News:

Standards & Audits | About PDCA | PDCA Services | Glossary | Miscellaneous |

HACCP

HACCP History:

A forerunner to HACCP was developed in the form of production monitoring process during World War II because traditional "end of the pipe" testing wasn´t an efficient way to ferret out artillery shells that would not explode.  HACCP itself was conceived in the 1960s when the US National Aeronautics and Space Administration (NASA) asked Pillsbury to design and manufacture the first foods for space flights.  However, it was thought that this would not give enough assurance of food safety; the only way to guarantee safety would be to test 100% of the product.  Instead, a preventive approach was sought and it was found in the engineering system Failure Mode and Effect Analysis (FMEA). Taking the FMEA approach as a starting point, the team adapted this into the basis of the HACCP system that we know today; a system that looks at what can go wrong at each step in the process and builds in control to prevent the problem from occurring.  Since then, HACCP has been recognized internationally as a logical tool for adapting traditional inspection methods to a modern, science-based, food safety system. The HACCP system was presented in public for the first time in 1971 at a food protection conference in the USA. Uptake of HACCP by food companies was initially slow, partly because the approach was not fully defined and partly because the HACCP was not required by regulators nor promoted internationally. This started to change in the 1980s when the US National Academy of Science recommended that HACCP be used by food factories and the International Commission for Microbiological Criteria for Foods both recommended its use and published a guide to the application of HACCP.  In 1994, the organization of International HACCP Alliance was established initially for the US meat and poultry industries to assist them with implementing HACCP and now its membership has been spread over other professional/industrial areas.  The inclusion of HACCP principles in food safety legislation has also been increasing around the word. On January 2006 most food businesses in the EU were required to implement a food safety management system based on Codex HACCP principles.

About HACCP:
The acronym HACCP stands for Hazard Analysis and Critical Control Point , which is systematic preventive approach to food safety and pharmaceutical safety that addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. HACCP systems are designed to prevent the occurrence of potential food safety problems so that key actions, known as Critical Control Points (CCPs) can be taken to reduce or eliminate the risk of food or medicinal hazards during all stages.  HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. This is achieved by assessing the inherent risks attributable to a product or a process and then determining the necessary steps that will control the identified risks. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world:
- Conduct a hazard analysis
- Identify critical control points
- Establish critical limits for each critical control point
- Establish critical control point monitoring requirements
- Establish corrective actions
- Establish record keeping procedure
- Establish procedures for ensuring the HACCP system is working as
Food Safety Management System (FSMS) is used as the International Standard integrates the principles of Hazard Analysis and Critical Control Point (HACCP) system and application steps developed by the Codex Alimentarius Commission and dynamically combines it with prerequisite programs PRP(s) necessary to control and reduce any food safety hazards identified for the end products delivered to the next step in the food chain to acceptable levels.  Hazard analysis is the key to an effective combination of control measures.  The International Standard requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, are identified and assessed, resulting in a clear determination of those to be controlled within the Organization and those that are to be controlled (or are already controlled) by other organizations within the food chain and/or by the final consumer.  Thus the standard provides the means to document and justify both inclusions and omissions in setting control measures.
- It is demonstrated that it has been developed in compliance with the requirements of the international Standard specified for the hazard analysis, PRP(s) and HACCP plan
- Specific measures have been undertaken to adapt the externally developed system to the Organization
- It has been implemented and is operated in accordance with the other requirements of the International Standard
- System management
- Interactive communication
- Prerequisite programs
- HACCP principles
- Process control

HACCP Application:
It is a fundamental requirement for any food process that the food produced should be safe for consumption.  Food safety is such a basic consumer expectation that is taken as read when choosing meal from the menu options.  However, there is a very real danger to consumers if necessary control measures are overlooked or mismanaged in the operation of a busy catering operation.
- Fish and fishery products
- Fresh-cut produces
- Juice and nectary products
- Food outlets
- Meat and poultry products
- School food and services
- Etc
EUREP G.A.P started in 1997 as an initiative by retailers belonging to the Euro-Retailer Produce Working Group (EUREP).  British retailers in conjunction with supermarkets in continental Europe were the driving forces.  They reacted to growing concerns of the consumers regarding product safety, environmental and labor standards and decided to harmonize their own often very different standards.

