety


Pre-requisite control Procedures, practices and processes which provide facility-wide control


Pre-requisite programme A group of facility-wide controls, grouped under one overall topic


Preventive control (PC) Procedures, practices and processes designed to significantly minimize or prevent the hazard (specific to a particular process step)


Preventive controls qualified individual

A person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system

FDA

Qualified individual A person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties

FDA

Severity How injurious to health the food safety hazard would be on the consumer


Significance A hazard that must be controlled in order to produce safe food


Verification Confirmation that the system is effective Developed by the author

Validation Objective evidence that the control is capable of providing food safety


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The Need for a Combined Approach

HACCP has been around since the late 1950s and became a recognized food safety approach, when in the 80s and 90s the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) published the seven principles. The Codex Committee then adopted these and further developed the methodology, by adding the CCP decision tree.

The use of the HACCP principles became law for particular food sectors in the US, the European Commission made it law in 2006 and today it is recognized as the leading food safety system all over the world.

The use of HACCP principles is driven by local law, customer requirements and also by standards, such as Global Food Safety Initiative (GFSI) recognised schemes.

The GFSI benchmarking scheme scope includes HACCP or HARPC-based requirements, which must meet NACMCF and Codex-based methodology.

These drivers mean that, even with the introduction of the preventive control rule and therefore HARPC, the need for a HACCP based system still also remains. Food facilities will continue to be requested by law, by their customers and by the certification standards that they adhere to, to comply with HACCP principles.

Therefore, there is a need for a combined HACCP and HARPC approach, one which takes into account the requirements for both standards and provides one cohesive methodology.

The methodology detailed in this book has been designed to comply with both the HACCP and HARPC requirements. In addition to this, it has been developed to meet the BRC Global Standard for Food Safety Issue 7, which is currently one of the most detailed GFSI recognized standards.

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How to Use This Book

This book has been designed to provide you with all the information and practical tools that you need to be able to develop your own combined HACCP and HARPC plan.

The first section of the book provides you with a comparison of the different standards and requirements for HACCP, based on NACMCF and Codex Alimentarius, the preventive control rule from FSMA and then also the requirements set out by the BRC Standard as a GFSI recognised scheme.

The BRC Global Standard for Food Safety has been selected as the GFSI recognised scheme for comparison and analysis, as this standard provides a detailed approach to the requirements of HACCP – with the aim of developing a best practice system, which will meet all other GFSI recognised schemes.

The aim of this book is to provide enough detail about the requirements for HACCP and the requirements for HARPC, and explain where the requirements are slightly contradictory, provide a solution for this.

Each section is colour coded, for ease of use and orientation.

Within each section the requirements are explained and the methodology for a combined system is described. Completed examples are provided and there are exercises at the end of each section for you to complete, to aid your understanding.

The exercises at the end of each section are also available for download for you to complete, and so that you can use the templates, if you wish, in your own combined HACCP and HARPC plan. To download the exercise templates go to http://www.techni-k.co.uk/HARPCexercisebook

To assist you when completing your plan, at the end of each section also has ‘Top Tips’. Here tips are provided, as a summary and reminder, so you can assess your plan against them to ensure that you’ve got everything covered. There is also a notes page at the end of each section, so you can make notes as you go through the methodology.

By following each section of this book and completing the assessment, following the step-by-step instructions and the exercise at the end of each, you should be able to build up your combined HACCP and HARPC folder. The ‘Top Tips’ will include how to set out your folder.

You’ll also find that we’ve included a ‘Notes’ page at the end of each section, so that you can make any notes that you need to while working through the book.

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Preparatory Stages

Obtain senior

management commitment

Establish the team

Define the scope of the study

Define the Pre-requisites

(Good manufacturing practices)

Assess severity

Assess likelihood

Establish significance

Define the pre-requisite con-

trols & preventive controls

Establish CCPs

Carry out validation or justifi-

cation of PCs & CCPs

Documentation & record

keeping

Review

The Stages Involved in Carrying Out a Combined HACCP & HARPC PlanThe following diagram shows the four stages of producing a combined HACCP and HARPC plan.

The initial chapter of this book compares the standards, side-by-side, so that the differences and similarities can be discussed. The book is then set out in four further chapters, which take you through each of the combined HACCP and HARPC stages stated above, step by step.

Each chapter of the book is colour coded, to help you easily identify the sections whilst working through your combined HACCP and HARPC plan.

Assessment Stages Continuation StagesExtraction Stages

Describe the product &

extract the hazards

Define the intended use, user

& extract the hazards

Construct flow diagram, describe

the process & extract the hazards

Define the hazards

Maintain the system

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Notes

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CHAPTER 1

Comparing the Standards

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Comparing the StandardsThe following pages compare the 12 logic sequence steps as defined in NACMCF and Codex, to the requirements of the preventive control rule and BRC Global Standard for Food Safety, issue 7.

The HACCP team

NACMCF/Codex Preventive control rule BRC Standard

Preparatory stage 1 - Assemble the team.

The team:• Ideally should be multi-

disciplinary• Can use outside expert help

The HARPC plan must be conducted or overseen by one or more preventive control qualified individual(s).

The HACCP must be created by a multi-disciplinary team including quality or technical, production or operations, engineering and any other departmental representatives that are applicable to the product and process.

The team leader must have an in-depth knowledge of HACCP principles and be able to demonstrate their capability.

The team members must have relevant and specific product and process knowledge to be able to pinpoint the pertinent hazards.

Third party assistance with the HACCP is acceptable, however the day-to-day running of the system must remain the responsibility of the site.

Comparison

To meet the BRC standard the competency of the team leader and the team will need to be able to demonstrate an understanding of HACCP and NACMCF or Codex principles.

The preventive control rule states that the team must include at least one preventive control qualified individual. The rule does not define ‘qualified’, but the qualified individuals need to be able to demonstrate an understanding of risk-based food safety relevant to their product and process.

