SQT Blog

The BRC project has been on the go since 1998 and there is no doubt that it has improved standards throughout the food manufacturing sector in this period but as with every standard that matures over time is its relevance declining?

ISO9000 suffered such a fate in the food sector as it was surpassed by FSSC which was newer and of greater relevance.  As one who reads many BRC non-conformance reports the same ‘low hanging fruit’ keeps appearing e.g. “No proof that blue plasters were metal detected.”  Do these types of observations really add value to the business with regards to Risk Management?

So what are the major changes to BRC Global Food Safety Standard Issue 7?
Supplier approval has been added to the list of fundamentals.  This was a given due to “horsemeatgate.”  The words fraud and integrity are a bit more prominent and Agents (Traders) are targeted.  There are significant improvements to ensure the integrity of the Supply Chain.  Clause 3.9 traceability has also been expanded with 3.9.3 being a new clause again focussing on raw material suppliers.

Another area significantly enhanced is customer focus and communication.  This is an area where the technical department must step-up.  The role of technical management has changed significantly over the past 24 months.  We need to communicate better both internally and externally so that the business needs of customers/retailers are understood by all in the manufacturing environment.

Learn what need to know about BRC on our one day programme…more

(Blog post based on draft standard of BRC Global Food Safety Standard Issue 7 which  will be published by January 2015. Audits according to the new standard will take place from July 2015)

Figures released from ISO show a large uptake over the previous twelve months.  There are over 19,573 standard developed by the ISO since its formation in 1947. The reach of the organisation has expanded with national members 164 countries, rising from 162 in 2011. Ireland’s representative body is the NSAI. The national members consist of 111 member bodies, 49 correspondent members and four subscriber members.

The number of active projects in 2012 has increased to 4056, from 4007 in 2011. Consequently, the number of standards published has also risen from 1208 in 2011, to 1280 in 2012.

A summary of the statistics is shown in the table below.

Table 1 Global Distribution of Certificates 2011 and 2012

Standard	No. of Certs Issued 2012	No. of Certs Issued 2011	Increase	Increase (%)
ISO 9001 (Quality)	1,101,272	1,079,647	21,625	2%
ISO 14001 (Environmental)	285,844	261,957	23,887	9%
ISO 50001 (Energy)	1,981	459	1,522	332%
ISO 27001 (Information Security)	19,577	17,355	2,222	13%
ISO 22000 (Food Safety)	23,231	19,351	3,880	20%
ISO/TS 16949 (Quality Automotive)	50,071	47,512	2,559	5%
ISO 13485 (Quality Medical Devices)	22,237	19,849	2,388	12%
Total	1,504,213	1,446,130	58,083	4%

Source (ISO, 2013)

From Table 1 above, it can be seen that the uptake for the seven most popular standards have all increased over the past year. The greatest increase in uptake has occurred with ISO 50001, with an increase of 332%.

This increase is due to the fact that ISO 50001 was released in June 2011, and therefore the 2011 figures represent six months of uptake. In addition this is the first internationally recognised energy management standard.  The large increase may be the result of companies with existing standards upgrading their systems to comply with the requirements of ISO 50001, as the standard is in its infancy.

Sustainable Energy Authority Ireland’s Large Industry Energy Network (LIEN) is a voluntary network comprising of 140 companies representing 60 percent of Ireland’s industrial energy usage. A staggering €60m in avoided energy costs has been achieved since 2008 with the Scheme. SEAI also have a scheme under the LIEN, called the Energy Agreements Programme (EAP), over which there are 80 members which requires organisations to implement an energy management system.

In addition to this Ireland is home to many of the world largest MNCs (e.g. Google, Pfizer) and these companies are paving the way for best practice energy management for their colleagues in other countries and this has been enforced further with the swift implementation of ISO 50001. Germany and the UK are the market leaders in the largest number of ISO 50001 certificates issued but Ireland is coming up behind these countries, and is driven by SEAI’s goal to ensure that all members of the EAP have achieved ISO 50001 certification by the end of 2013. (Brogan, 2012)

The global uptake of ISO 50001 over the first twelve months has exceeded that of ISO 14001 in its initial twelve month period, and is rivalling the number of uptakes of the ISO 9001 in the 1990’s.

ISO 9001 makes up the majority of the certificates issued with over 73% of the global total awarded in 2012.

