Title Page
-
Site conducted
-
Conducted on
-
Prepared by
-
Location
岗位职责 Responsibility
-
1. 是否包括公司所有岗位职责要求？对于特殊岗位，例如管理者代表、设备工程师、技术工程师、机修、灭菌操作工等要求是否明确？Does it include all job responsibilities? Are the requirements for special positions such as management representative, equipment engineer, technical engineer, machine repair, sterilization operator clear?
-
2. 是否有岗位评估？评估内容是否符合岗位职责要求？Is there a job evaluation? Does the evaluation meet the job responsibilities?
培训 Training
-
1. 是否有年度培训计划？培训计划是否满足要求？Is there an annual training program? Does the training program meet the requirements?
-
2. 根据年度培训计划检查培训记录，培训是否满足要求？（至少三个岗位）Check the training records against the annual training plan. Did the training meet the requirements? (At least three positions)
-
3. 新员工入职是否有入职培训？培训是否满足岗位职责要求？查看3个员工入职培训记录。Is there any orientation for new employees? Does the training meet the job responsibilities? Review the induction training records of 3 employees.
-
4. 在职员工是否有适时培训？是否加强岗位职责要求或提高岗位技能？查看3个员工培训记录。Are on-job staff trained in a timely manner? Are job responsibilities strengthened or skills improved? Review training records of 3 employees.
-
5. 培训记录是否满足要求，包括：策划、签到、培训材料、纪要、评估等内容？查看至少3份培训记录。Do training records meet requirements, including: planning, check-in, training materials, notes, evaluations, etc.? Review at least 3 training records.
-
6. 是否有员工培训记录汇总档案？检查档案上的培训记录，核实是否有实际培训。查看至少3个员工，每个员工至少3个培训记录。Is there a summary file of employee training records? Check the training records on file to verify that there is actual training. Review at least 3 training records for each 3 employee.
资质 Certificate
-
1. 是否至少有2个内审员？查看内审员资质及有效期。Are there at least 2 internal auditors? Check internal auditor qualification and validity period.
-
2. 微生物检验员是否有资质？查看资质及有效期。Are microbiological inspectors qualified? Check qualification and expiry date.
-
3. 灭菌人员是否有资质或培训记录？查看资质及有效期或培训记录及再培训要求。Do sterilization personnel have qualified or trained records? Check qualifications and expiry dates or training records and retraining requirements.
-
4. 洁净车间工作人员是否有健康报告且报告结果为合格？查看至少3个不同岗位人员。Does the clean room worker have a health report and the report result is acceptable? View at least 3 people in different positions.
-
5. 根据《岗位职责》查看3个岗位人员学历或学位，技能等是否满足要求？According to Job Responsibilities, check whether the education or degree and skills of the three positions meet the requirements?