The team members will need to include departments such as procurement and buying, as hazards relating to the inherent risks from the raw material need to be included, along with food fraud risks in the supply chain due to economic gain.


Scope


The team should define the scope• Start and end points• Hazards to be considered

No comparable requirements. A scope covering the products and processes must be defined.

Comparison

FDA have not stated that a defined scope is part of the requirements. However, it would be sensible to assume all include a scope of what is and is not to be included, plus the start and end points of the study should be included.

The scope to cover HARPC will need to be wider than the typical HACCP. It will need to cover processes outside the manufacturing process, such as:• The supply chain of the raw materials (to cover inherent risks of the raw materials and also food fraud)• NPD processes including artwork generation (to cover risks such as allergen labelling)• Post facility preventive controls that occur after the product has left the businesses control, where subsequent

steps make the product safe to eat

Pre-requisite programmes (PRPs)


NACMCF and Codex states that the HACCP plan must be based on good hygienic practices, which it defines as pre-requisite programmes.

The preventive control rule states that the facility must adhere to the Good Manufacturing Practices (GMPs).

The preventive control rule also requires the following to be part of the plan:• Process controls• Food allergen controls• Sanitation controls• Supply-chain controls• Recall plan• Other controls (which include other good manufacturing practices)

PRPs are required and may include:• Cleaning• Personal hygiene• Allergen control• Storage and transport controls• Engineering controls• Training

Procedures are required for the control measures and monitoring activities.

PRPs must be included in the development of the HACCP and regular review process.

Comparison

Pre-requisites are a must for both the HACCP and HARPC requirements, as they are essential part of ensuring that the system is based on good manufacturing practices.

The pre-requisites need to take into account the FDA’s Current Good Manufacturing Practices and the additional control measures defined in the preventive control rule, such as supply-chain controls and the recall plan.

There must be documented procedures and associated records where appropriate, to ensure that pre-requisite controls are effectively defined and managed.


Describe the product


Preparatory stage 2 - Describe the product and its distribution.

Relevant safety information about the product should include:• Composition• Intrinsics such as aw, pH etc.• Treatments which reduce,

eliminate or hold microbial levels, such as cooking, freezing etc.

• Packaging• Durability• Storage conditions• Distribution methods

No comparable requirements. A product description is required for each product or group of products, including:• Composition• Raw material country of origin• Product intrinsics• Key manufacturing processes• Packaging information• Storage and distribution

conditions• Shelf life

Comparison

Although the preventive control rule does not specifically state that a product description is required, it does however state that the inherent risks from the product are covered, which must include the storage conditions. In order to be able to assess the product effectively, the product intrinsics, composition, shelf life and storage conditions would be required.

A product description would normally also include details of when the product becomes safe to eat. Where this occurs at a step later in the supply chain, from further processing by another manufacturer or by the consumer this would need to be detailed. In order to comply with the preventive controls rule, where this is the case, the preventive control which is required at a later step in the supply chain would need to be defined. If this preventive control is to be applied by a subsequent manufacturing, packing or storage process, the FDA also requires the facility to agree this with those responsible at the subsequent step and obtain evidence of control.


Information sources


No comparable requirements. No comparable requirements. The HACCP plan needs to be based on comprehensive information and therefore sources of information should be referenced.

Comparison

The information sources that have been used during the creation of the HACCP study must be listed. This isn’t a requirement of the FDA, but clearly the FSMA Preventive control rule should be in the reference list.

In order for the qualified individuals to be able to conduct and implement a HARPC plan which complies with the preventive controls rule, the FDA would expect them to have an understanding of the information that would be required, and have access to such information.

Intended use & intended user


Preparatory stage 3 - Identify the intended use, describe the intended use and customers of the food

This should include:• Who the product is produced

for (the customer)• The expected uses by the

customer• Who the product is not suitable

for

No comparable requirements. The intended use of the product must be defined and any alternate uses. This must include the target market, consumer groups and whether the product is suitable for vulnerable groups.

Comparison

Although the preventive control rule does not require a description of the intended use or customer, it is essential to understand this, in order to be able to establish what the relevant hazards would be. Documenting the product description and intended use and user, provides clarity to the team and enables them to understand the pertinent hazards associated.

As discussed in the product description section on the previous page, the preventive control rule allows preventive controls to be applied outside the company’s control, such as cooking a raw product either by a further manufacturer or a consumer. Therefore, it is implied that intended use, instructions for use (such as cooking) and identification of the intended customer are required.


Process flow diagram


Preparatory stage 4 - Construct flow diagram/ develop a flow diagram which describes the product.

The process flow should cover all steps in the manufacturing process of the product, in line with the scope (start and end points)

Preparatory stage 5 - On-site confirmation of flow diagram

Walk the process flow, confirming the steps

No comparable requirements. A process flow diagram should be constructed for the product or group of products defined in the scope.

This should cover the manufacturing operation from raw material intake to dispatch.

The process flow diagram should include as a minimum: • The layout of the premises• The flow of equipment used• Raw material and packaging

inputs• Service inputs such as food

contact utilities• Directional flows and

interactions• Any processes that are

outsourced or subcontracted• Process delays• Rework and recycling of

product• Work in progress materials• Low, high risk and high care

zones• Waste

The food safety team must carry out an on-site confirmation of the process flow diagram for accuracy and this must be repeated at least annually.

The process flow must be verified for daily and seasonal variations.

Records of confirmation of the process flow must be recorded.

Comparison

The preventive control rule requires the inclusion of hazards which are inherent to the raw material and also those that may be due to food fraud (for economic gain). Therefore, the typical flow diagram which begins at raw material intake may not start early enough in the process. Either, all of the inherent raw material and food fraud hazards would need to be listed at the point of intake, or the flow diagram would start earlier at the point of procurement.

