IQA Audit Checklist

Kapco Manufacturing, Inc.
INTERNAL QUALITY AUDIT (IQA)

AUDIT CHECKLIST
Section / Dept.: MANAGEMENT
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
CHECK POINTS / CHECK ITEMS
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
1. Responsibility and Authority
1.0 Established Organizational Structure

--- clearly defined responsibility & authority based on
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
5.5.1, 5.5.2,
5.5.3
2. Customer Focus
2.0 Determination of customer requirements

2.1 Meeting customer requirements
2.2 Enhancement of customer satisfaction through product
and/or service enhancement
--- customer satisfaction rating
5.2 , 7.2.1,
8.2.1
FINDINGS / OBSERVATION
(Conformity / Observation / Minor NC / Major NC)

AUDIT CHECKLIST
Section / Dept.: MANAGEMENT
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
3. Management Commitment

3.0 Commitment and support to the established system
--- presence of appropriate Quality Policy
--- 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)
--- minutes of meeting
--- presentation materials
--- provision of resources
--- conduct of Business Planning (BP)
--- include Improvement Plans
3.1 Plans for maintenance & improvement of QMS
3.2 Effective implementation of QMS
--- rejection rate
--- sales margin / profit
--- employees performance
--- employees awareness & commitment to Quality Policy
--- include newly hired employees
4. Continual Improvement
4.0
4.1
4.2
4.3
Continuous assessment or review of Quality Policy

Continuous monitoring & improvement of Quality Objectives
Continuous assessment of audit results
Use of Corrective & Preventive action request
5. Control of Documents & Records
5.0 Documents must be under controlled issuance.

5.1 Latest version available at point of use.
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
5.1, 5.3,
5.4.1
5.6.1, 5.6.2,
5.6.3
6.1
5.4.2
8.5.1
4.2.3, 4.2.4
5.2 Obsolete documents removed to avoid misuse.

5.3 Documents & quality records are legible and readily identifiable.
5.4 Appropriateness of record filling.

AUDIT CHECKLIST
Section / Dept.: SALES & MARKETING
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
1. Customer Requirements

1.0
-------
1.1
-------
2. Order Handling
Determination of customer requirements

new customer
new product
new process
--- planning of product realization
Meeting customer requirements
contract review (review of order / changes in customer req't.)
statutory & regulatory requirements
delivery & post delivery activity
2.0 Determination of customer requirements (existing product)

--- receive customer order / PO / Delivery Schedule
2.1 Capacity Assessment

--- capacity plan
--- contract review
2.2 Order Acceptance

--- order dissemination
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
5.2
7.1
7.2.1
7.2.2

AUDIT CHECKLIST
Section / Dept.: SALES & MARKETING
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
3. Customer Satisfaction

3.0 Measurement of customer satisfaction / dissatisfaction
3.1 Enhancement of customer satisfaction
--- post sales service
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
8.2.1
6.1
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
5.0
------5.1
5.2
5.3
5.4
Control of documents & records

record of contract review
record of customer requirement
record of customer complaints
Documents must be under controlled issuance.
Latest version available at point of use.
Obsolete documents removed to avoid misuse.
Documents & quality records are legible and readily
identifiable.
4.2.3, 4.2.4
6.0
-------
Established Quality Objectives (Dept. Goal)

result of Dept. Goal
correction & corrective action taken for unmet goals
other improvement plans for Sales & Mktg.
8.2.3, 8.5.1

AUDIT CHECKLIST
Section / Dept.: HR & TRAINING
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
1. Provision of Human Resource
2. Provision of Infrastructure and

Work Environment

1.0 Assessment of manpower requirement
--- manpower plan / forecast
--- organizational review / future requirement
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
6.1
1.1 Recruitment
--- manpower requisition
--- provision through agency (if any)
--- qualification assessment
--- skills - req't. matching
--- hiring / deployment
6.2.1
1.2
-------
Competency assessment
TNA (new & existing employees)
development of Training Program
evaluation of training effectiveness
6.2.2
2.0
-------
Provision of necessary infrastructure

workspace
computers
service & transport vehicle
6.3, 6.4

AUDIT CHECKLIST
Section / Dept.: HR & TRAINING
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
3. Control of Documents & Records 3.0 Control of documents & records
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
4.2.3, 4.2.4
------3.1
3.2
3.3
3.4
record of education, training & experience of employees

record of manpower requirement
record of organizational review & assessment
identifiable.
4.0 Established Quality Objectives (Dept. Goal)

