Internal Audit Report

June 21, 2018 | Author: Liliana Hinojosa | Category: Documents


Comments



Description

Internal Audit Report
"Date: "28-MAR-18 "
"To: "Luis Garcia "
"CC: " "
"From: " "
"Subject: "Internal Audit – Audit # TIJ-2018-MAR-001 "
" " "
"Scope: "An audit of the Labels VS was performed on 27-MAR-18 to DDMMAA by Liliana Hinojosa, Danira"
" "Navarro, Ruben Alonso as part of the scheduled quality audit program. "
"Standard " ISO 9001:2015 ISO 13485:2016 21 CFR 820 "
"Audited "Other _____________________________ "
"Summary: "The audit included review of Department Procedures, Forms and Training Records (described "
" "below): "
"The following documents were reviewed during the audit: "
" "
"Information was provided by the following individuals: "
"Javier Quevedo "
"Additional comments about the audit: "
" "
"Findings identified from the previous internal audit were reviewed: "
"Audit Number: " "
"Corrective actions were effective?"Yes No If no, explain: "




Nonconformances summary

"Major Nonconformance – It is a general failure of a procedure or requirement of the norm/standard. "
"Occurs when: "
"There is a total failure of a procedure or work instruction that is critical to product quality or in "
"the Quality System. "
"There is a total absence of any procedure required by the Standard. "
"There are several minor faults in the procedure, when added collectively suggest a total or "
"substantial failure in the procedure. "
"Minor Nonconformance – Is an isolated observation to a specific part of a process or Quality System. "
"Example: lack of follow up to a procedure in a specific manufacturing area. "

"Requirement: " "
"Finding: " "
"Evidence " "
"Description: " "
"Assigned CAPA #" "
"Requirement: " "
"Finding: " "
"Evidence " "
"Description: " "
"Assigned CAPA #" "
"Requirement: " "
"Finding: " "
"Evidence " "
"Description: " "
"Assigned CAPA #" "

Trending: For each nonconformance (NC) and Observation (OBS) cited, record
the applicable standard for trending activities.
More than one standard may apply to each finding.
" "ISO 9001 "ISO 13485 "QSR "NC "OBS "Total "
"Management Responsibility "5.1, 5.2, 5.3, "5.1,5.2, 5.3, "820.20 " " " "
" "6.1,6.2, 6.3 7.4,"5.4, 5.5, 5.6 " " " " "
" "9.3 " " " " " "
"Document Control & Records "4.3, 4.4, 7.5. "4.2, 4.2.3, "820.20, 820.40, " " " "
" "7.5.2, 7.5.3 "4.2.4, 4.2.5 "820.180, 820.181, " " " "
" " " "820.186 " " " "
"HR, Training "7.1.2, 7.2, 7.3 "6.1, 6.2 "820.25 " " " "
"Infrastructure (EHS, MTO, "7.1.3, 7.1.4 "6.3, 6.4 "820.70(c)(d)(e)(f)(" " " "
"Facilities) " " "g) " " " "
"Product Realization "8, 8.1, 8.2, 8.5,"7.1, 7.2, 7.5 "820.60, 820.65, " " " "
" "8.5.5* " "820.86 " " " "
" " " "820.120, 820.130, " " " "
" " " "820.140, 820.150, " " " "
" " " "820.160 " " " "
" " " "820.75, 820.250 " " " "
" " " "820.70(a)(b)(h)(i)," " " "
" " " "820.184 " " " "
"Purchasing controls "8.4, 8.6 "7.4 "820.50 " " " "
"(Purchasing, Incoming, " " " " " " "
"Incoming Inspection) " " " " " " "
"Calibration "7.6 "7.1.5 "820.72 " " " "
"Internal Audits "9.2 "8.2.4 "820.22 " " " "
"Measurement, analysis and "9.1, 8.6, 8.7, "8.2, 8.3, 8.4, " " " " "
"improvement "10, 10.2, 10.3, "8.5 "820.90, 820.100, " " " "
"(Feedback, complaints, "10.1, 6.1, 8.5.5*" "820.198, " " " "
"Regulatory, NCR, data " " " " " " "
"analysis, improvement & CAPA)" " " " " " "
" " " " " " " "
"8.5.5* no post-delivery " " " " " " "
"activities " " " " " " "
" " " " " " " "
" " " " " " " "

"Closing Meeting: "

"Role "Name "Signature "Date "
"Report " " " "
"Originator/Auditor " " " "
"Auditor " " " "
"Department Signature " " " "
"Department Signature " " " "

Final Review/Approval


"Name (Print) "Signature "Date "
" " " "
" " " "
" " " "
" " " "
" " " "






Audit findings should be responded according to the guidelines below:
Major nonconformances = 30 days or less
Minor nonconformances = 60 days or less

The initial response should include the assignment to the appropriate
owners and the corrective action plan.
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