Table 2 Distribution of Certificates 2011 and 2012 in Ireland

Standard	Intro Year	No. of Certs Issued 2012	No. of Certs Issued 2011	Change (%)	Total Certs Issued
ISO 9001 (Quality)	1993	2,331	1,875	+24%	43,462
ISO 14001 (Environmental)	1999	417	663	-37%	4,947
ISO 50001 (Energy)	2011	35	n/a	n/a	35
ISO 27001 (Information Security)	2006	48	30	+60%	146
ISO 22000 (Food Safety)	2007	49	49	0%	246
ISO/TS 16949 (Automotive Quality)	2004	23	21	+10%	187
ISO 13485 (Medical Devices Quality)	2004	193	159	+21%	975
Total		3,096	2,797	+11%	49,998

(Source: ISO, 2013)

From Table 2, it can be seen that the distribution of ISO 9001 makes up the majority (over 75%) of the total number of certificates distributed. The uptake of this standard has increased 24% on the previous year also. The large uptake for this standard has been driven by the introduction of EU directives on products which specify minimum standards

ISO 9001

 

 

 

 

Figure 1 ISO 9001 Annual Distribution of Certificates

The distribution of ISO 9001 conformance certificates peaked in 2000 and 2001 where 3700 certificates were being issued annually. The uptake of the standard has dropped off since then to more modest levels. Yet 2012 saw an increase of 24% in certificates issued versus 2011, as 2331 certificates were issued.  From all the certificates distributed in 2012 in Ireland, over 75% of them were for ISO 9001.

ISO 14001

 

 

Figure 2 ISO 14001 Annual Distribution of Certificates

417 certificates distributed in 2012. This is lowest distribution rate of ISO 14001 certification for the previous five years. This drop off may be due to maturity of standard and proposed introduction of the new ISO 14001 in 2015.

ISO 50001

The number of ISO 50001 certificates issued in 2012 was 35. This number quite big considering it is a voluntary standard. The standard was only introduced in June 2011 and many companies with existing EnMS standards in place, such as EN 16001, may be waiting for their existing certification to expire prior to acquiring the new standard. The next ISO survey will give a good indication as to whether the SEAI met their goal stated above.

 

ISO 27001

 

 

Figure 3 ISO 27001 Annual Distribution of Certificates

There has been significant growth in the uptake of ISO 27001 since its uptake in 2006, where only six certificates were distributed, to 48 certificates being distributed in 2012.

ISO 22000 (Food Safety)

 

 

Figure 4 ISO 22000 Annual Distribution of Certificates

Launched in 2007, 23 ISO 22000 certificates were issued, and annually since 2010, the number of certificates issues has risen to 49.

 

ISO/TS 16949 (Automotive Quality)

 

 

 

Figure 5 ISO/TS 16949 Annual Distribution of Certificates

The adoption of ISO /TS 16949 has grown from seven in 2004 and 2005, to over 20 annually for the previous 6 years.

 

ISO 13485 (Medical Device Quality)

 

 

 

Figure 6 ISO 13485 Annual Distribution of Certificates

Progressive growth has occurred in the uptake of ISO 13485 since 2004. The number of certificates has increased tenfold from its introduction in 2004, where 19 certificates were issued, to 2012 where 193 certificates were issued.

 

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As allergen control is identified as one of the 10 fundamental clauses of the BRC Global Food Safety standard, FBOs, (Food Business Operators), need to have a structured approach to managing allergens within their operation.

A practical way of ensuring that your allergen management programme is fit for purpose is to ensure compliance with the 10 point allergen improvement plan.

1 Allergen policy As allergens are 1 of the 4 food safety hazards, companies need to develop an allergen policy to demonstrate their commitment to legal compliance.

2 Risk Assessment As all contempoary Food Safety standards are based on risk assessment, each manufacturing process step needs to be risk assessed for the potential of allergen x contamination.

3 Supplier Management As a significance number of allergen x contamination incidents occur off site at supplier locations, suppliers must be risk assessed for the potential of allergen x contamination.

4 Recipe/Spec Control All manufacturing recipes and other product specs need to address allergen content to ensure that required information is shared between businesses in the food chain.

5 Labeling Review All finished product labels must be validated prior to use to ensure that they comply with all relevant Labellling legislation, ref Commission Directive 2007/68/EC annex 111A.

6 Operational Control All risk assessment evaluations undertaken by the food safety team must be transferred to factory floor manufacturing operations to ensure the relevant knowledge is in place.

7 Cleaning Validation All cleaning operations which historically focussed on the elimination of microbiological, biological and chemical hazards need to be re-validated to ensure the same procedures are capable of eliminating allergenic hazards.

8 Employee Training All staff, via induction training or specific on-the-job training, need to be made aware of the allergen risks in the manufacturing environment.

9 Change Control/Change-Over When allergenic and non-allergenic materials are processed on the same manufacturing equipment, change over procedures need to be formalised to ensure x contamination does not occur and the correct label is applied to the new manufacturing product.

10 Consumer Data FBOs, in an effort to demonstrate due diligence, need to investigate all possible means, (product labeliing, product websites), to inform consumers of the risks associated with products being produced.

If this 10 point allergen improvement plan is followed by food businesses, they can demonstrate that they are taking a structured and logical approach to allergen management.

