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BRC GLOBAL STANDARDS SELF-ASSESSMENT TOOL
Basic Hygiene Category
Welcome to te BRC Glo!al Stan"ar"s Sel#-Assessment toolWe hope that you will fnd this useul when preparing your site or an audit against the BRCGlobal Standard or Packaging and Packaging Materials Issue ! "his tool will be applicable orall BRC Global Standard or Packaging and Packaging Materials issue audits in the Basic#ygiene Category!
Ho$ to %se te BRC Glo!al Stan"ar"s Sel#-Assessment tool
"his tool is designed to help you assess your operation against the re$uire%ents o theStandard and help prepare you or your certifcation audit!
"he checklist co&ers each o the re$uire%ents o the Standard and %ay be used to check yoursite's co%pliance with each o these re$uire%ents! "he checklist also allows you to addco%%ents or identiy areas o i%pro&e%ent in the e%pty bo(es pro&ided at the end o each
section!
While we hope that this tool is useul in helping you prepare or your audit it should not beconsidered as e&idence o an internal audit and will not be accepted by auditors during anaudit!
Training
"he BRC "raining )cade%y has courses a&ailable to i%pro&e the understanding o there$uire%ents or the BRC Global Standard or Packaging and Packaging Materials issue and%ay be useul or the person using the BRC Global Standards Sel*)ssess%ent "ool! +or urtherinor%ation on the courses a&ailable please &isit www!brctrainingacade%y!co%
F%rter &n#ormation
I you ha&e any urther $uestions about this sel*assess%ent tool or Issue please do nothesitate to contact the BRC Global Standards tea%!
,%ail - en$uiries.brcglobalstandards!co%
"elephone - /0/ 123 2454
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Re#) Cla%se Comme
nt
' Senior Management Commitment
')' Senior Management Commitment an" Contin%al
&m*ro+ement
S:I "he co%pany's senior %anage%ent shall de%onstrate that they
are ully co%%itted to the i%ple%entation o re$uire%ents o the
Global Standard or Packaging and Packaging Materials! "his shall
include pro&ision o ade$uate resources7 e;ecti&e co%%unication
and syste%s o re&iew to ensure continual i%pro&e%ent!
:pportunities or i%pro&e%ent shall be identifed7 i%ple%ented
and ully docu%ented!
8!8!8 "he site shall ha&e a docu%ented policy which states the site's intentionto %eet its obligation to produce sae and legally co%pliant products tothe specifed $uality7 and confr%s its responsibility to its custo%ers! "hisshall be6
• signed by the person with o&erall responsibility or the site
• co%%unicated to all sta;!
8!8!0 "he site's senior %anage%ent shall establish clear ob
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8!8!1 "he %ost senior production or operations %anager on site shallparticipate in the opening and closing %eetings o the audit or theGlobal Standard or Packaging and Packaging Materials certifcation!
Rele&ant depart%ental %anagers or their deputies shall be a&ailable as
re$uired during the audit!
8!8!2 "he site's senior %anage%ent shall ensure that the root causes o non*conor%ities identifed at the pre&ious audit against the Standard ha&ebeen e;ecti&ely addressed to pre&ent recurrence!
) syste% shall be in place to close out non*conor%ities raised in internal7second*party and third*party audits7 with consideration o the root cause!
>otes
'), Management Re+ie$
S:I "he site's senior %anage%ent shall ensure that a %anage%ent
re&iew is undertaken to ensure that the product saety and $uality
syste% is both ully i%ple%ented and e;ecti&e7 and that
opportunities or i%pro&e%ent are identifed
8!0!8 Manage%ent re&iew %eetings attended by the site's senior %anage%ent
shall be undertaken at appropriate planned inter&als? as a %ini%u%annually!
8!0!0 "he re&iew process shall include the e&aluation o6
• pre&ious %anage%ent re&iew docu%ents7 action plans andti%era%es
• results o internal7 second*party and third*party audits
• custo%er peror%ance indicators7 co%plaints and eedback
• re&iew o the ha@ard and risk %anage%ent A#)RM syste%
• incidents7 correcti&e actions7 out*o*specifcation results and non*
conor%ing %aterials
• resource re$uire%ents
• the site's peror%ance against the Standard and the ob
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>otes
')( Organisational str%ct%re res*onsi!ilities an" management
a%tority
S:I "he organisational structure shall be clear7 with defned
responsibilities7 and key sta; shall be aware o their
responsibilities with regard to packaging saety and $uality!
8!5!8 "he site shall ha&e a current organisation chart de%onstrating the%anage%ent structure o the co%pany!
"he responsibilities or the %anage%ent o acti&ities which ensureproduct saety7 $uality and legality shall be clearly allocated andunderstood by the %anagers responsible! It shall be clearly docu%entedwho deputises in the absence o the responsible person!
8!5!0 "he site's senior %anage%ent shall ensure that all e%ployees are awareo their responsibilities! Where docu%ented work instructions e(ist oracti&ities undertaken7 the rele&ant e%ployees shall ha&e access to theseand be able to de%onstrate that work is carried out in accordance withthe instructions!
>otes
, Ha.ar" an" ris/ management system
,)' Ha.ar" an" ris/ management team
S:I "he ha@ard and risk %anage%ent syste% shall be %anaged by a%ultidisciplinary tea% co%petent in ha@ard and risk analysis!
0!8!8 "here shall be a %ultidisciplinary tea% with a designated tea% leaderwho shall be suitably trained and able to de%onstrate co%petence ande(perience o ha@ard and risk analysis!