This raises an important point, a typical HACCP plan doesn’t cover all of the facility’s departmental processes that may have an impact on the safety of the product, it just focuses on the production process.

By not being restricted by a typical HACCP process flow, there are benefits in being able to widen the scope and include key non-manufacturing points, such as procurement, new product development, specification generation and artwork.


Hazard analysis


Principle 1 – Hazard analysis

• List the potential hazards• Carry out hazard analysis of

severity and likelihood• Consider control measures

Food safety hazard analysis must consider:• Known inherent hazards• Hazards which could ‘reasonably

occur’

The hazards categories that must be considered are:• Microbiological• Chemical, including radiological

(and although not stated explicitly allergens)

• Physical

The hazards may be caused because:• They are inherent to the raw

material or product• They occur through error during

the process• Be carried out deliberately for

economic gain (for food safety only)

Sources of hazards to be considered are:• The environmental (FDA

specifically quote pathogens from the environment which may contaminated ready-to-eat foods)

• The recipe or formulation• Ingredients (inherent risks)• The manufacturing processes• The fabrication of the facility• The equipment used• The tools used• The intended use of the food

The analysis must include:Severity and likelihood (FDA terms this probability of occurrence) in the absence of preventive controls.

The team must identify the relevant hazards for the product and process and then carry out hazard analysis, to control hazards which need to be prevented, eliminated or reduced to an acceptable level.

The hazard analysis should take into account severity and likelihood of the hazard.

The hazards must include micro-organisms of particular concern, presence of foreign bodies or chemicals and cross-contamination risks.

The severity must take into account any susceptible vulnerable groups.

Comparison

A combined system will need to widen the scope of the hazards assessed, to include:• Inherent risks in the raw materials (this is implied but not always covered in a typical HACCP)• Economic gain hazards

The BRC standard does include the requirement for raw materials assessments, however this wouldn’t typically be covered as part of the HACCP, but would sit as separate documents, such as:

• A raw material risk assessment• A raw material vulnerability assessment (the need for this will still remain to cover quality and integrity risks)


The way in which the hazard analysis must be carried out, has one fundamental difference between the HACCP requirements and the preventive controls rule.

In HACCP, the likelihood (or probability) would normally be assessed taking the controls into account. However, for HARPC the assessment must be carried out without taking the controls into account. This change should not create a problem for compliance to the NACMCF, Codex or BRC, as long as the principles of assessing severity and likelihood are adhered to, in order to establish significance.

The consequence of not taking the controls into account at this stage however, will mean that the number of significant hazards that go through to the next stage are much higher and will therefore need managing through the application of preventive controls.

Determine CCPs


Principle 2 - Determine CCPs, using a CCP decision tree

To control each of the significant hazards, preventive controls must be applied.

The FDA advise that these will include measures such as (these are examples, not an exhaustive list):• Process controls• Food allergen controls• Sanitisation controls• Supply chain controls• Recall plan

Controls must be provided for each hazard and control points which are critical to food safety must be identified.

A documented method for this assessment is required and a decision tree may be used, if this helps.

CCPs are points, steps, or procedures in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.

Where significant food safety risks are identified where there is no current control, the product or process must be adjusted so control can be applied.

Comparison

Any hazard that comes out of the assessment as significant needs to have a preventive control. Those that are not significant, can be managed through the pre-requisites.

This means, that there are now two levels of control:

Hazards which are not significant = managed by PRP controlsHazards which are significant = managed as preventive controls

In order to comply with the HACCP principles, CCPs will also need to applied where they are needed. For compliance to the BRC Standard, the typical CCP decision tree does not need to be used, the clause of the standard allows this, by the use of the word ‘may’:

“This requires a logical approach and may be facilitated by use of a decision tree.“

It does however, state a logical approach, so a method for determining the CCPs from the preventive controls would need to be established.


Establish critical limits


Principle 3 - Establish critical limits for each CCP

• Define the critical limits that will control the CCP

• Validate the critical limits

No comparable requirements. Critical limits must be defined for each CCP.

Each CCP must be validated.

Documented evidence of the validation is required. This must show that the critical limits set are capable of consistently producing safe food by controlling the hazard.

Comparison

A combined system would need to have critical limits for all the CCPs. Preventive controls however, do not require critical limits, as they are not controls in the pure HACCP sense – as they may include checks.

The preventive controls would require pass and fail criteria to be applied, even though these criteria may be more subjective.

Where critical limits are applied, these should be validated. Where criteria are applied instead, then these should be justified.


Establish monitoring


Principle 4 - Establish a monitoring system for each CCP

• Define how the CCP will be monitored using the critical limits

• Set the frequency of monitoring• Monitoring records to be

verified on completion

For each preventive control required to manage a significant hazard, a monitoring procedure must be created and implemented, which includes:• Frequency• Process• Completion of records

A process of monitoring each CCP must be defined.

The monitoring system must be able to detect if the critical limits are not met, in order for correction to be applied.

Records of the monitoring must be in place and these shall include the date and time of the monitoring.

Each record must be verified through the review and secondary sign off by an authorised person.

Comparison

Monitoring procedures and records will now be required for both CCPs and preventive controls.

CCP records must be verified through a second sign off to meet the BRC Standard.

For both preventive controls and CCPs, the frequency of the monitoring is important. The BRC Standard expects the frequency of monitoring to be such, that corrective action can be taken if needed, prior to the product being out of the facility’s control.


Establish corrective actions


Principle 5 - Establish corrective actions

Define what steps must be taken where monitoring shows deviation from the critical limits

A procedure must be created and implemented for each preventive control, which covers:• Where the monitoring

procedure highlights a problem• Where the monitoring

procedure has not been adhered to

The team must establish corrective actions and these must be documented.

Corrective action must be taken when the critical limits are not met.

An authorised person must be responsible for ensuring that unsafe product is not released.

Comparison

Corrective actions are required for both CCPs and preventive controls.

