Posts Tagged ‘responsibility’

Risk Management in AS9100C

Friday, April 3rd, 2009

In the new revision of the AS9100 standard, an emphasis is being placed on clause 7.1.2 – Risk Management. This is a new requirement to implement a risk management process applicable to the product and organization covering responsibility, criteria, mitigation, and acceptance. The purpose of adding risk management in clause 7.1.2 is to provide additional focus on product risk during product realization.

Unlike ISO/TS 16949 which makes a reference to the Failure Mode and Effects Analysis (FMEA) process or ISO 13485 which references ISO 14971 for guidance on risk analysis, AS9100 is less prescriptive about how this should be done. This lack of specificity should not be interpreted as a simple suggestion for risk analysis, but rather as a flexible mandate that allows an organization to choose the best method of analysis appropriate to the product.

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ISO Implementation – Get People Involved!!

Friday, February 13th, 2009

The proper implementation of any quality management system should invole all employees in some manner, regardless of the standard. Many times it is common to see procedures and work instructions developed by personnel who do not (or have never) been part of that function or process. This can be one of the biggest mistakes a company can make in implementing a quality system.

One of the key principles that ISO 9001 and many other standards were based on is the involvement of people. People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s improvement.

The resulting output of employee involvent can provide numerous benefits, such as:

  • Motivated, committed and involved people within the organization.
  • Innovation and creativity in furthering the organization’s objectives.
  • People being accountable for their own performance.
  • People eager to participate in and contribute to continual improvement.

    Applying the principle of involvement of people typically leads to employees:

  • understanding the importance of their contribution and role in the organization.
  • identifying constraints to their performance.
  • accepting ownership of problems and their responsibility for solving them.
  • evaluating their performance against their personal goals and objectives.
  • actively seeking opportunities to enhance their competence, knowledge and experience.
  • freely sharing knowledge and experience.
  • openly discussing problems and issues.

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