In the e&ent that the site does not ha&e the appropriate e(pertise in*house7 e(ternal e(pertise %ay be used to analyse any ha@ards and therisk o the% occurring7 andor de&elop and re&iew the ha@ard and risk%anage%ent syste%! #owe&er7 the day*to*day %anage%ent o thesyste% shall re%ain the responsibility o the site!
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>otes
,), Ha.ar" an" ris/ analysis
S:I ) docu%ented ha@ard and risk %anage%ent syste% shall establish
the e;ecti&eness o the site's prere$uisite progra%%es and
identiy any urther risks to the saety7 $uality and legality o
products!
0!0!8 "he scope o the ha@ard and risk analysis shall be clearly defned anddocu%ented and shall co&er all products and processes included withinthe intended scope o certifcation!
0!0!0 "he ha@ard and risk analysis tea% shall %aintain awareness o and takeinto account6
• historical and known ha@ards associated with specifc processes7 raw
%aterials or intended use o the product Awhere known
• known likely product deects that a;ect saety or $uality
• rele&ant codes o practice or recognised guidelines
• legislati&e re$uire%ents!
0!0!5 ) ull description o the product shall be de&eloped7 which includes allrele&ant inor%ation on product saety7 $uality and integrity! )s a guidethis %ay include6
• co%position Ae!g! raw %aterials7 inks7 &arnishes7 coatings and other
print che%icals
• origin o raw %aterials7 including use o recycled %aterials
• intended use o the packaging %aterials and defned restrictions onuse Aor e(a%ple7 direct contact with ood or other hygiene*sensiti&eproducts7 or the physical or che%ical conditions!
0!0!3 ) Dow diagra% shall be prepared or each product7 product group orprocess! "his shall set out each process step ro% the receipt o raw%aterials to dispatch to the custo%er! )s a guide7 this shall include7 asrele&ant6
• receipt and appro&al o artwork
• receipt and preparation o raw %aterials such as additi&es7 inks andadhesi&es
• each %anuacturing process step
• in*line testing or %easuring e$uip%ent
• the use o rework and post*consu%er recycled %aterials
• any subcontracted processes
• custo%er returns!
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"he accuracy o the process Dow shall be &alidated by the ha@ard andrisk analysis tea%!
0!0! "he ha@ard and risk analysis tea% shall identiy and record all potentialha@ards that are reasonably e(pected to occur at each step in relation to
the product and process! "he ha@ards considered shall include7 whererele&ant6
• oreign ob
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• product ailures
• fnished product recalls ro% consu%ers Aincluding syste% tests
• product withdrawals
• results o internal audits o prere$uisite progra%%es
• results ro% e(ternal and third*party auditors
• new de&elop%ents in the %arket or industry associated with
%aterials7 process or product!
>otes
,)( E3em*tion o# re4%irements !ase" on ris/ analysis
S:I "he ha@ard and risk analysis study shall be ully supported by the
i%ple%entation o the prere$uisites set out in re$uire%ents
clauses 3 to =! #owe&er7 the ha@ard and risk analysis %ay indicate
that so%e o the re$uire%ents %ay be e(e%pted!
0!5!8 ,(e%ptions shall be docu%ented and regarded as proposed e(e%ptionsor re&iew at audit! )cceptance or re
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>otes
(), Doc%mentation Control
S:I )n e;ecti&e docu%ent control syste% shall ensure that only the
correct &ersions o docu%ents7 including recording or%s7 are
a&ailable and in use!
5!0!8 "he co%pany shall ha&e a docu%ented procedure to %anage docu%entswhich or% part o the product saety and $uality syste%! "his shallinclude6
• a list o controlled docu%ents indicating the latest &ersion nu%ber
• the %ethod or the identifcation and authorisation o controlleddocu%ents
• a record o the reason or any changes or a%end%ents to docu%ents
• the syste% or the replace%ent o e(isting docu%ents when these are
updated!
5!0!0 Where docu%ents and records are in electronic or% these shall besuitably protected to pre&ent loss or %alicious inter&ention!
>otes
()( Recor" /ee*ing
S:I "he site shall %aintain genuine records to de%onstrate the
e;ecti&e control o product saety7 legality and $uality!
5!5!8 Records shall be legible7 appropriately authorised7 retained in goodcondition7 and retrie&able! Where records are in electronic or% theseshall be suitably backed up to pre&ent loss!
5!5!0 )ny alteration to records shall be authorised and
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>otes
()0 S*eci8cations
S:I )ppropriate specifcations shall e(ist or raw %aterials7
inter%ediate and fnished products7 and any product or ser&ice
which could a;ect the $uality o the fnished product and custo%er
re$uire%ents!
5!3!8 Specifcations shall be suitably detailed and accurate7 and shall ensureco%pliance with rele&ant product saety and legislati&e re$uire%ents!
5!3!0 "he co%pany shall seek or%al agree%ent o specifcations with rele&antparties! Where specifcations are not or%ally agreed then the co%panyshall be able to de%onstrate that they ha&e taken steps to put anagree%ent in place!
5!3!5 Where packaging or ood or other hygiene*sensiti&e products isproduced7 a declaration o co%pliance shall be %aintained which enablesusers o the packaging %aterials to ensure co%patibility between those%aterials and the product with which they %ay be in contact!
"he declaration o co%pliance shall contain as a %ini%u%6
• the nature o the %aterials used in the %anuacture o the packaging
• confr%ation that the packaging %aterials %eet rele&ant legal
re$uire%ents
• the inclusion o any post*consu%er recycled %aterials!
