1. heartbeatISO 9001:2015 以風險概念為基礎思考 (本文參考ISO/TC 176/SC2/N1269 www.iso.org/tc176/sc02/public)
    1. to explain risk-based thinking in ISO 9001
    2. to address perceptions and concerns that risk-based thinking replaces the process approach
    3. to address the concern that preventive action has been removed from ISO 9001
    4. to explain in simple terms each component of risk-based thinking
  2. 何謂風險概念思考？
    1. 思考風險並非預防.
    2. 風險原本即已存在於品質管理系統,風險概念思考為確保這些風險在此系統內,已被鑑別\考慮\控管.
      預防行動在之前版本已被提及,風險概念思考將其轉變為主動的,並非預防行動之反應
      一個風險概念思考的管理系統,其預防行動即已建置.吾人之每日生活即已充滿風險概念思考(影音)
    3. 風險通常被認知為負面,其實可能為正面或負面. 而機會通常被認知為正面,其實可能存在某種程度之負面風險
      Example:
      過馬路是為要到達對邊馬路,相對會有被撞之風險
      風險概念思考分析情況,以下述改進方式過馬路可增加機會：
      1. 走地下道
      2. 根據號誌走斑馬線,或
      3. 改道行走無來車道路
  3. 提及風險概念思考之章節
    1. Clause 4 - organization is required to address the risks and opportunities associated with its QMS processes
    2. Clause 5 – top management is required to
      1. Promote awareness of risk-based thinking
      2. Determine and address risks and opportunities that can affect product /service conformity　
    3. Clause 6 - organization is required to identify risks and opportunities related to QMS performance and take appropriate actions to address them
    4. Clause 7 – organization is required to determine and provide necessary resources (risk is implicit whenever “suitable” or “appropriate” is mentioned)
    5. Clause 8 - organization is required to manage its operational processes (risk is implicit whenever “suitable” or “appropriate” is mentioned)
    6. Clause 9 - organization is required to monitor, measure, analyse and evaluate effectiveness of actions taken to address the risks and opportunities
    7. Clause 10 - organization is required to correct, prevent or reduce undesired effects and improve the QMS and update risks and opportunities
  4. 為何使用風險概念思考
    1. improves governance 改進支配管理
    2. builds a strong knowledge base 建立強大的知識基礎
    3. establishes a proactive culture of improvement 主動改善
    4. assists with statutory and regulatory compliance 與符合法令法規鄉輔助
    5. assures consistency of quality of products and services 確保產品與服務品質之一致性
    6. improves customer confidence and satisfaction 改進客戶信心與客戶滿意
  5. 如何執行
    1. 根據議題鑑別風險
      Example:
      If I cross a busy road with many fast-moving cars the risks are not the same as if the road is small with very few moving cars. It is also necessary to consider such things as weather, visibility, personal mobility and specific personal objectives.
      Understand your risks
      What is acceptable, what is unacceptable? What advantages or disadvantages are there to one process over another?
      Example:
      Objective:  I need to safely cross a road to reach a meeting at a given time.
      1. It is UNACCEPTABLE to be injured.
      2. It is UNACCEPTABLE to be late.
    2. Reaching my goal more quickly must be balanced against the likelihood of injury. It is more important that I reach my meeting uninjured than it is for me to reach my meeting on time.
      It may be ACCEPTABLE to delay arriving at the other side of the road by using a footbridge if the likelihood of being injured by crossing the road directly is high.
      I analyse the situation. The footbridge is 200 metres away and will add time to my journey. The weather is good, the visibility is good and I can see that the road does not have many cars at this time.
      I decide that walking directly across the road carries an acceptably low level of risk of injury and will help me reach my meeting on time.
  6. 述及風險之計劃行動Plan actions to address the risks
    How can I avoid or eliminate the risk? How can I mitigate risks?
    Example: I could eliminate risk of injury caused by being hit by a vehicle if I use the footbridge but I have already decided that the risk involved in crossing the road is acceptable.
    Now I plan how to reduce either the likelihood or the impact of injury. I cannot reasonably expect to control the impact of a car hitting me. I can reduce the probability of being hit by a car. 
    I plan to cross at a time when there are no cars moving near me and so reduce the likelihood of an accident. I also plan to cross the road at a place where I have good visibility.
    Implement the plan – take action
    Example:
     I move to the side of the road, check there are no barriers to crossing. I check there are no cars coming.  I continue to look for cars whilst crossing the road.
    Check the effectiveness of the action – does it work?
    Example:
     I arrive at the other side of the road unharmed and on time:  this plan worked and undesired effects have been avoided.
    Learn from experience – improve
    Example:
    I repeat the plan over several days, at different times and in different weather conditions.
    This gives me data to understand that changing context (time, weather, quantity of cars) directly affects the effectiveness of the plan and increases the probability that I will not achieve my objectives (being on time and avoiding injury).
    Experience teaches me that crossing the road at certain times of day is very difficult because there are too many cars. To limit the risk I revise and improve my process by using the footbridge at these times.
    I continue to analyse the effectiveness of the processes and revise them when the context changes. 
    I also continue to consider innovative opportunities:
    1. can I move the meeting place so that the road does not have to be crossed?
    2. can I change the time of the meeting so that I cross the road when it is quiet?
    3. can we meet electronically?
  7. 結論
    風險概念思考:
    1. 不是新議題
    2. 您可能已完全俱備
    3. 持續性
    4. 確保更多風險認知與改進備戰準備
    5. 增進達標之可能性
    6. 降低負面結果之可能性
    7. 做好預防的習慣
  8. 其他參考文件
    ISO 31000:2009 Risk Management – Principles and guidelines
    PD ISO/TR 31004:2013 Risk management - Guidance for the implementation of ISO 31000
    ISO 9001:2015 Risk-based thinkingpower point presentation
    ISO 31010:2010  Risk management - Risk assessment techniques