PROCESS AUDIT CHECKLIST

Audit Area: Date:

Complies
QUESTION WHAT TO LOOK FOR: Yes / No
MATERIALS CONTROL
*Expedited shipments
Are raw materials on hand as needed? *Downtime
*Overtime yes

Does the Work Order match the product print
requirements and the materials used in production?
Is Material/Product identified at all stages of the
process?
Is non-conforming material traceable?
*Material description and quantity must be the same as used in
production.
yes
*Part Number,
*Status (OK to stock, Non-conforming),
*Supplier / Trico Lot Number, etc.
yes
*Identification of Rejection
*Disposition
*Results of sort/rework (if applicable)
*Disposition for rejected materials after sort/rework
*Control of rejected materials
yes

Does the control plan address incoming material/ *Control Plan

components through processing/ assembly? *Receiving Inspection Records
yes

Are material specifications requiring inspection *Material Certifications

identified? *Incoming Inspection Log
yes
MACHINERY / TOOLING / MEASUREMENT DEVICES (EQUIPMENT)

Is production equipment clearly identified? *Verify equipment identification

yes

Do defined PM responsibilities (maintenance, *Operator instructions

operator, other) exist? *Set-up / shut down procedures
yes
Are accurate and visible maintenance histories *PM records on the equipment
kept on all equipment? yes

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 Complies
QUESTION WHAT TO LOOK FOR: Yes / No
Does Tooling design contemplate the set-up and
quality problems of similar tools used in *Evidence that production experiences are used to design new tools.
production? yes

Is all process equipment available at the place of

work (computers, tools, gauges, measuring, and *Equipment/tools available at workstation
test equipment)?
yes

Is inspection, measuring, and test equipment

identified with a suitable indicator to show *Label on equipment with next calibration due date yes
calibration status?

Is measurement equipment within the calibration *Verify Calibration dates located on labels
due date? yes

Do instructions for set-up/changeover exist? *Documented Work Instruction/Procedure

yes
Do set-up/changeover instructions identify who is *Documented Work Instruction/Procedure
authorized to do what? yes
Is proper disposal of set-up parts (if non- *Documented Work Instruction/Procedure
conforming) defined? yes
Is proper disposal of set-up parts (if non- *Documentation
conforming) defined?

METHOD
*Operator knowledge of the procedure
Do start/stop instructions exist? *Instructions

Do instructions for running the process exist *Documentation

(operator instructions)?

Are all process documents used at the latest *Verify Revision Dates for Blue Print, PFMEA,
revision? Control Plan

Does a PFMEA exist? *PFMEA

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 Complies
QUESTION WHAT TO LOOK FOR: Yes / No

*Recent revision date,

Is the PFMEA a living document? *Change history

Does a PFD exist? *PFD

Are all steps in the process flow included in the *Correlation between PFD and PFMEA
PFD & PFMEA?

Does a Control Plan exist? *Control Plan

Are all stage of the process included in the Control *Correlation between PFD, PFMEA and Control Plan
Plan?

Are Significant / Critical characteristics identified on *Review PFMEA and Control Plan vs. Print
PFMEA and Control Plan?

*Instructions vs. Control Plan

Does each item identified on the control plan have *Gage instructions
inspection instructions associated with it? *Instructions

Are the inspection instructions being followed? *Operators ability to follow instructions
NO
Is there a plan for handling parts out of *Documentation
specification?

Does the action plan protect the customer? *Documentation

Is there a reaction plan for when processes are out *Documentation Work Instruction/Procedure
of control (parts still in specification)?

Are defined and separate containers available for *Containers and disposition documents
good, rework, & scrap product?

*Procedures
Is production stopped when a quality problem has *Production Records
been identified? *Talk To Operators

Is there a documented Non-Conformance Reaction *Documented plan

Plan? *Floor Audit

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 Complies
QUESTION WHAT TO LOOK FOR: Yes / No
Is it available to the operators on the production *Documented plan
floor? *Talk to Operators

Is suspect material identified at each process? *Segregation of suspect materials

*Non-conformance identification system

Is suspect material properly identified? *Documented Procedure/Work Instruction

How is non-conforming Material prevented from *Documentation Work Instruction/Procedure

returning to the production system?

PERSONNEL
Can the person(s) doing the check demonstrate the *Operators ability to perform instructions
proper reaction?

Does the operator have the skills to perform the *Operators ability to follow instructions
inspections?

Does the operator know where to find Procedures / *Operators ability to find instructions
Work Instructions?

Are Employees aware of the Company's Quality *Ask Operators what the Quality Objectives are
Objectives?

ADDITIONAL COMMENTS / OBSERVATIONS:

FCB051 2/24/2004 4 of 12
 Complies
QUESTION WHAT TO LOOK FOR: Yes / No

FCB051 2/24/2004 5 of 12
HECKLIST
Auditee(s):

COMMENTS

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 COMMENTS

FCB051 2/24/2004 7 of 12
 COMMENTS

El operador no siguio las instrucciones de inspeccion

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 COMMENTS

FCB051 2/24/2004 9 of 12
 COMMENTS

FCB051 2/24/2004 10 of 12
 AUDITORIAS AL SISTEMA DE CALIDAD DE U

REQUISITO # DESCRIPCION:

CONTROL DE LOS
EQUIPOS DE MEDICION Y
7.6 SEGUIMIENTO
S AL SISTEMA DE CALIDAD DE UNA EMPRESA

DESCRIPCION :
LA EMPRESA DEBE ASEGURAR LA CALIDAD DE LAS MEDICIONES PARA
GARANTIZAR COMO CONSECUENCIA LA CONFORMIDAD DEL PRODUCTO
CON LOS REQUISITOS ESTABLECIDOS. TRAZABILIDAD DE LOS PATRONES
DE CALIBRACION.. SE DEBE IDENTIFICAR EL EQUIPO DE INSPECCION Y
PRUEBAS CON UN INDICADOR QUE MUESTRE EL STATUS DE CALIBACION
DEL EQUIPO.