"his shall identiy any li%itations o use o the product and the usable lieo the packaging %aterial Awhere rele&ant!
Products shall %eet at least %ini%u% legal re$uire%ents in the countryo %anuacture7 and use7 where known!
5!3!3 "he presence o %anuacturer's trade%arks or logo on packaging%aterials shall7 where appropriate7 be or%ally agreed between rele&antparties!
5!3! ) specifcation re&iew process shall be operated where productcharacteristics change or at an appropriate predeter%ined inter&al!
5!3!= Where specifcations are in electronic or% these shall be suitablyprotected to pre&ent loss or %alicious inter&ention!
>otes
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()1 &nternal a%"its
S:I "he co%pany shall be able to de%onstrate it &erifes the e;ecti&e
application o the re$uire%ents o the Global Standard or
Packaging and Packaging Materials through internal audits!5!!8 "here shall be a scheduled progra%%e o internal audits throughout the
year with a scope which co&ers the ha@ard and risk %anage%ent syste%7prere$uisite progra%%es and all procedures that ha&e beeni%ple%ented to achie&e this Standard! )ll acti&ities shall be co&ered atleast annually!
"he internal audit progra%%e shall be ully i%ple%ented!
5!!0 "he scope and re$uency o the audits shall be established in relation tothe risks associated with the acti&ity and pre&ious audit peror%ance!
5!!5 Internal audits shall be carried out by appropriately trained7 co%petentauditors! )uditors shall be suFciently independent ro% the processbeing audited to ensure i%partiality Ai!e! they %ust not audit their ownwork!
5!!3 Internal audit reports shall identiy conor%ity as well as non*conor%ity!
Results shall be notifed to the personnel responsible or the processaudited! Root cause analysis shall be used to deter%ine appropriatecorrecti&e action! Correcti&e actions and ti%escales or theiri%ple%entation shall be agreed and co%pletion o the actions &erifed!
>otes
()2 S%**lier a**ro+al an" *er#ormance monitoring
S:I "he co%pany shall operate e;ecti&e7 docu%ented procedures or
appro&al and %onitoring o its suppliers!
5!=!8 "he site shall ha&e a docu%ented supplier appro&al procedure andcontinual assess%ent progra%%e in place7 based upon risk analysis!
"hese shall apply to suppliers o6• %aterials
• subcontracted processes
to the site and ensure that %aterials and ser&ices procured conor% todefned re$uire%ents7 where there is a potential i%pact to productsaety7 $uality or legality!
5!=!0 "he procedures shall include clear criteria or the assess%ent andappro&al o new suppliers! )ssess%ent %ay take the or% o6
• supplier certifcation with a scope co&ering the products supplied Ae!g!
against the appropriate BRC Global Standard7 or other G+SI
bench%arked sche%e
• supplier $uestionnaires
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• supplier audits!
"he site shall ha&e an up*to*date list o appro&ed suppliers!
5!=!5 Records o supplier assess%ent and necessary actions shall be
%aintained and re&iewed!
5!=!3 "he procedures shall defne how e(ceptions are handled? or e(a%ple theuse o products or ser&ices where audit or %onitoring has not beenundertaken! )ssess%ent Aon a batch or deli&ery basis %ay take the or%o6
• certifcate o analysis
• declaration o co%pliance!
>otes
()6 Management o# s%!contracte" *rocesses
S:I Subcontractors shall be %anaged e;ecti&ely to pre&ent any risk o
conta%ination or da%age and ensure that product is produced to
specifcation!
5!1!8 "he use o subcontractors and the status o the subcontractor withrespect to the Standard shall be notifed to the brand owner andorcusto%er!
5!1!0 Where any processes are subcontracted7 including artwork or pre*pressacti&ity7 the risks to the $uality and saety o the product shall beassessed! )ny risks shall be co%%unicated to rele&ant personnel ande;ecti&ely %anaged!
5!1!5 Clear specifcations shall be agreed or all work outsourced to asubcontractor!
5!1!3 Where any process steps in the %anuacture o the packaging orpackaging %aterial are subcontracted7 fnal release o the product shallre%ain the responsibility o the site!
Controls shall be in place or checks on fnished work to ensure productsaety and $uality %eets specifcation prior to dispatch to the fnalcusto%er!
>otes
()7 Management o# s%**liers o# ser+ices
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S:I "he co%pany shall be able to de%onstrate that where ser&ices are
outsourced7 the ser&ice is appropriate and any risks presented to
product saety7 $uality or legality ha&e been e&aluated to ensure
e;ecti&e controls are in place!
5!2!8 "here shall be a docu%ented procedure or the appro&al and %onitoringo suppliers o ser&ices! Such ser&ices %ay include7 but are not li%ited to6
• pest control
• transport and distribution
• storage and dispatch
• calibration ser&ices
• waste %anage%ent!
Pro&iders o utilities such as water7 electricity or gas %ay be e(cluded on
the basis o risk!
5!2!0 Eocu%ented agree%ents shall e(ist with the suppliers o ser&ices whichclearly defne ser&ice e(pectations and ensure potential risks associatedwith the ser&ice ha&e been addressed!
>otes
()9 Tracea!ility
S:I "he site shall be able to trace and ollow all raw %aterials through
processing to the distribution o the fnished product Apackaging
%aterial to the custo%er and &ice &ersa!
5!4!8 "he site shall ha&e a syste% which has the ability to trace and ollow allraw %aterials ro% the supplier through all stages o processing anddistribution o the fnished product and &ice &ersa! Where continuousprocesses are used or raw %aterials are in bulk silos7 traceability shall beachie&ed to the best practical le&el o accuracy!
