| 位置 |
频率 |
设备 |
停止控制 |
| 注意： |
TMV 结果：参考 TMV PEPF 00001509 获取 TMV 结果。MSA 接受标准是默认值，但可以是特定于业务的。 |
'有理由通过': 关键测量的理由应基于风险。例如，通过达到特定的业务可靠性水平。参见 |
工艺验证 TMV 指南。非关键测量可能具有与风险无关的接受理由，例如商业案例。 |
站内：制造后立即进行的检测 |
抽样：每批进行检测，但不是100%。样本量必须具有统计学依据。 |
审核：并非每批次都进行检测 |
*“防错检测”是一种检测控制，能够以极高的确定性识别现有缺陷。例如，通过使缺陷高度显眼或 |
通过存在缺陷而使组装变得不可能。这不是一种“预防控制”，它不能消除或减少发生。 |
完全避免发生。 |
NOTES:
TMV Result: Reference TMV PEPF 00001509 for TMV Result. MSA acceptance criteria are defaults, but can be business specific.
'Passing with Rationale': Rationale for critical measurements shall be risk based. For example, by meeting business specific reliability levels. See
Process Validation TMV guidance. Non-critical measurements may have non-risk related rationale for acceptance such as a business case.
In-station: Detections performed immediately after manufacture
Sampling: Detections performend on every lot but not 100%. Sample sizes must be statistically underpinned.
Audits: Detections not performed on every lot
*A 'Poka-yoke detection' is a Detection Control that identifies existing defects with high certainty. For example, by making defects highly visible or
by making assembly impossible because of the existence of a defect. This is not a 'Prevention Control' which eliminates or reduces the occurrences
from happening at all.| NOTES: |
| :---: |
| TMV Result: Reference TMV PEPF 00001509 for TMV Result. MSA acceptance criteria are defaults, but can be business specific. |
| 'Passing with Rationale': Rationale for critical measurements shall be risk based. For example, by meeting business specific reliability levels. See |
| Process Validation TMV guidance. Non-critical measurements may have non-risk related rationale for acceptance such as a business case. |
| In-station: Detections performed immediately after manufacture |
| Sampling: Detections performend on every lot but not 100%. Sample sizes must be statistically underpinned. |
| Audits: Detections not performed on every lot |
| *A 'Poka-yoke detection' is a Detection Control that identifies existing defects with high certainty. For example, by making defects highly visible or |
| by making assembly impossible because of the existence of a defect. This is not a 'Prevention Control' which eliminates or reduces the occurrences |
| from happening at all. | |
NOTES：TMV 结果：参考 TMV PEPF 00001509 获取 TMV 结果。MSA 验收标准为默认值，但可以是特定于业务的。'有理由通过'：关键测量的理由应为基于风险的。例如，通过满足特定于业务的可靠性水平。参见工艺验证 TMV 指南。非关键测量可能具有与风险无关的验收理由，例如商业案例。 |
| NOTES： |
| NOTES： |
TMV 结果：参考 TMV PEPF 00001509 获取 TMV 结果。MSA 验收标准为默认值，但可以是特定于业务的。'有理由通过'：关键测量的理由应为基于风险的。例如，通过满足特定于业务的可靠性水平。参见工艺验证 TMV 指南。非关键测量可能具有与风险无关的验收理由，例如商业案例。在站检测：制造后立即执行抽样：每批次执行检测，但非 100%。样本量必须具有统计支持。审计：每批次不执行检测在站检测：制造后立即执行 |
抽样：每批次都进行检测，但不是100%。样本量必须具有统计学依据。 |
审核：并非每批次都进行检测 |
*“防错检测”是一种检测控制，能够以极高的确定性识别现有缺陷。例如，通过使缺陷高度可见，或因存在缺陷而使装配变得不可能。这不是“预防控制”，后者能完全消除或减少缺陷的发生。 |
NOTES:,TMV Result: Reference TMV PEPF 00001509 for TMV Result. MSA acceptance criteria are defaults, but can be business specific.,'Passing with Rationale': Rationale for critical measurements shall be risk based. For example, by meeting business specific reliability levels. See,Process Validation TMV guidance. Non-critical measurements may have non-risk related rationale for acceptance such as a business case.,In-station: Detections performed immediately after manufacture,Sampling: Detections performend on every lot but not 100%. Sample sizes must be statistically underpinned.,Audits: Detections not performed on every lot,*A 'Poka-yoke detection' is a Detection Control that identifies existing defects with high certainty. For example, by making defects highly visible or,by making assembly impossible because of the existence of a defect. This is not a 'Prevention Control' which eliminates or reduces the occurrences,from happening at all.
