INTERNAL AUDIT CHECKLIST

Department : HOT SHOP AUDIT REF.: IQA Date :

Time : NC

Score
Auditee : Auditor : Shift : Remarks

CL.NO. Checkpoints Confirmation Observations Major/Minor/OI

Document

7.5.1 Is there a documented procedure for HOT SHOP Departmental

Department Procedure

Are the Quality objective deployed in the HOT SHOP

6.2.1/6.2.2 Department Departmental
i.e. Same Objective as determined along with the quality objectives.
policy or supporting departmental objectives.

6.1.2.1 Is there a formal process available for risk analysis? Risk Analysis

6.1.2.1 Are there any risks and opportunities identified? Any

Risk Analysis
Mitigation actions for risks identified?

6.1.2 Status of Mitigation actions implementation and

Risk Analysis
effectiveness?

1.Is there job setup perform such as Initial run of a Job,

8.5.1.3 material change over or job change required a new setup?
2.Is there maintained documented information for setup Setup Approval
personal? request & Setup
Approval Report

8.5.1.4 is there Verification after machine shut down?

Are the process inspection & testing is being carried out as

8.6.1 per defined frequency in PQCS / OPS/Inspections Inspection Report
standards/WI

Is there any concession approved from designated

8.7.1.1 Deviation Record
authority?

1.Is there suspected status is classified & controlled as

8.7.1.3/8.7.1.4 non-confirming product Rework Instruction/
2.Is there documented information available for verification Rework Record
of compliances to original specification

Is the material and parts flow secured against mix-ups /

8.5.2/8.5.2.1 Traceability System
exchanges by mistake and traceability guaranteed.

Do you have trace ability system - batch codification if heat

8.5.2 treatment is done, production month/year labelling or Traceability System
marking for final product (any process)

Are the Production Equipment ( Machine / Jig / Fixture / Master List,

8.5.1.6 Die ) that effect quality , and identify critical spare needed Critical Spare Part
as per replacement for expendable supplies List

8.5.4
Are tools, equipment and inspection, measuring and test Equipment
equipment stored correctly. Handling

Abnormal conditions / unexpected change ( Contingency

Plan )
6.1.2.3 Abnormal Conditions / Unexpected change to satisfy Contingency Plan
customer requirements in event of an emergency such as
labour shortage ,utility intruptions,key equipment failure

6.1.2.3 Is Contingency Plan tested for suitability and reviewed

Contingency Plan
annualy with CFT including top management?

Are the products / components appropriately stored and

Material Handling
8.5.4 are the transport means / packaging equipment tuned to
System Product
the special properties of the product / components.

Is there special charecteristics define in all operational PFD/CP/PFMEA/

8.3.3.3 document such as ( PFD /PFMEA/ Control Plan/Work OPS/Inspections
Instructions ) are specified by special symbol standards

Are the appearance item identify and displayed at the

required location.
Control of Limit Sample includes following information
1.Date of production of the limit sample
master List of Limit
2.Control No.
8.6.3 Sample/Identificatio
3.Inspection Items ( Scratch, Roughness, unevenness
n Tag
etc. )
4.Applicable Part Name & Part No.
Effective Period
6.Significant field.

master List of Limit

Are Limit sample retain considering damage,deteorition
8.6.3 Sample/Identificatio
etc.
n Tag

Operator Instructions & Standards

1. Is the work instruction language understood by
8.5.1.2 responsible person Work Instructions
2. Is the accessible for use at the designated work area.
3. Is the legible work instructions.

Die
1.) Is there maintenance & repair facilities and personnel? Unloading/Breakdo
8.5.1.6
2). Is there storage of tooling system appropriate? wn Intimation/Tool,
3). Is the Tooling modification & change records available? Die, Fixture Service
4). Is the tool/Die Identification system available? report, Tool History
Card

Lux Level for

8.6.3 Required lighting facilities provided for visual inspection
Inspection

Poke Yoke
10.2.4 Audit of poke-yoke whether it is in working condition
Verification

Is the Process Qualification made for process Validation/

8.2.3 PQS/SPC
Process Capability carried out for special characteristics

1). Is there change point Identification requirement

available?
Technical
1). Is there verification & validation activity as per
Noticem,Validation
8.5.6.1 plan/customer requirement?
plan & Record,
2.)Is there validate change before Implementation?
Change point
3.) Is there evidences & retention record available for
verification & validation?

Is there Non-Confirming Product disposition system

8.7.1.7 Rejection Record
available/followed?

Control of Record
7.5.3/7.5.3.1 Is the record have following requirement Records
identification,storage,Protection,retrivel,retention and
disposal of records
Records Retention
7.5.3.2 Is the statutory ,regulatory and customer requirement Retention system
follow

Is the competence defined for the personnel performing

7.2.2/7.2.1 Skill Matrix
Production process & Revaluate as defined interval
Corrective Action
●Is the Reviewing the nonconformities ( Including Customer
10.2 Customer Complaints ) Complaints/
●Verification of Nonconformity Implementation C'Measure
●Is the effectiveness of Corrective action review. Implementation

Score Guide lines :

MS/WFIM 09 FO 12, ISSUE 01 July 2017 Score Achieve 0 0 Major NC
1 Minor NC
Total Score 78 2 Opportunity for Improvement ( OI if Trend is improving )
3 Full fill the system Requirements
Score % 0.00

Auditee Signature : Auditor Signature :

 INTERNAL AUDIT CHECKLIST

Department : CNC SHOP AUDIT REF.: IQA Date :

Time : NC

Score
Auditee : Auditor : Shift : Remarks

CL.NO. Checkpoints Confirmation Observations Major/Minor/OI

Document

7.5.1 Is there a documented procedure for CNC SHOP Departmental

Department Procedure

Are the Quality objective deployed in the CNC SHOP

6.2.1/6.2.2 Department Departmental
i.e. Same Objective as determined along with the quality objectives.
policy or supporting departmental objectives.

6.1.2.1 Is there a formal process available for risk analysis? Risk Analysis

6.1.2.1 Are there any risks and opportunities identified? Any

Risk Analysis
Mitigation actions for risks identified?

6.1.2 Status of Mitigation actions implementation and

Risk Analysis
effectiveness?

1.Is there job setup perform such as Initial run of a Job,

8.5.1.3 material change over or job change required a new setup?
2.Is there maintained documented information for setup Setup Approval
personal? request & Setup
Approval Report

8.5.1.4 is there Verification after machine shut down?