5!4!0 Identifcation o raw %aterials7 inter%ediate products7 fnished products7non*conor%ing product and $uarantined goods shall be ade$uate toensure traceability!
5!4!5 )n appropriate syste% shall be in place to ensure the custo%er canidentiy a product or production lot nu%ber or the product7 or thepurposes o traceability!
5!4!3 "he syste% shall be tested to ensure traceability can be deter%ined ro%raw %aterials to the fnished product and &ice &ersa! "his test shall takeplace at least annually!
5!4! Where rework or any reworking operation is peror%ed7 traceability shall
be %aintained!
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>otes
()': C%stomer Foc%s an" Contract Re+ie$
S:I "he co%pany's senior %anage%ent shall ensure that processes
are in place to deter%ine custo%er needs and e(pectations with
regard to $uality7 saety and legality7 and ensure these are
ulflled!
5!8/!8 "he co%pany shall identiy those otes
()'' Com*laint an"ling
S:I Custo%er co%plaints relating to product saety or $uality shall be
e;ecti&ely handled and inor%ation used to reduce co%plaint
le&els!
5!88!8 )ctions appropriate to the seriousness and re$uency o identifed
proble%s shall be carried out pro%ptly and e;ecti&ely by
appropriately trained sta;!
5!88!0 Co%plaint data shall be analysed to identiy signifcant trends!
Where there has been a signifcant increase or repetition o a
co%plaint type7 root cause analysis shall be used to i%ple%ent
ongoing i%pro&e%ents to product saety7 legality and $uality7 and
to a&oid recurrence! "his analysis shall be %ade a&ailable to
rele&ant sta;!
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>otes
()', Management o# *ro"%ct $it"ra$als an" inci"ents an"
*ro"%ct recalls
S:I "he site shall ha&e syste%s in place to e;ecti&ely %anage any
product withdrawals or returns ro% custo%ers7 incidents and
product recalls in order to ensure that all potential risks to the
$uality and legality o products are controlled!
5!80!8 ) product withdrawal procedure shall be docu%ented and shall include asa %ini%u%6
• identifcation o the key personnel in&ol&ed in assessing potentialproduct withdrawals or returns7 with their responsibilities clearlydefned
• a co%%unications plan including %ethods o inor%ing custo%ers
• root cause analysis and correcti&e action to i%ple%ent appropriate
i%pro&e%ents as re$uired!
5!80!0 "he withdrawal procedure shall be capable o being operated at any ti%e
and will take into account notifcation to the supply chain7 stock return7logistics or reco&ery7 storage o reco&ered product and disposal!
5!80!5 "he designated %anager shall be responsible or ensuring that root causeanalysis is used to deter%ine and i%ple%ent pre&enti&e action andi%pro&e%ents as necessary!
5!80!3 "he co%pany shall pro&ide written guidance and training or rele&antsta; regarding the type o e&ent that would constitute an incident! )docu%ented incident reporting procedure shall be in place!
5!80! "he co%pany shall e;ecti&ely %anage an incident to pre&ent release oproduct where saety or $uality %ay ha&e been a;ected!
5!80!= ) procedure to %anage product recalls initiated by the brand owner or
specifer shall be docu%ented and shall include as a %ini%u%6
• identifcation o the key personnel in&ol&ed in assessing potential
recalls7 together with clearly defned responsibilities
• a co%%unications plan that includes %ethods o inor%ing custo%ers
and Awhere necessary regulatory bodies in a ti%ely %anner
• correcti&e action and business reco&ery
• re&iew o any recalls in order to conduct root cause analysis andi%ple%ent appropriate i%pro&e%ents as re$uired!
5!80!1 Where a site's products are in&ol&ed in a product recall7 the site shallassist with pro&ision o any inor%ation Asuch as traceability as re$uired!
5!80!2 "he product withdrawal procedure shall be tested at least annually toensure its e;ecti&e operation!
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"he results o the test7 and o any actual withdrawals7 shall be used tore&iew the procedure and i%ple%ent i%pro&e%ents as necessary!
>otes
0 Site Stan"ar"s
0)' E3ternal stan"ar"s
S:I "he site shall be o suitable si@e and construction7 in a suitable
location7 and %aintained to an appropriate standard to reduce therisk o conta%ination and acilitate the production o sae and legal
products
3!8!8 Consideration shall be gi&en to local acti&ities and the site en&iron%ent7which %ay ha&e an ad&erse i%pact on the $uality o the fnished product!Measures shall be taken to pre&ent conta%ination!
3!8!0 "he e(ternal areas shall be %aintained in good order! )ny grassed orplanted areas surrounding buildings shall be regularly tended and well%aintained! ,(ternal traFc routes under site control shall be suitablysuraced to a&oid conta%ination o the product!
3!8!5 "he building abric shall be %aintained to %ini%ise potential or pest
entry7 ingress o water and other conta%inants! ,(ternal silos7 pipeworkor other access points or the product andor raw %aterials shall beappropriately sealed and secured! Where possible7 a clean andunobstructed area shall be pro&ided along the e(ternal walls o thebuildings used or production andor storage!
3!8!3 Where natural e(ternal drainage is inade$uate7 additional drainage shallbe installed! Erains shall be properly protected to pre&ent entry o pests!
3!8! Where e(ternal storage o raw %aterials is necessary7 these shall beprotected in order to %ini%ise the risk o conta%ination!
