Anda di halaman 1dari 26

Kapco Manufacturing, Inc.

INTERNAL QUALITY AUDIT (IQA)


AUDIT CHECKLIST

Section / Dept.: MANAGEMENT Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. Responsibility and Authority 1.0 Established Organizational Structure 5.5.1, 5.5.2,
--- clearly defined responsibility & authority based on 5.5.3
organizational structure
--- responsibility and authority matrix
--- communication for changes in organizational chart
--- continuous assessment of job functions & org. structure
--- provision of human resource
--- identified & appointed QMR

2. Customer Focus 2.0 Determination of customer requirements 5.2 , 7.2.1,


2.1 Meeting customer requirements
2.2 Enhancement of customer satisfaction through product 8.2.1
and/or service enhancement
--- customer satisfaction rating
Kapco Manufacturing, Inc.
INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: MANAGEMENT Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
3. Management Commitment 3.0 Commitment and support to the established system 5.1, 5.3,
--- presence of appropriate Quality Policy 5.4.1
--- established measurable quality objectives
--- established quality objectives at different level or
functions in relation to Quality Policy
--- results of measurable quality objectives
--- conduct of Management Review (MR) 5.6.1, 5.6.2,
--- minutes of meeting 5.6.3
--- presentation materials
--- provision of resources 6.1
--- conduct of Business Planning (BP)
--- include Improvement Plans
3.1 Plans for maintenance & improvement of QMS 5.4.2
3.2 Effective implementation of QMS
--- customer satisfaction rating
--- rejection rate
--- sales margin / profit
--- employees performance
--- employees awareness & commitment to Quality Policy
--- include newly hired employees

4. Continual Improvement 4.0 Continuous assessment or review of Quality Policy 8.5.1


4.1 Continuous monitoring & improvement of Quality Objectives
4.2 Continuous assessment of audit results
4.3 Use of Corrective & Preventive action request

5. Control of Documents & Records 5.0 Documents must be under controlled issuance. 4.2.3, 4.2.4
5.1 Latest version available at point of use.
5.2 Obsolete documents removed to avoid misuse.
5.3 Documents & quality records are legible and readily identifiable.
5.4 Appropriateness of record filling.

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: SALES & MARKETING Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. Customer Requirements 1.0 Determination of customer requirements 5.2
--- new customer
--- new product
--- new process
--- planning of product realization 7.1

1.1 Meeting customer requirements 7.2.1


--- contract review (review of order / changes in customer req't.)
--- statutory & regulatory requirements
--- delivery & post delivery activity

2. Order Handling 2.0 Determination of customer requirements (existing product) 7.2.2


--- receive customer order / PO / Delivery Schedule

2.1 Capacity Assessment


--- capacity plan
--- contract review

2.2 Order Acceptance


--- order dissemination
Kapco Manufacturing, Inc.
INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: SALES & MARKETING Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
3. Customer Satisfaction 3.0 Measurement of customer satisfaction / dissatisfaction 8.2.1
--- customer satisfaction rating

3.1 Enhancement of customer satisfaction 6.1


--- post sales service

3.2. Action plans for dissatisfaction

4. Customer Communication 4.0 Acknowledgement of customer feedback & information 7.2.3

4.1 Customer complaints


--- corrective & preventive action

5. Control of Documents & Records 5.0 Control of documents & records 4.2.3, 4.2.4
--- record of contract review
--- record of customer requirement
--- record of customer complaints
5.1 Documents must be under controlled issuance.
5.2 Latest version available at point of use.
5.3 Obsolete documents removed to avoid misuse.
5.4 Documents & quality records are legible and readily
identifiable.
5.5 Appropriateness of record filling.
6. Continual Improvement 6.0 Established Quality Objectives (Dept. Goal) 8.2.3, 8.5.1
--- result of Dept. Goal
--- correction & corrective action taken for unmet goals
--- other improvement plans for Sales & Mktg.

