API审核反馈说明

API审核反馈说明

1.please provide full audit responses addressing any and all audit nonconformances identified by the auditor during the API audit.The API Associates and Licensing and Registration Committee will not review audits with findings until complete reponses are received that address all audit nonconformances.

1.在API审核期间，审核人员确认后，请提供完整的审核答复和所有不符合项。API 联合许可登记委员会将不会审查审计结果直到收到的所有审核不符合项完成答复。

2.your organization must respond to any nonconformances raised during your audit within 60 days.Failure to respond to nonconformances within that time frame may result in suspension.

2.你的组织必须在审核的60天内对任何不符合项进行答复。如果答复在此时间范围内答复失败，那么审核将会搁浅。

3. The audit response must clearly include the following items;

A.Correction-Provide a detailed explanation of what actions have been taken to correct the nonconformity.The correction should include an examination of the system to determine if there are other occurrences of the nonconformity that require correction.Provide the date of completion/implementation.

3.审核答复必须清楚地载明下列事项;

A。校准-对于纠正不符合项采取了哪行行动提供一个详细的解释。校正应包括系统的检查，以确定是否有其他的不符合项发生并需要修正。提供完成/实行日期。

B. Root Cause Analysis---Provide a detailed explanation of the cause of the nonconformity (i.e.,the reason \"why\"the nonconformity occurred ) . A simple re-wording of the nonconformity is not acceptable . Terms such as \"oversight\" or \"human error\" require further explanation .

B.根本原因分析-对造成不符合项原因提供一个详细的解释（例如，不符合项为什么发生的原因）。不符合项的一个简单的新措辞是不能接受的。术语如“监督”或“人为错误”需要进一步的解释。

C . Corrective Action (s)-Provide a detailed explanation of the action(s) taken/implemented to address the root cause (as indentified in item B) and minmize the likelihood of recurrence . Provide the date of completion / implementation .

C．纠正措施-对提出根本原因（如在项目B中确认）及轻视再次发生的可能性所采取/实施措施，提供一个详细的说明。提供完成/实行日期。

NOTES

API considers only actions that have been \"completed\" as acceptable . Future

sysytem revisions , training sessions , reviews , etc ., though indicating intent ,do not substantiate completed action .

Please do not provide any supporting evidence unless requested from API - include detailed decriptions in the nonconformance response to substantiate the actions taken .

If training is part of the correction(s) or corrective action(s) , your organization must include an evaluation of the training to ensure it was effective .

注意

API只考虑措施已经“完成”是可以接受的。未来的系统修订、培训课程、评论等。,虽然表明意图,但没有证实完成措施。

请不要提供任何证据,除非API要求——包括对证实实施不符合项答复的措施进行详细的描述。

如果培训是部分的校正(s)或纠正措施(s),你的组织必须有一个培训评估以确保它是有效的。

4 . You must use mycerts .api.org to submit your organization's audit responses to API . All login information was emailed to each user . If you are unable to locate your login information for mycerts click the following link for a new password; http://mycerts. api.org/layouts/SyntFBAiles/ResetPassword.aspx

你们必须用mycerts .api.org来提交你们组织的审核答复给API。所有的登录信息已经发送邮件给使用者。如果您找不到登录信息，请点击以下链接设置新密码：http://mycerts. api.org/layouts/SyntFBAiles/ResetPassword.aspx。

5 . At the conclusion of the API review , your organization will be notified through the myCerts web site of any unresolved noncnformances that must be addressed in order to close out the audit . This may include additional corrective actions and/or additional nonconformities that were identified as a result of the review of the audit report .

在API审核完成时，您的组织将通过myCerts网站通知的任何未解决的不符合项,并且为了完成审核必须解决。这可能包括被确定为审核报告的审议结果的额外的纠正措施和/或额外的不符合项。

*******************************************************

如果有任何问题，请发邮件给**********************。