>otes
0), B%il"ing #a!ric an" interiors
ra$ materials an"ling *re*aration *rocessing *ac/ing
an" storage areas
S:I "he internal site7 buildings and acilities shall be suitable or theintended purpose! )ll utilities to and within the production and
storage areas shall be designed7 constructed7 %aintained and
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%onitored to e;ecti&ely control the risk o product conta%ination!
3!0!8 Walls7 Doors7 ceilings Aincluding suspended ceilings and pipework shallbe %aintained in good condition and shall acilitate cleaning!
3!0!0 Where they constitute a risk to product7 and based on the likelihood andrisk o conta%ination7 windows and roo gla@ing shall be protectedagainst breakage!
3!0!5 Where they constitute a risk to product7 and based on the likelihood andrisk o non*production glass conta%ination7 all bulbs and strip lights7including those on Dying*insect control de&ices7 shall be ade$uatelyprotected!
3!0!3 Suitable and suFcient lighting shall be pro&ided to ensure a sae workingen&iron%ent7 correct operation o processes7 e;ecti&e inspection o theproduct and cleaning!
3!0! Suitable and suFcient &entilation shall be pro&ided!
>otes
0)( ;tilities
S:I Product $uality shall not be co%pro%ised by the location7
construction and deli&ery o the utilities to and within the
production and storage areas!
3!5!8 )ll water used in the processing o the products or e$uip%ent cleaningshall be potable or suitably treated to pre&ent conta%ination!
3!5!0 )ir7 co%pressed air or other gases that co%e into direct contact with thepackaging shall present no risk to product saety or $uality and shallco%ply with any rele&ant legal regulations!
>otes
0)0 Sec%rity
S:I Product and process integrity shall be assured through appropriate
site security pro&ision!
3!3!8 "he co%pany shall undertake a docu%ented risk assess%ent o thesecurity arrange%ents and potential risks to the products ro% any
deliberate atte%pt to inDict conta%ination or da%age! )reas shall beassessed according to risk? sensiti&e or restricted areas shall be defned7clearly %arked7 %onitored and controlled!
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Identifed security arrange%ents to reduce risks shall be docu%ented7i%ple%ented and re&iewed at least annually!
3!3!0 Measures shall be in place to ensure only authorised personnel ha&eaccess to production and storage areas7 and access to the site by
e%ployees7 contractors and &isitors shall be controlled!
) &isitor reporting syste% shall be in place! Sta; shall be trained in sitesecurity procedures and encouraged to report unidentifed or unknown&isitors!
3!3!5 ,(ternal storage tanks7 silos and any intake pipes with an e(ternalopening shall be suFciently secure to pre&ent unauthorised access!
>otes
0)1 Layo%t an" *ro"%ct otes
0)2 E4%i*ment
S:I ,$uip%ent shall be suitably designed or the intended purpose and
shall be %aintained and used so as to %ini%ise the risk to product
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saety7 legality and $uality!
3!=!8 ,$uip%ent shall be constructed o suitable %aterials and be designed toensure it can be e;ecti&ely cleaned and %aintained!
3!=!0 >ewly installed e$uip%ent shall be properly specifed beore purchase!>ew e$uip%ent shall be tested and co%%issioned prior to use and a%aintenance progra%%e established!
>otes
0)6 Maintenance
S:I )n e;ecti&e %aintenance progra%%e shall be in operation or
plant and e$uip%ent to pre&ent conta%ination and reduce the
potential or breakdowns!
3!1!8 ) docu%ented progra%%e o %aintenance shall be operated7 co&ering allite%s o production e$uip%ent and plant to pre&ent conta%ination andreduce the risk o breakdown!
3!1!0 Maintenance work shall not place product $uality or legality at risk!Maintenance work shall be ollowed by a docu%ented clearanceprocedure which records that e$uip%ent is cleared to resu%e production!
3!1!5 "ools and other %aintenance e$uip%ent shall be cleared away ater useand appropriately stored!
3!1!3 "e%porary repairs%odifcations using tape7 cardboard7 etc!7 shall only beper%itted in e%ergencies and where product conta%ination is not at risk!Such %odifcations shall be subotes
0)7 Ho%se/ee*ing an" cleaning
S:I #ousekeeping and cleaning syste%s shall be in place which ensurethat appropriate standards o hygiene are %aintained and that risk
o conta%ination to the product is %ini%ised
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3!2!8 Good standards o housekeeping shall be %aintained7 which shall includea clean as you go' policy!
3!2!0 Eocu%ented cleaning procedures shall be in place and %aintained orbuildings7 e$uip%ent and &ehicles! "he re$uency and %ethods o
cleaning shall be based on risk! Cleaning schedules and procedures shallinclude the ollowing inor%ation6
• ite%area to be cleaned
• re$uency o cleaning
• %ethod o cleaning
• cleaning %aterials to be used!
3!2!5 Cleaning che%icals shall be ft or purpose7 suitably labelled7 secured inclosed containers and used in accordance with %anuacturers'instructions! Materials and e$uip%ent used or cleaning toilets shall besegregated ro% those used elsewhere!
>otes
0)9 5ro"%ct contamination control
S:I )ll practicable steps shall be taken to identiy7 eli%inate7 a&oid or%ini%ise the risk o oreign body or che%ical conta%ination!
0)9)' Glass !rittle *lastics ceramics an" similar materials
control
3!4!8!8 "he co%pany shall use risk assess%ent to deter%ine whether glass orbrittle plastics Aother than the product in the production and storageareas pose a risk to product saety or integrity!