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: HR & TRAINING Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. Provision of Human Resource 1.0 Assessment of manpower requirement 6.1
--- manpower plan / forecast
--- organizational review / future requirement

1.1 Recruitment 6.2.1


--- manpower requisition
--- provision through agency (if any)
--- qualification assessment
--- skills - req't. matching
--- hiring / deployment

1.2 Competency assessment 6.2.2


--- TNA (new & existing employees)
--- development of Training Program
--- evaluation of training effectiveness

2. Provision of Infrastructure and 2.0 Provision of necessary infrastructure 6.3, 6.4


Work Environment --- workspace
--- computers
--- service & transport vehicle
Kapco Manufacturing, Inc.
INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: HR & TRAINING Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
3. Control of Documents & Records 3.0 Control of documents & records 4.2.3, 4.2.4
--- record of education, training & experience of employees
--- record of manpower requirement
--- record of organizational review & assessment
3.1 Documents must be under controlled issuance.
3.2 Latest version available at point of use.
3.3 Obsolete documents removed to avoid misuse.
3.4 Documents & quality records are legible and readily
identifiable.
3.5 Appropriateness of record filling.

4. Continual Improvement 4.0 Established Quality Objectives (Dept. Goal) 8.2.3, 8.5.1
--- result of Dept. Goal
--- correction & corrective action taken for unmet goals
--- other improvement plans for HR / Training

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: QM & DCC Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. QMS Planning, Implementaton & 1.0 QMS Planning 5.4.2
Maintenance --- QMS plan

1.1 QMS Plan implementation monitoring


--- monthly / quarterly / year-end report

1.2 QMS Implementation


--- conduct of Management Review
--- minutes of meeting
--- presentation materials

--- conduct of Internal Quality Audit 8.2.2


--- list of certified Auditors
--- Pre-Audit meeting
--- Master Audit Plan
--- Detailed Audit Plan
--- Audit Checklist
--- Result of Audit
--- Issued & verified CAR
--- conduct of Business Planning 8.5.1
--- minutes of meeting
--- list of Improvement Plans

--- establishment & monitoring of Dept. Goals 8.2.3


--- Dept. Goal monitoring (quarterly / annual)
--- issued CAR for goals not met

--- conduct of Analysis of Data 8.4


--- customer satisfaction rating
--- rejection rate

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: QM & DCC Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
2. Continual Improvement 2.0 QMS effectiveness 8.5.1, 8.2.1
--- customer and other parties' satisfaction

2.1 Corrective Actions 8.5.2


--- Issued & verified CAR

2.2 Preventive Actions 8.5.3


--- Issued & verified CAR
--- applied tools (PFMEA, SPC…)

3. Control of Documents / Records 3.0 Updated Masterlist of Documents / Records 4.2.3


--- revision of documents 4.2.4
--- review of documents
--- registration
--- distribution & retrieval
--- records archiving
--- records disposal
3.1 Documents must be under controlled issuance.
3.2 Latest version available at point of use.
3.3 Obsolete documents removed to avoid misuse.
3.4 Documents & quality records are legible and readily
identifiable.
3.5 Appropriateness of record filling.

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: PURCHASING Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. Qualification of New Supplier 1.0 Selection of New Supplier 7.4.1, 7.4.2
--- sample evaluation and qualification
--- qualification audit
--- audit result
--- accreditation
--- list of accredited supplier

2. Existing Supplier maintenance & 2.0 Continuous evaluation of supplier's performance 7.4.1
improvement --- Supplier's Performance Evaluation
--- Annual Supplier's Audit
--- Issued & verified CAR / PAR to suppliers
3. Provision / Procurement of Direct 3.0 Procurement Planning 6.1
& Indirect Materials --- basis of procurement
--- Procurement Plan
--- Purchase request 7.4.2
--- material requirement & specification
--- canvassing
--- Purchase Order
--- Receiving 7.4.3
--- DR / Invoice / Certificate of Analysis