GLOBAL G.A.P
About GLOBAL G.A.P.:
The challenge of globalizing markets is nowhere greater than in the primary food sector. GLOBAL G.A.P (formerly known as EUREP G.A.P) has established itself as a key reference for Good Agricultural Practices (G.A.P.) in the global market place, by translating consumer requirements into agricultural production in a rapidly growing list of countries; currently more than 100 on every continent.
- GLOBAL G.A.P is a private sector body that sets voluntary standards for the certification of agricultural products around the globe. The aim is to establish ONE standard for Good Agricultural Practice (G.A.P.) with different product applications capable of fitting to the whole of global agriculture
- GLOBAL G.A.P is a pre-farm-gate standard, which means that the certificate covers the process of the certified product from farm inputs like feed or seedlings and all the farming activities until the product leaves the farm. GLOBAL G.A.P is a business-to-business label and is therefore not directly visible to consumers
- GLOBAL G.A.P certification is carried out by more than 100 independent and accredited certification bodies in more than 100 countries. It is open to all producers worldwide
- GLOBAL G.A.P includes annual inspections of the producers and additional unannounced inspections
- GLOBAL G.A.P consists of a set of normative documents. These documents cover the GLOBAL G.A.P General Regulations, the GLOBAL G.A.P Control Points and Compliance Criteria and the GLOBAL G.A.P Checklist
As many other on-farm assurance systems have been in place for some time prior to the existence of GLOBAL G.A.P, a way had to be found to encourage the development of regionally adjusted management systems and so to prevent farmers from having to undergo multiple audits.  Existing national or regional farm assurance schemes that have successfully completed their benchmarking process are recognized as an equivalent to GLOBAL G.A.P.

Integrated Farm Assurance (IFA) Standard:
Integrated Farm Assurance (IFA) is a single integrated standard with modular applications for different product groups, ranging from plant and livestock production to plant propagation materials and compound feed manufacturing.

Plant Propagation Material (PPM) Standard:
Farm assured propagation material forms a good basis for a sound, farm assured plant production.  This is achieved by incorporating Plant Propagation Material (PPM) for further integration into the upstream supply chain.

Compound Feed Manufacturing (CFM) Standard:
Suitable animal nourishment is an integral part of the food chain. Qualified compound feed forms the basis of a farm assured livestock and aquaculture production.  Therefore it is essential to specifically define the requirements of producers of compound feed.
GLOBALG.A.P Risk Assessment on Social Practice (GRASP):

GLOBAL G.A.P now publishes the GLOBAL G.A.P Risk Assessment on Social Practice (GRASP)- after almost 5 years of stakeholder consultation with the support of GTZ, Coop, Edeka, Lidl, Metro AG and Migros and intensive stakeholder dialogue in more than 20 countries on 5 continents.


AS9100
As a result, ISO 9001 is totally encompassed within AS9100 with these additional requirements applied specifically addressing aviation safety concerns.  It is also the only standard which considers the role of the Regulatory Authorities and so many of the “add-ins” are directly traceable to FAA Regulations FAR Part 21 (Certification Procedures for Products and Parts), Part 39 (Airworthiness Directives) and Part 45 (Identification and Registration Marking). 

However it must be remembered that AS9100 remains complementary to contractual and applicable law and regulations.  Any business implementing an AS9100 compliant quality system must ensure the additional requirements of their customers, regulatory agencies (FAA, JAA etc) and local, state and national laws are referenced within the systems documentation. 
AS9100 is the quality management standard specifically written for the aerospace industry.  It had long been considered by some entities, such as the Federal Aviation Administration (FAA), that the ISO 9000 series of standards were inadequate in terms of ensuring quality and safety in the “high risk” aerospace industry. 

There is now a family of the AS9100 Standards applicable to different areas of the aerospace industry which includes the following: 
- Identify the requirements of AS9100 and how they apply to the business involved 
Once all the requirements of AS9100 have been met it is time for an external audit.  This should be carried out by a third party, accredited registrar.  The auditor will review the quality manuals and procedures.  This process involves looking at the company’s evaluation of quality and ascertains if targets set for the management programme are measurable and achievable.  This is followed at a later date by a full on-site audit to ensure that working practices observe the procedures and stated objectives and that appropriate records are kept.  AS 9101 will be used as the assessment checklist.  After a successful audit a certificate of registration to AS9100 will be issued.  There will then be surveillance visits (usually once or twice a year) to ensure that the system continues to work. 


SMETA
  • Suggested time plan for the audit,
  • Number of worker interviews suggested for the size of company,
  • Training and experience requirements for auditors,
  • Suggested pre-audit communication, and
  • Detailed audit execution.
  • Uses the ETI code and local law as the measurement tool, and
  • Includes the 2 modules of Health and safety and Labor standards as well as the optional pillars of Environment and Business Ethics.

