The BRC Global Standards for Food Safety

In 1998 the British Retail Consortium (BRC), responding to industry needs, developed and introduced the BRC Food Technical Standard to be used to evaluate manufacturers of retailers own brand food products. It is designed to be used as a pillar to help retailers and brand owners with their 'due diligence' defense, should they be subject to a prosecution by the enforcement authorities. Under EU food Law, retailers and brand owners have a legal responsibility for their brands.

The Global Standard for brc food safety was first developed in 1998 by the food service industry to enable their suppliers to be audited by third party Certification Bodies against a single consistent standard, reducing duplication of effort and enabling the food service industry to focus activities on areas of competitive advantage. Built on the principles of clear risk based requirements, informative report format and auditor competence, the
Standard has continued to develop and evolve with input from a wider base of international stakeholders including retailers, caterers, food manufacturers and Certification Bodies.

The Standard is closely managed by the BRC who license the use of the Standard to Certification Bodies who must be both accredited by their national Accreditation Body and abide by strict BRC requirements for auditor competency, reporting and performance.
In a short space of time, this Standard became invaluable to other organizations across the sector. It was and still is regarded as the benchmark for best practice in the food industry. This and its use outside the UK has seen it evolve into a Global Standard used not just to assess retailer suppliers, but as a framework upon which many companies have based their supplier assessment programmer and manufacture of some branded products.

The majority of UK, and many European and Global retailers, and brand owners will only consider business with suppliers who have gained certification to the appropriate BRC Global Standard.

Following the success and widespread acceptance of the Global Standard - Food, the BRC published the first issue of the Packaging Standard in 2002, followed by Consumer Products Standard in August 2003, and finally by the BRC Global Standard - Storage and Distribution in August 2006 . Each of these Standards is regularly reviewed and each standard is fully revised and updated at least every 3 years after extensive consultation with a wide range of stakeholders.

New editions of the Food and Packaging Standard have been published, respectively titled Global Standard for Food Safety and Global Standard for Packaging and Packaging Materials. Both the new BRC standards are differentiated by a number of innovations which have been developed in the course of extensive consultation with a wide range of stakeholders. These include:

    o Clearer and more detailed requirements.

    o Greater focus on analysis of potential hazards.

    o New specially-designed training courses.

    o Increased emphasis on senior management demonstrating their commitment to the aim of achieving a satisfactory quality management system.

    o Optional unannounced audits have been introduced for companies gaining brc certification grade A or B

    o More guidance on implementing HACCP based on Codex Alimentarius principles

    o Greater emphasis on senior management demonstrating their commitment to the aim of achieving product quality and safety and to ensuring corrective action for non-conformities is undertaken

    o Expanded sections on issues of major importance, such as allergens and identity preserved materials, laboratory management, and physical and chemical contamination control

    o A more rigorous grading system for grades B, C and D has been introduced with a re-visit by the certification body required within 28 days to verify corrective actions for grade C as well as audit frequency reduced to 6 months

    o Revision of product categories that focus on product technologies that are now cross referenced with fields of audit pertinent to auditor requirements

    o A new section has been introduced on site security requiring controlled access and training of staff, secure storage of materials and registration and approval of premises.

You can read more about Reason to choose BRC certification.

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Overview of BRC Standard

Space-age technology designed to keep food safe in outer space may soon become standard here on Earth. The Food and Drug Administration has adopted a food safety program developed nearly 30 years ago for astronauts and is applying it to seafood and juice. The agency intends to eventually use it for much of the U.S. food supply. The program for the astronauts focuses on preventing hazards that could cause food-borne illnesses by applying science-based controls, from raw material to finished products. FDA's new system will do the same.

Traditionally, industry and regulators have depended on spot-checks of manufacturing conditions and random sampling of final products to ensure safe food. This approach, however, tends to be reactive, rather than preventive, and can be less efficient than the new system.  The system is known as Hazard Analysis and Critical Control Point, or HACCP (pronounced hassip). Many of its principles already are in place in the FDA-regulated low-acid canned food industry. FDA also established HACCP for the seafood industry in a final rule December 18, 1995 and for the juice industry in a final rule released January 19, 2001. The final rule for the juice industry will take effect on January 22, 2002 for large and medium businesses, January 21, 2003 for small businesses, and January 20, 2004 for very small businesses.

In 1998, the U.S. Department of Agriculture has established HACCP for meat and poultry processing plants, as well. Most of these establishments were required to start using HACCP by January 1999. Very small plants had until Jan. 25, 2000. (USDA regulates meat and poultry; FDA all other foods.)