Are the process inspection & testing is being carried out as

8.6.1 per defined frequency in PQCS / OPS/Inspections Inspection Report
standards/WI

Is there any concession approved from designated

8.7.1.1 Deviation Record
authority?

1.Is there suspected status is classified & controlled as

8.7.1.3/8.7.1.4
non-confirming product Rework Instruction/
2.Is there documented information available for verification Rework Record
of compliances to original specification

8.5.2/8.5.2.1
Is the material and parts flow secured against mix-ups / Traceability
exchanges by mistake and traceability guaranteed. System

Do you have trace ability system - batch codification if heat

Traceability
8.5.2 treatment is done, production month/year labelling or
System
marking for final product (any process)

Are the Production Equipment ( Machine / Jig / Fixture / Master List,

8.5.1.6 Die ) that effect quality , and identify critical spare needed Critical Spare Part
as per replacement for expendable supplies List

8.5.4
Are tools, equipment and inspection, measuring and test Equipment
equipment stored correctly. Handling

Abnormal conditions / unexpected change ( Contingency

Plan )
6.1.2.3 Abnormal Conditions / Unexpected change to satisfy Contingency Plan
customer requirements in event of an emergency such as
labour shortage ,utility intruptions,key equipment failure

6.1.2.3 Is Contingency Plan tested for suitability and reviewed

Contingency Plan
annualy with CFT including top management?

Are the products / components appropriately stored and

Material Handling
8.5.4 are the transport means / packaging equipment tuned to
System Product
the special properties of the product / components.

Is there special charecteristics define in all operational PFD/CP/PFMEA/

8.3.3.3 document such as ( PFD /PFMEA/ Control Plan/Work OPS/Inspections
Instructions ) are specified by special symbol standards

Are the appearance item identify and displayed at the

required location.
Control of Limit Sample includes following information
1.Date of production of the limit sample
master List of Limit
2.Control No.
8.6.3 Sample/Identificati
3.Inspection Items ( Scratch, Roughness, unevenness
on Tag
etc. )
4.Applicable Part Name & Part No.
Effective Period
6.Significant field.

master List of Limit

Are Limit sample retain considering damage,deteorition
8.6.3 Sample/Identificati
etc.
on Tag

Operator Instructions & Standards

1. Is the work instruction language understood by
8.5.1.2 responsible person Work Instructions
2. Is the accessible for use at the designated work area.
3. Is the legible work instructions.

Die
1.) Is there maintenance & repair facilities and personnel? Unloading/Breakdo
8.5.1.6
2). Is there storage of tooling system appropriate? wn Intimation/Tool,
3). Is the Tooling modification & change records available? Die, Fixture
4). Is the tool/Die Identification system available? Service report,
Tool History Card

Lux Level for

8.6.3 Required lighting facilities provided for visual inspection
Inspection

Poke Yoke
10.2.4 Audit of poke-yoke whether it is in working condition
Verification

Is the Process Qualification made for process Validation/

8.2.3 PQS/SPC
Process Capability carried out for special characteristics

Is there Non-Confirming Product disposition system

8.7.1.7 Rejection Record
available/followed?

1.Is there any special characteristics identified for process

9.1.1.2/9.1.1.3
capability as per PFMEA/Control Plan? Processs Capabilty
2. Is there process capability carried out as per plan & Plan & Record
Analysed

1). Is there change point Identification requirement

available?
Technical
1). Is there verification & validation activity as per
Noticem,Validation
8.5.6.1 plan/customer requirement?
plan & Record,
2.)Is there validate change before Implementation?
Change point
3.) Is there evidences & retention record available for
verification & validation?

Control of Record
7.5.3/7.5.3.1 Is the record have following requirement
Records
identification,storage,Protection,retrivel,retention and
disposal of records
 Records Retention
7.5.3.2 Is the statutory ,regulatory and customer requirement Retention system
follow

Is the competence defined for the personnel performing

7.2.2/7.2.1 Skill Matrix
Production process & Revaluate as defined interval
Corrective Action
●Is the Reviewing the nonconformities ( Including Customer
10.2 Customer Complaints ) Complaints/
●Verification of Nonconformity Implementation C'Measure
●Is the effectiveness of Corrective action review. Implementation
MS/WFIM 09 FO
12, ISSUE 01 July Score Achieve 0 Score Guide lines :
2017 0 Major NC
Total Score 78 1 Minor NC
2 Opportunity for Improvement ( OI if Trend is improving )
3 Full fill the system Requirements
Score % 0.00

Auditee Signature : Auditor Signature :

 INTERNAL AUDIT CHECKLIST

Department : PAINT SHOP AUDIT REF.: IQA Date :

Time : NC

Score
Auditee : Auditor : Shift : Remarks

CL.NO. Checkpoints Confirmation Observations Major/Minor/OI

Document

7.5.1 Is there a documented procedure for PAINT SHOP Departmental

Department Procedure

Are the Quality objective deployed in the PAINT SHOP

6.2.1/6.2.2 Department Departmental
i.e. Same Objective as determined along with the quality objectives.
policy or supporting departmental objectives.

6.1.2.1 Is there a formal process available for risk analysis? Risk Analysis

6.1.2.1 Are there any risks and opportunities identified? Any

Risk Analysis
Mitigation actions for risks identified?

6.1.2 Status of Mitigation actions implementation and

Risk Analysis
effectiveness?

1.Is there job setup perform such as Initial run of a Job,

8.5.1.3 material change over or job change required a new setup?
2.Is there maintained documented information for setup Setup Approval
personal? request & Setup
Approval Report

8.5.1.4 is there Verification after machine shut down?

Are the process inspection & testing is being carried out as

8.6.1 per defined frequency in PQCS / OPS/Inspections Inspection Report
standards/WI

Is there any concession approved from designated

8.7.1.1 Deviation Record
authority?

1.Is there suspected status is classified & controlled as

Rework
non-confirming product
8.7.1.3/8.7.1.4 Instruction/
2.Is there documented information available for verification
Rework Record
of compliances to original specification

8.5.2/8.5.2.1
Is the material and parts flow secured against mix-ups / Traceability
exchanges by mistake and traceability guaranteed. System

Do you have trace ability system - batch codification if heat

Traceability
8.5.2 treatment is done, production month/year labelling or
System
marking for final product (any process)

Are the Production Equipment ( Machine / Jig / Fixture / Master List,

8.5.1.6 Die ) that effect quality , and identify critical spare needed Critical Spare Part
as per replacement for expendable supplies List

8.5.4
Are tools, equipment and inspection, measuring and test Equipment
equipment stored correctly. Handling

Abnormal conditions / unexpected change ( Contingency

Plan )
6.1.2.3 Abnormal Conditions / Unexpected change to satisfy Contingency Plan
customer requirements in event of an emergency such as
labour shortage ,utility intruptions,key equipment failure

6.1.2.3 Is Contingency Plan tested for suitability and reviewed

Contingency Plan
annualy with CFT including top management?