Based on risk-assessment, HACCP plans allow both industry and government to allocate their resources efficiently in establishing and auditing safe food production practices. Hence, HACCP has been increasingly applied to industries other than food, such as cosmetics and pharmaceuticals. This method, which in effect seeks to plan out unsafe practices, differs from traditional "produce and test" quality control methods which are less successful and inappropriate for highly perishable foods.  Similarly, FAO/WHO published a guideline for all governments to handle the issue in small and less developed food businesses.


Implementing HACCP:

The International Standard further clarifies the concept of prerequisite programs.  The prerequisite programs PRP(s) are separated into two subcategories: infrastructure and maintenance programs and operational applied and their feasibility for monitoring, verification or validation.

The effective production of safe products requires the balanced integration of both types of prerequisite programs and a detailed HACCP plan.  Infrastructure and maintenance programs are used to address basic requirements of food hygiene and accepted good (manufacturing, agricultural, hygienic, etc.) practices of a more permanent nature; whereas operational PRP(s) are used to control or reduce the impact of identified food safety hazards in the product or the processing environment.  The HACCP plan is used to manage the CCP(s) identified to eliminate, prevent or reduce specified food safety hazards from product, as determined during hazard analysis.  During hazard analysis the Organization determines the strategy to be used to ensure hazard control by combining the PRP(s) and the HACCP plan.  The International Standard requires that organizations identify, monitor, control and routinely update both the PRP(s) and the HACCP plan.

To facilitate the application of the International Standard, it has been developed as an auditable standard.  However, individual organizations are free to choose the necessary methods and approaches to fulfill the requirements of the International Standard.  To assist individual organizations with development and implementation of the International Standard an informative explanation and guide for its use are provided in the International Standard.

The International Standard recognizes that there are differences amongst organizations within the food chain.  It specifies a mechanism that will allow a small and/or less developed Organization, such as a small farm, a small packer-distributor, a small retail or food service outlet, to implement an externally developed and designed combination of PRP(s) and HACCP plan, if:

The most effective food safety systems are designated, operated and updated within the framework of a structured management system and incorporated into the overall management activities of the Organization.  This provides maximum benefit for the Organization and interested parties.  The International standard has taken due consideration of the provisions of ISO 9001 in order to enhance compatibility of both standards.

The International Standard specifies the requirements for a food safety management system that combines the following generally recognized key elements to ensure food safety along the food chain:


Food safety incidents cause much suffering; including mild to severe illness ad even death.  This has a major effect on suffers themselves and their families, and can ruin food business.  By looking at the causes of historical food safety incident, it could have been prevented.  This is particularly true if the food businesses concerned had implemented a food safety system based on HACCP and prerequisite programs.

In any food operation, food safety management is achieved through the application of system building blocks; safe recipe, process design, prerequisite programs and HACCP -operating under the framework of the overall operations management.

Areas where HACCP could be applied:

 

GLOBAL GAP

GLOBAL G.A.P. History:

The development of common certification standards was also in the interest of producers.  Those with contractual relations to several retailers explained that they had to undergo multiple audits against different criteria every year.  With this is mind, EUREP started working on harmonized standards and procedures for the development of Good Agricultural Practices (G.A.P.) in conventional agriculture including highlighting the importance of Integrated Crop Management and a responsible approach to worker welfare.

Over the next ten years a growing number of producers and retailers around the globe joined in with the idea as this matched the emerging pattern of globalised trading: EUREP G.A.P began to gain in global significance.  To align EUREP G.A.PS´s name with the now realized proposition as the pre-eminent international G.A.P.-standard and to prevent confusion with its growing range of public sector and civil society stakeholders, the Board decided to undertake the significant step to re-brand.  It was a natural path and evolution that led EUREP G.A.P to become GLOBAL G.A.P.  The decision was announced in September 2007 at the 8th global conference in Bangkok.


The GLOBAL G.A.P standard is subject to a three year revision cycle of continuous improvement to take into account technological and market developments.


The standard serves as a global reference system for other existing standards and can also easily and directly be applied by all parties of the primary food sector. In other words: GLOBAL G.A.P operates like a satellite navigation system.  It equips members with a reliable tool kit, which allows each partner in the supply chain to position themselves in a global market with respect to consumer requirements.


The GLOBAL G.A.P Plant Propagation Material standard V2.0 has become available for certification from March 2008 by approved Certification Bodies. The implementation and certification of the standard is voluntary.