HACCP has been endorsed by the National Academy of Sciences, the Codex Alimentarius Commission (an international BRC food standard-setting organization), and the National Advisory Committee on Microbiological Criteria for Foods. A number of U.S. food companies already use the system in their manufacturing processes, and it is in use in other countries, including Canada. British Retail Consortium



BRC Global Standards

As the "Voice of British Retailing", the British Retail Consortium (BRC) expresses the views of its members and keeps the press, parliamentarians, consumers and many other opinion formers informed about issues in the retail sector. We take a broad view of what issues are affecting retailers, inclusive of retail crime policy; environment, property and transport; regulatory and consumer affairs.

The BRC publish globally recognised Standards for best practice in product safety for Food, Packaging, Consumer Products, Storage & Distribution and Non-Genetically Modified Food. These Standards are the market leaders and provide a framework upon which many retailers, global brand owners and manufacturers use for their supplier assessment programme and due diligence defense support.
BRC Standards ensure best practice standards are developed, implemented and maintained.

 
Benefits of the BRC Global Standards

    o Comprehensive and focused on safety, legality and quality
    o Clear and detailed requirements based on HACCP principles supported by documented systems
    o Standardised reporting format providing information on how sites meet the requirements of the Standards 
    o Closure of all non-conformities identified at an audit with evidence included in the report before Certificates can be issued
   o Complementary with existing quality management systems e.g. ISO and HACCP where these meet the requirements of the Standard
    o Focuses on identifying and preventing hazards from contaminating food
    o Is based on sound science
    o Permits more efficient and effective government oversight, primarily because the record keeping allows investigators to see how well a firm is complying with BRC for food safety laws over a period rather than how well it is doing on any given day
    o Places responsibility for ensuring food safety appropriately on the food manufacturer or distributor
    o  Helps food companies compete more effectively in the world market
    o Reduces barriers to international trade.

Objectives of BRC

    - Equip individuals who have a general understanding of effective quality system and who have a background in quality or safety systems
    - Ensure a broad understanding of Hazard Analysis and its exact Relation with industrial legal and safety concerns.
    - Provide a framework  for effective control of factory environment Standards,  product, process and personnel

What does the standard require?
The standard contains a number of 'fundamental, requirements which must be well established, continuously maintained and monitored by the company. The requirements deemed as being fundamental are Haccp, the quality management system, internal audits, corrective actions, traceability, layout / product flow / segregation, housekeeping & hygiene, handling requirements for specific materials, control of operations and training.
Where a critical or major non conformance is raised against one of these requirements, this now leads to a full evaluation against the standard (i.e. another audit)


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ISO INTERNAL AUDITOR OBJECTIVES

1.   Collecting and Verifying Information

During the audit information relevant to the ISO audit objectives, scope and criteria, including information relating to interfaces between functions, activities and processes should be collected by appropriate sampling and should be verified. Only information that is verifiable may be audit evidence. Audit evidence should be recorded. The audit evidence is based on samples of the available information. There for there is a element of uncertainty in auditing and those acting upon the audit conclusions should be aware of this uncertainty.

The following figure provides an overview of the process, from collecting information to reaching audit conclusions: 

2.   AUDIT REPORTING

•   Team Meetings

At a daily meeting (or before the summery report is compiled) the auditors discuss their detailed observations with the audit team leader to determine if non – compliances exist and if applicable, are categorized.

When the audit team leader is satisfied with the evidence presented he / she in turn may discuss any non – compliance with the auditee’s representative to seek agreement that they exist. This is not to suggest a ‘bargaining’ situation, but one in witch the auditee is given an opportunity to discuss the non – compliance's and allow the production of any evidence to demonstrate that three is no deviation from the requirements.

Equally, the opportunity to discuss and recognize a non – compliance may enable the auditee to initiate corrective action.

In either event, the non – compliance is still recorded but the fact that corrective action has been taken it noted in the audit report.

It should be noted that non – compliance are owned by the auditee and not the auditor.

•   Non – Compliance Categorization

 It is common practice to classify non – compliances into categories. This subject is dealt with in Section 12.

Categorization of non – compliances is normally decided through discussion between the team leader and the auditors rather than applying a category at the time of the incident. Categorization is not an end in itself but an aid to assist the team leader to assess the severity of the non – compliance and form a reasoned judgment on the auditee’s FSMS arrangements.

•   Non – Compliance

Reporting non – compliances is the method used to indicate to an organization during an audit that there is a deviation to the laid down FSMS requirement and the applicable legislative requirements.

