White Paper Ensuring IFS Food Version 6 Compliance · 2020-01-18 · White Paper Ensuring IFS Food...

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Ensuring IFS Food Version 6 ComplianceUsing Checkweighing Applications

Contents

1 Introduction

1.1 Duty of Care

1.2 Due Diligence: what is it?

1.3 Hazard Analysis Critical Control Points

1.4 Is a Checkweigher a CCP?

2 Main Changes in IFS Food version 6

3 How can Checkweighers Help you Gain Compliance?

4 IFS 6 Compliant Checkweighing Systems

4.1 Automatic Product Reject Mechanism

4.2 Weigh light barrier and Conveyor Belt Speed Encoder

4.3 Lockable Bin, Reject Countercheck, and Reject Area Full

4.4 Countercheck for Complete path Monitoring

4.5 Operation Reset

4.6 Signal Light Pole

5 Management Responsibility

6 Summary

7 Literature References

8 More detailed information

IFS Ver. 6

2 Ensuring IFS Food Version 6 ComplianceMETTLER TOLEDO Garvens White Paper – www.mt.com/garvens-ifs

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e 1 Introduction

This paper outlines some of the main changes introduced by the IFS Food Version 6 Standard and how a checkweighing solution can ensure compliance with these new regulations. It considers what additional elements should be included in the process in order to safeguard customer welfare and provide the basis for a robust due diligence defence.

"IFS Food is a GFSI recognised standard for auditing food safety and quality of processes and products of food manufacturers. It concerns food processing companies or companies that pack loose food products.

IFS Food applies when products are “processed” or when there is a hazard for product contamination during primary packing. The IFS Food Standard is important for all food manufacturers, especially those producing private labels, because it contains many requirements related to specifications’ compliance. It supports production and marketing efforts for brand safety and quality.

IFS Food standard version 6 has been developed with full and active involvement of certification bodies, retailers, industry and food service companies from all over the world. It is an ever increasing responsibility of food manufacturers to take every precaution to ensure that their products are safe, free from contamination and are unlikely to harm the end consumer in any way." (http://www.ifs-certification.com/index.php/en/ifs-certified-companies-en/ifs-standards/ifs-food)

HACCP leads the way in providing a framework for food manufacturers to work within whilst the Global Food Safety Initiative (GFSI) manages and controls the bodies that can provide the certification and accreditation.The organisations and bodies that provide GFSI recognised schemes include the following:

• TheBritishRetailConsortium–BRC• TheInternationalFoodStandard–IFS• FSSC22000• SQF2000• DutchHACCP

Otherschemesexistbutthe5mentionedaboveprobablyequatetoover90%oftheadoptedstandardscurrentlybeing worked to.

In these litigious times, lawyers and consumers alike will seize on any opportunity to take legal action against manufacturers in the event of finding something awry with the product they have purchased. Food manufacturers supplying retail organisations will fully understand the need to ensure that their product quality is of the highest level.

It is therefore in the best interests of manufacturers to take steps to ensure systems and procedures are in place minimising the risk of litigation and, in the event of such an instance, having the necessary documentary evidence to prove that they have been duly diligent in the manufacturing process.

Are you confident that your systems and procedures will stand up to scrutiny under the new IFS Food Version 6 Standard?

3Ensuring IFS Food Version 6 ComplianceMETTLER TOLEDO Garvens White Paper – www.mt.com/garvens-ifs

1.1 Duty of Care

In law, we each have a Duty of Care which requires that we adhere to a standard of reasonable care while performing any acts that could possibly harm others. The Standard of Care is the degree of watchfulness, attentiveness, prudence and caution of an individual who is under a Duty of Care. In the food industry, the Standard of Care is determined by the standard that would be exercised by the reasonably prudent manufacturer of a product. Failure to meet the standard could be regarded as negligence, and any resulting damages may be claimed in a lawsuit by the injured party.

1.2 Due Diligence: what is it?

The Due Diligence defence is available to manufacturers accused of a breach of food safety regulations. Essentially, the defence is that the "accused" took all reasonable practicable steps to avoid the breach. It is a sufficient defence for the person charged to prove that:

• Allreasonableprecautionsweretaken• Theyexercisedallduediligencetoavoidtheoccurrence,whetherpersonallyorthroughanyperson

under their control.