Where a potential ha@ard is identifed7 the glass or brittle plastic shall becontrolled and recorded on a register which shall include6
• recorded checks o condition o ite%s7 carried out at a suitable
predeter%ined re$uency
• details on cleaning or replacing ite%s to %ini%ise potential or
product conta%ination!
3!4!8!0 Where non*production glass or brittle plastic breakage occurs7 aresponsible person shall be placed in charge o the clean*up operationand shall ensure that no other area is allowed to beco%e conta%inateddue to the breakage! )ny product that has beco%e conta%inated shall besegregated and disposed o!
)ll breakages shall be recorded in an incident report!
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>otes
0)9), Sar*s control
3!4!0!8 "here shall be a docu%ented policy or the control o the use o sharps!
3!4!0!0 Sharp blades7 e$uip%ent and tools shall not be let in a position thatallows the% to conta%inate the product!
3!4!0!5 Snap*o; blade kni&es shall not be used!
>otes
0)9)( Cemical an" !iological control
3!4!5!8 Processes shall be in place to %anage the use7 storage and handling o
non*production che%icals7 to pre&ent che%ical conta%ination! "heseshall include as a %ini%u%6
• a list o appro&ed che%icals or purchase
• a&oidance o strongly scented products
• the labelling andor identifcation o containers o che%icals at all
ti%es!
>otes
0)': Waste an" $aste "is*osal
S:I Suitable acilities shall be pro&ided or the storage and disposal o
process and other waste!
3!8/!8 Where licensing is re$uired by law or the re%o&al o waste7 it shall bere%o&ed by licensed contractors and records o re%o&al shall be%aintained and a&ailable or audit!
3!8/!0 Where appropriate7 waste shall be categorised according to legislati&ere$uire%ents based on the intended %eans o disposal Asuch asrecycling7 and segregated and collected in appropriate designated waste
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containers!
3!8/!5 Substandard trade%arked %aterials shall be rendered unusable througha destructi&e process! )ll %aterials disposed o shall be recorded!
>otes
0)'' 5est control
S:I "he co%pany shall be responsible or %ini%ising the risk o pest
inestation on the site!3!88!8 ) pre&enti&e pest control progra%%e shall be %aintained7 co&ering all
areas o the site under the site's control!
3!88!0 "he site shall either contract the ser&ices o a co%petent pest controlorganisation or shall ha&e appropriately trained sta; or the regularinspection and treat%ent o the site in order to deter and eradicateinestation!
3!88!5 Where a site undertakes its own pest control7 it shall be able tode%onstrate that6
• pest control operations are undertaken by trained and co%petent
sta; with suFcient knowledge to select appropriate pest control
che%icals and proofng %ethods and understand the li%itations ouse7 rele&ant to the biology o the pests associated with the site
• sta; undertaking pest control acti&ities %eet any legal re$uire%ents
or training or registration
• suFcient resources are a&ailable to respond to any inestation issues
• there is ready access to specialist technical knowledge when re$uired
• legislation go&erning the use o pest control products is understood
• dedicated locked acilities are used or the storage o pesticides!
3!88!3 Pest control e$uip%ent such as bait stations7 traps or electric Dy*killing
de&ices shall be appropriately located and operational!
3!88! In the e&ent o inestation7 i%%ediate action shall be taken to eli%inatethe ha@ard! )ction shall be taken to e&aluate the potential orconta%ination or da%age to packaging and checks instigated beorerelease!
3!88!= ) pest control %anual shall be %aintained which shall include6
• an up*to*date site plan identiying nu%bered pest control de&icelocations
• identifcation o the baits andor %onitoring de&ices on site
• details o pest control products used and instructions or their
e;ecti&e use
• detailed records o pest control inspections and o any pest
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inestation!
3!88!1 ,%ployees shall understand the signs o pest acti&ity and be aware o theneed to report any e&idence to a designated %anager!
>otes
1 5ro"%ct an" *rocess control
1)' 5ro"%ct "e+elo*ment
S:I Eocu%ented product de&elop%ent or %odifcation proceduresshall be in place to ensure the production o sae and legal
products to defned $uality para%eters!
!8!8 Custo%er re$uire%ents relating to the design7 de&elop%ent7specifcation7 %anuacture and distribution o the product shall bedocu%ented and agreed with the custo%er!
"his shall take into consideration process re$uire%ents and end use7where possible!
)ny critical*use para%eters shall be identifed and defned? or e(a%ple7barrier re$uire%ents7 %a(%in use te%perature7 %achine running7 use o recycled %aterials7 and testing re$uire%ents Aincluding %igration7 whererele&ant!
Special attention shall be paid to any %aterials that are re$uired orre$uested to be %anuactured ro% recycled %aterials7 to ensure thatthey are both appropriate and legal!
!8!0 "he site shall clearly defne and docu%ent when a production trial isre$uired!
Where appropriate7 production trials shall be carried out and testing shall&alidate that %anuacturing processes are capable o producing a saeand legal product to the re$uired $uality!
!8!5 "he co%pany shall ensure that production is carried out using defned
operating conditions that result in sae and legal products o theprescribed $uality!
!8!3 ) technical product specifcation shall be prepared and7 where possible7agreed with the custo%er or brand owner beore the production processbegins!
!8! Sa%ples as agreed with the specifer shall be retained or uturereerence!
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>otes
1), Gra*ic "esign an" art$or/ control
S:I )rtwork and all pre*press processes conducted by the site shall be
%anaged to ensure loss o inor%ation and &ariation ro%
custo%er specifcation is eli%inated!
