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Approved Supplier Porgramme - Part 5

Kevin Stretton - Monday, October 17, 2016

Fundamental concepts – Part 5


This week we continue using the theme connected with performance specifications in your role as a supplier to clients. More specifically, we start looking at labelling requirements & finished product specifications.

Product Specification & Labeling:

• Have we got the correct safety data sheets (SDS) or technical data sheets (TDS) which can be supplied to the client?

• Have we supplied the client with an operating manual and do these instructions include safe disposal at the end of the product’s life cycle? This applies to equipment as well as chemicals that may be sold as part of the technical support in a contract.

• Prior to full hand-over & sign off by the client have we provided training for the client’s employees? This is particularly important where environmental health & safety criteria may be involved.

• Do we use a hand-over & sign off agreement with the client and does this document clearly specify your willingness to provide the special quality of service that makes your organisation stand out from its competitors?

• Have we completed final checks on the product to ensure it meets legislative requirements?

• Is the product correctly labelled for compliance with any transportation requirements & standards?

Approved Supplier Programmes - Part 3

Kevin Stretton - Monday, October 10, 2016

Fundamental concepts – Part 3

 

As we’ve observed in the food sector having confidence in the supply chain which provides your organisation with raw materials is critical.

 

The same concepts apply for many other industry sectors where critical control points exist in supply chains & organisations cannot afford failures.

 

Raw Material Specifications:

 

    Consider those cases where a client’s specifications need equipment &/or materials and you can only source components from interstate or overseas suppliers.
  • •  How much control do you have?
  • •  What are the levels of quality?
  • •  Do you need rigorous specifications to ensure you do not have errors and upset your client?
  • •  Do you have high quality records for traceability?
  • •  What sort of relationship do you have with your raw material suppliers?
  • •  How much effort, finance & time are you investing in quality inspections & are there better    alternatives?
  • •  How much of the quality control checking are you sharing with your suppliers?
  • •  Do you and your suppliers of raw materials understand each other’s needs and requirements?
  • •  Have we completed checks against legislative requirements to ensure they are achieved & the    organisation is compliant?

Approved Supplier Programme - Part 2

Kevin Stretton - Friday, October 07, 2016
Fundamental concepts – Part 2

 

There are several major categories that can be considered as useful checks for establishing an approved suppliers’ programme.

 

These categories can also become useful checks for internal operations where your organisation is a supplier.

 

  1. 1.  Product &/or service development / innovation
  2. 2.  Evaluation & monitoring
  3. 3.  Raw Material Specifications
  4. 4.  Manufacturing & Service Specifications
  5. 5.  Product Specification & Labelling

 

Product &/or service development / innovation:

 

  • •  Irrespective of whether your company is certified to Australian or international standards there    are legal obligations regarding design of products & services.
  • • These legal obligations must be identified and integrated into your design criteria & specifications.

  • •  This extends to the legal obligations of your suppliers.
  • •  In addition to equipment build / construction, are there any service specifications that need to be included in the

        design phases?

     

    Evaluation & monitoring:

     

      •  Your clients may request you to occasionally submit evidence and responses to questionnaires that provide them     with a ‘picture’ of your organisation’s level of compliance and management maturity.
    • •  These questionnaires often include important areas such as the extent & type of insurance     protection and procedural documentation for employee training.

     

    Therefore your organisation needs to: 

     

    • •  Respond honestly to these questions; and
    • •  Progressively develop your management systems such that each improvement is seen, perceived & interpreted     by the client from  one questionnaire to the next.
    • •  Adopt a similar approach with your suppliers.

    Approved Supplier Programmes

    Kevin Stretton - Monday, October 03, 2016

    Fundamental concepts – Part 1

     

    In an increasingly complex relationship clients are demanding more from their suppliers and it often feels as though your organisation is the ‘meat in the sandwich’.

     

    The recent scandals in European food supply chains are a good example.


    So how do you stay on top of these supply chain pressures?

     

    Some important concepts to remember include suppliers being one of many in a long supply chain and a mistake by one of your suppliers can cost you losses in:       

                                                                

    1. 1.  Client reputation & satisfaction
    2. 2.  Money
    3. 3.  Time

     

    Therefore it’s as important for you to be clearly specifying your requirements, developing sound relationships with and investing time in your suppliers.

     

    Our next set of articles will provide brief guidelines to assist you with understanding what can be done to formalise your system and minimise the risks associated with client & supplier relationships. 

     

    For example identify what:-

     

    1. 1.  Your clients will be looking for in supplier compliance
    2. 2.  You can do to improve relationships with your suppliers

    QA in Brief - ISO9001 2015 Update #16

    Kevin Stretton - Monday, February 08, 2016

    Leadership

     

    Leadership requirements in the new standard have been designed to refocus an organisation’s quality system & how the following 2008 categories are applied:-

      Authority, communication & responsibilities

    Customer focus

    Management commitment & responsibility

    Management review

    Planning  & objectives

    Quality policy

     

    Within the 2008 version the requirements were limited to the organisation ‘looking inwards’.

     

    The 2015 standard now requires organisations to ‘look inwards and outwards’, understanding their processes and structures in the context of their community and industry sectors. There is an expectation that certified organisations will develop, display and promote leadership in a social context whilst understanding the needs of parties within and external to the company.