--- result of Dept. Goal
--- correction & corrective action taken for unmet goals
8.2.3, 8.5.1
--- other improvement plans for HR / Training

AUDIT CHECKLIST
Section / Dept.: QM & DCC
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
1. QMS Planning, Implementaton &
Maintenance

1.0 QMS Planning
--- QMS plan
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
5.4.2
1.1 QMS Plan implementation monitoring

--- monthly / quarterly / year-end report
1.2 QMS Implementation
--- conduct of Management Review
--- presentation materials
--- conduct of Internal Quality Audit
--- list of certified Auditors
--- Pre-Audit meeting
--- Master Audit Plan
--- Detailed Audit Plan
--- Audit Checklist
--- Result of Audit
--- Issued & verified CAR
8.2.2
--- conduct of Business Planning

--- list of Improvement Plans
8.5.1
--- establishment & monitoring of Dept. Goals

--- Dept. Goal monitoring (quarterly / annual)
--- issued CAR for goals not met
8.2.3
--- conduct of Analysis of Data

--- rejection rate
8.4

AUDIT CHECKLIST
Section / Dept.: QM & DCC
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
3. Control of Documents / Records

2.0 QMS effectiveness
--- customer and other parties' satisfaction
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
8.5.1, 8.2.1
2.1 Corrective Actions

8.5.2
2.2 Preventive Actions

--- applied tools (PFMEA, SPC)
8.5.3
3.0
-------------
4.2.3
4.2.4
Updated Masterlist of Documents / Records

revision of documents
review of documents
registration
distribution & retrieval
records archiving
records disposal
3.1
3.2
3.3
3.4

identifiable.

AUDIT CHECKLIST
Section / Dept.: PURCHASING
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
1. Qualification of New Supplier
1.0 Selection of New Supplier

--- sample evaluation and qualification
--- qualification audit
--- audit result
--- accreditation
--- list of accredited supplier
2. Existing Supplier maintenance &

improvement
2.0
-------
Continuous evaluation of supplier's performance

Supplier's Performance Evaluation
Annual Supplier's Audit
Issued & verified CAR / PAR to suppliers
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
7.4.1, 7.4.2
7.4.1
3. Provision / Procurement of Direct

& Indirect Materials
3.0 Procurement Planning

--- basis of procurement
--- Procurement Plan
--- Purchase request
--- material requirement & specification
--- canvassing
--- Purchase Order
--- Receiving
--- DR / Invoice / Certificate of Analysis
6.1
7.4.2
7.4.3

AUDIT CHECKLIST
Section / Dept.: PURCHASING
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.

4.0
------4.1
4.2
4.3
4.4

record of supplier qualification
record of supplier evaluation
record of supplier's audit
identifiable.
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
4.2.3, 4.2.4
5.0
-------

other improvement plans for Purchasing
8.2.3, 8.5.1

AUDIT CHECKLIST
Section / Dept.: WAREHOUSE
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
1. Control, Monitoring & Preservation
of Customer Property (including
Non-Conformities)

1.0 Receiving of Customer Property
--- DR / Receiving Report
--- found non-conformity
--- inferiority report
--- disposition (return / scrap / dispose)
1.1
-------
Monitoring of customer property

stock card
inventory
issuance slip
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
7.5.4, 8.3
7.5.4
1.2 Identification & Traceability

--- traceability tags / record
--- FIFO
--- signage
--- label
1.3
-------
2. Control, Monitoring & Preservation

of Direct & Indirect Materials
(including Non-Conformities)
7.5.3
Preservation of Customer Property / Product

required environmental condition
packaging & storage
handling
7.5.4, 7.5.5
2.0 Receiving Direct & Indirect Materials

--- DR / Invoice / Receiving Report
8.3

AUDIT CHECKLIST
Section / Dept.: WAREHOUSE
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.