Are the products / components appropriately stored and

Material Handling
8.5.4 are the transport means / packaging equipment tuned to
System Product
the special properties of the product / components.

PFD/CP/
Is there special charecteristics define in all operational
PFMEA/OPS/
8.3.3.3 document such as ( PFD /PFMEA/ Control Plan/Work
Inspections
Instructions ) are specified by special symbol
standards

Are the appearance item identify and displayed at the

required location.
Control of Limit Sample includes following information
1.Date of production of the limit sample master List of
8.6.3
2.Control No. Limit
3.Inspection Items ( Scratch, Roughness, unevenness Sample/Identificati
etc. ) on Tag
4.Applicable Part Name & Part No.
Effective Period
6.Significant field.

master List of
8.6.3
Are Limit sample retain considering damage,deteorition Limit
etc. Sample/Identificati
on Tag

Operator Instructions & Standards

1. Is the work instruction language understood by
8.5.1.2 responsible person Work Instructions
2. Is the accessible for use at the designated work area.
3. Is the legible work instructions.

Die
Unloading/Breakd
1.) Is there maintenance & repair facilities and personnel?
own
2). Is there storage of tooling system appropriate?
8.5.1.6 Intimation/Tool,
3). Is the Tooling modification & change records available?
Die, Fixture
4). Is the tool/Die Identification system available?
Service report,
Tool History Card

Lux Level for

8.6.3 Required lighting facilities provided for visual inspection
Inspection

Poke Yoke
10.2.4 Audit of poke-yoke whether it is in working condition
Verification

Is the Process Qualification made for process Validation/

8.2.3 PQS/SPC
Process Capability carried out for special characteristics

Is there Non-Confirming Product disposition system

8.7.1.7 Rejection Record
available/followed?

1). Is there change point Identification requirement

available?
Technical
1). Is there verification & validation activity as per
Noticem,Validatio
8.5.6.1 plan/customer requirement?
n plan & Record,
2.)Is there validate change before Implementation?
Change point
3.) Is there evidences & retention record available for
verification & validation?

Control of Record
7.5.3/7.5.3.1 Is the record have following requirement
Records
identification,storage,Protection,retrivel,retention and
disposal of records
Records Retention
7.5.3.2 Is the statutory ,regulatory and customer requirement Retention system
follow

Is the competence defined for the personnel performing

7.2.2/7.2.1 Skill Matrix
Production process & Revaluate as defined interval
 Corrective Action
●Is the Reviewing the nonconformities ( Including Customer
10.2 Customer Complaints ) Complaints/
●Verification of Nonconformity Implementation C'Measure
●Is the effectiveness of Corrective action review. Implementation
MS/WFIM 09 FO
12, ISSUE 01 July Score Achieve 0 Score Guide lines :
2017 0 Major NC
Total Score 78 1 Minor NC
2 Opportunity for Improvement ( OI if Trend is improving )
3 Full fill the system Requirements
Score % 0.00

Auditee Signature : Auditor Signature :

 INTERNAL AUDIT CHEC

Department : Store AUDIT REF.: IQA

Score
Auditee : Auditor :

CL.NO. Checkpoints Confirmation Document

Is there a documented procedure for Store

8.5.4.1 Departmental Procedure
Department?

Are the Quality objective deployed in the Store

Department
6.2.1/6.2.2 Departmental objectives.
i.e. Same Objective as determined along with the
quality policy or supporting departmental objectives.

Is There a documented procedure for material

8.5.4.1 Departmental Procedure
receiving, identification & Storage

Are the raw materials/Parts identified,

8.5.4.1 handled ,packed and stored adequately to preserve Preservation of product
the nonconformity of product?

Are the Quality objective deployed in the HOT SHOP

Department
6.2.1/6.2.2 Departmental objectives.
i.e. Same Objective as determined along with the
quality policy or supporting departmental objectives.

6.1.2.1 Is there a formal process available for risk analysis? Risk Analysis

Are there any risks and opportunities identified? Any

6.1.2.1 Risk Analysis
Mitigation actions for risks identified?

Status of Mitigation actions implementation and

6.1.2 Risk Analysis
effectiveness?

Is the condition of materials/product laying in stocks

8.5.4.1 Daily Stock Assessment
assessed?

8.5.4.1 Is there FIFO system Implemented? FIFO System Followed

Is frequency of such assessment defined and what

8.5.4.1 Inventory assessment
is the basis taken for the same?

Do you take any action to prevent the

8.5.4.1 dust ,rust,moiture& rain etc. for stock & unfinished Action plan/ Work Instructions
products.

Is there Preservation, pacakging & labeling as per

8.5.4.1 Packing condition
requirement of customer?
 8.5.1.7 Is system for inventory management defined? Inventory management

is there Min-Max inventory level defined Min-Max inventory level

How are the obsolete

products/components/materials lying in stores dealt? Incoming Rejection Material
8.5.4.1
Are these considered and controlled as per disposition
nonconforming materials ( Disposal )?

Control of Record
7.5.3/7.5.3.1 Is the record have following requirement Records
identification,storage,Protection,retrivel,retention and
disposal of records

Records Retention
7.5.3.2 Is the statutory ,regulatory and customer Retention system
requirement follow

Is the competence defined for the personnel

7.2.2/7.2.1 performing Production process & Re-evaluate as Skill Matrix
defined interval

MS/WFIM 09 FO 12, ISSUE 00 DEC 2015 Score Achieve 0

Total Score

Score % #DIV/0!

Auditee Signature :
AL AUDIT CHECKLIST

Date :
Time : NC
Shift : Remarks

Observations Major/Minor/OI
Score Guide lines :
0 Major NC
1 Minor NC
2 Opportunity for Improvement ( OI if Trend is improving )
3 Full fill the system Requirements

Auditor Signature :
 INTERNAL AUDIT CHECKLIST

Department : HR AUDIT REF.: IQA Date :

Time : NC

Score
Auditee : Auditor : Shift Remarks

CL.NO. Checkpoints Confirmation Observations Major/

Document Minor/OI

Is there a documented procedure for training / competency Departmental

7.2/7.3/7.5 & motivation of employee
Procedure

Are the Quality objective deployed in the HR Department

6.2.1/6.2.2 i.e. Same Objective as determined along with the quality policy or Departmental
supporting departmental objectives. objectives.