NOTES: TMV Result: Reference TMV PEPF 00001509 for TMV Result. MSA acceptance criteria are defaults, but can be business specific. 'Passing with Rationale': Rationale for critical measurements shall be risk based. For example, by meeting business specific reliability levels. See Process Validation TMV guidance. Non-critical measurements may have non-risk related rationale for acceptance such as a business case.
NOTES:
NOTES:
TMV Result: Reference TMV PEPF 00001509 for TMV Result. MSA acceptance criteria are defaults, but can be business specific. 'Passing with Rationale': Rationale for critical measurements shall be risk based. For example, by meeting business specific reliability levels. See Process Validation TMV guidance. Non-critical measurements may have non-risk related rationale for acceptance such as a business case. In-station: Detections performed immediately after manufacture Sampling: Detections performend on every lot but not 100%. Sample sizes must be statistically underpinned. Audits: Detections not performed on every lot In-station: Detections performed immediately after manufacture
Sampling: Detections performend on every lot but not 100%. Sample sizes must be statistically underpinned.
Audits: Detections not performed on every lot
*A 'Poka-yoke detection' is a Detection Control that identifies existing defects with high certainty. For example, by making defects highly visible or by making assembly impossible because of the existence of a defect. This is not a 'Prevention Control' which eliminates or reduces the occurrences from happening at all.| NOTES: <br> TMV Result: Reference TMV PEPF 00001509 for TMV Result. MSA acceptance criteria are defaults, but can be business specific. <br> 'Passing with Rationale': Rationale for critical measurements shall be risk based. For example, by meeting business specific reliability levels. See <br> Process Validation TMV guidance. Non-critical measurements may have non-risk related rationale for acceptance such as a business case. <br> In-station: Detections performed immediately after manufacture <br> Sampling: Detections performend on every lot but not 100%. Sample sizes must be statistically underpinned. <br> Audits: Detections not performed on every lot <br> *A 'Poka-yoke detection' is a Detection Control that identifies existing defects with high certainty. For example, by making defects highly visible or <br> by making assembly impossible because of the existence of a defect. This is not a 'Prevention Control' which eliminates or reduces the occurrences <br> from happening at all. |
| :--- |
| NOTES: TMV Result: Reference TMV PEPF 00001509 for TMV Result. MSA acceptance criteria are defaults, but can be business specific. 'Passing with Rationale': Rationale for critical measurements shall be risk based. For example, by meeting business specific reliability levels. See Process Validation TMV guidance. Non-critical measurements may have non-risk related rationale for acceptance such as a business case. |
| NOTES: |
| NOTES: |
| TMV Result: Reference TMV PEPF 00001509 for TMV Result. MSA acceptance criteria are defaults, but can be business specific. 'Passing with Rationale': Rationale for critical measurements shall be risk based. For example, by meeting business specific reliability levels. See Process Validation TMV guidance. Non-critical measurements may have non-risk related rationale for acceptance such as a business case. In-station: Detections performed immediately after manufacture Sampling: Detections performend on every lot but not 100%. Sample sizes must be statistically underpinned. Audits: Detections not performed on every lot In-station: Detections performed immediately after manufacture |
| Sampling: Detections performend on every lot but not 100%. Sample sizes must be statistically underpinned. |
| Audits: Detections not performed on every lot |
| *A 'Poka-yoke detection' is a Detection Control that identifies existing defects with high certainty. For example, by making defects highly visible or by making assembly impossible because of the existence of a defect. This is not a 'Prevention Control' which eliminates or reduces the occurrences from happening at all. | |