In section 2 of the BRC Standard corrective actions are only required for CCPs. However, clause 3.7.1 (corrective and preventive actions) requires all procedures within the quality management system to have corrective and preventive actions defined. Therefore, it is sensible to assume that the BRC Standard would expect preventive control procedures to have corrective and preventive actions detailed.

Establish verification procedures


Principle 6 - Establish verification procedures

• Define the verification activities• Review of the plan

The FDA state that verification must be implemented to show that the preventive controls are working.

Verification would include activities such as:• Checking and signing off that

preventive control records have completed and completed correctly

• Testing of raw materials, in process materials or finished product

• Verifying the accuracy of monitoring or measuring equipment

• Environmental testing• Reviews, including trending e.g.

complaints

Verification procedures must be established to prove that the food safety system is effective.

Results of the verification activities must be recorded and reviewed at the food safety team meetings.

Verification activities may include:• Review of non-conforming

product• Internal audits• Review of incidents, withdrawals

and recalls• Complaint review

Comparison

All of the standards require verification activities to take place to ensure that the food safety plan is effective.


Documentation & record keeping


Principle 7 -Establish documentation and record keeping

To be able to provide evidence that the system is under control

FSMA expects food facilities to have records to prove that preventive controls have been applied and adhered to and these must be available on request of an audit.

The hazard analysis must be reviewed every 3 years as a minimum.

It must also be reviewed when:• There is a significant change

which may change the hazards which affect the food

• New information regarding food safety is received

• A preventive control is found to be ineffective

Where the FDA say ‘where a preventive control is found to be ineffective’, they do not mean each time a preventive control monitor highlights a problem, or where a monitoring procedure has not been adhered to – but when it is realized that an existing preventive control does not control the identified hazard.

Documentation and records must be held, in order for verification activities to take place.

HACCP reviews must take place at least annually and these should include a review of the pre-requisite controls.

Reviews should also be conducted when:• Raw materials or suppliers

change• Changes to product formulation

occur• Processes or equipment

changes• Changes in packaging occur• There are changes in storage or

transport• Environmental conditions

change• If consumer use changes• New information is received• A recall occurs

Continuous improvement must be applied, to ensure that review information is incorporated into the plan.

Comparison

All of the standards require verification activities to take place to ensure that the food safety plan is effective.

The FDA require a minimum 3 yearly review, however to comply with the BRC Standard a yearly minimum review is required.


Notes


CHAPTER 2

Preparatory Stages


Preparatory Stages

The aim of the preparatory stages is to prepare the foundations for the food safety plan to be developed, documented and implemented.

This includes:• Gaining senior management commitment• Establishing the team• Defining the scope of the study• Defining the pre-requisites (good manufacturing practices)

In a traditional HACCP plan, the preparatory stages would also include elements such as:• Defining the product• Detailing the intended use and the intended user• Constructing the process flow diagram

The methodology provided in this book, splits these elements away from the preparatory stages and places them in a new stage called the hazard extraction stage.

In a typical HACCP, the section of defining the product, the intended use and the intended user has been underutilized. By splitting out these steps into the extraction stage, the true benefit of this work can be appreciated and used to extract the pertinent food safety hazards.

The creation of the process flow diagram, the process description and assessing the process for hazards, also sits perfectly within this stage.

The following preparatory stages explain how the foundations should be set in readiness for the following stages in the combined HACCP and HARPC plan.


Obtain Senior Management Commitment

Although the BRC requirements will be the key driver for ensuring that the combined HACCP and HARPC system is fully supported by senior management commitment, it is essential to the success of any food safety system.

Senior management commitment is required to ensure that the food safety system is fully supported from a high level, so that it becomes an intrinsic part of the day to day activities within a food business.

Management needs to provide the key resources to ensure that the system is effective at all times. These resources include the provision of experienced and qualified personnel, time and capital. Capital expenditure will need the budget holders to appreciate the rationale behind such spend.

A food safety system requires management commitment to communicate the food safety message throughout the workforce, in order for it to be understood at all levels. Many of the key controls rely on personnel to understand the importance of the steps where product safety could be compromised.

It is vital for agreed communication channels to be in place, to ensure that the information flows between all levels of the departmental management team, and also, up from and down to the workforce. This will include communication through regular review meetings and from verification activities, such as internal auditing.

To ensure that the food safety system is not a purely paper exercise, continuous improvement of the system is required. This will require resources to be applied to both corrective and preventive actions, which arise from monitoring or verification activities.

Provision of the required resources on an ongoing basis such as training is key, to ensure that the system is maintained. This will include the provision of refresher training of the food safety team, plus introductory training for new members. A programme of specific procedural training, relevant to their activities will also be required for all key personnel involved in monitoring tasks.

Although record keeping has been a key element for facilities who are adhering to the BRC Standard, the FDA have now stated that all preventive controls must be evidenced, meaning that records are required to show that the food safety system is effective. Commitment is therefore required to provide the resource and systems to allow records to be produced and then, filed in such a way that they are easily accessible when required for inspection.

Top Tips

• Management commitment is essential to ensure that the food safety system is effective• Ensuring that records are kept, filed and easily accessible is key, without evidence the system cannot be

proven to be effective• Senior management must provide the resources required to ensure that the food produced is safe• The management’s commitment to food safety should be visible within the culture of the business


Notes


Establish the Team

Ensuring that the HACCP and HARPC plan is developed by a competent multi-disciplinary team is essential to meeting the BRC standard. The FDA has also stated that the risk-based preventive food safety plan must be developed or overseen by one or more preventive controls qualified individuals.

Therefore, the team must:• Have a team leader• Include team members that cover the specific products and processes assessed• Be qualified and competent

BRC require the right expertise to be available within the team which may include:• Technical or Quality• Engineering• Production or Operations• Distribution

The list of key members who will bring the right experience and knowledge to the team will depend on the product and processes covered.

