General Questions – Background

advertisement
BRC Global Standard for
Food Safety Issue 6
Frequently Asked Questions BRC Food Standard Issue 6
Specific questions relating to the clauses and protocol of the Global Standard
for Food Safety Issue 6 are detailed below.
The BRC operate an enquiry service and if you are unable to find an answer
to your particular question then please contact
brcglobalstandards@brc.org.uk.
General Questions – Background
Audit Duration
Audit duration - Will audit duration calculator change for unannounced
audits?
It is not expected that the time required for unannounced audits will be
significantly different from that for the announced audit program i.e. typically a
total audit time of 2 days.
Background
Risk assessment - What would you expect to see for a risk assessment,
since the Standard now bases many of the requirements on this?
Some sort of documentation would be expected to be seen as evidence of the
thought process and conclusions made as to the risks to products. However,
the principles and objectives behind 'risk assessment' are to ensure that the
company has considered the issues pertinent to the requirements and can
justify the reasons for their policy or procedures, responding to the challenge
by an auditor. In some instances it would be appropriate to have a detailed
document (along the principles of a HACCP plan) showing those
considerations, an example may be the risk rating for suppliers and the
subsequent approval process or the risks to product from physical
contamination which would be included within the HACCP plan. However,
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page1 of 18
other requirements such as the policy on where beard snoods shall be worn
could be evidenced in other ways such as a documented policy, to the
understanding by staff and the reasoning behind this policy. This would
include considerations of best practice within the industry and be open to
challenge by an auditor. The need for a documented risk assessment would
be particularly pertinent where you have decided not to adopt procedures for
a particular requirement e.g. not wearing beard snoods in a particular area.
Audit Reports
What is meant by product safety rationale within the report?
This provides users of the report with a clear overview of the basis for the
safety of the products. It also ensures that the auditor and the site have
carefully considered the rational for the safety of the products and that these
have been addressed within the HACCP study
Surveillance audit reporting - If a Certification Body undertakes a
surveillance audit of a certificated site, for instance to follow up
concerns, do they submit this report to the BRC?
Where a Certification Body needs to carry out an additional visit to a site for
instance for surveillance or investigation of an issue the CB will provide a visit
report for the site. This will not be in the style of the official BRC audit report
so that this is not confused with the full audit report. This report does not need
to be uploaded to the BRC Directory, however should be available to BRC on
request. Where the surveillance visit results in the suspension or withdrawal
of a certificate, the BRC shall be notified.
Scope
Why have the BRC working group made changes to what can be
included and excluded from the scope of the audit and certification.
To effectively and consistently meet the requirements expected by the
Standard sites need to operate a food safety culture and consistent way of
working. It would generally be expected that the whole of a site should
therefore be operating to the same standards and the certification scope apply
to the whole site. The exclusions of some processes and areas can lead to
double standards and is not within the spirit of what BRC certification is
intended to demonstrate. Whilst exclusion of some product areas will be
accepted the standard gives new guidance on conditions which must be met
when making such exclusions.
What are factored goods?
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page2 of 18
Factored goods are products which are purchased sold or distributed by a site
but which undergo no process at the audited factory. Factored goods are
often products bought in by a company to compliment the range of products
manufactured at the site to provide a more comprehensive product range.
Packing or repacking operations are classed as a process and would not be
classed as factored goods.
Scope Factored Goods - My Company handles mostly factored goods
with a small amount of cheese cutting and packing. Therefore we have
always had the Food Standard. Should I now go for the S&D Standard, in
fact do I now need both?
As factored goods are not included within scope it may be appropriate for the
company to have both Storage and Distribution – including the wholesale
module as well as Food standard for the cheese cutting and packing
operation. The two audits may be carried out simultaneously where the
auditor is suitably qualified to reduce costs.
If a winery does most of their own bottling but uses a service provider
for bottling their sparkling wine which then comes back to them for final
approval and marketing can this be included within the scope?
No. In this case bottling would be included in the scope but bottling of
sparkling wine should be shown as an exclusion.
Defining product scopes on the audit report - Can crop monitoring be
included within the defined scope?