A non – compliance is a non – fulfillment of specified requirements (GMP, SSOP, QMS, Quality, Environment).

Non – compliances arise from OBSERVATIONS made during an audit.

An observation is a statement of fact recorded on the checklist. The audit team will then review all of their observations to determine which of them are to be reported as non – compliances. The audit team shall ensure that non – compliances are documented in a clear, concise manner and are supported by objective evidence.

•  Non – Compliance Categorization

All non – compliances have to be dealt with regardless of how important an impact they may on the established system. It is common practice to categories non – compliances to enable the overall effectiveness of a QMS management system and the urgency of corrective action to be assessed.

There is no defined standard for categorization of NCR’s, so if categorization is to be applied the methods are required to be defined by the auditing organization and made clear to the auditee at the start of the audit.

Categorization of NCR should be based on deviation to the FSMS / legislation and impact on product / process and its risk. Observations need to support the grading with sufficient justification.

A typical classification is as follows:-

• Critical

The absence or total breakdown of a FSMS to meet the requirements of ISO 22000 and the requirements of applicable regulations that impact QMS.

E.g. seriously inadequate hazard analysis, insufficient CCps are identified, no action responding to violation of critical limits, use unsafe water etc.

One critical NCR will lead to failure of certification. A re – audit is normally required within six months after initial audit.

• Major

 A  non – compliance which is likely to result in the failure of the QMS system or reduce its ability to assure safety of processes or products.

E.g. improper control of chemical compound, shop workers are not very hygienic or there is no necessary action to prevent food from contamination etc.

If there is any major NCR, registration is recommended subject to a satisfactory verification visit. Verification visits will be arranged within eight weeks after the audit to verify effectiveness of corrective actions.

• Minor

System deficiency (ies), which do not directly affect the QMS, but need to be improved.

E.g. environment of production areas is not in good condition, which may contaminate food, inadequate light in production areas or cleaning facility is not in a good condition etc.

When there are only minor NCRs and its number will not obstruct the system operation, registration can be recommended subject to a satisfactory review and verification of document evidence to corrective action. Document evidence, including self –declaration of corrective actions, is required to be submitted within four weeks after the audit.

A number of minor lapses of the same content (incorrect issue of documentation in use in several areas) show a system breakdown and may therefore be regarded as more serious and be upgraded.

It is normal with certification bodies that once a corrective action has been agreed that the check for practice effectiveness may be left until the next surveillance visit.

Categorization of non – compliances is normally decided through discussion with the lead auditor and the auditor rather than applying at the time of the incident.

Categorization is not an end in itself but an aid to assist the lead auditor to assess the severity of the non – compliance and form a reasoned judgment on the auditee’s QMS management system.

If the audit was undertaken for a ‘customer’ or a ‘third party’, then it may well be up to them to decide on the acceptances of any non – compliance. This may be influenced by any contractual or specification requirements. The lead auditor should be made aware of any such restriction.

•  Reporting Non – Conformities

During the audit, the auditor will be documenting observations of the system. These observations may well result in non – conformities being raised. When the auditor decides that there is a non – compliance, then a written report will be submitted. This type of report is commonly referred to as a NCR (Non – Compliance Report).

There should be sufficient detail in the report to clearly identify all the facts concerned, the specification requirement and the evidence of the non – compliance. It is important that sufficient information is provided to ensure traceability to the source of the problem in order that effective corrective action can be completed.

A quick guide is to examine and describe the:-

•            Where – the area where the non – compliance was found or can be identified.
•            When – date of audit.
•            What – description of the problem.
•            Why – a statement of the requirements from the specification or procedure.
•            Who – not the report must not attribute blame.

REMEMBER someone has to read the report. Clarity of information and the inclusion of as many facts as possible will assist the reader to understand your findings THE FIRST TIME.

The auditor must produce absolute proof that non – compliances exist.

A typical non – conformity report is attached.

3.      Objective Evidence

 Often members of the work force will give a rehearsed version of the controls being applied. It is there fore very important during and audit to establish that the facts investigated by the auditor and the observations made are a true and accurate reflection of the way in which the food system is applied.

4.      Audit Report Observations

Statements NOT substantiated by objective evidence may be made as comments if the auditor thinks this will be useful or constructive.

These are usually observations noted during the ISO audit, which did not require non  compliance to be raised since they do not contravene a standard or process, but could included in the audit report to assist the assessed organization with potential improvement.

The auditor should exercise care when making observation for improvements to ensure that the auditee understands that he / she is responsible for any decision taken. 