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: PURCHASING Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
4. Control of Documents & Records 4.0 Control of documents & records 4.2.3, 4.2.4
--- record of supplier qualification
--- record of supplier evaluation
--- record of supplier's audit
4.1 Documents must be under controlled issuance.
4.2 Latest version available at point of use.
4.3 Obsolete documents removed to avoid misuse.
4.4 Documents & quality records are legible and readily
identifiable.
4.5 Appropriateness of record filling.
5. Continual Improvement 5.0 Established Quality Objectives (Dept. Goal) 8.2.3, 8.5.1
--- result of Dept. Goal
--- correction & corrective action taken for unmet goals
--- other improvement plans for Purchasing

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: WAREHOUSE Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. Control, Monitoring & Preservation 1.0 Receiving of Customer Property 7.5.4, 8.3
of Customer Property (including --- DR / Receiving Report
Non-Conformities) --- found non-conformity
--- inferiority report
--- disposition (return / scrap / dispose…)

1.1 Monitoring of customer property 7.5.4


--- stock card
--- inventory
--- issuance slip
1.2 Identification & Traceability 7.5.3
--- traceability tags / record
--- FIFO
--- signage
--- label

1.3 Preservation of Customer Property / Product 7.5.4, 7.5.5


--- required environmental condition
--- packaging & storage
--- handling

2. Control, Monitoring & Preservation 2.0 Receiving Direct & Indirect Materials 8.3
of Direct & Indirect Materials --- DR / Invoice / Receiving Report
(including Non-Conformities) --- found non-conformity
--- disposition (return / scrap / dispose…)

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: WAREHOUSE Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
2.1 Monitoring
--- stock card
--- inventory
--- requisition slip

2.2 Identification & Traceability 7.5.3


--- traceability tags / record
--- FIFO
--- signage
--- label
2.3 Preservation of Direct & Indirect Materials 7.5.5
--- required environmental condition
--- packaging & storage

3. Control of Documents & Records 3.0 Control of documents & records 4.2.3, 4.2.4
--- record of non-conformity
--- record of requisition / issuance
3.1 Documents must be under controlled issuance.
3.2 Latest version available at point of use.
3.3 Obsolete documents removed to avoid misuse.
3.4 Documents & quality records are legible and readily
identifiable.
3.5 Appropriateness of record filling.

4. Continual Improvement 4.0 Established Quality Objectives (Dept. Goal) 8.2.3, 8.5.1
--- result of Dept. Goal
--- correction & corrective action taken for unmet goals
--- other improvement plans for Warehouse

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: FEM / CALIBRATION Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. Provision, Maintenance and 1.0 Assessment / Forecast of Infrastructure requirement 6.1, 6.3,
Improvement of Infrastructure --- plans for infrastructure needs 6.4
--- list of Machines / Equipment
--- work environment requirement

1.1 Maintenance of Infrastructure


--- Preventive Maintenance (PM) Plans
--- PM conducted & results
--- troubleshooting conducted & results
--- Job orders received
--- job orders accomplished

1.2 Improvement of Infrastructure


--- improvement plans for infrastructure

2. Control & maintenance of 2.0 Identification of MMD 7.6


Monitoring & Measuring Devices --- identification tag
(MMD) --- list of MMD

2.1 Maintenance of MMD


--- list of MMD that requires calibration and/or validation
--- calibration schedule of MMD
--- calibration conducted
--- calibration sticker

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: FEM / CALIBRATION Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
3. Control of Documents & Records 3.0 Control of documents & records 4.2.3, 4.2.4
--- record of PM
--- record of calibration
--- record of Machine / Equipment history
3.1 Documents must be under controlled issuance.
3.2 Latest version available at point of use.
3.3 Obsolete documents removed to avoid misuse.
3.4 Documents & quality records are legible and readily
identifiable.
3.5 Appropriateness of record filling.