The activities of growing are not within the scope of the BRC audits and are
covered by various farm assurance schemes such as GLOBALGAP. We
would not expect to see the word monitoring on the BRC audit report scope.
Monitoring is part of the process of supplier and raw material approval which
should be expected of all sites – all be it for fresh produce this activity may be
a much more active engagement with the grower particularly where crops are
grown under contract.
New Factories
When can we book an audit for our newly built factory?
Manufacturing units that are newly built or ‘commissioned’ must ensure that
systems and procedures in place are compliant before an initial BRC audit is
undertaken. It is at the discretion of the company when they wish to invite a
certification body to carry out an audit; however they must be able to
demonstrate that systems and processes are well established, compliant and
monitored. It is unlikely that full compliance can be satisfactorily demonstrated
within a 3 month period from commencement of operation. A company may
wish to consider a pre-assessment towards the end of this 3 month period.
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page3 of 18
With respect to a new production site within an established company, the site
systems and procedures may reflect that systems already established with
other sites within the company, but a full audit must establish compliance
against BRC requirements for the new site.
Head office audits
What happens to the non-conformities raised at these audits – are they
included as part of all the other sites audits or only the site on which the
head office resides (if, of course, there is one production site close by or
on the same premises)?
Any non-conformities should be included in the report of the first site after the
Head office audit. If any of these head office non- conformities are not
corrected then these will be included in subsequent site reports. This is
described in the standard on page 111
Standard Specific Questions
Section 1 Management commitment
Clause 1.1.7 What is defined as ‘a current issue’ of the Standard as
required by clause 1.1.7?
An ‘original’ issue of the Global Standard for Food Safety Issue 6 must be
available on site. These are available through the BRC Bookshop in various
languages, in print and as a PDF (where usage rules apply). This must not be
a photocopy and should be made available to all relevant staff to ensure they
understand The Standard’s requirements.
Clause 1.1.8 When will a major non-conformity be awarded against
maintenance of certification?
A major non-conformity will be awarded where the company has not
undertaken an audit within the audit due date (as indicated on the certificate).
It is recognised that there may be specific circumstances where audits cannot
occur within the certification cycle for instance packing of seasonal product, or
access restrictions to the site and these are outlined within the Standard
protocol Section III paragraph 12. Moving the audit date to a more
‘acceptable’ date for reasons of combining audits, lack of personnel or
undertaking building work is not an acceptable reason for missing the due
date. It is not a justifiable reason to delay audits where sites are not in full
production, since there is a 28 day window in which the audit can occur and it
is presumed that there will be occasions within that period where production is
planned. Audits must however be undertaken whilst there are products are
being manufactured. Justified reasons should be agreed with your
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page4 of 18
Certification Body prior to any delay with your audit booking. It is the
certificated company’s responsibility to ensure a suitable audit date is agreed
within the appropriate timescale. Where the company is not required to have
certification by customers and where certificates have lapsed for more than 6
months re-entry to the BRC Certification scheme will be considered as a new
application and the clause 1.1.8 will not apply.
Clause 1.1.9 - who are defined as the ‘most senior’ production or
operations manager on site to attend meetings?
The objective behind this requirement is to ensure that the conclusions of the
audit and any actions required to correct non-conformities are effectively
understood, agreed and there is the authority to ensure these are carried out.
Whilst it may be the case that the most senior personnel may be absent on
the day of the audit, there will always be someone on site that will be
responsible for the daily running of the site.
Clause 1.1.10 What should happen if a declared corrective action plan
for a root clause has not been implemented at the next audit?
This would result in a non- conformity against clause 1.1.10
Where a non- conformity has recurred from the previous audit this may be
raised both against the individual clause which has been failed and also may
be evidence of failure against 1.1.10
Clause 1.2.1 How do you audit effectiveness of deputies
This is not just about having a documented organisation structure but should
include an assessment of how people are managed so that for instance there
is cover for holidays. Deputies must be suitably competent to pick up tasks
which they may need to deputise for. A deputy may be a more senior
manager in the structure.
Section 2 HACCP – Food Safety Plan
Clause 2 What documentation do you need to keep for HACCP?