GLOBAL G.A.P has set rules and regulations to acknowledge an established assurance system of Compound Feed Manufacturers (CFMs). It helps livestock and aquaculture producers to select appropriate and assured resources for suppliers of compound feed.  The GLOBAL G.A.P module serves as a reference standard for use by compound feed manufacturers and compound feed manufacturer assurance schemes to demonstrate that they follow the GLOBAL G.A.P requirements.  GLOBAL G.A.P recognizes existing CFM-standards and quality assurance systems of compound feed manufacturers.


The GRASP Technical Committee has reviewed the project output and incorporated the input from another public consultation.  The GLOBAL G.A.P Risk Assessment on Social Practice is a voluntary assessment which can be done at the same time as a GLOBAL G.A.P audit.  The outcome of the assessment does not affect the GLOBAL G.A.P certification but serves as additional information to supply chain partners who have been granted access to the results.

More than 150 GLOBAL G.A.P auditors have been specially trained to conduct GRASP assessments.  A database application has been developed to upload the assessment results in the GLOBAL G.A.P database.  In addition, 11 National Interpretation Guidelines of the Module have been developed by local multi stakeholder groups and are now ready for implementation. GRASP can only be implemented in countries where such a GRASP National Interpretation Guideline exists.

The GRASP toolkit will raise the awareness of the importance of social issues in agriculture as well as provide practical guidance on what a producer can do to promote good social practices in their operations.

 

GMP

GMP History:

In 1990, FDA undertook the start of the revision of the CGMP regulation to add the design controls authorized by the Safe Medical Devices Act.  Also, the agency believed that it would be beneficial to the public and the medical device industry for the CGMP regulation to be consistent, to the extent possible, with the requirements for quality systems contained in applicable international standards, primarily, the International Organization for Standards (ISO) 9001:1994 "Quality Systems-Model for Quality Assurance in Design, Development, Production, Installation, and Servicing,” and at the time the ISO committee draft (CD) revision of ISO/CD 13485 "Quality Systems--Medical Devices--Supplementary Requirements to ISO 9001.”  After an extensive effort, the part 820 revision was published on October 7, 1996 (61 FR 52602) and went into effect June 1, 1997.  The preamble describes the public comments received during the development of the QS regulation and describes the FDA Commissioner´s resolution of the comments.  Thus, the preamble contains valuable insight into the meaning and intent of the QS regulation.

 

Selection and Use of the GMP:

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.  The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s).  CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act).  Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices.  This regulation became effective on December 18, 1978, and was codified under part 820.

 

Implementing GMP:

The QS regulation embraces the same "umbrella´´ approach to the CGMP regulation that was the underpinning of the original CGMP regulation.  Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device.  Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.

 

Manufacturers should use good judgment when developing their quality system and apply those sections of the QS regulation that are applicable to their specific products and operations, 21 CFR 820.5 of the QS regulation.  Operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, distribute, etc. devices that meet the quality system requirements. The responsibility for meeting these requirements and for having objective evidence of meeting these requirements may not be delegated even though the actual work may be delegated.

 

FDA has identified in the QS regulation the essential elements that a quality system shall embody, without prescribing specific ways to establish these elements.  Because the QS regulation covers a broad spectrum of devices, production processes, etc., it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices.

 

Application and Benefits of GMP:

The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices.  A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.  Certain components such as blood tubing and diagnostic x-ray components are considered by FDA to be finished devices because they are accessories to finished devices.  A manufacturer of accessories is subject to the QS regulation.

 

GMP benefits and rules:

-   Get the facility design right from the start

  Validate processes

  Write good procedures and follow them

  Identify who does what

  Keep good records

  Train and develop staff

  Practice good hygiene

  Maintain facilities and equipment

  Build quality into the whole product lifecycle

  Perform regular audits

 

GMP Exemptions :

FDA has determined that certain types of medical devices are exempt from GMP requirements.  These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892.  Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).  Medical devices manufactured under an investigational device exemption (IDE) are not exempt from design control requirements under 21 CFR 820.30 of the QS regulation.