"Taking all reasonable precautions" includes setting up systems of control which are appropriate to the risk. What is reasonable is determined by the size and resources of the business. "Exercising all due diligence" involves having procedures in place which review and audit the system to ensure it is operating effectively.

Whether or not a defence will be successful depends on the circumstances surrounding each case.

1.3 Hazard Analysis Critical Control Points

In food production, most manufacturers utilise a Hazard Analysis Critical Control Points (HACCP) based system as a framework to identify where hazards might occur. The HACCP structure is then used to put into place procedures mitigating the risk of the hazard from occurring in the first place. The HACCP process strictly monitors and controls each manufacturing step, to reduce the probability for hazards to occur.

HACCP is based on 7 core principles:

• Conductafoodsafetyhazardanalysis• Identifythecriticalcontrolpoints(CCPs)(pointatwhichahazardisoptimallycontrolled)• EstablishcriticallimitsforeachCCP• EstablishCCPmonitoringrequirements• EstablishcorrectiveactionswhenmonitoringindicatesthataparticularCCPisnotundercontrol• Establishrecordkeepingprocedures• Establishprocedurestoverifysystemisworkingasintended

1.4 Is a Checkweigher a CCP?

The manufacturing environment and general food processing can create the risk of contamination occurring. Although a checkweigher is not normally considered as a CCP, in combination with a metal detector or X-ray inspection system it often acts as a critical control point to mitigate this risk.


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e The recent changes to the ISF standard have made a change in how you should consider the role of a checkweighing solution as there is now a far greater emphasis on:

• Product analysis• Process verification and control• Qualitychecking• Monitoring production and record keeping

Furthermore, a suitable checkweighing system will allow manufacturers to fully maximise the opportunity to deliver the absolute best level of consumer and brand protection. All conveyor systems used to inspect products should be specifically designed to do just that and not just simply provide a "tick in a box" that says inspection equipment is on the line and functioning.

2 Main Changes in IFS Food Version 6

• A slightly revised scoring system will be implemented to better identify companies implementing best practices

• Clear rules for determining audit duration have been created, based on a pragmatic calculation tool, which will provide the minimum mandatory audit duration to be applied by all certification bodies,

• IFSIntegrityProgram,whichwascreatedin2010tomonitorperformanceofcertificationbodiesandofauditors,will be described in the new audit protocol,

• As IFS Food is not only a food safety but also a quality standard, version 6 will include more quality requirements (e.g. nutritional analyses, more requirements on weight control, more requirements on the quality/quantity of information provided on labelling, etc.),

• In order to comply with GFSI Guidance document version 6, food defence requirements will be introduced in IFS Food audit check-list. Exhaustive guidelines will also be developed in order to help companies implement those requirements, based on risk assessment and – most of all – on legislation of destination country.

• IFS auditors will be approved for products and technology scopes. Technology scopes are newly introduced to improve auditors’ expertise even more on products and processes. (http://www.ifs-certification.com/index.php/en/ifs-certified-companies-en/ifs-standards/ifs-food)

3 How can Checkweighers Help you Gain Compliance?

Checkweighers are a common sight in most modern food manufacturing plants and the technology employed is considered highly reliable. Alarming is the fact that upon investigation, products returned as a complaint are invariably detectable by the on-line equipment. This points the finger of suspicion at the operational procedures in place in the manufacturing or inspection process.

Simply installing a checkweighing system may not totally eradicate the incidence of faulty product reaching the enduser.AtotalapproachtoQualityManagementmustbeemployed.

A checkweighng system fitted with suitable components and the installation of suitable software options will not only go a long way in providing a solution but will also provide compliance with the new ISF Food version 6 Standards.


In the table below we have outlined some of the new regulations and show how a checkweighing solution will ensure compliance.

New in IFS Food version 6 (listing not complete) Checkweighing solution

2.2.3.8.1 KO N° 2: Specific monitoring procedures shall be established for each CCP to detect any loss of control at that CCP. Records of monitoring shall be maintained for a relevant period. Each defined CCP shall be under control. Monitoring and control of each CCP shall be demonstrated by records. The records shall specify the person responsible as well as the date and result of the monitoring activities.