You need to ensure that the information on which the HACCP plan is based is
referenced and available on request by the auditor. This may include
published literature on known hazards, codes of practice or legislation. You
need to keep records of HACCP team meetings and the decisions which were
reached. You should have documents to demonstrate how the decisions for
establishing CCPs were reached.
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page5 of 18
Clause 2.1 How many people should make up the HACCP food safety
team and what training do they require?
The number of people on the HACCP food safety team should be pertinent to
the size and structure of the company as the team should include
representatives of each department with responsibility for operation of The
Standard. It should not be too large and note that 1 person does not constitute
a ‘team’. It would be expected that participants should have appropriate
training, with particular regard to the team leader. This may be achieved
through external, industry recognised training specific to HACCP but may
equally be achieved by a good quality internal course. At the audit, the
competency and understanding of the HACCP team would be assessed as
well as the quality of the resultant HACCP plan. Note that if the HACCP plan
has been prepared with the help of an external consultant, internal staff must
still be fully conversant with the plan, principles and practices associated with
it. Records need also to demonstrate the training of the external consultant in
HACCP principles.
Clause 2.10.2: … “checking and verification of electronic records
associated with the monitoring of CCP’s…” – what would be the
minimum required here as evidence of compliance?
This is likely to depend upon the particular record and the form it takes. This
may include the addition of an electronic signature to the record to
demonstrate checking or may take the form of an electronic or physical form
completed to demonstrate an electronic record has been checked. Electronic
records should where ever possible include an electronic record of any
changes.
Section 3 Food Safety and Quality Management System
Clause 3.1.1 Do procedures all have to be documented?
‘Procedures’ are referenced frequently within the Standard. A procedure must
be documented (refer to glossary).
Clause 3.4.2 What training do internal auditors have to have completed
and what does ‘independent from audited department’ mean?
Internal auditors should be able to show via training records that they have
received formal training either via attendance of an external course or via
training within the company. Training should cover the planning and
scheduling of internal audits, preparing reports and follow up of audit findings.
The objective behind the requirement for auditors to be independent of the
area being audited is to ensure that the audit is rigorous and thorough and is
not influenced by the work which may need to be carried out to effect
corrections and improvements. Auditors should not be biased or influenced.
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page6 of 18
External auditors may need to be used where there are insufficient internal
resources
.
Clause 3.4.5.2 Filtration of compressed air – can the filter be anywhere
in the compressed air system and what size filter is expected?
The objective of the filter is to prevent dust particles and lubricating oil from
the compression system from contaminating the products. The best position
and size of the filter may vary depending on the position of the compressor
and lay out of the compressed air system and the source of the air used. The
site should be able to justify the effectiveness of the filtration system
employed
Clause 3.5.3 How do you manage outsourced activities e.g. cleaning –
what records would you expect to see?
The performance of the supplier should be formally reviewed at a frequency
appropriate to the service. In the case of an out sourced cleaning service the
standards of cleaning would be expected to be assessed as part of the audit
process (3.4.4) and records maintained of feedback on performance to the
cleaning company – for instance a report book is often used.
Other services such as Pest control, laundry services may be reviewed with
the supplier on a 6 monthly or annual basis and a record kept of the review for
instance minutes of such a meeting.
Clause 3.5.4.1: …”declaration to brand owner of outsourced processes.”
– is this only for retail branded products or for particular markets e.g.
the UK?
No this requirement applies to any product manufactured on behalf of a
customer. The standard isn’t applied differently for different markets or
different customers.
Clause 3.9.2 How accurate does the quantity check / mass balance on
traceability need to be?
It is unlikely that the mass balance check will be able to account for all
materials to an accuracy of 100%; however, the company needs to justify the
discrepancies and demonstrate they understand the nature of the variance
through dehydration of fresh ingredients, typical wastage on equipment and
portion variances for example. The principle of this requirement is to ensure
that the traceability system is effective and mass balance is a key measure of
this workability and highlights areas for improvement.
Clause 3.10 Would I be expected to do root cause, trend analysis etc. for
complaints that are caused by customer abuse?
