VBA高级应用例程 ESAC 2008-06 (Complete)
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
1.0 Q U A L I T Y M A N A G E M E N T
1.1
The quality system is documented,controlled, and maintained to clearly describe current practice.Documented procedures required.Records required.
Quality manual and all QS
procedures show revision control (sign-offs & dates), history of changes, quality organization's responsibilities
1.0 Q U A L I T Y M A N A G E M E N T
1.2
Quality reports, trend charts and data analysis identify areas of opportunity and are used by
management on a routine basis.Records required.Product quality yield data, top problems and corresponding improvement actions, status of preventive/corrective actions taken, internal audit results
1.0 Q U A L I T Y M A N A G E M E N T
1.3
Quality performance targets are clearly defined, included in the business plan and monitored for improvements.
Strategic and tactical objectives,goals, action plans, etc.
1.0 Q U A L I T Y M A N A G E M E N T
1.4
Executive management participates in periodic quality system reviews that address quality related feedback from customers and internal quality metrics. Records required.
Analysis of field failures,inspection yields, resource needs, internal audit results,corrective action status, etc.
2.0 C O N T I N U O U S I M P R O V E M E N T
2.1
Preventive actions are taken based on the analysis of significant business trends, design reviews,customer satisfaction surveys or other meaningful inputs.
Documented procedures required.Records required.
Management review meetings,goal setting, performance measurement, internal audits,action plans, customer surveys
2.0 C O N T I N U O U S I M P R O V E M E N T
2.2
A formal approach is used to actively pursue cost containment and other continual improvement activities throughout the organization. Documented procedures required. Records required.
Employee involvement /
recognition program, Lean, Six Sigma, kaizen, SPC, 5-S, cost reduction program, preventive actions
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
S
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence AUDIT FINDINGS & OBSERVATIONS
N o t A p p l i c a b l e
N o t V e r i f i e d
Supplier Self-Audit SCORE Supplier
CA-PA Req'd?(Y / N)
On-Site Audit SCORE After CAPA Verif. SCORE
Completion
Date (mm/dd/yy)
Status
0-Jan-00
Requirements
Typical Objective Evidence 1.0 Q U A L I T Y M A N A G E M E N T
1.1
The quality system is documented,controlled, and maintained to clearly describe current practice.Documented procedures required.Records required.
Quality manual and all QS
procedures show revision control (sign-offs & dates), history of changes, quality organization's responsibilities
1.0 Q U A L I T Y M A N A G E M E N T
1.2
Quality reports, trend charts and data analysis identify areas of opportunity and are used by
management on a routine basis.Records required.Product quality yield data, top problems and corresponding improvement actions, status of preventive/corrective actions taken, internal audit results
1.0 Q U A L I T Y M A N A G E M E N T
1.3
Quality performance targets are clearly defined, included in the business plan and monitored for improvements.
Strategic and tactical objectives,goals, action plans, etc.
1.0 Q U A L I T Y M A N A G E M E N T
1.4
Executive management participates in periodic quality system reviews that address quality related feedback from customers and internal quality metrics. Records required.
Analysis of field failures,inspection yields, resource needs, internal audit results,corrective action status, etc.
2.0 C O N T I N U O U S I M P R O V E M E N T
2.1
Preventive actions are taken based on the analysis of significant business trends, design reviews,customer satisfaction surveys or other meaningful inputs.
Documented procedures required.Records required.
Management review meetings,goal setting, performance measurement, internal audits,action plans, customer surveys
2.0 C O N T I N U O U S I M P R O V E M E N T
2.2
A formal approach is used to actively pursue cost containment and other continual improvement activities throughout the organization. Documented procedures required. Records required.
Employee involvement /
recognition program, Lean, Six Sigma, kaizen, SPC, 5-S, cost reduction program, preventive actions
0-Jan-00
Requirements Typical Objective Evidence
0-Jan-00
Requirements Typical Objective Evidence
0-Jan-00
Requirements Typical Objective Evidence
0-Jan-00
Requirements Typical Objective Evidence