Saturday, March 17, 2012

OHSAS 18001 Guidelines and Safety Policies

OHSAS 18001 Policy Guidelines:

The OHSAS Policy is a public statement by the organisation of its intentions and principle in relation to its overall OHSAS performance, which provides a framework for action and for the setting up its OHSAS objectives and targets. The OHSAS Policy acts as the driving force behind all of the enterprise's activities in the OHSAS field, and can have far-reaching business implications for the future direction of the enterprise. It should be integrated into the enterprise's overall business strategy and should also be compatible with other organisational policies such as Quality or Occupational Health and Safety. It must therefore be initiated, developed and actively supported at the highest levels within the organisation.

The responsibility for developing the OHSAS 18001 Policy should therefore rest with those at the very top of the enterprise (e.g. the Board of Directors or other governing body) and it should be signed by the Chairman, Chief Executive or similar top manager as evidence of commitment. Management will then be responsible for implementing the policy, but continuing support from the top of the enterprise will be needed during the further development of the OHSAS management system and for the organisational changes, which will result from its implementation.

DEVELOPING THE OHSAS 18001 SAFETY POLICY:


The OHSAS Policy is based in part on the findings and conclusions of the Initial OHSAS Review. A number of important factors need to be considered. These are essential to ensure that the policy relates not only to the enterprises individual needs and ideas, but is also in line with recognized ohsas 18001 certification good practice and any relevant industry-specific guidelines. If the enterprise is interested in working towards certification of its OHSAS management system (now or in the future) then it may also be important to ensure that the policy will conform to the requirements of such a standard.

Once a policy has been developed and published, the enterprise's OHSAS performance will be judged against it. It is therefore worthwhile spending time to ensure that the policy provides and exact statement of the enterprise's objectives and can be used as a basis for the development of targets and the OHSAS programme.
Other important sources of information for input into the OHSAS safety Policy development process include the following:  
  • The result of the Initial OHSAS review
  • The enterprise's value and beliefs, such as its (desired) relationship with its employees, the local community and the general public.
  • The enterprise's business strategy and strategic plan elements relating to the enterprise's (OHSAS) direction, opportunities and risks, medium and long term planning including internal and external limits, and opportunities in capabilities and resources.
  • Any existing statement on OHSAS aspects; mission statements, old policies, previous statements of commitment in internal/external reports.
  • Other policies in existence: such as occupational health, safety, quality
  • The views of stakeholders (shareholders, staff) and other interested parties
  • Written standards: available recognized ohsas 18001 standard for occupational health and safety  management system which include prescribed elements for OHSAS Policy statements
  • General statements of OHSAS principles: e.g. from government, public bodies, industry associations, which are relevant to the individual enterprise
  • Other codes to which the enterprise subscribes
  • Examples of OHSAS Policy statements: from similar companies or enterprises
  • Clear definition of the geographical and organisational boundaries of the policy: which countries/regions and which sites, departments or activities are to covered by the policy
  • Any specific local or regional conditions.
CONTENT OF THE OHSAS 18001 SAFETY POLICY:

An OHSAS Policy should clearly delineate the OHSAS areas to be addressed by the enterprise of Organisation and should be relevant to its activities, products and /or services. The policy may address very broad aspects of the enterprise's activities (such as waste reduction), depending on the nature of those activities. Many ohsas 18001 policies also include aspects of occupational health and safety including statements regarding the working OHSAS.

Some ideas for the content and wording of statements of commitment in an ohsas safety policy are given below. However, these should not be copied as such and should always be placed in context. The policy must be appropriate to the individual enterprise. It may be as brief as one sentence or as long as 10 pages.

General Principles:
  • Define extent of OHSAS responsibility (customers, suppliers, staff etc.)Ensure minimum of compliance with legislation
  • Provide for development of corporate standards in the absence of legislation.
  • Establish system to ensure full control of OHSAS situation (impact and risks)
  • Make commitment to continual improvement in OHSAS performance (step by step); this is also a requirement in ohsas 18001  -standard, such as ISO 14001
  • Make commitment to prevention of pollution if compliance with iso 14001 is intended
  • Develop OHSAS performance evaluation procedures and indicators
  • Embody life cycle thinking
  • Work towards the achievement of sustainable development
  • Commit to development and implementation of an OHSAS system
  • Provide adequate resources for OHSAS management
Strategy and Planning:
  • Consider OHSAS issues in investment policy and practice
  • Minimize the OHSAS impacts of new developments through the use of OHSAS management procedures and OHSAS impact assessment in strategic planning, and project definition and implementation
  • Influence suppliers in order to ensure that they contribute to the realization of the policy.
Specific Policy Goal: 
  1. Support for the use of best available technology and management practices.
  2. Promotion of appropriate OHSAS legislation and requirements
  3. Waste reduction / minimization
  4. Reduction in consumption of resources (materials, water, energy)
  5. Prevention of pollution
  6. Reduction or elimination of (specific) emissions to the OHSAS
  7. Commitment to recovery and recycling, as opposed to disposal where feasible
  8. Reduction in the use of hazardous substances and use of alternatives where possible
  9. Reduction in packaging
Compliance:
  1. Co-operation with regulatory authorities
  2. Compliance with OHSAS regulations in all areas of operations
  3. Compliance with local or corporate ohsas 18001 standards whichever are the most stringent
  4. Compliance with the principles set down by the industry association or the ICC Business Charter for Sustainable
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    Tuesday, February 28, 2012