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page7 of 18
If there were the same repeated complaints being received then a root cause
analysis should be undertaken to see if there is an issue with the packaging
instructions for the product which may be leading to customer abuse. A
change in this may reduce complaints.
Section 4 Site Standards
Clause 4.2.3 What is the “registration” that this clause requires?
This clause relates to legal requirements to register premises with
enforcement authorities pertinent to food safety and quality and includes as
examples the requirement for food businesses to be registered with the local
authority in the UK under Regulation (EC) No. 852/2004 on the Hygiene of
Foodstuffs, Article 6(2) or that food premises in the USA must be registered
with the US treasury under the 'Public Health Security and Bioterrorism
Preparedness and Response Act of 2002'. It does NOT include other legal
registrations related to personnel health and safety such as fire regulations or
employment law as this is outside the scope of the Standard
.
Clause 4.3.1 Why is an area containing cooked meats not always
considered to be a high risk area?
High Risk areas contain only components/foods which have undergone a
cook or similar process to achieve a 6 log reduction of Listeria. Where a single
area has by necessity to include some components which have received a
lesser kill as well as fully cooked components for instance a sandwich
preparation area this will be classed as a high care area.
Clause 4.3.1 How should the production zone categories be interpreted
for products which meet the product characteristics for high care but
are fully enclosed for instance within enclosed packaging equipment
until filled and sealed e.g. dairies filling milk into cartons.
In such circumstances the production area would be considered as an
enclosed product area although additional precautions would be required
when breaking into the lines or filler for maintenance. Where ever equipment
is entered for instance to free product jams, cleaning etc. the necessary
hygiene requirements to ensure the safety of the products must be completed
before recommencing packing.
Clause 4.3.1 If mayonnaise is produced in the same area as ready meals
does the area become high risk or high care?
It is necessary to ensure that where a range of products are produced that the
appropriate risk area is applied to the particular product. This may identify a
need for segregation between areas. Mayonnaise may be either high care or
low risk depending upon the recipe and process most mayonnaise is ambient
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page8 of 18
stable and would be considered as low risk. Ready meals similarly may fall
into low risk, high care or high risk depending on process given, cooking
instructions and expected customer usage.
Clause 4.3.5. What would be an acceptable alternative to a physical
barrier between low risk and a high care operation? Would time
separation be acceptable?
Time separation would be an acceptable alternative in high care areas (but
not high risk). The auditor must critically examine the arrangements for this to
ensure that potential risks for contamination have been addressed and that
the procedures for time segregation are consistently workable before
accepting this solution. This must be described within the audit report.
Clause 4.5.1 Can a company rely on the chemical analysis provided by
the water authority or do they have to sub-contact the chemical analysis
to an Accredited Laboratory.
The type of chemical checks should be based on a risk assessment. For
instance if as in the UK the water is supplied by a water authority an analysis
from the authority would suffice unless there are other risks identified in the
delivery system e.g. Lead pipes. Where water is extracted from bore holes
and or sites have on site treatment facilities then additional checks will be
required to ensure the water is not contaminated either at the bore hole or in
treatment.
Clause 4.6.2 Requires equipment to be suitable for food contact where
appropriate and meet legal requirements – I can’t obtain a certificate of
conformity for machinery we’ve had on site for years, what can I do?
The requirement is designed to ensure that manufacturers are complying with
relevant legislation, for example the EU ‘Materials and articles intended to
come into contact with food Regulation 1935/2004’ and that such materials do
not constitute a hazard to food. General principles should be to use approved
suppliers known to supply products designed for food use. All new food
contact equipment should be purchased with a certificate of conformity or
specification detailing its suitability for food use; this may also be confirmed by
a symbol or label on the product. Where this evidence is not available, then a
risk assessment should be carried out to justify its use and determine that it is
not a food safety risk. The risk assessment should consider factors such as,
the nature of the food contact surface material and its known characteristics
e.g. stainless steel is known to be a food grade material; length of contact
time with the food and the nature of the food and its potential for
contamination e.g. fatty foods may be more at risk from migration of
contaminants from a plastic container for example. Further clarification should
be sought e.g. from equipment manufacturer or testing such as migration
tests where required.