5.      Preparing the Summary Report

At the conclusion of the audit, the team leader (lead assessor) in consultation with the team auditors will prepare a summary report.

This report is normally hand written, while a formal typed copy is prepared later and subsequently submitted. An example of a suitable format is included at the end of this section.

As its title implies, the report summarizes the detailed reports of non – compliances and observations, notes any corrective action to be taken and, depending on the authority given, may allow the team leader to give a recommendation that the auditee’s FSMS arrangements are ACCEPTABLE, CONDITIONAL or unacceptable.

(Acceptability may be conditional on certain agreed corrective action being completed to the satisfaction of the team leader or customer, ie a CONDITIONAL recommendation).

The three levels of recommendation may be applied as follows:-

å       Acceptable - award certificate or accept as an approved supplier.

å       Conditional – includes statement of agreed corrective action to be completed prior to acceptance being granted.

å       Unacceptable – failure due to a number of serious non – compliances.

A conditional recommendation report will indicate the corrective action required. The team leader may make recommendations as to the way in witch corrective action providing there is a clear understanding of the relationship between the two organizations in terms of any cost or liability that may arise from taking the required corrective action.

It is the 3^rd party certification body which makes the decision to award a certification, not the auditor. The auditor only makes a recommendation.

In the case of an audit by a certification body, the team leader will always make a recommendation against the relevant specification.

For 2^nd party audits it will be up to the purchaser to decide what action is taken following an audit based on the auditor’s recommendations and other commercial factors, ie price, delivery etc when placing a supplier on their approved supplier list.

6.     The Closing Meting and Presenting the Summary Report

The summary report is formally presented at a closing Meeting attended by the audit team and the auditee’s management representatives. At this meeting the team leader shall:-

å       Thank the management for their assistance and co – operation.

å       Point out that only a sample of the FSMS arrangements has been taken and that the audit result has been determined against this sample.

å       Propose that any questions for clarification of the report findings are kept until the end of the presentation.

å       Present a summary of the findings and quantify the non – compliances raised.

å       Invite each auditor to report their detailed findings and give a recommendation.

å       Invite questions for clarification only and give answers

å       Agree on any follow – up action which may be required, This may already have been agreed on non – compliance reports (NCR’s)

å       Advise the auditee on the procedure for processing the final report (depending on the instructions given to the team leader), but in any case advise that fully written report will be raised.

å       Agree the duration of any approval that may be granted.

å       Make a statement regarding confidentiality of information.

Note:

The team leader may choose to present the whole report and only ask the auditors to deal with the questions relating to their area of audit.

Before departing the team leader will normally leave a copy of Summary Report and the original non – compliance reports.

7.      Agreement and Follow – up of Corrective Action

 Where the corrective action is required, the team leader may have agreed a date upon which a revisit to the auditee is to take place in order to verify that all non – compliances have been successfully corrected.

It may be that the nature and number of non – compliances require a further complete re – audit. If so, the team leader will state this at the closing meeting and in the final report.

Source: ISOQualityKit.Com
For More info about ISO Certification process visit Global Manager Group website

What Is CE Marking?

The CE Mark is a mandatory European marking for certain product groups to indicate conformity with the essential heath and safety requirements set out in European Directives. The letters ‘CE’ are an abbreviation of Conformity Europeans, French for European conformity. The CE Marking of products as “passport” which can allow a Manufacturer to freely circulate their products within the European market place.
The CE Mark declares that your product complies with the Essential Requirements of the applicable EU Directives.

CE Marking

Applicable requirements are set forth in various European Directives that replace individual country safety standards. The Directives apply to products manufactured within but also exported to the European Union.
The CE Mark is placed on a product as the manufacturer’s visual identifier that the product meets the requirements of relevant European Directives. It is mandatory for a wide range of products sold within or exported to the European market.
To facilitate free trade and ensure the safety of certain products, European countries have developed a series of standards, or Directives as they are called. Compliance is mandatory. It is a legal obligation on the part of the manufacturer or his agent. Penalties for failing to get CE-Marking for a product can be severe.
If you wish to sell your products within the European Union member states and the European Economic Area, the product in question must comply with the Directive(s). This also applies if you are a manufacturer who wants to export products into the European Member countries.
The Directives replace individual country standards as they relate principally to the safety of these products.

What products do the Directives cover?
The Directives apply to a wide range of products. The most notable products that likely need CE-marking are:

    * pressure equipment
    * machinery of almost any description
    * electrical and electronic equipment
    * medical devices and equipment
    * personal protective equipment
    * equipment for use in potentially explosive environments

There are certain exclusions, but if you manufacture any of the above types of equipment or products then one or more of the Directives almost certainly apply.