    Advantages of ISO 9001 14001 Integrated Management System

    ISO 9001 and ISO 14001 Quality Environment Integrated Management Standard consist of Integrated ISO 9001-2008 and ISO 14001-2004. The ISO 9001 14001 integrated management system is central to strategy for developing a quality, environmentally sustainable business. Implementing integrated management system (IMS) on quality and environment the performance of the employees can be improved which helps in reducing cost of production and maintain quality of products. Also with iso 9001 14001 - quality and environment management system, companies maintain their quality environmental issues. It is essential that environment, quality and environmental safety issues are involved within an organization's day-to-day activities and that they are an integral part of their overall management system.

    Implementation of proper ISO integrated system as per requirement of iso 9001-2008 and iso 14001-2004 standard improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage and avoidance of litigation. ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive. ISO 9001 14001 standard certification includes documents of all procedures and processes, including operational and documentation control, the establishment of emergency procedures and responses, and the communication with employees, to ensure they can competently implement the necessary processes and record results. ISO 9001 14001 quality environmental management can be a very effective ISO QMS EMS certification tool to identify these cost savings opportunities for some organizations. Some other organizations can falter in its planning, lack of senior management commitment and poor understanding of how it should be implemented and find themselves managing an ineffective iso 14001 EMS Certification. Among the wide advantages of the ISO Quality System standard to make vibrant culture some are as follows:

    Key Advantages of ISO 9001 14001 Integrated Management System
    • Creates a more efficient, effective operation.
    • Increases customer satisfaction and retention.
    • Reduces third party ISO 9001 14001 audit .
    • Improved quality (reduction in waste, rework, scrap, less complaints, etc.).
    • Reduction of waste and consumption of resources.
    • Reduce operating costs.
    • Increase long term viability of businesses.
    • Enhance market share and increase growth in sales.
    • Identification of possible areas which can save costs such as recycling, landfill costs, utilities.
    • Positive response from investors, lenders,& insurers.
    • Improves employee motivation, awareness, and morale with the help of ISO 9001.
    • Promotes international trade.
    • Increases profit by implementing ISO Quality System.
    • Greater control of processes and activities throughout organization.
    • An onward journey of improvement is possible on an on-going basis.
    • Minimizing the risk of regulatory and environmental liability fines.
    • Improving an organization’s efficiency Increases customer satisfaction and retention.
    • Provides competitive advantage against companies that do not adopt the standard.

    Global Manager Group is a leading name for iso 9001, iso 14001, ohsas 18001 consultancy services. They also offers readymade iso 9001 14001 ready to use documents as well as hse manual and hse audit checklist for integrated management system implementation.

    Thursday, June 2, 2011

    Objective of ISO 9001 Quality Management System

    The objective of ISO standard certificate is to promote the development of standardization and related activities with a view to facilitate the international exchange of goods and services, and to develop corporation in the spheres of intellectual, scientific, technological and economic activity. Work of the ISO results in international agreements, which are published as international standards.

    Why ISO?

    ISO is well established in many diverse fields and will continue to grow for the following reasons:
    •     Worldwide progress in trade liberalization
    •     Interdependence of sectors
    •     Worldwide growth of communication systems
    •     Need of global standards in emerging technologies
    •     Standardization of economic policy for achieving sustainable growth.
     
    Who Can Go For ISO

    ISO can be granted to any organization regardless of what it does, its size, or whether it’s in the private, or public sector. It is applicable across an entire gamut of industrial sectors ranging from manufacturing, service and academic organizations.

    Is Certification Expensive For Small Organizations?

    Bureau of Indian Standards always gives the small-scale industries a discounted fee structure to encourage them to take up certification. Similarly, most of the other certifying bodies also help the small companies, in this regard. The Government of India also gives a subsidy to the tune of Rs. 75,000/- to small-scale industries.