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page9 of 18
Clause 4.8.4 What would be acceptable arrangements for changing
facilities for High care operations?
The objective of the clause is to ensure that protective clothing once applied is
not contaminated particularly by pathogens before entry into the high care
area. Time segregation i.e. a shared changing facility with low risk staff but
with different shift start patterns would be acceptable. It may be necessary for
the changing facilities to be cleaned between different groups of workers
depending on risk. The auditor must be satisfied that the potential risks have
been assessed and procedures are capable of being consistently operated
without abuse.
Clause 4.8.5 Are boot wash facilities acceptable on entrance to High risk
areas?
High risk areas need a higher level of environmental control than in high care
areas due to the nature of the products handled. The use of clean footwear
worn only in the high risk area and effective measures for changing into such
footwear is the preferred option to meet the requirements of the Standard.
The use of boot wash facilities at the entrance to a high risk area will be
acceptable where this is managed and validated to effectively prevent the
introduction of pathogens. The site shall have undertaken a risk assessment
to identify the suitability of the boot wash facilities and controls to manage the
effective sanitation of footwear. The controls shall have been validated by
microbiological swabbing of footwear and the floors and drains in the high risk
area, to demonstrate the absence of Listeria species.
For such controls to be effective it would be expected that this includes the
following:
The footwear shall be company issued and of a design which is easily
cleaned i.e. smooth upper surfaces, cleats on soles shall be sufficiently
spaced so as not to trap dirt which may not easily be removed by boot wash
equipment.
Consideration of the potential for gross contamination of boots prior to boot
washing i.e. the footwear shall not be worn outside of the facility or in low risk
processing areas prior to entering the high risk area.
The boot wash equipment shall be suitably designed, well maintained and
demonstrably effective to clean and sanitise the foot wear. F042 Issue 1 BRC
Global Standard for Food Safety Issue 6 Position Statements Released
8/5/2012 Page5
The minimum cleaning time and levels of detergent and sanitiser used shall
be determined, documented and controlled to ensure effective cleaning of
footwear.
Records shall be maintained of detergent/sanitiser checks, and effectiveness
of cleaning of the boot wash facilities.
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page10 of 18
Clause 4.8.6 dictates the requirements for hand washing facilities to be
used before entering production. Does this mean that roller towels can’t
be used?
This requirements clearly specifies what can and can’t be used and includes
that roller towels cannot be used at hand washing stations in production areas
as they are not ‘single use’; they can however, be used in toilets but only if
they are not the only facilities provided before re-entering production.
Clause 4.8.6 Is there a relaxation of the requirement for hand cleaning
facilities in low risk factories for example flour mills, breweries, produce
pack houses.
There remains a requirement for providing hand cleaning facilities to enable
employees to wash their hands before entry to production areas (note this
may be in a changing or toilet area). The use of gel sanitisers alone does not
provide a suitable alternative as this does not clean the hands but provides
only a partial sanitising effect.
Clause 4.9.3.4.3: …”records shall be maintained of all container
breakages….” High speed filling lines in the wine/beverage industry
often incorporate automatic clean cycles following a breakage in the
filler but no records are kept. What does the standard expect in such
situations?
In such circumstances the site must be able to demonstrate that the automatic
process they have established is effective in preventing the potential spread
of glass to other open containers, effectively removes all glass during the
wash phase and separates effectively at risk product for disposal. Where this
can be shown to be effective then routine monitoring of the filler for glass and
an effective process to hold any suspect product could be accepted. The
procedure must be verified on a regular basis
Clause 4.10.3.1 Metal Detection would a low or zero number of
customer complaints be justification for not having a metal detector? Do
different rules apply when packing branded or customer label products?
Whilst complaint levels is a factor in making a decision on the necessity for
metal detection this alone will not be taken as justification that a metal
detector is not required – not least because it is well known that many
contamination issues go un reported by customers. Any justification for the
absence of metal detection should be based on the nature of the product, risk
to the consumer and alternative controls in place at the site which prevent
metal contamination. So for example metal in a meat pie or sausage would
probably only be detected when the product is in the mouth where as a piece
of metal in a bag of potatoes would hopefully be found before consumptionpresenting a low customer risk. The meat pie would be expected to be metal
detected.