2.2.3.8.4 The CP’s shall be monitored and this monitoring shall be recorded.

2.2.3.10 Establish verification procedures (CA Step 11 – Principle 6)Procedures of verification shall be established to confirm that the HACCP system is effective. Veri-fication of the HACCP system shall be performed at least once a year. The results of this verification shall be incorporated into the HACCP system.

2.2.3.11 Establish documentation and record keeping(CA Step 12 – Principle 7)Documentation shall be available covering all processes, procedures, control measures and re-cords. Documentation and record keeping shall be appropriate to the nature and size of the company.

5.3.1 The criteria for process validation and control shall be clearly defined.

5.3.5 Process validation shall be performed using the collected data that is relevant for product safety and the processes. If substantial modifications oc-cur, a re-validation shall be carried out.

Software Option:Local Audit Trail for Complete Process AccountabilityAn audit trail is a list which records all activities and parameter changes. It is a complete historical record of who changed what and when.

The Audit Trail function operates completely auto-matically in the background and only requires user intervention on very rare occasions e.g. if the number of entries exceeds the maximum limit.

The history lists the following data:• an (invisible) index for each entry• a date/time stamp • the user-ID (login name)• modification area• the modified parameter detail name• the old and new parameter values• an explanation (if required)

For more information request the application note: App_07atwww.mt.com/garvens-app


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5.5.2 A procedure shall exist to define compliance crite-ria for lot quantity checking. This procedure shall also, among others, take into consideration the tare, the density and other critical attributes.

Software Option:Action CounterAutomatic sorting of samples for quality inspectionSelective rejection of accepted products for the quality assurance inspection. Rejection of a pre-defined number of accepted products for further scrutiny by the quality control rejector after a predefined number of products (batch) have been weighed. For the fulfilment of the batch sizes only the “good” products are counted by the Sync-light barrier.

For more information request the application note: App_09atwww.mt.com/garvens-app

5.5.3 Checks shall be implemented and recorded, ac-cording to a sampling plan which ensures a proper representation of the manufacturing lot.

Software Option:Sample Function (Spotcheck)For Additional Quality ControlThe sample key allows the operator to remove x number of products from the production line for further evaluation using a rejecting device without stopping the production process or causing unnecessary downtime. The data of all sampled products is stored and can be printed for quality control record keeping. For more information request the application note: App_20atwww.mt.com/garvens-app

A full version of all the main changes with version 6 can be found at:http://www.ifs-certification.com/images/downloads/en/Design_Short_Version_IFS_Food_6_Jan_2012%20_english_final.pdf


4 IFS 6 Compliant Checkweighing System

4.1 Automatic Product Reject Mechanism

The system should include an automatic product reject mechanism. The mechanism is activated when the checkweigher has identified a contaminated or off-weight product. Its purpose is to remove the product from the production line prior to despatch. The type of rejection mechanism should be designed for the products being inspected and will therefore be dependent upon the parameters of the application. It should take into account line speed, throughput, product weight, shape and dimensions and the nature of the packaging material. This not only ensures maximum rejection capability but also takes away reliance on line operators which can, in many instances, be the biggest cause of process failure. It is recommended that the use of a "stop-alarm and manual rejection" type system should only be specified in extreme circumstances.

Many types of reject mechanisms are available. Most are pneumatically-operated such as air-blast mechanisms, pushers, sweep arms, etc. Such pneumatically-operated reject systems may be fitted with an air failure switch which will raise an alarm if the air pressure falls below a critical point that could prevent efficient rejection taking place. To increase the overall fail-safe nature of pneumatically operated reject systems compressed air reservoirs can also be fitted.

4.2 Weigh light barrier and Conveyor Belt Speed Encoder

These work in conjunction with the reject device and checkweigher to determine the exact position of a contaminated product on the conveyor belt so that the pack is successfully removed from the line. The weight light barrier identifies the presence of each pack at known fixed distances from the weighcell and the reject mechanism.

If using a conveyor system that utilises a variable speed drive, a belt speed encoder should be used in conjunction with the weighlight barrier to control the operation of the reject mechanism. This ensures that the time between the weight being measured and the reject mechanism operating is calculated accurately enabling the reject mechanism to identify the product irrespective of line speed. This is also a requirement if the line in question is prone to frequent stopping and starting.