 

 

                                                                             AS9100

AS9100 History:

AS9000 was first published in August 1997 and was written with input from a number of large aerospace prime contractors including Lockheed Martin, Northrop Grumman and GE Aircraft Engines and was written against the clauses of ISO 9001.  In late 1999, the first revision of AS9100 was published by The Society of Automotive Engineers (SAE International) with input from the American Aerospace Quality Group (AAQG) and support from the International Aerospace Quality Group (IAQG) and the Society of British Aerospace Companies (SBAC).  The current version of AS9100 aligns the standard with ISO 9001 and has extra requirements regarding Regulatory Compliance and the following aerospace-sector specific requirements:

- Configuration management

- Design phase, design verification, validation and testing processes

- Reliability, maintainability and safety

- Approval and review of subcontractor performance

- Verification of purchased product

- Product identification throughout the product’s life cycle

- Product documentation

- Control of production process changes

- Control of production equipment, tools and numerical control machine programmes

- Control of work performed outside the supplier’s facilities

- Special processes

- Inspection and testing procedures

- Methods, resources and recording

- Corrective action

- Expansion of the internal audit requirements in ISO 9001

- First article inspection

- Servicing, including collecting and analysing data, delivery, investigation and reporting and control of technical documentation

- Review of disposition of non conforming product



 

AS9100:

 

Selection and Use of the AS9100 Family of Standards:

AS 9101 - Quality System Assessment (the checklist corresponding to AS9100 rev B)

AS 9102 - Aerospace First Article Inspection Requirements

AS 9104 - Standard for overall control of Aerospace Scheme

AS 9110 - Requirements for Maintenance Organisations

AS 9120 - Requirements for Stockists and Distributors

 

Implementing AS9100:

- Establish quality objectives and how they fit in to the operation of the business

- Produce a documented quality policy indicating how these requirements are satisfied

- Communicate them throughout the organisation

- Evaluate the quality policy, its stated objectives and then prioritise requirements to ensure they are met

- Identify the boundaries of the management system and produce documented procedures as required

- Ensure these procedures are suitable and adhered to

- Once developed, undertake internal audits to ensure the system carries on working


 

Application and Benefits of AS9100:

Implementing AS9100 will motivate staff by defining their key roles and responsibilities.  Cost savings can be made through improved efficiency and productivity as product or service deficiencies will be highlighted.  From this, improvements can be developed, resulting in less waste, inappropriate or rejected work and fewer complaints.  Customers will notice that orders are met consistently, on time and to the correct specification. This can open up the market place to increased opportunities.  An additional benefit due to the standardised processes and procedures is the reduction in multiple expectations due to the consistency in verification.  Beside to additional benefits:

- Registration to AS9100 by an accredited registrar shows commitment to quality and customers and a willingness to work towards improving efficiency

- It demonstrates the existence of an effective quality management system that satisfies the rigours of an independent, external audit and addresses the additional safety, reliability and quality concerns specific to the aerospace industry

- An AS9100 certificate enhances company image in the eyes of customers, employees and shareholders alike

- It gives a competitive edge to an organisation’s marketing


CHAIN OF CUSTODY (COC)

FSC Chain of Custody (CoC) certification allows companies to label their FSC products, which in turn enables consumers to identify and choose products, f orest derived products, which support responsible forest management.

 

CoC History:

CoC begins with forest management certification: Environmental movement beginning in the 1960s increased awareness of need for responsible forest management,

- Forest Stewardship Council: Started in 1993 by a variety of interest groups, primarily in the environmental community, worldwide standard, with national or regional variations- 166 million hectares of land certified worldwide, and CoC standard only recognizes wood coming from FSC certified forests, Non-certified material must meet certain requirements (controlled wood).  Certification schemes accredit third-parties to conduct independent audits to forest certification standards, Over 24,000 CoC certifications worldwide,

- Sustainable Forestry Initiative: Started in 1994 by the forest products industry, now governed by an independent board, based in North American,

- Increased pressure on manufacturers to demonstrate their forest-based products are produced sustainably: (1) Chain of custody standards developed in the early to mid 2000s to trace certified forest products through the supply chain, and (2) Provides assurance that a product was produced in a sustainable manner,

- Chain of custody standard recognizes SFI, ATFS, CSA, and other PEFC certifications; (1) Non-SFI certified material procured outside North American must not come from controversial sources, (2) Non-SFI certified material procured from N.A. considered non-controversial.

Types of CoC Certification :

The CoC Program sets standards for three types of CoC certifications that companies can choose from depending on their scale and type of operation:

- Individual CoC Certification : The main standard within the CoC Program is the CoC Certification standard for individual companies that manufacture and trade FSC certified forest products (FSC-STD-40-004).

- Multiple Site CoC Certification: Small enterprises may form or join a group of operations and apply for Group CoC Certification.  FSC has specifically designed Group CoC Certification to make certification more accessible to small companies (FSC-POL-40-002).  Larger companies operating at multiple locations can, if they comply with certain requirements, choose to apply for Multi-site CoC Certification (FSC-STD-40-003).  This makes use of elements of scale and thus is more economical than seeking a separate certificate for each site.  Both, Group and Multi-site Certification require common, centrally administered and monitored control and reporting systems.  These allow Certification Bodies to evaluate participating operations or sites based on samples.