It is a requirement of the preventive controls rule to include food safety hazards caused by intentional adulteration for economic gain. This will most likely mean that expertise from departments such as procurement, purchasing or buying should also be included.

The role of the team leader

The team leader is responsible for ensuring that the team meet their objectives. The team leader must also have a strong understanding of the HACCP and HARPC requirements, so that they can ensure that all elements of the developed and implemented plan are compliant.

The team leader would co-ordinate the team to ensure that:• There is a competent team in place, covering all of the required expertise for the product and processes

under consideration• The team meet and carry out working parties to ensure that the combined HACCP and HARPC plan is

developed and documented• The development and implementation of the plan meets the requirements• The assessment is carried out in a structured and methodical manner, which is detailed in the facility’s

procedures• Any actions raised out of the meetings or working parties are logged, actioned and completed• The preventive controls and CCPs established through the risk assessment are fully implemented• Monitoring procedures, critical limits and criteria are validated or justified• Effective procedures and records are in place• All personnel who are carrying out preventive controls or CCPs are trained for their duties• The team meets to review the HACCP and HARPC plan at least annually or when changes occur


Preventive Controls Qualified Individual (PCQI)

The FDA has stated that the one or more preventive controls qualified individuals (PCQI) must develop or oversee the HACCP and HARPC plan. It is therefore sensible, for this person to be the team leader.

The definition provided by the FDA of a preventive controls qualified individual (PCQI) within the act is:

“A person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is

otherwise qualified through job experience to develop and apply a food safety system”

The PCQI must carry out or oversee the following:• Development of the HARPC plan• Validation or justification of the preventive controls• Review the records for their effectiveness prior to implementation• Approve the corrective actions for the preventive controls• Review the HARPC plan

All of the activities above sit within the requirements for the team leader and so, it would be advisable for this person to carry out both roles.

It is important to recognize that there may be more than one PCQI in the HACCP and HARPC team. The PCQI does not also have to work for the facility, but may be a contracted third party.

Training & competency

All members of the team must be able to show that they are competent in hazard analysis for food safety principles and that they have an understanding of what makes their product and processes safe.

The BRC Standard does not stipulate that a particular formal qualification is required, but the members of the team must be able to show competency. By this, they must be able to talk through the general principles of food safety hazard analysis and how their plan was developed. They must also be able to explain what preventive controls and CCPs are in place for the facility, why they are important to protect food safety and how these are effectively managed.

The team leader must have a detailed knowledge of the methodology used for the food safety hazard analysis and be able to explain this in depth.

The FDA have stated that the preventive controls qualified individual (PCQI) must be qualified and this can be achieved by either of the following methods:

• Successful completion of training• Job experience

In order to be qualified through training, the PCQI must complete a training course which meets a standardized and FDA recognised curriculum.

For a PCQI to be qualified through job experience, this person must be able to confidently, competently and in detail talk about:

• The HARPC methodology• The food safety elements relating to the raw materials, product and process • Key factors in validating or justifying the preventive controls• What makes the monitoring activities and corrective actions effective • How and when reviews must take place


Deputies

For compliance to the BRC Standard, it is essential for the team to be effective at all times, and so, there must be suitable and sufficient deputies available to cover the core members of the team. These deputies, could be listed as additional members, to make it clear that they would not typically be part of the team but would attend reviews as additional support members or deputize for core members.

Top Tips

• The team should be multi-disciplinary, ensuring the right experience of product and processes are included• The team must have a team leader, who ideally should also be the preventive control qualified individual as

well• The team need to be able to demonstrate that they are competent, either through training or experience• In order for the team to include the required knowledge to assess raw materials, it is a good idea to include

procurement or purchasing• Make sure you keep your team information up to date. As people leave or join the team, update the team

details• Include copies of qualifications in the folder, behind the team details


Team example

The following table shows how the food safety team can be documented. Where members of the team have qualifications, copies of these certificates should be placed in your folder.

Sandwiches Ltd – Food Safety Team

Core Team Member Job Title HACCP Team Role Experience & Qualifications

Jessica Brown Quality Manager Team leader & PCQI Food safety hazard analysis training and FSPCA Recognised Qualification

Kate Shaw Engineering Manager Team member Food safety for engineers. Qualified electrical and mechanical engineer

Ruth Allen Production Manager Team member Experience of ready to eat products and sandwiches since 1995. Food safety hazard analysis training

Melanie Murray Procurement Manager Team member Experience of the supply chain, in a range of raw material sectors since 2001

Greg Marsh Distribution Manager Team member Experience of chilled distribution chains since 2008

Additional Team Member

Job Title HACCP Team Role Experience & Qualifications

Adele Sweet Quality Assistant Team leader Food safety hazard analysis training. Process control (quality) and laboratory experience since 2010

Charlie Coulter Third party consultant PCQI Food safety hazard analysis training and FSPCA Recognised Qualification


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Notes


Define the Scope of the Study

The purpose of the scope, is to define what elements are to be covered in the assessment; to provide clear statements of what is included in the assessment and what is not included in the assessment.

Defining what’s in & what’s out

Clearly stating the scope, ensures that the team are clear about what must be covered in the assessment and what is not covered. This must include a clear statement of:

1. The start and end points of the study2. Where the responsibility of the business begins and where it ends3. The products and processes covered

Given that the raw materials are to be assessed for both their inherent risk and also for food safety contamination caused deliberately for economic gain, the start point of the assessment would need to be earlier than in a typical HACCP plan, to ensure it covered the elements of procurement.

Products and processes covered

The products and processes covered where possible, should be grouped to reduce repetition within the plan. Where products are similar and follow the same processes, they should be grouped together.

The food safety point

To comply with the preventive control rule, the FDA also expect any preventive controls which are essential to food safety (that are applied after the product has left the facility) to be included in the assessment. For this reason, the scope must also include a statement which details at what point the product will become safe to eat.