4.3 Lockable Bin, Reject Countercheck, and Reject Area Full

The purpose of the reject collection bin is to provide temporary storage of rejected (i.e. contaminated) products. The bin must be lockable to make sure that contaminated packs cannot be removed and re-introduced to the production line after the inspection system. The key for the lock should never be left in situ and should be held by a senior/authorised staff member. This removes the potential for others to gain access to contaminated product, consistent with Due Diligence and HACCP principles.

A reject countercheck sensor should be situated in or across the mouth of the reject bin. Once a faulty product has been detected, the system can be configured to expect a further signal from the reject confirmation sensor that a pack has entered the reject bin. If no such signal is received, a system alarm is raised and the conveyor is stopped.

For more information request the application note: App_24 at www.mt.com/garvens-app


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e A bin full sensor removes the risk that a contaminated pack fails to be removed from the conveyor because the collection bin is full of rejected products. Once the level approaches the bin capacity (recommended to be set at 80%full),analarmcanbeactivatedortheconveyorcanbeconfiguredtostopsothatthebincanbeopenedandthe reject products removed for disposal. This avoids the risk of a failed rejection due to the collection bin being full.

A tunnel guard or enclosure should be fitted to the outfeed side of the system. This should extend from the out-feed side of the checkweigher to a point beyond the end of the reject bin as a minimum. The purpose of this guard is to prevent unauthorised removal of products from the system that may be contaminated which could accidentally be re-introduced to the system after the point of rejection.

4.4 Countercheck for Complete path Monitoring

The Countercheck option typically uses a photoelectric sensor located in the normal flow of products downstream of the reject mechanism. This sensor tracks products through the system by synchronizing with the Weigh Light Barrier WLB and accurately monitoring production for any of the three common package handling conditions (see three modes of operation). If more than one rejecter is present in the system, for instance in applications where one rejecter is for off-weight products and the second is for contaminated products, the Countercheck sensor must be located downstream of the last rejecter.

As each item enters the system and breaks the WLB it is tracked until it passes the countercheck sensor. Given the speed of the conveyors and the distance between the WLB and the countercheck sensor, the checkweigher calculates a time window in which the item is expected to pass the countercheck sensor. The system knows and tracks the position of each item after it has passed the WLB. This tracking function defines the point-in-time (or window) when the package is expected to pass the countercheck sensor. Given this tracking function Countercheck can monitor the product flow and detect common process faults.

Countercheck – Three modes of operation requiredA countercheck function should monitor production flow in three separate ways and will alert the operator in the event a fault is detected. Each monitoring function guards against common product classification and handling problems encountered in processing.

• Bad products in good path – This mode monitors the production flow for bad products which have not been correctly rejected and remain in the good path.

• Missing good products in good path – This mode monitors the production flow for missing good products. In production environments it is not uncommon for items to fall or be physically removed from the production line after they have passed the checkweigher's WLB and have been classified.

• Total flow check – This mode not only monitors if a bad product enters the good path and if all good products remain in the good path but also monitors if an unexpected or foreign items enters the good path. For instance, if someone places a product, which has fallen from the production line or has been rejected, back onto the production line.

For more information request the application note: App_29 at www.mt.com/garvens-app

4.5 Operation Reset

All of the fail-safe elements that result in the conveyor being stopped should be linked to a password protected reset function rather than a push button. Only authorised and nominated operators should be allowed to restart the system after the fault or condition has been rectified. The password should never be left with the system and should only be known by the authorised operator.


4.6 Signal Light Pole

A warning light pole attached to the checkweigher can signal warning faults. It is usually a high visibility colour-coded fault beacon, enabling rapid identification and rectification of the problem. This will help to ensure downtime is kept to a minimum. Audible alarms can also be configured to be activated when the warning pole operates. It is recommended that if any of these fault conditions occur during normal manufacturing, the process should cease immediately until the fault condition in question is rectified and the system has been validated and documented as fully functioning by the appropriate system test procedure.

5 Management Responsibility

If a checkweigher is considered to be a CCP, it is a management responsibility to ensure that all personnel treat it accordingly. Operators must be aware that their actions are critical to the operation of the control point and as such, any misdemeanour will be subject to disciplinary action.