Our next public Food Allergen Control training course takes place on 23rd April in Dublin

When attending a BRC conference in 2009 given by one of the leading certification bodies, I came across the following information that struck a chord with me as I believed it summarised in a nutshell the weaknesses in many a HACCP system.

Lack of risk assessments: Most Food Business Operators, (FBOs), have undertaken some form of risk assessment, however when challenged they are not confident in explaining the outcomes. This is because they are not familiar with the methodologies used and do not understand how risk is calculated based on probability and severity.

Confusion of hazard: When asked what hazards exist in the food environment a frequent response is ‘temperature’. Temperature is not a hazard, it’s the exact opposite to a hazard as it is a control measure. When asked what is the hazard in cooking, another common answer given is inadequate time/temperature. This again is not a hazard, it is the cause of the hazard. The actual hazard in cooking is biological survival. Hence hazard, cause, and control are three totally different concepts.

Confusion of Control and Monitoring: As Control is Principle 1 and Monitoring is Principle 4 of the seven HACCP principles, they need to be viewed as two separate elements of a Food Safety Management System, (FSMS). In a cooking process, control is the heat that kills the bug and monitoring is the means by which we prove that the control has worked. Historically there has been excessive focus on monitoring to the detetriment of understanding what control measures actually are.

Lack of Prerequisite programmes: As food safety is currently on a move towards ‘Back to Basics’ a strong robust prerequisite programme is essential to the manufacture of safe food. BRC lists 9 prerequisites yet FSSC requires 15. In my view 15 is the definitive list and companies should strive to develop a Prerequisites programme in compliance with FSSC (Food Safety System Certification).

Poor CCP Identification: How many Critical Control Points, (CCPs)? Too many or too few? When faced with this challenge, FBOs tend to identify excessive numbers of CCPs so that they can’t be accused of leaving some out. This is not always necessarily a good thing as it can dilute the focus from the truly ‘life or death’ process steps which if they fail, human health will be seriously affected.

Lack of Validation: As validation is not listed as one of the seven HACCP principles unlike verification, many Food Safety professionals are very uncomfortable when asked for validation data or validation studies. As validation is essentially generating proof that something ‘can work’, and verification is generating data that something ‘is working’, validation comes first hence with the ‘Back to Basics’ approach to food safety, auditors are now looking for the validation data.

Failure to record decision making: As current Food Safety legisation and voluntary Food Safety standards are written to allow FBOs make their own decisions pertaining to CCP identification, identification of hazards and risk assessment, the reason for such decisions must be recorded as otherwise the basis for such decisions may be lost over time due to personnel change, memory lapses etc. It is not satisfactory for a Technical Manager to explain that a particular process step is a CCP ‘because it was so before I arrived’.

If as a Food Safety professional you are confident that your FSMS is designed in such a way that the seven problems mentioned above are addressed, you can be confident of a successful outcome in any HACCP audit.

As per BRC Global Food Safety Standard Revision 6, Corrective Action and Root Cause Analysis are viewed as two different things.

Corrective Action is defined as ‘Action to eliminate the cause of a detected non-conformity deviation’

Root Cause is defined as ‘Underlying cause of a problem which if adequately addressed will prevent the recurrence of the problem’

As both definitions are remarkably similar, it is quite difficult to understand one from the other. Applying both terms to a metal detection scenario …

If metal is detected in the product

Corrective Action initially focusses on the removal of the hazard from the product and the identification of where the hazard originated from.

Root Cause Analysis will look at how we allowed the hazard to contaminate the product in the first place …
– Why did our Preventive Maintenance programme fail?
– Have we committed sufficient resources to the maintenance department?
– Do the maintenance personnel fully understand their vital role in hazard control?
– Had our process risk assessment identified the hazard as a reasonable hazard?
As per the Root Cause definition, these are the underlying causes which if addressed will prevent the recurrence of the problem.

As the TESCO Food Manufacturing Standard, (TFMS), requires as an aspiration under section one, that food safety team leaders be trained in advanced HACCP, (FETAC level 6), the need for competency, and confidence in risk assessment, legislation, validation and verification has never been greater.

As the contemporary approach to food safety is to ensure hazards are controlled at factory floor level, by production and maintenance/engineering personnel, technical management by your traditional Quality Assurance Manager is changing. When the TFMS defines the make-up of the food safety team it mentions production, engineering and technical personnel, but there is no mention of Quality. The responsibility for the delivery of a quality product lies primarily with production, with technical personnel providing support, via validation and verification protocols. The requirement on 2nd and 3rd party audits for “validation studies” is becoming a common request, a request that is often met with a blank face.

This Advanced HACCP course (FETAC level 6), will provide those who have already attended the Intermediate HACCP course (FETAC level 5), with the additional level of knowledge, skill and know-how, to lead their food safety team through the demanding process of risk assessment, thus ensuring that their FSMS, (Food Safety Management System), is developed, implemented, validated and verified to the best practice standard.