6.1.1 Is there a formal process available for risk analysis? Risk Analysis

Are there any risks and opportunities identified? Any

6.1.2 Mitigation actions for risks identified? Risk Analysis

Status of Mitigation actions implementation and

6.1.2 effectiveness? Risk Analysis

Do you make the education plan for employee ( by class,

7.2 speciality , external or contractual, beginners )? Training Plan

Do you implement the education as planned and keep the

7.2 records?

Is education given to managers and supervisor?

Training Plan &
Records
Do you perform the practical training ( On job ) of Workers.

AUDITEE AUDITOR
 Do you record the education history of each individual?

7.2.2 Do you make skill sheet ( Matrix ) of each individual? Skill Matrix

7.2.2 Is there Guidance available for operator training Training Manual

is there any selection criterion available for contractor / Recruitment

7.2.2 agency providing contractual labour Procedure

7.1 Are resource required for the process available Recruitment

Procedure

Abnormal conditions / unexpected change ( Contingency Plan

) Contingency
6.1.2.3 Abnormal Conditions / Unexpected change to satisfy Plan
customer requirements in event of an emergency such as
labour shortage ,utility intruptions,key equipment failure

6.1.2.3 Is Contingency Plan tested for suitability and reviewed Contingency

annualy with CFT including top management? Plan

7.2.1 is there any system to allow operations only by qualified Training

operator Methodology

7.2.1 Is internal training environmental material regulation carried Training Manual

out

Organization
5.3 is there roles & Responsibility defined for each employee. Chart

Are criteria determined to ensure that the HRD Process are Competency
6.2.2.1 effective ( No of Retraining required, gap between
competency required vs Actual ) Matrix

AUDITEE AUDITOR
 Departmental
6.2.2.1 Are the method available for above criteria. Procedure
Departmental
6.2.2.1 Are performance indicator measure & analysed. Objective

Corrective &
6.1/ 10.2 Are corrective & Preventive action taken when criteria's are Preventive
not met. Action

Dose the organization have a process for motivating the

7.3.2 employees to achieve the quality objective and continuous Training
improvement ( Kaizen awards , attendance awards etc. ) Procedure

7.4 What are the inputs communicated to various department Communication

and how they are communicated. Matrix

Is there any process established at all levels for promoting

7.3.1 Quality Technological awareness throughout the organization Training
( Quality Circle, Visual aids ) Procedure

Continual
Are the area of continuous improvements identified for Improvement
6.2 improving effectiveness of QMS in HRD Department. Procedures

7.2.1 Is the competence defined for the personnel performing Skill Matrix
Production process & Re-evaluate as defined interval

NOM-011-STPS-2001 Ruido areas de trabajo, PROY-NOM-

035-STPS-2016 Factores de riesgo psicosocial, PROY-NOM- Skill Matrix
036-1-STPS-2017, Factores de riesgo ergonómico.

MS/WFIM 09 FO 12, ISSUE 01 July 2017 Score Achieve Score Guide lines :
0 Major NC
Total Score 1 Minor NC
2 Opportunity for Improvement ( OI if Trend is improving )
3 Full fill the system Requirements
Score %

Auditee Signature : Auditor Signature :

AUDITEE AUDITOR
 CHECK LIST AUDITORIA INTERNA
LOGO EMPRESA
Departamento : CONTROL DE CALIDAD AUDITORIA REF.: SPC/2018/AI12 Fecha:
Hora : NC

Score
Auditado : Auditor : Turno : Observaciones
CLAUSULA NO. Punto a Revisar Documento a Confirmar Observaciones Mayor/Menor/Opor.

8.5.1 Are the process inspection & testing is being carried out as per defined frequency in
Inspection Report 10
PQCS / OPS/Inspections standards/WI

is there setup approval done as per defined standards Setup approval report 10

8.7.1 Are rejects, rework, and adjustment parts, as well as internal residues strictly separated
Reject , Rework Record 10
and identified & Record Maintain

8.7.1 Is the material and parts flow secured against mix-ups / exchanges by mistake and
Identification & Traceability 10
traceability guaranteed.

8.5.1.6 Are tools, equipment and inspection, measuring and test equipment stored correctly. List of Tools & Equipments 10

Abnormal conditions / unexpected change ( Contingency Plan )

6.1.2.3 Abnormal Conditions / Unexpected change to satisfy customer requirements in event of Contingency Plan 10
an emergency such as labor shortage ,utility intruptions,key equipment failure

6.1.1 Is there a formal process available for risk analysis? Risk Analysis 10

6.1.2 Are there any risks and opportunities identified? Any Mitigation actions for risks identified? Risk Analysis 10

6.1.2 Status of Mitigation actions implementation and effectiveness? Risk Analysis 10

8.3.3.3 Are the special characteristics identified in the PFMEA , PQCS,Operations standards ,
OPS,Inspections standards 10
Inspections standards, etc.

6.2 Are the Quality Objectives deployed in the department? PI data 10

6.1.2.2/10.2 Are correction and Preventive actions taken in case the Criteria are not met? Action plan 10

Are the appearance item identify and displayed at the required location.
Control of Limit Sample includes following information
1.Date of production of the limit sample
8.6.3 2.Control No. master List of Limit
10
3.Inspection Items ( Scratch, Roughness, unevenness etc. ) Sample/Identification Tag
4.Applicable Part Name & Part No.
Effective Period
6.Significant field.

master List of Limit

8.6.3 Are Limit sample retain considering damage,deteorition etc. 10
Sample/Identification Tag

Is there understanding of statistical concepts variation ,stability , process capability& over

9.1.1.2 Training Record 10
adjustment?

8.6.2 Are Layout Inspections at specified frequency included in control plans being carried out? Layout Plan 10

Does the verification of effectiveness of layout inspection functional testing has done?
8.6.2 Layout Reports & Records 10
Records for the same are maintained?

Are the instruments / Gauges / Test Soft Wares used for testing / verification in quality
7.1.5 Calibration History Card/ Plan 10
calibrated or verified?

Is MSA carried out for such instruments, which are referred in Control Plans?
7.1.5 MSA Plan / MSA Report 10
What are improvement plans for enhancing Measurement Systems?