- Project Certification: Individual objects or buildings of any size or scale that are built or renovated on a one-off basis can achieve FSC certification. The CoC Program sets the requirements for their use of FSC certified wood and post-consumer reclaimed wood material and products (FSC-STD-40-006).

 

The CoC Program also provides additional standards that may be combined with the CoC Certificate according to the scope of the organization seeking certification, including:

- Controlled wood standards: The FSC Controlled Wood Standard is for companies that source non-certified material to be included in the production of FSC Mix products.  The non-certified material is controlled to avoid mixing of wood from unacceptable sources with FSC certified material in FSC Mix products.

FSC Standard for Company Evaluation of FSC Controlled Wood (FSC-STD-40-005): This standard has been designed to allow companies to avoid trading in illegally harvested wood, wood harvested in violation of traditional and civil rights, wood harvested in forests where high conservation values are threatened by management activities, wood harvested in forests being converted to plantations or non-forest use, wood from forests in which genetically modified trees are planted.

FSC Controlled Wood Standard for Forest Management Enterprises (FSC-STD-30-010): This standard specifies basic requirements applicable at the forest management unit (FMU) level for forest management enterprises to demonstrate to a company or third party certification body that wood supplied is controlled.

 

- Reclaimed Material : Reclaimed forest-based materials can be used as components in FSC certified products and projects.  The CoC Program sets the requirements for purchasing, verification and classification of these materials.

 

 

Selection and Use of the CoC standards that share many common elements:

- Management systems: Training and Procedures or work instructions,

- Verification of supplier’s certification,

- System to ensure non-certified material does not come from uncontrolled (FSC) or controversial (SFI/PEFC) sources,

- System to ensure incoming material is from a certified source; e.g. Load tickets for raw logs and invoices, shipping documents for semi-finished material (paper, lumber),

- Systems for making claims: FSC; Transfer, percentage system, volume credit and SFI/PEFC; Physical separation, percentage system, volume credit as a part of the percentage system,

- Passing claims to the next entity in the CoC through invoices and shipping documents, or other means of communication,

- Procedures to ensure proper logo and label use,

- Procedures to address outsourcing, and

- Procedures to address auditing of multi-site organizations.

 

 

Implementing CoC:

- Quality system: Responsibilities, Procedures, Training, Records…

- Field of application of the CoC: Products groups, Supplies (Inputs specifications and Supplier´s validation),

- Purchase of non-certified material, creation of raw material on site,

- Material delivery and storage (Inputs identification and Separation),

- Monitoring of the volumes, and

- Sale and delivery.

 

 

Application and Benefits of CoC:

CoC certification is essential for businesses seeking to access environmentally and socially aware markets, or to demonstrate compliance with public and private procurement policies that specify environmentally responsible materials.   These include the EU Eco-label scheme for furniture or the US Green Building Leadership in Energy and Environmental Design (LEED) rating system.

 

 

The SEDEX Members Ethical Trade Audit (SMETA) was developed by the SEDEX Associate Auditor Group (AAG). Global forum of majorbrand companies to: Enable and promote responsible sourcing practices,Labor standards, Health and safety, Environmental management, Business Integrity…

 

SMETA incorporates three elements: A common best practice guidance on conducting ethical trade audits, A common audit report format, and A common corrective action plan format.  SMETA is not a code of conduct, a new methodology, or a certification process, but describes an audit procedure which is a compilation of good practice in ethical audit technique.  The SMETA documents are designed to be used in conjunction with current established practices by experienced auditors to help them to conduct high quality audits that will be accepted by multiple retailers and brands.  Recently the AAG has also produced a Guide to Completing a SMETA Report and a Guide to Completing a SMETA Corrective Action Plan Report.  These have been put together using fictitious information to demonstrate to SMETA users how to complete a SMETA report and gives more explanation of the type of information required.