    Benefits:
    •     The client favors the ISO certified company
    •     Development of streamlined and well defined procedures
    •     Clarity about processes and objectives in the organization
    •     Improved predictability and reliability
    •     Increased efficiency
    •     Confidence in operations
    •     Better realization of client and industry expectations
    •     Focus on continual improvement for every process
    •     Quality manual becomes an important marketing support document not only for new projects but also for image enhancement
    •     Easy monitoring of internal work
    •     System based working - easier and faster training of new employees.
     Will ISO: 9000 System Increase Documentation?

        Previous version of ISO: 9000 (1994) emphasize on documents and document control. But as per new standard the extent of documentation can differ from company to company in a simplified manner.

        ISO: 9000 quality management system requires records at relevant stages, which provide data for continual improvement and can be used for legacy as a data bank.   
      
    Is ISO: 9000 Certification Applicable For Product Quality?

    ISO: 9000 is applicable for the management system only and not for product quality. Implementation of ISO: 9000 quality management system assures product quality instead of ensuring product quality.

    Procedure For Getting ISO 9000 Certification
    1.     Framing quality policy and quality objectives.
    2.     Preparation of quality manual and process procedures in line with ISO 9001 document requirements.
    3.     Awareness training program for all staffs shall be arranged.
    4.     Internal quality auditors shall be trained.
    5.     Internal quality auditing shall be conducted.
    6.     Management review of quality management system.
    7.     Co-ordination with certification body.
    8.     Certification auditing.
    9.     ISO: 9000 certification.
    10.     Periodical auditing every six months by certification body.
    Why Does ISO-9000 Implementation Fail?
    •     Over emphasis on documentation
    •     Poorly designed system
    •     Inexperience of the personnel
    •     Insufficient top management commitment
    •     Prohibitive cost factors
    How Does ISO 9000 System Improve the Performance of A Company?
    •     ISO 9000 system identifies the important processes.
    •     The current status of the performance of the process is measured.
    •     A target is fixed for improvement (quality objective).
    •     An action plan is prepared and implemented.
    •     The improvement is measured and enhanced.
    •     The improvement cycle is checked for its effectiveness through internal auditing and management review.
    •     After achieving the target, new target is fixed.

    Read other latest post about ISO 14001 - Environment Management System.
    Source: ISOqualitykit.com

    Wednesday, May 4, 2011

    Overview of ISO 14000 Standards

    ISO 14000 series is voluntary and based on international consensus as 65 countries are participating in the standards development process. The ISO 14001standards are generic, i.e. applicable to both manufacturing and service organization, in public and private sectors. They say what should be done by an organization to manage the impact on the environment of its activities, but do not dictate how to do it. Thus ISO 14001 EMS has impact on the issues listed below.

    Following issues for Industry are  considered

    • Air Pollution
    • Water Pollution
    • Water use
    • Other Resource Use
    • Hazardous Substances
    • Biological Hazards
    • Radiation
    • Waste
    • Noise
    • Community Concerns
    • Wildlife & Habitats
    • Accidents & emergencies
    • Planning Issues 
    • Interface with other Health & Safety Issues

    ISO 14000 series of standards can be classified as the specification standard and guidance standard. ISO 14001 is the only specification standard to which companies would be registered. All other standards mentioned in the Table-1 are guidance standards and so are not prescriptive.

    The overall aim of this international standard is to support environmental protection and prevention of pollution in balance with socio - economic needs. However, it is not intended to be used to create non-tariff trade barriers or to increase or change an organization's legal obligations.
       
    This international standard does not incorporate occupational health and safety management system elements. Nevertheless, the certification / registration process will only be applicable to aspects of the environmental management system. The company has to take ISO 14001 training and make targets related to environment issues for long run and achievement for the same. Also provisions for emergency so that environment is no where affected by the company. The elements of  ISO 14000 are listed below.

    ISO 14001 Environment Management System - EMS


    The ISO 14001 Specification envisages 5 Core Elements for EMS, for the purpose of certification by third parties. These are:
       
    1. Commitments and Policy
    An organization should define its environmental policy and focus on what needs to be done for ensuring continual environmental performance. It should also ensure commitment to the policy.

    2. Planning
    An Organization should formulate a plan to fulfill its environmental policy.

    3. Implementation
    For effective implementation an Organization should develop the capabilities and support mechanisms necessary to achieve its environmental policy, objectives and targets.

    4. Measurements and Evaluation
    An organization should measure, monitor and evaluate its environmental performance.

    5. Reviews and Improvement
    An organization should review and continually improve its environmental management system, with the objective of improving its overall environmental performance.


    Source: Globalmanagergroup.com
    You can read my other post about Benefits of ISO 14001 EMS here.

    Monday, March 28, 2011

    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.

    For More information on BRC certification consultancy visit : Globalmanagergroup.com

    Saturday, February 26, 2011

    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)


    For more information about BRC Food Standard and Certification visit : Globalmanagergroup.com

    Wednesday, December 29, 2010

    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 3rd 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 2nd 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
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