Reject , Rework Record / Defect

8.7.1.4 Do work instructions for re-inspection of re-work products for the type of defects exist? 10
Matrix,WI

Is there a system for taking concessions on Non-conforming Products from customer

8.7.1.1 Deviation Request 10
prior to further processing?

8.7.1.1 Do records of concessions mention Quantity or Expiration period by customer? Deviation Request 10

8.7.1.1 What type of Marking / Identification is provided to customer “Concession” Products”? Identification & Traceability 10

Is there any customer complaints closed or not Customer Complainst 10

is there customer complaints tracking record available customer complaints tracking sheet 10

Is there customer return record available Customer return register 10

Is there customer return rejection analysis available Customer return analysis record 10

Is there a system for utilizing a process for Problem Solving, leading to root cause
10.2 8D/ CAPA Report 10
identification and elimination?

Is the Process Qualification made for process Validation/ Process Capability carried out
8.2.3 PQS/SPC 10
for special characteristics

8.7.1.7 Is there Non-Confirming Product disposition system available/followed? Rejection Record 10

is there inhouse daily shop wise rejection review record available Rejection Record/Analysis 10

Control of Record
7.5.3/7.5.3.1 Is the record have following requirement Records 10
identification,storage,Protection,retrivel,retention and disposal of records

7.5.3.2 Records Retention

Retention system 10
Is the statutory ,regulatory and customer requirement follow

Is the competence defined for the personnel performing Production process & Revaluate
7.2.2/7.2.1 Skill Matrix 10
as defined interval
Corrective Action
●Is the Reviewing the nonconformities ( Including Customer Complaints )
●Verification of Nonconformity Implementation Customer Complaints/ C'Measure
10.2 10
●Is the effectiveness of Corrective action review. Implementation

Puntuación alcanzada 350 Guía de puntuación:

Puntaje total 350 0 NC MAYOR, 3 NC menor, 7 Oportunidad de mejora (Obs. si la tendencia está mejorando)
10 Cumple con los requisitos del sistema
Puntuación % 100.0%
Nombre y Firma del Nombre y Firma del
Auditado : Auditor:
 INTERNAL AUDIT CHECKLIST

Department : Recieving Quality AUDIT REF.: IQA Date :

Time : NC

Score
Auditee : Auditor : Shift : Remarks
Confirmation
CL.NO. Checkpoints Document Observations Major/Minor/OI

Is there a documented procedure for Quality Assurance of Received Departmental

8.6
material Procedure

Are the Quality objective deployed in the Quality Department for

Incoming Quality Departmental
6.2
i.e. Same Objective as determined along with the quality policy or Objective
supporting departmental objectives.

Are the Quality objective deployed in the HOT SHOP Department

Departmental
6.2.1/6.2.2 i.e. Same Objective as determined along with the quality policy or
objectives.
supporting departmental objectives.

6.1.2.1 Is there a formal process available for risk analysis? Risk Analysis

Are there any risks and opportunities identified? Any Mitigation

6.1.2.1 Risk Analysis
actions for risks identified?

6.1.2 Status of Mitigation actions implementation and effectiveness? Risk Analysis

Abnormal conditions / unexpected change ( Contingency Plan )

Abnormal Conditions / Unexpected change to satisfy customer
6.1.2.3 Contingency Plan
requirements in event of an emergency such as labour
shortage ,utility intruptions,key equipment failure

Is the acceptance criteria estabilished and implemented to ensure

8.6.6 Incoming Standard
that purchased product meet the specified product requirement

Are there any customer supplied inspection tool /gauge?

8.5.1.6 List of Gauges
if Yes,how these tools / gauges are identified for tool ownership?

Are all the inputs available for monitoring & Measurements of product
8.4.2 ( Receving inspection standards , drawing ,sample plan, Standard/Drawings
Gauge ,Instruments )

Are the instrument/ Gauges used for testing / verification in quality

7.1.5.2 Calibration Record
calibrated or varified?

Is there a documented procedure for Non conforming of Received

material ?
8.7.1.2
Are the responsibility and authorities for dealing with non-conforming NC Product
product defined in the procedure ? Handling
Procedure
Does the procedure address identification and control of non-
8.7.1
conforming product prevent unintended use or delivery?

Do the procedure address the way of disposition of the non

8.7.1.7 Rework Record
conforming product in form of rework, use as it ,alternate use?

Are records of nature of non conformities and concessions

8.7.1.1 Deviation Record
maintained?

Is there continually improve the suitability, adequacy and Improvement

10.3
effectiveness of the Quality Management system? Records

8.4.1.2 Is there any supplier evaluation plan? Supplier Audit Plan

Is there any system for measurements of supplier perormance

●Supplier Performance rating
8.4.2.4 Supplier Rating
●Best Supplier in a month
●Worst Supplier in a month

Is there any rule or procedure defined for product / process/ plant Change point
change from supplier? Control Procedure

1). Is there change point Identification requirement available?

8.5.6.1 1). Is there verification & validation activity as per plan/customer Technical
requirement? Noticem,Validation
2.)Is there validate change before Implementation? plan & Record,
3.) Is there evidences & retention record available for verification & Change point
validation?

Control of Record
Is the record have following requirement
7.5.3/7.5.3.1 Records
identification,storage,Protection,retrivel,retention and disposal of
records

Records Retention
7.5.3.2 Retention system
Is the statutory ,regulatory and customer requirement follow

Is the competence defined for the personnel performing Quality

7.2.2/7.2.1 Skill Matrix
process & Re-evaluate as defined interval

Corrective Action
Customer
●Is the Reviewing the nonconformities ( Including Customer
Complaints/
10.2 Complaints )
C'Measure
●Verification of Nonconformity Implementation
Implementation
●Is the effectiveness of Corrective action review.

MS/WFIM 09 FO 12, ISSUE 00 DEC 2015 Score Guide lines :

Score Achieve 0 Major NC
1 Minor NC
Total Score 2 Opportunity for Improvement ( OI if Trend is improving )
3 Full fill the system Requirements

Score %
Auditee Signature : Auditor Signature :
 INTERNAL AUDIT CHEC

Department : R&D AUDIT REF.:

Score
Auditee : Auditor :

CL.NO. Checkpoints Confirmation Document

Is there a documented procedure available for R&D

8.3.2.1 Department
Departmental Procedure

Are the Quality objective deployed in the R & D

6.2.1/6.2.2 Department Departmental objectives.
i.e. Same Objective as determined along with the quality
policy or supporting departmental objectives.

6.1.2.1 Is there a formal process available for risk analysis? Risk Analysis

Are there any risks and opportunities identified? Any

6.1.2.1 Risk Analysis
Mitigation actions for risks identified?

Status of Mitigation actions implementation and

6.1.2 Risk Analysis
effectiveness?

1). Is there development plan/ timing plan available?

2). Is there development plan/ Timing Plan reviewed
Timing Plan/APQP
timely?