     

    As a result this approach is moving organisations closer to a formalised corporate social responsibility context than was previously the case. It also means that the external and internal relationships of an organisation must now be interpreted with respect to business exposure, risk, opportunities and threats.

     

    Additionally, the display of commitment must now come from the executive, senior or strategic management group rather than an appointed management representative which is no longer required in the new standard.

    QA in Brief - ISO9001 2015 Update #15

    Kevin Stretton - Friday, February 05, 2016

    Documented requirements

     

    Many of the requirements for documented procedures have changed from the 2008 version. However, fundamental criteria for the design or structure of documents remain and these include:-

      Approved access or permission levels to use or view documentation

    •      Controls

    •      Distribution of documents

      Formats

    •      Identification of documents

    •      Retrieval methods

     

    In the standard’s new context of risk management organisations may need to consider how they identify critically important documentation, assess the risk levels, protect their information, maintain confidentiality and allocate responsibility for the use of documentation.

     

    It could be interpreted as a broadening or an extension of the importance of electronic data management contained within the 2008 version and a way of encouraging organisations to pay greater attention to all documentation (information).

     

    However, it may be too early in the implementation phase yet to obtain clear interpretations from auditors on how widely they’ll apply the new requirements for management of documentation. If organisations already have a mature certified system then current documentation requirements should be compliant.

    QA in Brief - ISO9001 2015 Update #14

    Kevin Stretton - Monday, February 01, 2016

    A significant change – understanding risk

     

    In previous versions of ISO9001 the concept of risk was indicated and yet rarely understood, assessed and controlled by organisations.

     

    The 2015 version requires a significant change in thinking and approach.

     

    Organisations are now required to identify external & internal business exposures, assess the level of risk these issues pose, rank the issues for significance and plan controls for improvement.

     

    Part of the risk management process requires that relevant personnel who may have involvement with the quality system are identified and their needs are taken into consideration.

     

    Once all of this data and information is collated, planning must be capable of demonstrating how the organisation’s strategic objectives will be protected or adapted to meet new challenges all of which must be completed within a defined scope and application of the quality management system (QMS).

     

    Whilst providing greater flexibility on how organisations adapt their QMS the 2015 version of ISO9001 calls for a greater level of business analysis as the basis for informed decision making and risk management.

    QA in Brief - ISO9001 2015 Update #13

    Kevin Stretton - Friday, January 29, 2016

    The revised quality concepts

     

    Within the 2008 framework mandating a documented quality management system companies were required to demonstrate how they controlled:-

     

      Internal auditing

      Policy & objectives

      Quality manual & procedures

      Preventive action

    •      Records

     

    It’s important to note that internal auditing, policy objectives and preventative action are inter-connected with each other and closely linked to continual improvement methods.

     

    However, with changes to the 2015 version all of these requirements have been reorganised and so your organisation has a unique opportunity to adapt creatively to those changes while demonstrating control of risk.

     

    Areas to consider are:-

     

      Context of the organisation compared with its community and industry sectors

      Decisions made or based on evidence and facts, not opinions

      Engagement of people (external to and within the organisation)

      Evaluating the organisation’s performance

      Improvement

      Increased customer focus

      Leadership (not just management commitment)

      Managing relationships

      Operations – how they are structured and controlled

      Planning

      Process based controls and thinking (no matter what industry sector you are in)

      Support mechanisms

    QA in Brief - ISO9001 2015 Update #12

    Kevin Stretton - Tuesday, December 15, 2015

     

    The six (6) obligatory procedures

    Within the 2008 framework mandating a documented quality management system companies were required to demonstrate how they controlled:-
    ·   Internal auditing
    ·   Policy & objectives
    ·   Quality manual & procedures
    ·   Preventive action
    ·   Records

    It’s important to note that internal auditing, policy objectives and preventative action are inter-connected with each other and closely linked to continual improvement methods.

    With changes to the 2015 version all of these requirements have been removed and so your organisation has a unique opportunity to adapt creatively to those changes while demonstrating control of risk.

    Areas to consider are:-

     

    ·  Context of the organisation compared with its community and industry sectors

    ·  Decisions made or based on evidence and facts, not opinions

    ·  Engagement of people (external to and within the organisation)

    •    Evaluating the organisation’s performance

    •    Improvement

    •    Increased customer focus

    •    Leadership (not just management commitment)

    •    Managing relationships

    •    Operations – how they are structured and controlled

    •    Planning

    •    Process based controls and thinking (no matter what industry sector you are in)

              •    Support mechanisms

     

     

     

    QA in Brief - ISO9001 2015 Update #11

    Kevin Stretton - Sunday, November 29, 2015
    Preventive Action

    In successive versions of ISO9001 the terms ‘corrective and preventive’ action have caused considerable confusion among employees, managers and team leaders. The decision to remove all references to ‘preventive action’ will reduce confusion and should help a company focus attention on analysing the root causes of quality issues.

    This will become more important as the three standards (AS/NZS4801, ISO9001 & 14001) are aligned with a core theme based on risk management.

    Being able to demonstrate an understanding of your organisation’s root causes, how these are linked with systemic improvement & the size of risk will progressively become an auditor’s focus.