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page11 of 18
It is important to recognise that the requirements of the standard apply
irrespective of whether the products are branded or retailer own label the
standard applies to the food safety and quality systems at the site. The BRC
Certificate demonstrates a minimum level of food safety at the site and must
be consistently applied to all products within the audit scope.
Please see the decision tree shown in the Issue 6 Position Statements
document for further information.
Clause 4.10.3.3 This requests “a belt stop system with an alarm where
the product cannot be automatically rejected e.g. very large packs”. Are
there other instances where stop belt systems would be acceptable?
Other examples could include delicate products where the use of a belt stop
system is necessary to prevent damage to the finished product e.g. quiches,
gala pies, freshly topped decorated pies, decorated celebration cakes,
chocolate gateaux etc. The BRC have produced a Position Statement
(reference F042) relating to the acceptability of metal detectors.
Section 5 Product Control
Clause 5.2 I handle nuts on my site, but add a statement on my
packaging stating ‘it cannot be guaranteed that this product is free of
nut traces’ – do I have to comply with any of the requirements of section
5.2?
Yes, you still have to carry out a risk assessment and consider what steps are
appropriate for your company to minimise the potential for cross
contamination.
Clause 5.2 I do not handle any allergen containing materials on my site
and am not making any ‘nut free’ claims, are the clauses of 5.2
applicable?
The following clauses would still be applicable 5.2.1.and 5.2.9
Clause 5.3 Do the requirements of this section apply to mandatory legal
claims such as country of origin labelling?
Yes- where ever information such as country of origin is marked on a product
the manufacturer must be able to demonstrate that this is correct and this
section sets requirements to be met to achieve this.
Clause 5.3.2 Mass Balance for product claims. Is it necessary to carry
out a mass balance test on every product where a claim is made?
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page12 of 18
The objective of the mass balance traceability is both to demonstrate that
sufficient detailed records are maintained to allow an accurate mass balance
test to be carried out at any time with any particular process and secondly to
check that errors/mixing of products has not occurred i.e. the claim is valid.
The test shall be carried out at least once every 6 months however where
applicable products are produced using very different processes it may be
necessary to check more regularly to ensure that each production process is
controlled. It will not be necessary to check each individual product every 6
months unless this is a requirement of the particular scheme associated with
the claim.
The test should as a minimum take a batch of incoming raw material (for
which the claim relates e.g. Aberdeen Angus Beef ) and identify where all of
this batch was used, this may include wastage and remaining stock if
appropriate. The test should be able to account for the use of all of a batch of
materials.
Section 6 Process Control
Clause 6.1.1. Do I have to emphasise “milk” in recipes if all I make is
cheese and all the recipes contain milk?
No If an allergen is used in all products manufactured at a factory there would
be no absolute requirement to emphasise this on the recipe, however should
the product range change this would be required.
Clause 6.1.4 Is it a requirement to undertake temperature distribution
studies in cold stores and freezers? For small freezers the temperature
goes up and down on defrost and whilst filling and emptying.
The objective is to ensure that products can be consistently stored within the
temperature ranges specified and are therefore not at risk of spoilage within
shelf life. The level of risk will depend upon the product, time spent in storage
and margin allowed by the temperature settings of the store. Temperature
distribution studies would not be necessary for small chill or cold stores where
product is stored only for short periods.
Section 7 Personnel
Clause 7.2.1 Is the wearing of wedding bands including “Rhukhi”
friendship bands (Hindu/Siekh) acceptable?
Where such jewellery cannot be effectively cleaned or may present a risk of
contamination this must either be removed or covered.
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page13 of 18
Clause 7.2.2: Requires hand cleaning to be performed on entry to the
production area. Does this apply in enclosed product areas?