8.3.1.2 1). Is there manufacturing process risk analysis available

such as FMEA's, Process Flow, control plan & standard
FMEA, Process Flow,
work Instructions?
Control Plan & standard
2). Is there review of manufacturing process risk analysis
work instructions
such as FMEA's, process flow, control plan & standard
work instructions?

Manufacturing Feasibility
1).Is there special characteristic identified?
8.3.3.2 2). Is there targets for productivity, process capability, Feasibility Study
timing & cost available?
3). Is there past problems included?

1). Is there special Characteristics identified in drawings,

Drawing/FMEA/Control
FMEA, Control Plan & standard work/operator
Plan/Standard Work
8.3.3.3 Instructions?
Instruction/List of Special
2). Is special characteristics identified with specific
Characteristics
marking/Symbol?
 1). Is there Validation plan available?
2). Is there validation records available?
3). Is there any abnormality or problem during validation Validation
8.3.4 activity? plan/Record/Action Taken
4). Is there action taken against problem found during
validation activity?

Is there measurement & analysis results available &

8.3.4.1 reviewed in MRM?
Records & MRM

Is there validation according to customer requirements Customer & regulatory

8.3.4.2 including regulatory requirements? requirements

Identification and traceability

8.5.2 Is the traceability system included in all Operational Traceability System
document

8.3.6 Is there any change point control system available? Change Point Control

1). Is there change point Identification requirement

available?
1). Is there verification & validation activity as per Technical
8.5.6.1 plan/customer requirement? Noticem,Validation plan &
2.)Is there validate change before Implementation? Record, Change point
3.) Is there evidences & retention record available for
verification & validation?

8.5.6.1.1 Is there any temporary change in process control? Document Issue Records

Is the Record available of issue Mass Production Mass Production

8.5.1 Transition Declaration prior going to Mass Production Declaration

7.2.2/7.2.1 Is the competence defined for the personnel performing

Skill Matrix
Production process & Revaluate as defined interval

Control of Record
7.5.3/7.5.3.1 Is the record have following requirement Records
identification,storage,Protection,retrivel,retention and
disposal of records

Records Retention
7.5.3.2 Is the statutory ,regulatory and customer requirement Retention system
follow

Corrective Action
●Is the Reviewing the nonconformities ( Including
Customer Complaints/
10.2 Customer Complaints )
C'Measure Implementation
●Verification of Nonconformity Implementation
●Is the effectiveness of Corrective action review.

MS/WFIM 09 FO 12, ISSUE 00 DEC 2015 Score Achieve

 Total Score

Score % #DIV/0!

Auditee Signature :
NAL AUDIT CHECKLIST

Date :
Time : NC
Shift : Remarks

Observations Major/Minor/OI
Score Guide lines :
0 Major NC
1 Minor NC
2 Opportunity for Improvement ( OI if Trend is improving )
3 Full fill the system Requirements
Score Guide lines :
0 Major NC
1 Minor NC
2 Opportunity for Improvement ( OI if Trend is improving )
3 Full fill the system Requirements

Auditor Signature :
 INTERNAL AUDIT CHECKLIS

Department : Purchase AUDIT REF.: IQA

Score
Auditee : Auditor :

CL.NO. Checkpoints Confirmation Document

Are the process identified and established ?

8.4 i.e. Supplier ,Performance monitoring, Purchase -local, Departmental Procedure
Purchase-Imports, Supplier Development, etc.

Are the Quality objective deployed in the Purchase

6.2.1/6.2.2 department.
Departmental objectives
i.e. Same Objective as determined along with the
quality policy or supporting departmental objectives.

8.4.1.2 Dose they have a process for supplier selection Supplier Selection
Procedure

6.1.2.1 Is there a formal process available for risk analysis? Risk Analysis

6.1.2.1 Are there any risks and opportunities identified? Any

Risk Analysis
Mitigation actions for risks identified?

6.1.2 Status of Mitigation actions implementation and

Risk Analysis
effectiveness?

Abnormal conditions / unexpected change

( Contingency Plan )
6.1.2.3 Abnormal Conditions / Unexpected change to
Contingency Plan
satisfy customer requirements in event of an
emergency such as labour shortage ,utility
intruptions,key equipment failure

Is Contingency Plan tested for suitability and

6.1.2.3 reviewed annualy with CFT including top Contingency Plan
management?
are records maintained as a result of necessary actions
8.4.2.1 taken for improvement in supplier performance & its supplier performance
effectiveness ?

Is statutory and regulatory requirements implemented

8.4.2.2 at supplier end? Declaration from Supplier

1)Is Approved Supplier List available? Approved Supplier

8.4.2.3 2.) Is supplier compliance to ISO 9001 through Second List/ISO Certificates
Party Audits.
 Are the supplier selected on base of following
1). An assesment of the selected supplier's risk to
8.4.1.2 product confirmity Supplier Selection
2).relevant quality & delivery performance Procedure
3). An evaluation of the supplier's quality management
system

Are the frequancy of supplier visit/audits are defined to Supplier Selection

8.4.1.2 know their status of system development?are records Procedure
maintained?

Actions plan are prepared in joint discussion with your

8.4.2.5 supplier for estabilishing / upgrading the system as per Supplier Selection
IATF 16949:2016 Procedure

Has customer prescribed any source to purchase Supplier Selection

8.4.1.3 products,materials ,tools or services under contractual Procedure
conditions?

Is supplier performance been monitored based on

following:
●Delivery product confirmity to requirements Supplier Performance
8.4.2.4 ●Customer disruptions at the receiving plant Rating Procedure
●Delivery schedule performance
●Number of occurences of Premium Freight
●Customer Notification on quality / Delivery Issues

Are they any outsource process identified in the

organization?
8.5.1.6 E.g Casting ,Machining,painting Job Responsibility
Note : Are any technical responsibility with in the
organization delegated for outsource process

8.5.1.6 are control of these outsource process identified in the Supplier QMS
QMS? Improvement Plan

Is there a system exist for process/plant change request Change management

8.5.6.1 from supplier?are the responsible person defined for
approval of chage request? System

Control of Record
7.5.3/7.5.3.1 Is the record have following requirement Records
identification,storage,Protection,retrivel,retention
and disposal of records

Records Retention
7.5.3.2 Is the statutory ,regulatory and customer Retention system
requirement follow

Corrective Action
●Is the Reviewing the nonconformities ( Including Customer Complaints/
10.2 Customer Complaints ) C'Measure
●Verification of Nonconformity Implementation Implementation
●Is the effectiveness of Corrective action review.
 Is the competency defined for the personnel performing Competency
purchase process ?
7.2.2/7.2.1
Are input for Purchase process identified in terms of Training Need
training needs? Identification