 

SMETA is sponsored by: The Grocery Manufacturers Association (GMA) and The European Brands Association (AIM): (1) A common audit format developed and accepted by AIM PROGRESS members to be uploaded to SEDEX, (2) Common suppliers assessment method (audit), and (3) Greater emphasis on environmental and business integrity than a regular SMETA audit

 

Responsible sourcing: (1) Process to purchase goods and services without causing unnecessary harm to, or exploiting humans, animals or the natural environment and (2) Core principles: Respect for human rights, Core labor rights and dignity at work, Health and safety in the workplace, Fair remuneration, Freedom of association, Diversity and respect for difference, Opportunity for development, Business integrity: no bribery or illegal trade, Respect for the environment…

 

Implementing SMETA:

SMETA Guidance Includes:

 

SMETA Methodology:

 

SMETA Supplement for Service Providers:

Guidance supplement for Assessing Working Conditions for Employees of Service Providers and Contractors working at sites of SEDEX Member companies or remotely from their employer’s operation.

 

Shadow SMETA Audit Feedback Form:

In a drive for continuous improvement auditors are keen to hear from anyone who has observed a SMETA audit being conducted.  Self Assessment Questionnaire (SAQ) is a questionnaire which will take just a few minutes to complete. Responses will be used to inform the AAG of best practice in auditing and to help SEDEX improve the SMETA best practice guidance and report formats.

 

Pre-Audit Information Pack:

The information pack provides suppliers with essential pre-audit information to help them prepare for a SMETA audit.  It has been assembled from an auditor’s perspective, and for an auditor’s use, as this group is often the first contact a supplier has with the SEDEX system.  Other types of members (and non-member users of SMETA) may also find it useful for informing their suppliers of the audit process.  By making the pack widely available in a standard format the AAG hopes to further increase the consistency of the SMETA process.  The guide has been put together in stand-alone sections so that users can select the parts which are appropriate for them.

 

SMETA Support Documents for Members:

The SEDEX working groups have produced a series of documents which members may find useful when involved with SMETA audits. These are available to members in the ‘Resources’ section of the SEDEX system: SMETA documents, Guide to Social Systems Auditor Competencies, Non – Compliance Guidance, Corrective Action Guidance, Draft Guidance for an assessment process of Environment and Business Ethics…

 

 

Application and Benefits of SMETA:

Branded goods manufacturers have high Corporate Social Responsibility (CSR) aspirations, including Responsible Sourcing, and need to (1) Make sure these are not put at risk by issues such as poor labor standards in supply chains, (2) Take active measures to mitigate such risk, and (3) Be efficient and effective in implementing such measures.

 

SMETA Objectives are to promote responsible sourcing within the supply chain and to improve efficiency and effectiveness of the evaluation; Common assessment methodology and Exchange of assessment data, Reduce burden of audit overload amongst suppliers, to seek convergence with other similar initiatives…

 

SMETA is designed to reduce duplication of effort in ethical trade auditing, benefitting retailers, consumer brands, and their suppliers. It was developed in response to member demand for an ethical audit report format that could more easily be shared.  Companies who are not members of SEDEX are also encouraged to use SMETA. By making SMETA publicly available, helps to promote greater transparency of audit methodology as well as to share knowledge about auditors’ qualifications and the practices that underpin SMETA reports.



ISO 45001:2018

BSI ISO 45001:2018

The British Standard is the UK implementation of ISO 45001:2018. It supersedes BS OHSAS 18001:2007, which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee HS/1, Occupational health and safety management. ISO 45001:2018 document provides a framework to enable businesses to implement effective arrangements for managing occupational health and safety (OH&S). The requirements should be met in a way that is proportionate to the hazards identified and the OH&S risks to be managed.

 

For smaller businesses or those with less complex and/or less hazardous operations, managers and workers may in many cases already have a good sense of their main workplace risks; this standard simply provides a framework for managing them in a more structured way. Organizations should create documented information to meet the requirements of this standard to the extent necessary for the effective establishment, implementation and maintenance of the OH&S management system and to comply with relevant legislation. Under UK legislation, organizations cannot delegate legal responsibility for the day-to-day control of OH&S risk even if third-party expertise, advice or services are used.

 

The Standard was prepared by Project Committee ISO/PC 283, Occupational health and safety management systems .

 

Introduction of BSI ISO 45001:2018

Background: An organization is responsible for the occupational health and safety of workers and others who can be affected by its activities. This responsibility includes promoting and protecting their physical and mental health. The adoption of an OH&S management system is intended to enable an organization to provide safe and healthy workplaces, prevent work-related injury and ill health, and continually improve its OH&S performance.

 

Aim of an OH&S management system

The purpose of an OH&S management system is to provide a framework for managing OH&S risks and opportunities. The aim and intended outcomes of the OH&S management system are to prevent workrelated injury and ill health to workers and to provide safe and healthy workplaces; consequently, it is critically important for the organization to eliminate hazards and minimize OH&S risks by taking effective preventive and protective measures.