!0!8 "he site shall ha&e a docu%ented artwork %anage%ent procedureco&ering the acti&ities or which the site has responsibility! "his %ayinclude7 but is not li%ited to6
• collation o inor%ation to be included into artwork
• receipt o artwork fles ro% the custo%er
• &erifcation o co%pleted artwork and appro&al by the custo%er!
!0!0 ) process shall be in place to seek or%al acceptance and appro&al ofnal product concepts and artworks by the specifer!
"he outco%e shall be docu%ented!
!0!5 Where appropriate7 print trials shall be carried out and testing shall&alidate that the agreed product $uality and print standards can be
consistently achie&ed!
!0!3 Printing e$uip%ent such as plates7 silk screens7 anilo( rollers7 cylindersand blankets shall be &erifed as being correct to specifcation andartwork &ersion or agreed %aster prior to use7 and ully traceable to thecusto%er's appro&ed origination %aterial!
!0! Custo%er*appro&ed reerence %aterial7 including artwork %asters andcolour standards used during print runs7 shall be controlled to ensure%ini%isation o degradation7 and shall be returned to appropriate storageater use!
"he site shall ha&e a policy to address re$uire%ents or renewal oappro&ed %asters7 as necessary!
!0!= "he site shall ha&e a docu%ented procedure or %anaging changes toartwork and print specifcations to %anage obsolete artwork and printing%aterials!
!0!1 Where artwork fles and appro&ed %asters are in electronic or%7 theseshall be suitably protected to pre&ent loss or %alicious inter&ention!
>otes
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1)( 5ac/aging *rint control
S:I Where packaging %aterials are printed or decorated7 procedures
shall be in place to ensure that the inor%ation is ully legible and
correctly reproduced to the custo%er's specifcation and legalre$uire%ents!
!5!8 )n assess%ent shall be carried out o the pre*press acti&ity7 print processand handling o printed packaging Aproduct to identiy6
• risks o loss o essential inor%ation
• %i(ing o printed product!
Controls shall be established and i%ple%ented to reduce the risksidentifed!
!5!0 Printing plates7 cylinders7 cutting dies7 print blankets and any otherprinting e$uip%ent shall be appropriately stored to %ini%ise da%age!
!5!5 ,ach print run shall be appro&ed against the agreed standard Aor %astersa%ple! "his shall be recorded!
!5!3 ) syste% shall be in place to detect and identiy printing errors during therun7 and to sort these errors ro% the acceptable printed %aterial!
!5! Where co%posite print is used Aa %i(ture o di;erent designs printedtogether7 a process shall be in place to ensure e;ecti&e segregation odi;ering print &ariants!
!5!= Sa%ples o printed packaging shall be retained together with productionrecords or a period o ti%e to be agreed with thecusto%erspeciferbrand owner!
!5!1 )ny unused printed product shall be accounted or and either disposed o or identifed and appropriately stored!
!5!2 Highting in print inspection cabinets and other %eans o printcolourchecking shall be agreed with the custo%er or conor% to acceptedindustry standards!
>otes
1)0 5rocess control
S:I Eocu%ented procedures shall be in place to ensure e;ecti&e
$uality assurance o operations throughout the process!
!3!8 ) re&iew o the %anuacturing and7 where applicable7 printing processshall identiy %anuacturing process control points that could signifcantlya;ect the $uality o the products produced!
!3!0 +or each %anuacturing process control point7 %achine settings or
process li%its shall be established and docu%ented - the processspecifcation!
!3!5 ) bill o %aterials and process specifcation Aincluding %anuacturing
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process control points shall be a&ailable or each batch or lot duringproduction!
!3!3 Eocu%ented process checks shall be undertaken at start*up7 ollowingadotes
1)1 Cali!ration an" control o# meas%ring an" monitoring
"e+ices
S:I Measuring e$uip%ent used to %onitor %anuacturing process
control points7 product $uality and legality shall be calibrated!
!!8 "he site shall identiy and control in*line and o;*line %easuring
e$uip%ent used to %onitor product saety and $uality!
!!0 Where possible7 calibration shall be traceable to a recognised national orinternational standard! Where a traceable calibration is not possible7 thesite shall de%onstrate the basis by which standardisation is carried out!
!!5 Results and any actions taken when %easuring e$uip%ent is ound to beoperating outside the specifed li%its shall be docu%ented!
>otes
1)2 5ro"%ct ins*ection testing an" meas%ring
S:I "he co%pany shall use appropriate docu%ented procedures and
acilities when undertaking or subcontracting inspection and
analyses critical to product saety7 legality and $uality!
!=!8 uality checks shall be carried out to de%onstrate that the fnishedproduct is within the tolerances laid down in the agreed product
specifcation and conor%s to legal re$uire%ents! "he re$uency o checks shall be in accordance with industry*acceptedpractice or custo%er re$uire%ents and based on risk analysis!
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!=!0 #a@ard and risk analysis principles shall be used to deter%ine the needor in*line product testing e$uip%ent to ensure product saety7 $ualityand legality!
!=!5 "he accuracy o in*line e$uip%ent shall be specifed Awith per%itted
tolerances7 ha&ing due regard to the product para%eter beingcontrolled!
!=!3 "he co%pany shall establish7 docu%ent and i%ple%ent procedures orthe operation7 routine %onitoring and testing o all e$uip%ent used inproduct inspection7 testing and %easure%ent!
!=! Routine o;*line $uality checks shall be carried out at appropriate stagesin production to de%onstrate that the product is within the toleranceslaid down in the agreed product specifcation!