Score Achieve 0
MS/WFIM 09 FO 12, ISSUE 00 DEC 2015 Total Score
Score % #DIV/0!
Auditee Signature :
NAL AUDIT CHECKLIST

Date :
Time : NC
Shift : Remarks

Observations Major/Minor/OI
Score Guide lines :
0 Major NC
1 Minor NC
2 Opportunity for Improvement ( OI if Trend is improving )
Auditor Signature :
3 Full fill the system Requirements
 CHECK LIST AUD
LOGO EMPRESA
Departamento : MANTENIMIENTO AUDITORIA REF.: SPC/2018/AI12
Auditado : Auditor :
CLAUSULA NO. Punto a Revisar Documento a Confirmar

¿Existe un procedimiento documentado disponible para el Procedimiento del

8.5.1.5
departamento de mantenimiento? departamento

Son los objetivos de calidad desplegados en el departamento

6.2.1/6.2.2 de mantenimiento.
Objetivos del Departamento
Es decir, los objetivos del departamento son los mismos que
tiene la gerencia para la revisión administrativa? .

8.4.1.2 Se tiene un proceso de selección de proveedores. Procedimiento de selección de

proveedores

6.1.2.1 ¿Existe un proceso formal disponible para el análisis de

Análisis de Riesgo
riesgos?

6.1.2.1 ¿Existen riesgos y oportunidades claramente identificados

Análisis de Riesgo
c/u? ¿Acciones de mitigación para los riesgos identificados?

6.1.2 ¿Cuál es Estado de implementación y efectividad de las

Análisis de Riesgo
acciones de mitigación?

Condiciones anormales / cambio inesperado (Plan de

contingencia)
6.1.2.3  Condiciones anormales / cambio inesperado para satisfacer
Plan de Contingencia
los requisitos del cliente en caso de una emergencia, como
escasez de mano de obra, interrupciones de servicios
públicos, falla de equipos clave"

¿Se han Probado periódicamente los planes de contingencias Plan de Contingencia y una
6.1.2.3 para efectividad (ej., simulaciones, conforme sea simulación, ej. subestación
apropiado);? eléctrica.
¿Se verifica la idoneidad del Plan de Contingencia y se revisa
6.1.2.3 anualmente en conjunto con el equipo multifuncional, incluida Plan de Contingencia
la alta gerencia?
¿Existe un listado del equipo de proceso (con codificación),
8.5.1.5 necesario para producir el producto conforme al volumen Lista de Maquinaria y Equipos
requerido?

¿Existe disponibilidad de piezas de repuesto para los Listado de partes o refacciones

8.5.1.5
equipos / máquinas identificados? críticas con min y Max.

Se cuenta con plan de Mantenimiento preventivo y predictivo Plan de mantenimiento

8.5.1.5
y registros. preventivo e informe de MP
 ¿Hay provisión para el embalaje y conservación de equipos,
8.5.1.5/8.5.4 Manejo y cuidados de equipos
herramientas y medidores?

Formato de historial de la
8.5.1.5 Manteniendo la ficha de historial de la máquina.
máquina
MTBF & MTTR, o equivalentes
¿Hay MTBF (Tiempo medio entre fallos) y MTTR (Tiempo
8.5.1.5 de reporte fallas y tiempo
medio entre reparaciones calculado con frecuencia definida?
muerto
8.5.1.5 ¿Qué medidas se tomaron para prevenir la avería? Plan de acción en el tiempo

Hoja de verificación de la
¿Cómo se pone en marcha un equipo después después de un
8.5.1.4 máquina y aprobación del
período de paro planificado y no planificado?
producto

8.5.1.4 ¿Esta el registro de cada equipo disponible? Revisar llenado de registro

¿Hay registros de mantenimiento para cada equipo Registro/Almacenamiento de

8.5.1.4
identificado? registros

Control de Registro
¿El registro tiene los siguientes requisitos de identificación,
7.5.3/7.5.3.1 almacenamiento, protección, recuperación, retención y Archivos
eliminación de registros?
Retención de registros

Sistema de retención de
7.5.3.2 ¿Se cumplen los requisitos legales, reglamentarios y de los
registros y req específicos del
clientes?
cliente (cuando aplique)

Acción correctiva
● ¿Está revisando las no conformidades (incluidas las quejas Quejas de clientes /
10.2 de los clientes)? Implementación de mediciones
● Verificación de Implementación de No Conformidad o métricos
● Es la efectiva la revisión de acciones correctivas .

¿Esta la competencia definida para el personal que realiza el

proceso de Mantenimiento? Competencia / Perfil del puesto
7.2.2/7.2.1
¿Se tienen definidos los entrenamientos por tipo de puesto Identificación de necesidades de
(mecánico, eléctrico etc.)? entrenamiento o matriz de
multihabilidades
Puntuación alcanzada
Puntaje total

Puntuación %

Nombre y Firma del

Auditado :
CHECK LIST AUDITORIA INTERNA

Fecha:
Hora : NC
Score

Turno : Observaciones
Observaciones Mayor/Menor/Obs.

10

10

10

10

10

10

10

10

10

10

10

10
 10

10

10

10

10

10

10

10

10

10

10

10

240 Guía de puntuación:

0 NC MAYOR, 3 NC menor, 7 Oportunidad de mejora (Obs. si la tendencia está
240 mejorando)
10 Cumple con los requisitos del sistema
100.0%

Nombre y Firma del Auditor:

 INTERNAL AUDIT CHECKLIST

Department : Marketing AUDIT REF.: IQA

Score
Auditee : Auditor :

CL.NO. Checkpoints Confirmation Document

8.2 Is there a documented procedure available for

Departmental Procedure
Marketing Department

Are the Quality objective deployed in the Purchase

6.2.1/6.2. department.
2 Departmental objectives
i.e. Same Objective as determined along with the
quality policy or supporting departmental objectives.

8.4.1.2 Dose they have a process for supplier selection Supplier Selection Procedure

6.1.2.1 Is there a formal process available for risk analysis? Risk Analysis

6.1.2.1 Are there any risks and opportunities identified? Any

Risk Analysis
Mitigation actions for risks identified?

6.1.2 Status of Mitigation actions implementation and

Risk Analysis
effectiveness?