Yes as this is good practice for the food industry
Clause 7.4: 2 Protective clothing has changed from Issue 5 with the
removal of the wording “based on a risk assessment” how does an
industry now justify that they do not have protective clothing in the true
definition of clothing that is worn to protect the product from possible
contamination from the person. But rather clothing/uniforms that are
worn to protect personal clothing from getting dirty.
The standard now states ‘suitable’ so instead of risk assessing the site must
define what is suitable for that process. Protective clothing but not necessarily
head coverings would be expected to be supplied to employees working in
enclosed product areas as for instance in a winery.
Clause 7.4. Does the company need to supply protective clothing to
contractors performing construction or maintenance work in their
facility? Or….do they need to ensure that they are wearing protective
clothing that is appropriate to the area?
The intention of the clause is to ensure adequate protection for products. The
level of controls will depend upon the product risk zone and extent of work
undertaken.
Building as in construction work should be screened from production areas
and builders should not enter the active production area whilst production is in
process.
In low risk open product areas the company may supply protective clothing for
sub-contractors or where provided by the contractor this needs to comply with
site requirements. Generally speaking we would not expect sub contract
engineers to be working in high care or high risk areas during production
periods. Where this is necessary the subcontractors shall be supplied with the
company issued protective clothing and follow the site changing procedures
before entering the area in order to protect the products.
Clause 7.4.2 Are head coverings required in enclosed product areas e.g.
wine bottling, breweries?
The standard requires that protective clothing is available that fully contains
scalp hair to prevent contamination – Where the product and packaging is
fully protected from the risk of contamination for instance enclosed product
areas head coverings would not be an absolute requirement. It should be
noted that whenever equipment is opened or lines broken into the staff
concerned must wear protective clothing and head coverings.
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page14 of 18
Clause 7.4.4 What would be an acceptable certification for Laundries?
There are a range of certification standards for Laundries operating in
different parts of the world. Where a certification scheme is used the site must
be able to demonstrate to the auditor that the scheme fulfils the requirements
of 7.4.4
Unannounced audit schemes
Please see the full unannounced audit guide for more details on this scheme.
Enrolment Scheme
How does the weighting work for the Enrolment scoring system?
The weighting will be based on the severity of the non-conformity i.e. Critical,
Major, Minor and how the clause relates to the 3 levels in the GFSI Global
Markets Capacity Building Programme.
GFSI have a programme which identifies particular requirements for Basic
Level and Intermediate level compliance as stepping stones to achieving
eventual certification against a GFSI benchmarked scheme such as BRC. The
requirements within BRC Issue 6 have been matched to the requirements at
the different levels within the GFSI programme. Failure against BRC
requirements equivalent to GFSI Basic level will be more heavily weighted
than failure against equivalent Intermediate level requirements.
Does BRC provide a scoring system to calculate the score for auditors?
Yes the BRC will be issuing a spread sheet to automatically calculate the
Enrolment scores.
Is there be a separate audit report template for enrolment.
Yes. The report format will be visually distinct to prevent confusion between
enrolment and certificated audit reports. The contents of the reports will be
identical except that the audit result section is based on a total score and
score per section. The non- conformance reporting section will be slightly
different to allow for an action plan where correction cannot be achieved
within 28 days.
Our site was not certificated and received the enrolment audit report.
How soon can I undertake a new audit?
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page15 of 18
The sites in the Enrolment program are likely to have a significant amount of
work to do to ensure non conformities identified have been effectively
addressed before commissioning the new audit. Due to the nature and
number of non-conformities, it is unlikely that these nonconformities can be
addressed and fully effective improvements implemented and established
within a 28 day period; although there may be some exceptions. It is likely;
therefore, that in most cases the re-audit will take place after the 28 day
period and typically a 3 month period may be required to fully establish new
systems or patterns of working.
Auditing the Standard
Why are the BRC now insisting on more of the audit time being spent in
the factory?
Concerns have been expressed that not enough time is spent in production
and too much time spent reviewing paperwork in the office. Users of the
Standard for supplier approval are rightly concerned to ensure that emphasis
is given to the factory environment; product and food safety controls in
production and working practices since these directly affect the safety and
quality of the food being produced. It is expected that at least 50% of the audit
is spent in the production and ancillary areas. This should include assessing
the production process, observing activities, interviewing staff in production,
reviewing relevant procedures/work instructions recording forms within the
production area. These are all things that good auditors will already have
been doing and need to be adopted by all.
