Internal audit conclusion This int

Internal audit conclusion
This internal audit is 1st time for KF6, during audit activities and after I got audit result
I would to summary some problem that we should to improve as below;
Internal auditor still have low-experience about how to finding of evidence.
Some auditor gave difficult question to auditee, auditee do not understand then effect
to they can not shown the evidence correct with question.

Auditee use more time to find the evidence to show during auditor ask to the evidences.
Audit program still not good enough, some audit subject that audit cover all department

Recommendation for improvement

1 Re-training about ISO 13485 requirement, clarify explanation about what is requirement
need and what evidence that Our organization define.
2 Adjust audit period [increase], because it's will help auditor and auditee to find and show
what evidence needed and also make completely record of evidence.
3 Re-training internal audit concept course [in-house or outside training] to Auditor.
4 Review QP12, QP18, QP14 and QP09
QP14 shall review the product requirement relate Cleanliness of Product [req.7.5.1.2.1].
Due to the customer process requirement that have not require of product cleaning process
before delivery to Customer [daiken]. Revise QP14 may need and also review and revise of QM.
5 Closely monitoring and follow up of each Check sheet and Record by each department leader.
6 if possible, the internal audit shall perform again by select weak section/activities to audit.

ผลลัพธ์ (อังกฤษ) 2:

Internal Audit conclusion
This internal Audit is 1st time for KF6, during Audit Activities and after I got Audit Result
I would to Summary Some Problem that we should to improve as Below;
Internal Auditor still have low-Experience About How to Finding of Evidence.
Some. Auditor Gave difficult question to Auditee, Auditee do not Understand then Effect
to they Can not shown the Evidence Correct with question. Auditee use more time to Find the Evidence to Show during Auditor ask to the evidences. Audit Program still not good Enough, Some Audit. subject that Audit Cover all Department Recommendation for Improvement 1 Re-Training About ISO 13485 requirement, clarify explanation About what is requirement Need and what Evidence that Our Organization define. 2 Adjust Audit period [increase], because it's Will Help Auditor and Auditee to Find. and Show what Evidence Needed and also Make completely Record of Evidence. 3 Re-Training internal Audit Concept course [in-House or Outside Training] to Auditor. 4 Review QP12, QP18, QP14 and QP09 QP14 Shall review the product requirement Relate Cleanliness of. product [Req.7.5.1.2.1]. Due to the Customer Process requirement of product that have not Require Cleaning Process Delivery to Customer before [Daiken]. Revise May Need QP14 and also Revise and review of QM. 5 Monitoring and closely follow up of each Check Sheet and Record by each Department Leader. 6 if possible, the internal Audit Shall select Perform Again by weak section / Activities to Audit.

ผลลัพธ์ (อังกฤษ) 3:

Internal audit conclusion.This internal audit is 1st time for KF6 during audit, activities and after I got audit result.I would to summary some problem that we should to improve as below;Internal auditor still have low-experience about how to finding of evidence.Some auditor gave difficult question, to auditee auditee do not understand then effect.To they can not shown the evidence correct with question.Auditee use more time to find the evidence to show during auditor ask to the evidences.Audit program still not good enough some audit, subject that audit cover all department.Recommendation for improvement.1 Re-training about ISO, 13485 requirement clarify explanation about what is requirement.Need and what evidence that Our organization define.2 Adjust audit period [increase], because it 's will help auditor and auditee to find and show.What evidence needed and also make completely record of evidence.3 Re-training internal audit concept course [in-house or outside training] to Auditor.4 Review QP12 QP18 QP14 and QP09,,,QP14 shall review the product requirement relate Cleanliness of req.7.5.1.2.1 Product [].Due to the customer process requirement that have not require of product cleaning process.Before delivery to Customer [Daiken]. Revise QP14 may need and also review and revise of QM.5 Closely monitoring and follow up of each Check sheet and Record by each department leader.6 if possible the internal, audit shall perform again by select weak section / activities to audit.