risk based thinking (rbt)

  1. Q

    Qualitative or Quantitative? Risk method evaluation

    Hello everybody In the approach to manage risk under 9001 2015, I´m considering this. I use the equation Risk value = PxI Once I get the value, I have a table of values which correspond to a Type of risk, ranking form A to D. My sources to evaluate P and are just references, events in...
  2. Q

    Questions about the Risk-based approach to QMS processes

    1. I keep reading, "you're probably already doing it since the standard has always implicitly required it. It just makes it more explicit now." If that's the case, then what exactly needs to be changed? 2. I don't know if this will be worded properly, but we've already "approached" our...
  3. S

    Risk based approach - Procedures already take a risk-based approach to QMS processes

    Hi everyone, If the company's procedures comply with QSR since they market in the US as well, don't the procedures already take a risk-based approach to QMS processes? I understand that QSR is risk-based or assumed to be risk-based. For example, having a written quality agreement is a risk...
  4. M

    Can Scope of Equipment Control be Tied to Risk?

    21 CFR 820.72 (Inspection, Measuring, and Test Equipment) says: I'm interpreting this as reading: "if a piece of equipment is used for any inspection, measurement, or test, it must be routinely calibrated, inspected, checked, and maintained." Is my interpretation incorrect? If not, is...
  5. S

    How we can use risk analysis for suppliers

    hi every body my question is related to 8.4.2.5 how we can use risk analysis for supplier
  6. Q

    Criteria to pursue an opportunity

    hello everybody Does anybody know methods to use in order to decide if is worth to pursue an opportunity? (6.1 Actions to address risks and opportunities). I think that similar to the way we evaluate a risk, maybe would also exist something for opportunities. Something like PxB...
  7. Q

    Risk (closeout and options for the addressing)

    Hi all To all of you who have had experience in managing risks, I´m facing two issues, I hope you can help me. 1 How to close out the risk? If at certain time risk was mitigated? or when is under control? when to stop the follow-up? 2 Exactly what apply for every option in 6.1 ?, I...
  8. A

    AS9100 Rev D - List of Required Procedures

    Dear All, Can any provide me list of procedures which are compulsory for AS9100D. Can organisation exclude the procedure of AS9100 D related to Clause No. 4 i.e. Context of The Organisation and Risk based Thinking. if yes kindly share the valid reason. Our organisation does not have...
  9. Q

    Risk Based Thinking - Is a Documented Procedure required?

    Is it requested a documented procedure to establish the method followed to meet this requirement for risk analysis? Could you share your experience and eventually some templates to follow? thanks
  10. Q

    ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?

    Hi all Regarding of documented evidences in 6.1, I don´t see any specific information required. Would it be needed to have only a list of identified and treated risks, also to have the evidences of the follow-up and actions plans? Additional, evidences of a swot and list of interested...
  11. J

    Using Complaint Rate to Update FMEA P.O.C

    I am looking for some information and guidance on how to properly analyze a need to update an FMEA POC based on the rate of complaints received. My specific situation at the moment is that I have a complaint lodged that relates to an identified risk. The risk was assigned a severity of 2...
  12. M

    Risk Identification and Risk Assessment for any Process - Is it necessary?

    Dear all I asked my question (whether it is necessary to identify and assess risks for any QMS processes) in another thread, but I could not receive a clear answer. Based on clause 6.1.1, the organization shall determine its risks and opportunities (e.g. emerge of new competitors). Based on...
  13. Y

    Examples of Risk and Opportunities based on ISO 9001:2015

    Hi, Could anyone please help me to understand, Whether all identified risks are associated with opportunities? and quote couple of examples please. Many thanks
  14. mguilbert

    Free Risk Management Webinar - Design for Quality - May 2017

    Good Afternoon All, I found this free webinar that may be helpful to some on Risk management. It is not ISO but still may help. The webinar is titled "Design for Quality: A Risk Based Approach"...
  15. Mikishots

    Issue - "Issue" vs. "Risk" in ISO 9001:2015 and AS9100 Rev D (Definitions)

    I've recently completed my Probitas authentication for AS9100D Lead Auditor, and a question came up that elicited an unclear response from our trainer. The question surrounds the use of the term "issues" in Clause 4.1: "The organization shall determine internal and external issues (my emphasis)...
  16. C

    What is the difference between "Overall Risk" and "Risk"? (ISO 14971)

    I'm seriously at a loss here. Before I start, don't chime in with something like "Overall residual risk evaluation is the point where residual risk is viewed from a broad perspective." Please just don't :frust: Scenario A The first analysis lends itself to modularity, and so I've broken...
  17. Q

    Risk Management - Additional Process in ISO 9001:2015?

    Hi all I have ISO 9001 2008, and I'm planning the trancision to 2015 and have a general process map, where main processes are shown. Please share your opinions if Risk management should be added as an additional process with its proper Kpi. Thanks in advance for your help
  18. M

    Is Identification of Risks and Opportunities required for QMS Processes?

    Dear all I searched in ISO 9001 requirements to find a requirement about the necessity for risk identification for any QMS processes. As you know, in 4.4.1 f) the standard requires that the QMS process shall address risks and opportunities determined in accordance with the requirement of...
  19. Q

    Tools for Risk - ISO 9001:2015 - Suggestions

    Hello everyone Please advise on the next point. Im trying to comply with 6.1 in 9001 2015 (risks) and I´m trying to use ISO 31010 as a reference. Additionally I have seen information on the web, where it is mentioned that for complying to the risk assessment for 9001, it could be used a...
  20. C

    What is considered a "Critical" Raw Material? (Re: DNA Synthesis)

    This was the closest forum to my question. We a re a start up DNA synthesis company looking to get certified for ISO 9001:2015. I am seeking advice on what is considered a "critical" raw material. We track the raw materials we use, but we have no process of inspection before use. The raw...
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