Gathering food safety information

By spending time pulling together all the information essential to product safety, this ensures that the team and the preventive controls qualified individual (PCQI) can show that they understand exactly what needs to be included in the assessment. This information can then be used when defining which hazards need to be included (see extraction stages).

In the scope, a list of all the relevant food safety information references used (books, texts, legislation) should be documented. Although this list sits within the scope, in practice the list would need to be compiled during the extraction stages of the assessment.

HACCP and HARPC scope

The FDA have defined the scope of the hazard analysis plan, which focuses solely on food safety, as detailed in the following sections.

The hazards categories that must be considered are:• Microbiological


• Chemical, including radiological• Physical

In addition to the above, allergenic hazards need to be covered in order to comply with HACCP and the BRC Standard.

The hazard analysis must consider:• Known inherent hazards• Hazards which could ‘reasonably occur’

The hazards may be caused because• They are inherent to the raw material or product• They occur through error during the process• They could be carried out deliberately for economic gain (for food safety only)

The FDA have identified the following as sources of hazards which must be included:• The environmental • The recipe or formulation• The manufacturing processes• The fabrication of the facility• The equipment used• The tools used• The intended use of the food

The above hazards will be assessed as part of the extraction stage, see page 37.

Top Tips

• The scope makes it really clear to the team and anyone inspecting the food safety system, what is included and what is not included

• Remember, these are statements of fact, so they need to be short and to the point• Make sure your scope clearly states what parts of the supply chain the business is responsible for, and, what

they are not responsible for• When detailing what products and processes are in the scope, list the types or groups of product, rather than

listing all of the individual products• The food safety point is key – when will the product become safe to consume? Does this point occur within

your responsibilities or after it has left the facility?• Make sure you have evidence of the preventive controls that are applied after the product has left your

control, if this is where the product becomes safe


Scope example

The following provides an example of how the scope of your assessment could be documented. It also gives you a structure to which you can use.

Meat Products Ltd. – Combined HACCP and HARPC Scope

Start and end points of the study: The food safety assessment starts at the point of procurement of the raw materials and ends at the point of dispatch to the customer

Responsibilities: The responsibility of Meat Products Ltd. begins at the point of procurement of the raw materials and ends at the point of delivery to the customer. Third party hauliers are employed to pick up the product from the manufacturing facility and deliver the product to the customer. Therefore, the delivery step in the supply chain is the responsibility of Meat Products Ltd

Products covered: The products covered by the food safety assessment are raw sliced and diced meat

Processes covered: The processes included in the assessment are receipt of raw materials, butchery of carcasses, automated slicing and dicing of the meat, packing and labelling

The food safety point: The point at which the product becomes safe to eat, is on completion of cooking. The product that is dispatched from Meat Products Ltd. is not ready-to-eat. The product is sold as an ingredient and further processing includes cooking to make the product safe. To ensure that the preventive control of cooking is applied after the product has left the facility, minimum cooking instructions are stated on the finished product specifications. The specification is signed by both parties.

Types of hazard covered: The types of hazard considered are:• Microbiological• Chemical• Radiological• Allergenic• Physical

Sources of hazards covered: The hazard analysis covers:• Known or inherent hazards from the raw materials, product or process• Hazards which could reasonably occur from the environmental,

fabrication, equipment or process• Hazards carried out deliberately for economic gain

Information sources: Add related information sources or texts for the product or process.


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Notes


Define the Pre-requisites (Good Manufacturing Practices)

A pre-requisite programme is a group of facility-wide controls, grouped under one overall topic. Pre-requisite programmes are the building blocks or base for good manufacturing practice. Without a strong structure of pre-requisite programmes (PRPs), a food safety plan will not have a good foundation to work from.

Originally HACCP plans had a limited number of PRPs and associated controls, which meant that the hazard analysis highlighted a large number of CCPs.

Over time, PRPs have developed and so, the level of control has improved, therefore reducing the number of CCPs required. This reduction of CCPs, puts more focus on ensuring that the pre-requisite controls are robust and effective, to safeguard the production of safe food. Therefore, establishing and implementing pre-requisite programmes which underpin the food safety management system is key.

The FDA as part of FSMA have modernized the regulations on current good manufacturing practices (GMPs). These topics are typical pre-requisite programmes, to which the detail of the controls within each may be expanded as shown in the example below.

PRP PRP controls

Personnel Disease control and health screening, personal hygiene procedures, protective clothing controls, hair control, hand washing procedures, jewelry control, eating and drinking controls

Plant and grounds Building and grounds control, storage, waste routes, drainage, waste treatment, plant design and construction, lighting, pest proofing, ventilation and extraction

Sanitary operations Maintenance of buildings, equipment and tools, chemical control, pest control and cleaning

Sanitary facilities and controls

Utilities including water supply, facilities including toilets and hand washing and waste control

Equipment and utensils Manufacturing, processing, packing or holding equipment design and construction, food contact materials including gas and compressed air, calibration and control of measuring devices

Processes and controls Process controls, product testing procedures, non-conforming (rejected) product, raw material and finished product controls

Warehousing and distribution

Storage and transport controls

Defect action levels Finished product standards and specifications

In addition to the above good manufacturing practices, the FDA have added the requirement to the HARPC plan to include written preventive controls for:

• Process controls• Food allergen controls• Sanitation controls• Supply-chain controls• Recall plan• Other controls (which include other good manufacturing practices)


The above are also examples of typical pre-requisite programmes, although some of the requirements are duplicated with the GMPs.

In order to comply with the BRC Standard the following additional pre-requisites would need to be added to the list, as a minimum:

• Traceability• Security• Contamination control (e.g. wood, glass and hard plastics)• Training and supervision• New and existing product development

By combining all of the topics, a full list of pre-requisite controls can be developed, an example of this is provided on the following page.

