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articles:risk-based_audits [2022/06/03 09:10] – [Risk-Based Internal Audits] rrandall | articles:risk-based_audits [2022/08/30 16:06] – [Risk-Based Internal Audits] rrandall | ||
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</ | </ | ||
- | Expanding on the above description of a " | + | Expanding on the above description of a " |
+ | |||
+ | Some specific " | ||
* Where the CB issued nonconformities during their most recent audit? If so, which area and how many nonconformities (Majors/ | * Where the CB issued nonconformities during their most recent audit? If so, which area and how many nonconformities (Majors/ | ||
- | * Where nonconformities were issued during the previous Internal Audit? (If so, which area and how many nonconformities (Majors/Minors) were identified? | + | * Experiencing high numbers of new employees |
- | * Failing to meet established Quality Objectives? If so, which areas/ | + | * Where “key” employees have been added or replaced? |
- | * That received " | + | * That have undergone significant change(s) (e.g., improvements, |
- | * That were responsible for the shipment of nonconforming | + | * With complex processes |
- | * Where multiple instances of nonconforming products were identified | + | * Involving “Special” processes (e.g., Soldering, Welding)? |
- | * That have been the subject of one or more " | + | |
* Considered to have High or Medium risk levels (particularly subject to [[articles: | * Considered to have High or Medium risk levels (particularly subject to [[articles: | ||
- | * With complex processes (e.g., Unique/ | ||
- | * Requiring personnel to hold valid competency certifications (e.g., [[https:// | ||
* Requiring the use of customer-mandated suppliers? | * Requiring the use of customer-mandated suppliers? | ||
- | * Experiencing high numbers of new employees and/or high employee " | ||
- | * Where the functions and/or processes have undergone a significant change (e.g., improvement)? | ||
- | * Where new processes have been implemented (e.g., a new product line introduced)? | ||
- | <note important> | + | When performing " |
- | * Require frequent calibration | + | * Where nonconformities were issued? If so, which area and how many nonconformities |
- | * Has a low "accuracy ratio" (i.e., the ratio between | + | * Where Quality Objectives had not been achieved, and actions implemented in order to achieve them? |
- | </ | + | * That received |
+ | * Where multiple instances of the same or similar nonconformities identified | ||
+ | * That had “Open” or “Pending” corrective Actions at the conclusion of the audit? | ||
+ | * Considered to have High or Medium | ||
An " | An " | ||
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☝ Remember... the " | ☝ Remember... the " | ||
- | For example, if we're determined that there are one or more special processes being performed, a common | + | For example, if you've determined that there are one or more special processes being performed, a common |
+ | * personnel | ||
+ | * monitoring and measuring equipment have a high accuracy ratio (i.e., the ratio between the instrument and the tolerance measured), e/g., ≥10:1. | ||
<note tip>As you define the risk-based audit criteria for your organization... you will likely realize that the information from previous internal audits is not entirely adequate to support risk-based audit planning! Any shortcomings in the previous internal audit reports should be addressed by better defining the specific " | <note tip>As you define the risk-based audit criteria for your organization... you will likely realize that the information from previous internal audits is not entirely adequate to support risk-based audit planning! Any shortcomings in the previous internal audit reports should be addressed by better defining the specific " |