!=!= Procedures shall be in place to ensure the reliability o test results!
!=!1 Where the co%pany undertakes or subcontracts analyses critical to
product saety or legality7 the laboratory or subcontractors shall ha&egained recognised laboratory accreditation or operate in accordance withthe re$uire%ents and principles o IS: 81/0 or the test undertakenAGeneral re$uire%ents or the co%petence o testing and calibrationlaboratories! Eocu%ented otes
1)6 Control o# non-con#orming *ro"%ct
S:I "he site shall ensure that out*o*specifcation product is clearly
identifed and $uarantined!
!1!8 Clear procedures or the control o out*o*specifcation or non*conor%ing%aterials shall be in place7 docu%ented and understood by all personnel! "hese shall include the e;ecti&e identifcation and $uarantining o%aterials beore a decision has been %ade on their fnal disposition!
!1!0 >on*conor%ing %aterials shall be assessed and a decision taken tore
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1)7 &ncoming goo"s
S:I Inco%ing goods shall be appropriately checked or contents7
packaging integrity and potential conta%ination
!2!8 "he site shall docu%ent a raw %aterials and inter%ediate product intakeprocedure to ensure that inco%ing goods %atch purchase or productspecifcations! "his %ay take the or% o6
• purchase orders
• deli&ery notes!
!2!0 Receipt docu%ents andor product identifcation shall acilitate correctstock rotation o goods in storage!
>otes
1)9 Storage o# all materials an" interme"iate an" 8nise"
*ro"%cts
S:I "he risk o conta%ination o raw %aterials and fnished products
shall be %ini%ised while in storage
!4!8 )ll %aterials7 work in progress and product shall be properly identifedand protected during storage by appropriate packaging to protect theproduct ro% conta%ination!
!4!0 Storage7 including o;*site storage7 shall be controlled to protect theproduct ro% conta%ination!
!4!5 "he site shall ensure that ha@ardous che%icals are handled in such a waythat risk to product $uality and legality is %ini%ised!
!4!3 Material intended or recycling shall be appropriately protected againstconta%ination ha@ards!
>otes
1)': Dis*atc an" trans*ort
S:I "he dispatch and transport o fnished products shall be
undertaken in a %anner that %ini%ises the risk o conta%ination
or %alicious inter&ention and %aintains product $uality and
legality!
!8/!8 )ll products and %aterials shall be identifed and either protected during
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• the na%e o the trainee and confr%ation o attendance
• the date and duration o the training
• the title or course contents7 as appropriate
• the training pro&ider Ae(ternal or internal pro&ider!
Where training is undertaken by agencies on behal o the co%pany7records o the training shall be a&ailable!
=!8! "he site shall put in place docu%ented progra%%es co&ering the trainingneeds o rele&ant personnel!
>otes
2), 5ersonal ygiene
ra$ materials an"ling *re*aration *rocessing *ac/ing
an" storage areas
S:I "he co%pany's personal hygiene standards shall be de&eloped to
%ini%ise the risk o product conta%ination ro% personnel! "hese
standards shall be appropriate to the products produced and be
adopted by all personnel7 including agency*supplied sta;7contractors and &isitors to the production acility!
=!0!8 "he re$uire%ents or personal hygiene shall be deter%ined on the basiso risk7 docu%ented and co%%unicated to all personnel! "his shalladdress6
• hand washing
• wearing o otes
2)( Sta= #acilities
S:I Sta; acilities shall be suFcient to acco%%odate the re$uired
nu%ber o personnel and shall be designed and operated to
%ini%ise the risk o product conta%ination! Such acilities shall be
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kept in a good and clean condition!
=!5!8 ,ating Aincluding the eating o conectionery and chewing o gu% ortobacco7 drinking and s%oking shall not be allowed in locker andchanging roo%s!
=!5!0 Suitable and suFcient hand*washing acilities shall be a&ailable to enablecleaning o hands beore co%%encing work and as necessary during thecourse o work! Such hand*washing acilities shall pro&ide7 as a %ini%u%6
• suFcient $uantity o water at a suitable te%perature to encouragehand washing
• unscented li$uid soap or oa%
• ade$uate hand*drying acilities
• ad&isory signs to pro%pt use Aincluding signs in appropriate
languages!
=!5!5 "oilets shall not open directly into storage7 processing or production areasin order to pre&ent the risk o conta%ination to product! "oilets shall bepro&ided with suitable and suFcient hand*washing acilities!
=!5!3 +acilities or &isitors and contractors shall enable co%pliance with thesite's hygiene policy!
=!5! ,ating Aincluding the eating o conectionery and chewing o gu% ortobacco7 drinking and s%oking shall not be allowed in production orstorage areas!
=!5!= Erinking o water ro% purpose*%ade dispensers andor by usingdisposable conical cups or spill*proo lidded containers %ay be allowed7pro&ided it is confned to a designated area away ro% e$uip%ent!
>otes
2)0 5rotecti+e cloting
S:I )ppropriate protecti&e clothing shall be worn in production and
storage areas to %ini%ise the risk o product conta%ination!
"he risk o product conta%ination ro% clothing7 hair or personal
ite%s shall be %ini%ised!
=!3!8 #a@ard and risk principles shall be used to deter%ine the need orprotecti&e clothing7 including gar%ents and ootwear in raw %aterialshandling7 preparation7 production and storage areas!
Where no need or protecti&e clothing has been established by riskassess%ent7 it shall be ully
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• the wearing o protecti&e clothing on the