2.1
-------
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
Monitoring
stock card
inventory
requisition slip

--- FIFO
--- signage
--- label
7.5.3
2.3 Preservation of Direct & Indirect Materials

--- required environmental condition
--- packaging & storage
7.5.5
3.0
----3.1
3.2
3.3
3.4

record of non-conformity
record of requisition / issuance
identifiable.
4.2.3, 4.2.4
4.0
-------
8.2.3, 8.5.1

other improvement plans for Warehouse

AUDIT CHECKLIST
Section / Dept.: FEM / CALIBRATION
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
1. Provision, Maintenance and
Improvement of Infrastructure

1.0 Assessment / Forecast of Infrastructure requirement
--- plans for infrastructure needs
--- list of Machines / Equipment
--- work environment requirement
1.1 Maintenance of Infrastructure

--- Preventive Maintenance (PM) Plans
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
6.1, 6.3,
6.4
--- 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

Monitoring & Measuring Devices
(MMD)
2.0 Identification of MMD

--- identification tag
--- list of MMD
2.1
-------
7.6
Maintenance of MMD
list of MMD that requires calibration and/or validation
calibration schedule of MMD
calibration conducted
--- calibration sticker

AUDIT CHECKLIST
Section / Dept.: FEM / CALIBRATION
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.

3.0
------3.1
3.2

record of PM
record of calibration
record of Machine / Equipment history
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
4.2.3, 4.2.4
3.3 Obsolete documents removed to avoid misuse.

3.4 Documents & quality records are legible and readily
identifiable.
4.0
-------

other improvement plans for Facility & Maintenance section
8.2.3, 8.5.1

AUDIT CHECKLIST
Section / Dept.: PRODUCTION PLANNING & CONTROL
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
1. Order Handling

1.0 Received accepted customer order
--- delivery schedule from customer
1.1 Production planning
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
7.2.3
--- production plan / schedule

--- material plan
--- inventory
1.2 Production execution
--- monitoring of production flow / status
2. Control, monitoring & preservation

of customer property (including
non-conformity)
1.3 Delivery to customer

--- delivery schedule
--- actual delivery vs. delivery plan
--- DR and Invoice
8.2.1
2.0 Receiving of Customer Property

--- DR / Receiving Report
7.5.4
2.1
-------
Monitoring of customer property

stock card
inventory
issuance slip

--- FIFO
--- signage
--- label
7.5.3

AUDIT CHECKLIST
Section / Dept.: PRODUCTION PLANNING & CONTROL
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.

2.3 Preservation of Customer Property
--- required environmental condition
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
--- packaging & storage

2.4 Release of Customer Property / Product
--- delivery of conforming product to customer
--- legal & regulatory documents
--- DR & Sales Invoice
7.5.1
2.5 Disposition for non-conforming product

--- scrap / return to customer
--- record of MRB
8.3
3.0
----3.1
3.2
3.3
3.4

record of delivery
identifiable.
4.2.3, 4.2.4
4.0
-------
8.2.3, 8.5.1

other improvement plans for PPC

AUDIT CHECKLIST
Section / Dept.: PRODUCTION
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
1. Production
1.1. Control, monitoring & preservation
of customer property (including
non-conformity)
1.2. Monitoring & measurement of
processes & product
1.0 Receiving of Production Schedule

--- communicated production schedule / delivery schedule
1.1 Receiving of customer property

--- receiving record / material requisition
--- identification & traceability
--- runcard
--- lot number
1.2 Production
--- 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

--- inspection & test conducted before release
--- approval of release or endorsement
7.5.3, 7.5.4
7.5.1, 8.3
8.2.4

AUDIT CHECKLIST
Section / Dept.: PRODUCTION
Auditee/s: __________________________________
__________________________________
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
FUNCTIONS / REQM'T.

Employees Performance
clearly defined responsibility & authority
employee's productivity
employee's training / orientation
Audit
Scope
2. Personnel Management
2.0
-------
3.0
------3.1
3.2
3.3
3.4

record of production
record of productivity
identifiable.
4.2.3, 4.2.4
4.0
-------
8.2.3, 8.5.1

other improvement plans for Production
5.5.1, 6.2.2

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

Auditor/s: _______________________________
__________________________________
FUNCTIONS / REQM'T.
1. Inspection
_______________________________
Audit
Scope
1.0 Receiving of materials from previous process

--- receiving record
1.1. Handling, protection & preservation

of product
1.2. Monitoring & measurement of

processes & product
1.1 Product inspection

--- availability of ISI
--- availability of WIS
8.2.4
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

--- handling / packaging of conforming products
--- proper label
2. Control of non-conformity
7.5.5
2.0 Clear identification of non-conformity

--- labels / stickers
--- rejection box / quarantine area
2.1 Verification of non-conformity

AUDIT CHECKLIST
8.3
Section / Dept.: FINAL VISUAL INSPECTION (FVI)

Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
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
3.0
---------
employee's qualification
4.0
------4.1
4.2
4.3
4.4

record of inspection (good / reject)
identifiable.
4.2.3, 4.2.4
5.0
-------
8.2.3, 8.5.1

other improvement plans for FVI
5.5.1, 6.2.2

AUDIT CHECKLIST
Section / Dept.: QC - ENG'G.

Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
1. Planning of Product Realization
(New Product)
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________

1.0 Determination of objective, process, inspection, test, criteria
of product acceptance
Audit
Scope
7.1, 7.2.1
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

(Existing Product)
2.0 Incoming Inspection

--- IQC conducted
--- 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
8.1, 8.2.3,
8.2.4

AUDIT CHECKLIST
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.

2.3
-------
Product Inspection & Testing

WIS
use of MMD
corrections & corrective action taken for non-conformity result
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
7.5.1
2.4 Approval of Release

--- basis for approval
2.5 Corrective Actions taken for non-conformities exceeding

allowable quantity or percentage defect
--- issued & verified CARs.
3. Analysis of Data
3.0 Analysis of Data

--- trending / charting of results of analyses
--- analysis of rejection or non-conformities
4.0
---------
employee's qualification
8.5.2
8.4
5.5.1, 6.2.2

AUDIT CHECKLIST
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope
5.0
------5.1
5.2
5.3
5.4

record of inspection (good / reject)
identifiable.
4.2.3, 4.2.4
5.0
-------
8.2.3, 8.5.1

other improvement plans for QC-Eng'g.

AUDIT CHECKLIST
Section / Dept.: _________________________
Auditee/s: __________________________________
__________________________________
FUNCTIONS / REQM'T.
Date of Audit: _______________________

Auditor/s: _______________________________
_______________________________
Audit
Scope

IQA Audit Checklist

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Kapco Manufacturing, Inc.

INTERNAL QUALITY AUDIT (IQA)

CHECK POINTS / CHECK ITEMS

Date of Audit: _______________________

1. Responsibility and Authority

1.0 Established Organizational Structure

2.0 Determination of customer requirements

Kapco Manufacturing, Inc.

CHECK POINTS / CHECK ITEMS

Continuous assessment or review of Quality Policy

5. Control of Documents & Records

5.0 Documents must be under controlled issuance.

Date of Audit: _______________________

5.2 Obsolete documents removed to avoid misuse.

5.4 Appropriateness of record filling.

Kapco Manufacturing, Inc.

CHECK POINTS / CHECK ITEMS

Determination of customer requirements

2.0 Determination of customer requirements (existing product)

2.1 Capacity Assessment

2.2 Order Acceptance

Date of Audit: _______________________

Kapco Manufacturing, Inc.

CHECK POINTS / CHECK ITEMS

Date of Audit: _______________________

3.2. Action plans for dissatisfaction

4.0 Acknowledgement of customer feedback & information

4.1 Customer complaints

5. Control of Documents & Records

Control of documents & records

Established Quality Objectives (Dept. Goal)

Kapco Manufacturing, Inc.

2. Provision of Infrastructure and

CHECK POINTS / CHECK ITEMS

Date of Audit: _______________________

Provision of necessary infrastructure

Kapco Manufacturing, Inc.

CHECK POINTS / CHECK ITEMS

3. Control of Documents & Records 3.0 Control of documents & records

Date of Audit: _______________________

record of education, training & experience of employees

4.0 Established Quality Objectives (Dept. Goal)

--- other improvement plans for HR / Training

Kapco Manufacturing, Inc.

CHECK POINTS / CHECK ITEMS

Date of Audit: _______________________

1.1 QMS Plan implementation monitoring

--- conduct of Business Planning

--- establishment & monitoring of Dept. Goals

--- conduct of Analysis of Data

Kapco Manufacturing, Inc.

3. Control of Documents / Records

CHECK POINTS / CHECK ITEMS

Date of Audit: _______________________

2.1 Corrective Actions

2.2 Preventive Actions

Updated Masterlist of Documents / Records

Documents must be under controlled issuance.

Kapco Manufacturing, Inc.

CHECK POINTS / CHECK ITEMS

1. Qualification of New Supplier

1.0 Selection of New Supplier

2. Existing Supplier maintenance &

Continuous evaluation of supplier's performance