4. Continual Improvement 4.0 Established Quality Objectives (Dept. Goal) 8.2.3, 8.5.1
--- result of Dept. Goal
--- correction & corrective action taken for unmet goals
--- other improvement plans for Facility & Maintenance section

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: PRODUCTION PLANNING & CONTROL Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. Order Handling 1.0 Received accepted customer order 7.2.3
--- delivery schedule from customer

1.1 Production planning


--- production plan / schedule
--- material plan
--- inventory

1.2 Production execution


--- monitoring of production flow / status

1.3 Delivery to customer 8.2.1


--- delivery schedule
--- actual delivery vs. delivery plan
--- DR and Invoice

2. Control, monitoring & preservation 2.0 Receiving of Customer Property 7.5.4


of customer property (including --- DR / Receiving Report
non-conformity) --- found non-conformity
--- inferiority report
--- disposition (return / scrap / dispose…)

2.1 Monitoring of customer property


--- stock card
--- inventory
--- issuance slip

2.2 Identification & Traceability 7.5.3


--- traceability tags / record
--- FIFO
--- signage
--- label

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: PRODUCTION PLANNING & CONTROL Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
2.3 Preservation of Customer Property
--- required environmental condition
--- packaging & storage

2.4 Release of Customer Property / Product 7.5.1


--- delivery of conforming product to customer
--- legal & regulatory documents
--- DR & Sales Invoice

2.5 Disposition for non-conforming product 8.3


--- scrap / return to customer
--- record of MRB

3. Control of Documents & Records 3.0 Control of documents & records 4.2.3, 4.2.4
--- record of delivery
--- record of non-conformity
3.1 Documents must be under controlled issuance.
3.2 Latest version available at point of use.
3.3 Obsolete documents removed to avoid misuse.
3.4 Documents & quality records are legible and readily
identifiable.
3.5 Appropriateness of record filling.

4. Continual Improvement 4.0 Established Quality Objectives (Dept. Goal) 8.2.3, 8.5.1
--- result of Dept. Goal
--- correction & corrective action taken for unmet goals
--- other improvement plans for PPC

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: PRODUCTION Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. Production 1.0 Receiving of Production Schedule
--- communicated production schedule / delivery schedule
1.1. Control, monitoring & preservation
of customer property (including
non-conformity) 1.1 Receiving of customer property 7.5.3, 7.5.4
--- receiving record / material requisition
1.2. Monitoring & measurement of --- identification & traceability
processes & product --- runcard
--- lot number
--- found non-conformity
--- inferiority report

1.2 Production 7.5.1, 8.3


--- line preparation
--- process parameter checking before production
--- visible WIS
--- established process flow (Control Plan)
--- production output report (good / reject)
--- proper identification & segregation of non-conformity

1.3 Issuance to next process / Releasing or Endorsement 8.2.4


--- inspection & test conducted before release
--- approval of release or endorsement

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: PRODUCTION Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________
Audit FINDINGS / OBSERVATION
FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
2. Personnel Management 2.0 Employees Performance 5.5.1, 6.2.2
--- clearly defined responsibility & authority
--- employee's productivity
--- employee's training / orientation

3. Control of Documents & Records 3.0 Control of documents & records 4.2.3, 4.2.4
--- record of production
--- record of non-conformity
--- record of productivity
3.1 Documents must be under controlled issuance.
3.2 Latest version available at point of use.
3.3 Obsolete documents removed to avoid misuse.
3.4 Documents & quality records are legible and readily
identifiable.
3.5 Appropriateness of record filling.

4. Continual Improvement 4.0 Established Quality Objectives (Dept. Goal) 8.2.3, 8.5.1
--- result of Dept. Goal
--- correction & corrective action taken for unmet goals
--- other improvement plans for Production

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: FINAL VISUAL INSPECTION (FVI) Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. Inspection 1.0 Receiving of materials from previous process
--- receiving record
1.1. Handling, protection & preservation
of product
1.1 Product inspection 8.2.4
--- availability of ISI
1.2. Monitoring & measurement of --- availability of WIS
processes & product

1.2 Clear identification of conforming products


--- labels / stickers
--- box / stock area

1.3 Inspection output


--- records of output
--- records of non-conformity

1.4 Approval for release or delivery to customer 7.5.5


--- handling / packaging of conforming products
--- proper label

2. Control of non-conformity 2.0 Clear identification of non-conformity 8.3


--- labels / stickers
--- rejection box / quarantine area

2.1 Verification of non-conformity

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST
Section / Dept.: FINAL VISUAL INSPECTION (FVI) Date of Audit: _______________________
Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
2.2 Disposition for non-conformity
--- record of MRB
--- rework / re-process / scrap / return to customer