In order to create a combined HACCP and HARPC plan, the pre-requisite programmes need to be expanded to not only include pre-requisite facility-wide controls, but also preventive controls that are related to the PRP topic.

Without expanding the PRP topics to include preventive controls, the quality management system would need to include both PRP procedures and preventive control procedures. By placing preventive controls under the umbrella of the PRP topics, it allows the number documents to be reduced.

Each pre-requisite programme will require a policy or procedure which defines how the facility will adhere to the requirements. In order for this policy or procedure to be clear, it should be structured so that the pre-requisite controls and preventive controls are separated. The format of the procedure may look something like the template provided on page 34.

Where specific step by step instructions are required in order to train out and manage the preventive controls, additional work instructions will also be required. These can be referenced in the overall PRP topic procedure.

Top Tips

• Pre-requisites are facility-wide groups of controls• Pre-requisite procedures or policies are required for each topic, which detail how each of the pre-requisite

controls are managed• To prevent the need for a separate procedure for each preventive control, it is advisable to sit the preventive

controls under the pre-requisite topics


Pre-requisite programmes example

It is good practice to provide a list of all of the pre-requisite controls that are included in each pre-requisite topic, this way the references for each procedure that contain the detail of how these controls are managed can be referenced. See the example below.

PRP PRP controls

Personnel Disease control and health screening, personal hygiene procedures, protective clothing controls, hair control, hand washing procedures, jewelry control, eating and drinking controls, visitor and contract controls

Plant and grounds Building and grounds control, storage, waste routes, drainage, waste treatment, plant design and construction, lighting, pest proofing, ventilation and extraction

Sanitary operations Maintenance of buildings, equipment and tools, chemical control, pest control

Sanitary facilities and controls

Utilities including water supply, facilities including toilets and hand washing, waste control and positive air pressure

Equipment and utensils Manufacturing, processing, packing or holding equipment design and construction, food contact materials including gas and compressed air, calibration and control of measuring devices, equipment specifications, food grade certificates, breakdown procedures, controlled maintenance hand-back procedures and planned preventative maintenance

Process controls Process controls, product testing procedures, non-conforming (rejected) product, quarantine procedures, raw material and finished product controls, recipe control, decanting procedures and positive release

Warehousing and distribution

Storage controls, vehicle breakdown procedures, stock rotation and environmental controls

Defect action levels Finished product standards and specifications

Food allergen controls Allergen segregation, cross-contamination procedures and spill procedures

Sanitation controls Cleaning procedures, CIP systems and cleaned equipment segregation

Supply-chain controls Contract management, raw material approval, intake acceptance procedures, raw material specifications and packaging migration controls

Recall plan Incident, withdrawal and recall procedures

Traceability Mass balance, traceability systems and procedures

Security Site and product security procedures

Contamination control Glass and hard plastic control, breakage procedures, wood policy and sharps control

Training and supervision Competency control, training and supervision

New and existing product development

Change management, product development procedures, shelf life procedures and trial control


Pre-requisite programmes exercise

Using the following template, list your pre-requisite programmes and the controls that are included under each topic. An additional column has been provided, as it is good practice to provide references for each relevant procedure.

PRP PRP controls


Pre-requisite procedure template example

The pre-requisite procedures form the core of the overall quality management system. Therefore, it is useful to have these as the reference point to which all other procedures, including preventive control work instructions within the system can be linked to.

Pre-requisite Procedure

1. Purpose

In this section, state the aim of the procedure.

2. Definitions

Add in here any definitions that are relevant to the content of the procedure.

3. Responsibilities

In this section, detail the responsibilities of the senior management to the requirements of the procedure. Also, detail the specific departmental role responsibilities.

4. Related documents

Here related documents can be referenced. Preventive control work instructions used to train personnel on their specific responsibilities, which can be referenced here as well. Also ensure that any relevant records are referenced.

5. Pre-requisite controls

Detail each pre-requisite control and the requirements for each.

6. Preventive controls

For each preventive control detail the significant food safety hazard that it controls, an overview of the monitoring activity, frequency and corrective action. Reference the specific work instruction that is to be applied.


Notes


CHAPTER 3

Extraction Stages


Extraction Stages

Now that the preparatory stage has been completed, the foundations of the combined HACCP and HARPC system are in place.

The foundations are:• Senior management are committed to a food safety culture and so, are committed to providing the required

resources• The food safety team has been established, with the required experience and level of training to ensure that

they are competent in their roles• The scope of the system has been agreed and documented• The foundational pre-requisites are in place, robust and effective

The next step is to complete the extraction stage. This is a new stage which is unique to this methodology.

Although the some of the elements within the extraction stage of product description, intended use and intended user have been a requirement in HACCP for some time, typically the purpose of these have not been fully utilized.

The extraction stage has been designed to ensure that the information provided in the product description, intended use and user, are fully utilized, this is achieved by carrying out an assessment on the information to extract the pertinent hazards.

The principle of this extraction, is similar to the understood and accepted process which is applied when assessing the process flow chart for hazards. The process flow is designed and then each step in the process flow is evaluated, to identify which hazards should be assessed within the hazard analysis.

Applying this theory to the product description, intended use and intended user means that the information is gathered and documented, then assessed to extract the hazards that need to be put through the hazard analysis.

In order to comply with the preventive controls rule, the FDA have specified that the raw materials must be assessed for their inherent risks and also for adulteration due to economic gain. This is aligned with the ‘composition’ and ‘origin’ requirements detailed in the BRC Standard, under product description. By expanding these sections, the raw materials can be fully assessed, to ensure that the key food safety hazards are extracted.

The extraction process is shown in the diagram below.