6 Summary

This white paper has shown how the IFS Food version 6 Standard may affect your production line processes offering workable solutions. The concept of Due Diligence and its importance, in terms of providing a basis for a legal defence if a customer claims to have found metal contamination in a food product, is also included.

6 Infeed sensor

2 Audit Trail log, high security log-in facility and reset

1 Signal light pole 3. Advanced metal detector search head

7a Reject confirmation sensor

4 Automatic product reject mechanism. One for contami-nated and one for under/over weight products

5 Countercheck sensor

7b Bin full sensor 8 Weigh light barrier


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eThe paper identifies how a checkweighing system under the new regulations and if suitably configured, can help you meet your due diligence needs, and also conform to the seven HACCP principles:

• Conductafoodsafetyhazardanalysis• IdentifytheCriticalControlPoints(CCPs)(pointatwhichahazardisoptimallycontrolled)• EstablishcriticallimitsforeachCCP• EstablishCCPmonitoringrequirements• EstablishcorrectiveactionswhenmonitoringindicatesthataparticularCCPisnotundercontrol• Establishrecordkeepingprocedures• Establishprocedurestoverifysystemisworkingasintended.

Furthermore, a checkweighing system will provide the opportunity to deliver the highest level of consumer and brand protection. All conveyor systems used to inspect food products should be specifically designed to do just that and not just simply provide a "tick in a box" that says metal detection equipment is on the line and functioning.

7 Literature References

British Retail Consortium (BRC)http://www.brc.org.uk

Food Standards Agency (FSA)http://www.food.gov.uk/

International Food Standard (IFS)http://www.food-care.info

ISO22000:2005-FoodSafetyManagementSystemStandardhttp://www.lrqa.co.uk/products/otherproducts/iso22000/

SafeQualityFood(SQF)Institutehttp://www.SQFI.com


8 More detailed information

Checkweighing software compendium The checkweighing software compendium describes software functions and options for achieving easy

navigation as well as optimisation of the checkweigher system. It supplies a comprehensive overview of the checkweigher models in the X series. The compendium can help producers, for example, shorten the changeover times when changing the production

line.Inaddition,therearesolutionsforimprovedfillquantity checking, perfect product transport and the greatest possible data security. www.mt.com/garvens-software

Guidelines for weighing technologyCreating an effective checkweighing program

The Garvens guideline "Principles of Checkweighing" is recommended as a reference document. It offers insight into all aspects of checkweighing, starting with the basic principles up to the implementation of a comprehensive checkweighing program.

This70-pageFREEguidelinehelpsproducersasacompanion document for setting up this sort of weighing program, and is required reading for everyone who has anything to do with checkweighing systems.www.mt.com/cwguide

CalculatorsROI calculator for inline checkweighersThis calculator helps you to work out the amount of savingsyoucanachievebyminimisingoverfillingandwaste. Including sample calculation.www.mt.com/garvens-roi

Manual or in line weighing? Comparison of manual and dynamic weighing This calculator helps you to decide whether replacing a static scale with a dynamic scale would be more profitableforyou.www.mt.com/garvens-dynamic

White papersOverall Equipment Effectiveness (OEE)This white paper provides a detailed description of the overall equipment effectiveness and demonstrates, using a simple calculation, how you can increase productivity at a low cost.www.mt.com/garvens-oee

Principles of hygienic design This white paper covers all aspects of the hygienic design of checkweighers. The last chapter describes a tool that helps you to assess hygiene requirements.www.mt.com/garvens-hygiene

OptimisationoffillingsystemsThiswhitepaperrelatestotypicalproblemswithfilling,andofferstipsandsolutionsforoptimisingthefillquantities – this has a direct effect on quality and cost-effectiveness.www.mt.com/garvens-filler

Total Cost of Ownership (TCO)This white paper explains in detail the most important components of total cost of ownership and describes in detail how to calculate the TCO including potential savings and typical cost drivers.www.mt.com/garvens-tco

On-demand webinarsThose who are interested can access on-demand webinars,withflexibilityaroundtheclock.Youcanobtainspecificinformationaboutapplicationsandproducts, learn about everything related to trends in the sector and standards, and obtain useful and informative illustrations.www.mt.com/pi-ondemandAvailable webinars on checkweighing:

TheEuropeanDirective2004/22/EC(MeasuringInstruments Directive, MID)

Maximiseyourprofitsthroughintelligentweighingtechnology

High performance checkweighing for an optimum overall equipment effectiveness

Pharmaceutical serialisation – selection of the right equipment suppliers

Weight measurement for the improvement of your products and processes

www.mt.com/garvensFor more information

Mettler-Toledo Garvens GmbHKampstrasse 731180 Giesen Germany

Telephone +49 (0) 5121 933-0Fax +49 (0) 5121 933-456E-mail [email protected]

Subject to technical modifications.© 2012 Mettler-Toledo Garvens GmbH

Contact:For more information about checkweighing solutions please contact your local METTLER TOLEDO representative.

Australia –Mettler-ToledoLtd.,Victoria3207Austria–Mettler-ToledoGmbH,1230Vienna Belgium – N.V. Mettler-Toledo S.A., 1932 Zaventem Brazil – Fabrima Máquinas Automaticas Ltda., Guarulhos, SP Bulgaria–RomyTech,8,PrelomSt.,1113Sofia China–Mettler-ToledoInternationalTradingCo.,Ltd.,Shanghai200233Croatia–Mettler-Toledod.o.o.,HR-10000Zagreb Czech Republic–Mettler-Toledospol,s.r.o.,10000Praha Denmark–Mettler-ToledoA/S,2600Glostrup Egypt – Anasia - Egypt for Trading S.A.E, 11361 Cairo Finland–OyG.W.Berg&Co.AB,01511Vantaa France–DivisionProductInspectionS.A.,78222Viroflaycedex Germany –Mettler-ToledoProductInspection,31180Giesen Greece – NEFTON TECHNOLOGIES SA, 15344 Gerakas, Attica Hungary – Mettler Toledo Kft., 1139 Budapest India–MettlerToledoIndiaPrivateLimited,Mumbai400072 Indonesia–PT.MitraPack,Jakarta,10730Israel–Agentek(1987)Ltd.,61580Tel-Aviv Italy–Mettler-ToledoS.p.A.,20026NovateMilanese Korea–Mettler-Toledo(Korea)Ltd.,Seoul137-130Malaysia–Mettler-Toledo(M)Sdn.Bhd.,40150ShahAlam,Selangor Malta–LaboPharmLtd,ATD1400 Mexico–Mettler-Toledo,S.A.deC.V.,11570MexicoD.F.Netherlands – Mettler-Toledo Product Inspection BV, 5215 ML's Hertogenbosch New Zealand – J.L. Lennard Ltd., Auckland 1644 Norway–Mettler-ToledoAS,0581Oslo Philippine –L+HAutomation,INC,MandaluyongCity1550Poland–Mettler-ToledoSp.z.o.o.,02-822Warszawa Romania – O.F. Systems s.r.l., Bucharest Russia–Mettler-ToledoVostok,101000MoskowSaudi-Arabia – Anasia Trading Co. Ltd, Jeddah 21533 Serbia–Trimd.o.o.,35000JagodinaSingapore – Mettler-Toledo (S) Pte. Ltd., Singapore 139959 Slovakia–Mettler-Toledospol,s.r.o.,83103BratislavaSlovenia – Mettler-Toledo d.o.o., 1261 Ljubljana Dobrunje South Africa–Microsep(PTY)LTD.,2018SouthAfrica Spain–Mettler-ToledoS.A.E.,08908BarcelonaSweden–Mettler-ToledoAB,12008Stockholm Switzerland–Mettler-ToledoGmbH,8606GreifenseeTaiwan – Mettler-Toledo Pac Rim AG, Taipei 114 Thailand–Mettler-Toledo(Thailand)Ltd.,Bangkok10320 Turkey – Mert Teknik Mühendislik Ve, 34235 Esenler, Istanbul United Arabian Emirates – Himatrix ME LLC, 119396 Dubai United Kingdom – Mettler-Toledo Ltd., Leicester, LE4 1AW United States–Mettler-ToledoHi-Speed,Inc.,Ithaca,NY14850 Vietnam – Mettler-Toledo Vietnam LLC, Ho Chi Minh City

White Paper Ensuring IFS Food Version 6 Compliance · 2020-01-18 · White Paper Ensuring IFS Food...

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