 

Implementing an OH&S management system conforming to this document enables an organization to manage its OH&S risks and improve its OH&S performance. An OH&S management system can assist an organization to fulfil its legal requirements and other requirements.

 

Success factors: The implementation of an OH&S management system is a strategic and operational decision for an organization. The success of the OH&S management system depends on leadership, commitment and participation from all levels and functions of the organization. The implementation and maintenance of an OH&S management system, its effectiveness and its ability to achieve its intended outcomes are dependent on a number of key factors, which can include:

a) top management leadership, commitment, responsibilities and accountability;

b) top management developing, leading and promoting a culture in the organization that supports the intended outcomes of the OH&S management system;

c) communication;

d) consultation and participation of workers, and, where they exist, workers’ representatives;

e) allocation of the necessary resources to maintain it;

f) OH&S policies, which are compatible with the overall strategic objectives and direction of the organization;

g) effective process(es) for identifying hazards, controlling OH&S risks and taking advantage of OH&S opportunities;

h) continual performance evaluation and monitoring of the OH&S management system to improve OH&S performance;

i) integration of the OH&S management system into the organization business processes;

j) OH&S objectives that align with the OH&S policy and take into account the organization hazards, OH&S risks and OH&S opportunities;

k) compliance with its legal requirements and other requirements.

 

Demonstration of successful implementation of this document can be used by an organization to give assurance to workers and other interested parties that an effective OH&S management system is in place. Adoption of this Standard, however, will not in itself guarantee prevention of work-related injury and ill health to workers, provision of safe and healthy workplaces and improved OH&S performance.

 

The level of detail, the complexity, the extent of documented information and the resources needed to ensure the success of an organization OH&S management system will depend on a number of factors, such as: — the organization context, — the scope of the organization OH&S management system; — the nature of the organization activities and the related OH&S risks.

 

 

Scope of BSI ISO 45001:2018

The standard specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.

 

The standard is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformities associated with its activities.

 

The standard helps an organization to achieve the intended outcomes of its OH&S management system. Consistent with the organization OH&S policy, the intended outcomes of an OH&S management system include: a) continual improvement of OH&S performance; b) fulfilment of legal requirements and other requirements; c) achievement of OH&S objectives.

 

The standard is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.

 

The standard does not state specific criteria for OH&S performance, nor is it prescriptive about the design of an OH&S management system. The standard enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing. The standard does not address issues such as product safety, property damage or environmental impacts, beyond the risks to workers and other relevant interested parties.

 

The standard can be used in whole or in part to systematically improve occupational health and safety management. However, claims of conformity to this document are not acceptable unless all its requirements are incorporated into an organization OH&S management system and fulfilled without exclusion.


ISO 22301

Business Continuity: ISO 22301 is the Business Continuity Management System standard. Business Continuity Management System (BCMS) has been developed to protect companies from the risks associated with downtime which can occur due to unexpected disruptions or disasters.


FSC

  The Forest Stewardship Council (FSC) is an international non-profit, multi-stakeholder organization established in 1993 to promote responsible management of the world´s forests. The FSC does this by setting standards on forest products such as paper and wood used in the packaging industry, along with certifying and labeling them as eco-friendly.


Gluten Free

There is currently no cure for people suffering from celiac disease or non-celiac gluten sensitivity or intolerance, nor is there any on the horizon. The only mitigation or treatment is a strict gluten-free diet. Foods coming out of sites and systems certified to the Gluten-Free Certification Program (GFCP) Global Standard will satisfy that essential need.


FSMA

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, 2013 enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.


BRCGS for food safety, packaging and storage & Distribution

BRCGS is a market-leading global brand that helps build confidence in the supply chain. The BRCGS Global Standards for Food Safety, Packaging and Storage & Distribution, set the benchmark for good manufacturing practice, and help provide assurance to customers that products are safe, legal and of high quality.


FSSC

Food Safety System Certification 22000 (FSSC 22000) is a GFSI benchmarked food safety standard for companies in the food, feed and packaging industries. This ISO based scheme was created to fill the global need for a Food Safety Standard for companies already certified.


SQF

The Safe Quality Food (SQF) Program is a rigorous and credible food safety and quality program that is recognized by retailers, brand owners, and food service providers world-wide. Recognized by GFSI, the SQF family of food safety and quality codes is designed to meet industry, customer, and regulatory requirements for all sectors of the food supply chain, from the farm all the way to the retail stores

  web design and development
Consultancy firm that specializes in helping the Food   Packaging industries

Food Safety Auditor Professional Coaching