This is an essential part of the combined HACCP and HARPC plan, for two reasons:1. It provides a structured approach for the team and PCQI to follow, to ensure that all pertinent hazards are

included in the assessment and no relevant hazards are missed2. It ensures that only the hazards that could ‘reasonably occur’ are included, as stated by the FDA

Ensuring that only hazards which could reasonably occur are included in the hazard is key, to ensuring that the hazard analysis is focused and targeted to true food safety issues.

Product description

Process flow diagram

Intended use & userExtraction of the pertinent

hazardsHazard analysis


Shelf life validation

By compiling the food safety information in the product description, intended use and intended user, the key food safety elements that are highlighted through this process can be used to validate the safety of the product, such as testing the product for aw, pH and relevant pathogens over the life of the product. The intended use also provides information on how the shelf life testing should be carried out, to mimic that of the intended user. For example, if the label instructions state that the product must be consumed within 3 days of opening, it would be advisable for the product to be opened 3 days before the end of life as part of the shelf life trials.


Define the Product & Extract the HazardsThe BRC Standard states that a full product description is required, which details all of the information that makes the finished product safe, including:

• Composition• Raw material country of origin• Key manufacturing processes• Packaging information• Storage and distribution conditions• Product intrinsics• Shelf life

The preventive control rule also states that an assessment of the raw materials is required, to establish:• The inherent risks from the raw materials• Any risks associated with raw materials which may be adulterated for economic gain, due to food fraud

Using the above requirements, the list of elements to be covered as part of the product description can be structured as follows:

• Raw materials1. Inherent risks from ingredients2. Food safety risks from food fraud, including origin3. Inherent risks from packaging

• Product:1. Inherent risks2. Intrinsics3. Food safety treatments4. Food safety hurdles (environmental conditions, e.g. temperature and modified atmosphere packing)5. Shelf life

Each of the above elements are explained in the following sections.


Product description

The product description should be based on the scope of the combined HACCP and HARPC plan, which was set in the preparatory stage.

Where products have been grouped together, the product description can be conducted together. Where there are key distinct food safety differences between the products, these elements of the description should be separated to ensure that the information remains clear.

Raw materials

The raw materials that are used to produce the product or group of products listed in the scope of the assessment, should be listed. Where there are a large number of ingredients, they can be grouped as long as the raw materials in each group have the same inherent and food fraud risks. Each raw material or group of raw materials should then be assessed for the following.

Inherent risks from ingredients

An inherent risk is one that is associated with a raw material, something that is naturally expected because of the characteristic of the raw material. For example, it is reasonable to expect that there may be small fragments of bone in duck meat, or Salmonella in raw chicken.

Working through each raw material or group of raw materials, establish if there are any microbiological, physical, chemical, allergenic or radiological hazards associated with them.

Food safety risks from food fraud, including origin

The FDA state that food safety hazards which may be caused by fraudulent activities for economic gain should be included in the hazard analysis. The FDA do however, reiterate that these types of hazard would only need to be included in rare cases, and where there has been “a pattern of economically motivated adulteration in the past”.

Hazards which only impact quality or the integrity of the product are not to be included. The requirement only includes food safety hazards.

Hazards are also limited to those due to food fraud. Acts of terrorism should not be included, as these will be dealt with as part of the FSMA Intentional Adulteration Rule.

Instances where spices have been adulterated causing an allergenic hazard, may sit within this requirement.

The BRC Standard requires the country of origin of the raw materials to be taken into consideration, as ingredients purchased from uncontrolled areas of the world may be more at risk.

Again, assess each raw material or group of raw materials and list the pertinent hazards where they apply.

Inherent risks from packaging

The same principle applies for packaging as it does with ingredient raw materials. Where packaging raw materials have inherent risks, these should be listed. Examples of this may be: glass contamination from the use of glass jars or chemical migration from food contact plastic packaging.

Working through the list document the relevant hazards.

1

2

3


Product

Following the product or product groups detailed in the scope of the plan, the key food safety information should be detailed.

Inherent risks

Here the key food safety information relating to the finished product should be described. This should include a description of the recipe formulation and any inherent hazards that arise from this.

For example, where pitted olives are being produced, there may be an inherent risk from stones, this would be a pertinent food safety risk that should be described and the relevant hazards extracted.

Intrinsics

Intrinsics are the key characteristic compositional elements of the product, that control the safety of the food, such as the pH, aw or alcohol content. The intrinsics should be detailed and any food safety hazards extracted.

Food safety treatments

A treatment is typically a process that is carried out to the product to make it safe. Treatments may be processes such as cooking, pasteurization, sterilization, filtration and sieving.

Ensuring that these treatments are applied effectively is essential and therefore, once described, the food safety hazards associated with them should be extracted. The extracted hazards can then be applied to the relevant steps in the process flow diagram where these treatments take place.

Food safety hurdles

A food safety hurdle is designed to restrict or control growth of pathogens throughout the shelf life of the product. Think of it as a barrier that the bacteria have to ‘get over’ to be able to grow.

These hurdles can be applied as a single hurdle or a number of hurdles, that overall make the product safe. They typically change the environment of the food, so that it is not suitable for the bacteria to grow to unsafe numbers.

Hurdles include factors such as temperature control of the product or where the gas content of the packed product is adjusted (e.g. MAP packing).

List the food safety hurdles that are applicable to the product or group of products and then, extract the hazards that are relevant.

Shelf life

The shelf life that is applied to the product should be documented. The main focus here is to state:• The overall life of the product• Whether the shelf life is classed as a 'best before' or 'use by'

Where a 'use by' is applied to the product, for food safety purposes, the extracted hazards may be due to the wrong date code being specified on the label at packing.

Top Tips

• Remember there is a purpose to writing about the product description, the aim is to document the information that makes the product safe

• Food safety treatments are processes (typically manufacturing activities) that are applied to make the product safe

• A food safety hurdle is a barrier that pathogenic bacteria have to ‘get over’ to be able to grow

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haccp - amazon s3 · haccp plan, on how they could adapt their current food safety systems to meet...

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