2.3 Record of non-conformity that reaches customer


--- received CAR from customer
--- corrective actions taken

3. Personnel Management 3.0 Employees Performance 5.5.1, 6.2.2


--- clearly defined responsibility & authority
--- employee's productivity
--- employee's training / orientation
--- employee's qualification

4. Control of Documents & Records 4.0 Control of documents & records 4.2.3, 4.2.4
--- record of inspection (good / reject)
--- record of non-conformity
--- record of productivity
4.1 Documents must be under controlled issuance.
4.2 Latest version available at point of use.
4.3 Obsolete documents removed to avoid misuse.
4.4 Documents & quality records are legible and readily
identifiable.
4.5 Appropriateness of record filling.

5. Continual Improvement 5.0 Established Quality Objectives (Dept. Goal) 8.2.3, 8.5.1
--- result of Dept. Goal
--- correction & corrective action taken for unmet goals
--- other improvement plans for FVI

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST
Section / Dept.: QC - ENG'G. Date of Audit: _______________________
Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
1. Planning of Product Realization 1.0 Determination of objective, process, inspection, test, criteria 7.1, 7.2.1
(New Product) of product acceptance

1.1 Test Run

1.2 Sample approval

1.3 Establishment of Control Plan (CP)


--- communicated change in CP (4M Change)

2. Quality Control & Assurance 2.0 Incoming Inspection 8.1, 8.2.3,


(Existing Product) --- IQC conducted 8.2.4
--- ISI / WIS
--- inspection result
--- communication w/ customer incase of non-conformity

2.1 Process parameter checking before operation


--- WIS / Checksheets

2.2 Process parameter checking during operation


--- In-Process Quality Control
--- actual parameters used vs. Control Plan
--- corrections made for out-of-specs parameters

Kapco Manufacturing, Inc.


INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: QC - ENG'G. Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
2.3 Product Inspection & Testing 7.5.1
--- WIS
--- use of MMD
--- corrections & corrective action taken for non-conformity result

2.4 Approval of Release


--- basis for approval

2.5 Corrective Actions taken for non-conformities exceeding 8.5.2


allowable quantity or percentage defect
--- issued & verified CARs.

3. Analysis of Data 3.0 Analysis of Data 8.4


--- trending / charting of results of analyses
--- analysis of rejection or non-conformities

4. Personnel Management 4.0 Employees Performance 5.5.1, 6.2.2


--- clearly defined responsibility & authority
--- employee's productivity
--- employee's training / orientation
--- employee's qualification
Kapco Manufacturing, Inc.
INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: QC - ENG'G. Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)
5. Control of Documents & Records 5.0 Control of documents & records 4.2.3, 4.2.4
--- record of inspection (good / reject)
--- record of non-conformity
--- record of productivity
5.1 Documents must be under controlled issuance.
5.2 Latest version available at point of use.
5.3 Obsolete documents removed to avoid misuse.
5.4 Documents & quality records are legible and readily
identifiable.
5.5 Appropriateness of record filling.

5. Continual Improvement 5.0 Established Quality Objectives (Dept. Goal) 8.2.3, 8.5.1
--- result of Dept. Goal
--- correction & corrective action taken for unmet goals
--- other improvement plans for QC-Eng'g.
Kapco Manufacturing, Inc.
INTERNAL QUALITY AUDIT (IQA)
AUDIT CHECKLIST

Section / Dept.: _________________________ Date of Audit: _______________________


Auditee/s: __________________________________ Auditor/s: _______________________________
__________________________________ _______________________________

Audit FINDINGS / OBSERVATION


FUNCTIONS / REQM'T. CHECK POINTS / CHECK ITEMS
Scope (Conformity / Observation / Minor NC / Major NC)

Anda mungkin juga menyukai