EU Directives
Directives apply to 99% of all industrial and domestic products sold in Europe; it is the distinctive CE mark that signifies compliance with the applicable Directives. Without the CE mark and the correct documentation, manufacturers and importers are at an immediate disadvantage when competing against compliant competitors.

Complying with Directives
The requirements of the Directives are to ensure that manufacturers have identified and addressed all aspects of design and manufacturing that could impact safety and the safe operations of the equipment.

The actions required to become compliant with the Directives vary according to which Directive(s) apply and the type or classification of the equipment as defined by the Directive(s). However, there are some general steps you should follow:

   1. Determine which, if any, EU Directives apply to your product(s),
   2. Determine the extent to which your product already complies with the essential requirements of the Directives.
   3. Choose conformity assessment routes. Depending on the nature of the equipment or product, you may be able to implement and declare compliance and affix the CE mark without assistance or service from an external company.

A Notified Body is an independent body appointed by an agency within one of the European countries, usually governmental, as being capable of performing the duties of a Notified Body as defined by the Directives.


Source:  ISOQualityKit.com

ISO: 9001-2008 Quality Manual (8 Chapters and 5 Annexure)

ISO: 9001-2008 Quality Manual (8 Chapters and 5 Annexure)

ISO 9001 Helps In Improvement of Supply Chains

Just what can purchasers reasonably expect from suppliers who put forward their company's ISO 9001 certification as an argument in favor of their products or services? ISO provides answers to this and related questions in an updated edition of its online brochure, ISO 9001 What does it mean in the supply chain?

The document is particularly aimed at purchasing managers of business enterprises and public sector officials responsible for procurement, but it will also be useful for organizations representing consumer interests as well as for consumers themselves.

ISO 9001 is implemented by organizations in more than 136 countries and has become the global benchmark for quality management systems (QMS). The standard is used as a framework for providing assurance about the supplier's ability to satisfy quality requirements and ISO 9001 certification is often a market requirement for suppliers to participate in supply chains or to bid for procurement contracts. It is also widely used as a marketing argument by companies selling goods or services to consumers.

For these reasons, the update of ISO 9001 What does it mean in the supply chain? is timely. It provides concise answers to common questions such as:

* What does conformity to ISO 9001 mean?
* How does ISO 9001 help you in selecting a supplier?
* How can purchasers be sure that the products they receive will meet their requirements?
* How can you have confidence that your supplier meets ISO 9001?
* Can suppliers claim that their goods or services meet ISO 9001?
* What can a customer do if things go wrong?

In addition, the document serves as a "mini-primer" to ISO 9001 because it includes brief, but essential, explanations of the standard, quality management systems and the options for claiming conformity with ISO 9001.

"The documents provides purchasers with the information needed to ensure that the ISO 9001 standard is used to its full potential in the business-to-business supply chain."


Source: Globalmanagergroup.com

Need Of ISO 14001 Documents

ISO: 14001 are a generic document and it does not specify "how" to do, but only states "what" to do. As per the standard, the Environment Management System should be documented and be demonstrable in the manner consistent with the requirements of ISO 14001 models. The total demonstration in the Environment Management System consists of four tiers of documents.

1.Environment Manual
2.Procedure Manual
3.Work Instruction/Operating Procedure Manual
4.Forms, Records

The amount of documentation should support and efficient Environment assurance system without creating a paper bureaucracy. The details for documenting above four tiers of documents is described in this paper.

NEED FOR DOCUMENT CONTROL: -

The Environment System consists of a number of documents. Some system should be provided for safe keeping of complex records. It is important to clearly define as to where they should be kept and for how long, and who is responsible for them. Each written procedure should be checked and signed by an authorized person, with issue number and issue date. The management representative should have a list of all completed ISO procedures, applicable to the individual departmental activities. Against each listed document the number should be shown together with the date of the latest change. It is also called a "Master Copy". It is a yardstick against which any other controlled copy can be judged.

From time to time the Committee for Management Review and Corrective Action may put forward recommendations for change in the procedure. The Management Representative should be responsible for implementing the change. For making a change, the new page should be circulated to the keeper of the controlled copy of the document with an instruction to insert the new page in order and return the replaced page to the Management Representative. Thus outdated ISO documents will be removed from circulation. The change, which has been made, should be known to the staff and everyone should implement the new procedure. When a number of major changes have been made, a complete new manual has to be issued. The retention period for these records can be predefined either contractually or by the policy and it is to be mentioned in the Environment Manual.