Abnormal conditions / unexpected change

( Contingency Plan )
6.1.2.3 Abnormal Conditions / Unexpected change to
Contingency Plan
satisfy customer requirements in event of an
emergency such as labour shortage ,utility
intruptions,key equipment failure

Is Contingency Plan tested for suitability and

6.1.2.3 reviewed annualy with CFT including top Contingency Plan
management?
 Is method of measurement of customer
satisfaction/Perception determined?
●Customer Feedback
●Customer Audit
●Customer Survey
●Feedback to obtaine product image in the market
8.2.1 Customer Satisfaction index
●Handling customer complaints
●Increase market share
●Repeative order
●Cost effective
●Enhance met in product properties
●Product development and inovation etc.

Is following consider in customer satisfaction,as a

minimum.
Delivered part Quality Performance
8.2.2.1 Customer Line Distruptions Customer Satisfaction index
Delivery Performance
Incident Premium fraight
Customer notification ( Including penalty etc ) on
Quality / Delivery issue

8.2.1 Are corrective action identified if the customer Corrective & Preventive action
requirement are not full filled?

Are the requirement reviewed and necessory input

8.2.3 from various departmrnt obatined prior to
organization commitment?

Are the record of above reviews and action arising

due to this review maintained?

Are the relavent document amended and

communicated to the relavent department in case of
amendment to the order?

Is the output from the marketing department

communicated to the relavent department

Control of Record
7.5.3/7.5. Is the record have following requirement
3.1 Records
identification,storage,Protection,retrivel,retention and
disposal of records
 Records Retention
7.5.3.2 Is the statutory ,regulatory and customer requirement Retention system
follow

Corrective Action
●Is the Reviewing the nonconformities ( Including
Customer Complaints/
10.2 Customer Complaints )
C'Measure Implementation
●Verification of Nonconformity Implementation
●Is the effectiveness of Corrective action review.

Is the competency defined for the personnel performing

MKT process ? Competency
7.2.2/7.2.
1
Are input for MKT process identified in terms of training
needs? Training Need Identification

MS/WFIM 09 FO 12, ISSUE 00 DEC 2015 Score Achieve 0

Total Score 39
Score % 0
Auditee Signature :
AUDIT CHECKLIST

Date :
Time : NC
Shift : Remarks

Major/
Observations
Minor/OI
Score Guide lines :
0 Major NC
1 Minor NC
2 Opportunity for Improvement ( OI if Trend is improving )
Auditor Signature :
3 Full fill the system Requirements
 INTERNAL AUDIT CHECKLIST

Department : Quality Control AUDIT REF.: IQA Date :

Time : NC

Score
Auditee : Auditor : Shift : G Remarks
CL.NO. Checkpoints Confirmation Document Observations Major/Minor/OI

Are the process inspection & testing is being carried out as per defined frequency
8.5.1 in PQCS / OPS/Inspections standards/WI Inspection Report

is there setup approval done as per defined standards Setup approval report

Are rejects, rework, and adjustment parts, as well as internal residues strictly
8.7.1 separated and identified & Record Maintain Reject , Rework Record

Is the material and parts flow secured against mix-ups / exchanges by mistake
8.7.1 and traceability guaranteed. Identification & Traceability

Are tools, equipment and inspection, measuring and test equipment stored
8.5.1.6 correctly. List of Tools & Equipments

Abnormal conditions / unexpected change ( Contingency Plan )

Abnormal Conditions / Unexpected change to satisfy customer requirements in
6.1.2.3 event of an emergency such as labor shortage ,utility intruptions,key equipment Contingency Plan
failure

6.1.1 Is there a formal process available for risk analysis? Risk Analysis

Are there any risks and opportunities identified? Any Mitigation actions for risks
6.1.2 identified? Risk Analysis

6.1.2 Status of Mitigation actions implementation and effectiveness? Risk Analysis

Are the special characteristics identified in the PFMEA , PQCS,Operations

8.3.3.3 standards , Inspections standards, etc. OPS,Inspections standards

6.2 Are the Quality Objectives deployed in the department? PI data

6.1.2.2/10 Are correction and Preventive actions taken in case the Criteria are not
.2 met? Action plan

Are the appearance item identify and displayed at the required location.
Control of Limit Sample includes following information
1.Date of production of the limit sample
2.Control No. master List of Limit
8.6.3 3.Inspection Items ( Scratch, Roughness, unevenness etc. ) Sample/Identification Tag
4.Applicable Part Name & Part No.
Effective Period
6.Significant field.

8.6.3 Are Limit sample retain considering damage,deteorition etc. master List of Limit
Sample/Identification Tag

9.1.1.2 Is there understanding of statistical concepts variation ,stability , process Training Record
capability& over adjustment?

8.6.2 Are Layout Inspections at specified frequency included in control plans Layout Plan
being carried out?

8.6.2 Does the verification of effectiveness of layout inspection functional Layout Reports & Records
testing has done? Records for the same are maintained?

7.1.5 Are the instruments / Gauges / Test Soft Wares used for testing / Calibration History Card/ Plan
verification in quality calibrated or verified?

Is MSA carried out for such instruments, which are referred in Control
7.1.5 Plans? MSA Plan / MSA Report
What are improvement plans for enhancing Measurement Systems?

8.7.1.4 Do work instructions for re-inspection of re-work products for the type Reject , Rework Record / Defect
of defects exist? Matrix,WI

Is there a system for taking concessions on Non-conforming Products

8.7.1.1 from customer prior to further processing? Deviation Request

8.7.1.1 Do records of concessions mention Quantity or Expiration period by Deviation Request

customer?

8.7.1.1 What type of Marking / Identification is provided to customer Identification & Traceability
“Concession” Products”?

Is there any customer complaints closed or not Customer Complainst

is there customer complaints tracking record available customer complaints tracking sheet

Is there customer return record available Customer return register

Is there customer return rejection analysis available Customer return analysis record

9.2.2.4 Verify identification of the stages (Production & Delivery) and frequency Product Audit Plan
of Product Audit?

9.2.2.3 Is ‘Process Audit” carried out at each Manufacturing Process? Verify Process Audit Plan
frequency and check List.

Is there a system for utilizing a process for Problem Solving, leading to

10.2 root cause identification and elimination? 8D/ CAPA Report

7.2.2 Is the competence defined for the personnel performing Quality process Skill Matrix
& Re-evaluate as defined interval

MS/WFIM 09 FO 12, ISSUE 00 DEC 2015 Score Achieve 0 Score Guide lines :
Total Score 72 0 Major NC
1 Minor NC
Score % 0 2 Opportunity for Improvement ( OI if Trend is improving )
Auditee Signature : Auditor Signature :
3 Full fill the system Requirements