Our next Advanced HACCP course, (FETAC Level 6), is scheduled for 11-12 February. Our next Intermediate HACCP course, (FETAC Level 5), is scheduled for 22-23 January. Both will be held in Dublin.

This is the question that European and Irish retailers are asking of themselves and their suppliers. European food safety legislation 852/2004 requires Food Business Operators (FBOs) to develop HACCP systems but what does this actually mean to people?

The production of safe food invariably comes down to three basic things in the majority of Food Businesses:
1 The control of contamination
2 The control of growth of microorganisms
3 The kiling of bacteria if the process is capable of doing so

Point 1 above is controlled by focussing on three simple things: Premises, Plant and People. 300 years ago when pigs were killed on the side of the street, people cleaned up after themselves as they knew before the advance of modern microbiology that dirt attracts rodents and all other nasty things. In modern food processing this is where the attention is now being focussed. Pre-operational hygiene inspections at 5am or 6am are becoming the norm in deciding whether these companies are suitable suppliers or not. There is no excuse for dirt, never has been, and never will be as dirt is visible. Visible organic matter left on a food contact surface for 10 hours at ambient temperature can cause a lot of damage.

Point 2 above is controlled by focussing on two simple ideas; temperature control and time control. These are quite easy to control as modern refridgeration allows us to set temperatures in any room to +/- 1deg. Time is controlled by dating and labelling of food.

Point 3 is controlled by proper cooking if cooking is a step in the process.

By looking after these three basic things, the food will invariably be safe. Simply Back to Basics. Sometimes the complexity of legislation unintentionally may take our focus off the basics.

The Food Safety Authority of Ireland, (FSAI) has called on food manufacturers to strengthen food allergen controls and labelling policies following an audit of compliance with allergen labelling legislation. Results of the FSAI audit, published in June of this year, revealed that the management and control of food allergens in some food businesses was insufficient to protect the health of people with food allergies or intolerances. The audit was conducted on a selection of small, medium and large food businesses and showed that food allergen labelling was applied in an inconsistent and sometimes incorrect manner.

More details on the audit can be found here.

We are currently taking bookings on our next Food Allergen Control training course on 11th October in Dublin. This course will provide an excellent opportunity for food businesses to review and strengthen their food allergen control and labelling policies.

The FSAI (Food Safety Authority of Ireland) has published a booklet on New Food Information Regulation. The booklet gives food businesses operators (FBOs) an easy to understand overview of some of the upcoming changes to food labelling under the new food information regulations.

According to the FSAI webiste While the original objectives and components of current labelling legislation still apply, some new requirements are being introduced under Regulation No. (EU) 1169/2011, which will modernise the current system.

The booklet highlights new elements of the Regulation including allergen information, date of minimum durability, nutrition declaration, front of pack labelling and country of origin labelling.

The FSAI is encouraging all food businesses to familiarise themselves with the new regulatory requirements and download the booklet, which is available on their website.

Management commitment as defined by the FDA within any FBO, (Food Business Operator), is the framework which must be created whereby food safety can be seamlessly implemented at factory floor level. The following is how the FDA measure management commitment when undertaking food safety inspection audits.

The senior management of participating firms should provide a clear and visible commitment to the HACCP study. The firm may demonstrate this commitment by the following activities:
– Appointing a HACCP Administrator
– Providing adequate authority and resources to HACCP Team/Participants
– Implementing prerequisite programs
– Implement HACCP plan

HACCP Administrator
The HACCP Administrator should be trained in HACCP principles and acknowledged as responsible for oversight of the HACCP program. The HACCP administrator’s duties during a study include the following:
– Leading the HACCP team and ensuring all training requirements are identified / met
– Confirming that the prerequisite programs are in place
– Validating the HACCP system on behalf of the firm
– Performing periodic audits of the HACCP plan to confirm that the plan is being fully implemented. (verification)
– Ensuring that the HACCP system continues to be representative of actual operating conditions by making necessary changes to conform with alterations to the plant, process or product; (review)

Skills required by HACCP Administrator and HACCP Team
The HACCP Administrator/ HACCP Team needs to have a thorough understanding of:
– Performance of a hazard analysis and determination of critical control points;
– Requirements for prerequisite programs
– Preparation and implementation of a HACCP plan in the establishment; and
– Verification that the HACCP plan has been successfully implemented, including a timeframe for revalidation

Training of Line Employees
Line employees and floor staff should be trained such that they understand their specific functions and duties; and how these are to be performed under a HACCP system/plan. At a minimum
– The importance of the critical control points for which they are responsible
– The critical limits associated with a given CCP
– The procedures for monitoring these critical limits
– The corrective actions to be taken if there are deviations from the critical limits; and
– The records that are to be kept