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3 Management systems Print

As a framework to ensure that STRICTLY CONTROLLED CONDITIONS are maintained will require a balance of management systems and technical procedures, it may be worthwhile as a next step to review and document those management systems and technical procedures which you have already in place, or plan to introduce in the near future.  Depending on the details of your actual operation, you may already have various environmental and safety controls in place, and you will be subject to a range of European and national legislation with respect to safety, environment, worker protection, classification and labelling among other topics.

It is recommended that you would take advice from your national industry or trade association and carry out a thorough review of the legislation requirements for your business sector, if you have not already done so.  Some national trade associations will provide regular updates for a small fee.  Depending on the nature of your operation, you may be required to have an IPPC licence in place (or another environmental permit from national or local authority) and you may be required to have systems in place to comply with other European directives such as:

  • Chemical Agents Directive (chemical substances) 98/24/EC
  • ATEX (working flammable atmospheres) 99/92/EC
  • IPPC (Environmental Control) 96/61/EC
  • Seveso Directive* (control of major accidents) 96/82/EC

*Note, even if you are not listed as a Seveso site, that there are certain obligations on all manufacturers which derive from this legislation.  In this context, all industrial operations are required to have an emergency plan with provision for fire drills and training etc.

All of these Directives will have been transposed into national law in each member state, and you will be able to get references and texts from your national competent authority or trade association.

If you are manufacturing or using chemical substances including intermediates, you will already be familiar with the typical documentation concerning classification, labelling, safety data sheets and so on.  It will be necessary for you to have training systems and methods in place for all employees managing equipment or unit operations, and handling or using chemical substances, and this training will include the use of personal protective equipment (PPE).

It may be helpful for you at this point to list the various systems and controls you may have in place or be planning to install, and table 3.1 suggests some typical examples with some comments.

Table 3.2 is a blank table which will allow you to compile your own register.

TopicTypical SystemsComment
Organisation and ManagementISO 9000, GMP, Other documented control systemsDocumented management systems, with change control, ideally subject to outside audit, provide a comprehensive framework for management of a company's technical procedures, and can demonstrate compliance to customers and authorities.
Environmental ManagementISO 14000, EMAS, other systems to comply with IPPC licence or local/national environmental requirements.Documented, with framework for management of technical procedures, designed to support and demonstrate compliance with legislation.
Manufacturing Operations and Worker ProtectionSafety management system (SMS), accredited to international system, or based on industry codes, company developed responses to health and safety legislation.Documented, with change control, provide framework for overall management of company's safety plan, emergency procedures, worker protection and other topics.
Chemical SubstancesSMS.  Company's response to chemical substance directive and any national legislation or codes of practice, Written risk assessments, list of standard operating procedures (SOP's).  File of safety data sheets.Facilitates overview and control of company systems and procedures, and demonstration of compliance.
TrainingCompany training programme with any provision for individual assessment and qualification or authorisation for more demanding tasks.  Training in use of personal protective equipment (PPE) and emergency procedures and drills.Documented within e.g. ISO 9000 or other management system.  Should include qualification and training of employees, and authorisation/suitability for specific tasks.
Classification and LabellingISO 9000/SMS/other systems which define company's response to earlier EC directives, now incorporated in REACH.  File of safety data sheets and SOP's for packaging, labelling and warehouse operations.Documented systems for control of classification and labelling, provision of safety information and checks and implementation.
Other Topics Relevant to your Industry or geographic location??Include whatever may be relevant to your circumstances

Table 3.1          Management Systems and Technical Controls

TopicSystems in PlaceComment/Notes
   
   
   
   
   
   
   
   
   
 

Table 3.2 Blank table

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Last Updated ( Friday, 27 February 2009 )
 
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