When calculating the audit time in the factory what does this include?
Whilst most of the time allocated to the factory (GMP) audit is expected to be
spent within the processing areas of the factory the inspection of ancillary
areas including storage facilities, exterior areas, engineering facilities,
transport, canteen and staff facilities are also included when calculating the
total time in the factory. The audit report shall show an estimate of the time
spent auditing the factory.
What is expected by the BRC of auditors when opening equipment to
inspect cleaning?
To ensure that the standards of cleaning are properly challenged it is
expected that some equipment should be opened for instance by removing
panels or dismantled to check that cleaning is more than superficial.
Sites need to know in advance e.g. at the opening meeting that this will be
part of the site audit and any necessary arrangements should be made for
engineers to be present.
It is NOT expected that lines will be stopped for inspection. The audit should
be limited to lines or equipment not in production at the time of the factory tour
or the inspection of equipment outside of production periods.
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page16 of 18
Auditors must at all times be aware of and obey health and safety rules at the
sites.
How does the BRC expect the traceability (vertical audit) to be
undertaken?
BRC expect a traceability check (vertical audit) to be carried out on a product
selected by the auditor. This is in addition to the review of the method of
achieving traceability which forms part of the GMP audit.
The exercise shall be based on a product selected by the auditor the product
shall have been produced typically in a 2-5 months period prior to the audit
date. Where a claim is made about a component of the product (as per 5.3)
the test shall include a mass balance of the material subject to the claim. The
mass balance test should be in both directions (finished product to raw
material and vice versa).
BRC suggest the vertical audit (i.e. traceability documentation plus all
associated production and raw material documentation) should be carried out
only as part of the trace backwards from finished product to raw materials. To
undertake such an exercise in both directions would be too time consuming
unless issues are suspected.
Where the site produces products which make a claim of provenance (5.3) the
product selected for the traceability study should be a product for which such
a claim is made.
Details should be captured in the auditor’s checklist and summarised in the
final audit report.
What is expected of auditors when carrying out line start up or Pre
operation checks?
Where ever possible auditors should arrange to carry out an inspection of
lines before the start of production. Typically this would be accompanied by
the person who normally undertakes this check for the site being inspected.
The objective is both to ensure the standards of cleaning are good enough
and assess how the site undertakes such a check and the standards the site
its self expects.
There will be some production processes where such checks are impossible
for instance continuous processes or where timing is such that this would be
impractical. The auditor’s notes should indicate where a check has been
completed and if not why not.
What are the BRC’s expectations when examining records during the
documentation review?
It is important that when examining records this is a fair but true test of the
sites records and procedures. It is expected that the auditor shall manage the
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page17 of 18
selection or records to demonstrate compliance. The factory inspection shall
be used by the auditor to identify actual records to be examined during the
documentation audit. This could include
Employee names for – training record review
Reference numbers of measuring equipment – for review of calibration
records
Examples of glass/plastic items to check against the glass register
Can non-conformities be issued against Statements of intent (SOI)?
Yes and these can be minor, major or critical
Statements of intent summarise the overall objectives and the clausal
requirements below show how these can be achieved through policies and
procedures e.g. customer complaints (3.10) – the intent is that complaints are
reduced. It maybe that the company meets all the individual requirements by
having procedures for recording and investigating but complaints may still be
increasing – therefore the intent is not met. In this case a non-conformity
could be raised against the statement of intent.
I have had a BRC audit and am not happy with the non-conformities
identified or the grade awarded – what can I do?
The company has the right to appeal the certification decision made by the
certification body which should be made in writing to the certification body
within 7 days of the decision. The certification body shall give a full written
response within 30 days following a full and thorough investigation. The
company also has the option to contact the BRC if resolution cannot be
attained by the two parties.
F039 Issue 3
Released 4/11/2013
Issue 6 FAQ’s
Page18 of 18
Download