1. SCAN Report Validity
The SCAN Audit is valid for one (1) year. To qualify for a 2-year audit cadence, the following criteria must be met: (请您根据需要下拉查看中文信息)
- A compliance score of 95% or higher, with all Corrective Actions addressed and approved by SCAN; or
- A compliance score between 85% and 94%, provided the country security risk is Low, Guarded, or Elevated, And all Corrective Actions are addressed and approved by SCAN
- In addition to the above requirements, 12 months from the day the audit was conducted, the facility must complete a SCAN self-assessment assigned by SCAN PMT
Please note: Under any circumstance listed below, the facility’s eligibility for the two (2) year audit cadence will be removed and the audit will be valid for one (1) year:
- CAPAs are not completed or submitted, the report will be tagged “CAPAs: No response – Closed”.
- CAPA rejected due to the audited facility not submitting sufficient response based on SCAN requirements after 3 CAPA rounds. Your score for this question will remain unchanged and the report will be tagged “CAPAs: Partially addressed – Closed”.
- Selecting the option “Will not implement/will not comply with corrective action request” as this indicates acknowledgement of the non-compliance. Your score for this question will remain unchanged and your report will be tagged “CAPAs: Partially addressed – Closed”.
Remark:
- Please contact SCAN@SCRiskSolutions.com if you need to know your current audit report validity or Country risk level of your location.
- In regard to the audit rating or audit result per specific member, please contact them directly for more information.
2. Audit Cadence: for SCAN re-audit
SCAN will process the re-audit 2 months prior to the audit expiration date on behalf of the SCAN Association. You can also apply for a re-audit earlier as needed by following the hyperlink Supplier Requested Onsite Audit to request the audit.
1. SCAN 报告有效期
SCAN 审核报告有效期默认为一年。如果符合以下其中一条标准,审核的周期为两年:
- 您的初始审核报告分数≥(大于或等于)95%,且所有CAPA均已完成并获得 SCAN 批准
- 您的初始审核报告分数≥ 85% - 94%,国家安全风险为Low, Guarded, 或 Elevated,且所有CAPA均已完成并获得 SCAN 批准
- 除上述要求外,自审核之日起 12 个月内,机构必须完成 SCAN 项目管理团队分配的 SCAN 自我审核
请注意:在下列任何情况下,机构将失去可能被奖励两(2)年审核周期的资格,审核有效期为一(1)年:
- 如果没有任何CAPA完成或提交,报告被标记为 "CAPA: 无响应 - 已关闭”。
- 由于受审核机构在三 (3) 轮 CAPA 后未根据 SCAN 要求提交足够的响应,CAPA 被拒绝。 您在此问题上的得分将保持不变,报告被标记为 "CAPAs: 部分处理 - 已关闭”。
- 选择 "不执行/不遵守纠正措施要求 "选项,因为这表示承认不合规。您在该问题上的得分将保持不变,您的报告被标记为 "CAPAs: 部分处理 - 已关闭"。
备注:
- 如需了解当前审核报告的有效期或所在国家的风险等级,请联系 SCAN@SCRiskSolutions.com。
- 关于每个特定SCAN会员的审核评级或审核结果,请直接联系他们以获取更多信息。
2. SCAN复审周期
SCAN 将代表 SCAN 协会在审核到期日前 2 个月发起重新审核。您也可以根据需要提前申请重新审核,方法是点击超链接 Supplier Requested Onsite Audit 来申请审核。
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