Internal Audit Checksheet - IATF 16949 - 2016

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Company

Logo Internal Audit Checklist (as per IATF 16949:2016)

Date of Audit :10/4/2023

Clause Audit Checkpoint

4.1 Understanding the organization and its context


4.1 List of External & Internal Issue with their review frequencey

4.2 Understanding the needs and expectations of interested


parties
4.2 List of interested parties and their needs & expectations with
review frequency and linkage with organization QMS

4.3 Determining the scope of the quality management system


4.3 The scope of QMS with justification of any exlcusion in the quality
manual

4.3.1 Determining the scope of the quality management system ---


supplemental
4.3.1 Supporting functions shall be included in the scope of the Quality
Management System (QMS).

4.3.2 Customer-specific requirements


4.3.2 Customer-specific requirements and it's linkage with organization
QMS.

Quality management system


4.4 4.4.1 - List of Processes and their interaction, Turtle Diagram

4.4.1.1 Conformance of products and processes


4.4.1.1 List of processes including outsourced process
4.4.1.2 Product safety
4.4.1.2 Documented processes for the management of product-safety
related products and manufacturing-processes

5.1 Leadership and commitment


5.1, 5.1.1, 5.1.1 General
5.1.1.1 Corporate responsibility
5.1.1.1 Corporate responsibility policies including code of conduct, anit-
bribery policy, whistle blowing, etc.

5.1.1.2 Process effectiveness and efficiency


5.1.1.2 Review of Process effectiveness and efficiency in MRM / regular
meetings
5.1.1.3 Process owners
5.1.1.3 List of Processes with responsibility for implementation
5.1.2 Customer Focus
List of customer and applicable statutory and regulatory
5.1.2 requirements , CSR
Risks and opportunities Identification

5.2 Policy
5.2.1 Developing the quality policy
Availability of quality policy
5.2
5.2.2 Communicating the quality policy
understanding of quality policy by employees

5.3 Organizational roles, responsibilities and authorities - as per


5.3 organization chart
5.3.1 Organizational roles, responsibilities, and authorities –
supplemental
5.3.1 Responsibility for customer requirements deployment, customer
portal access, etc.
5.3.2 Responsibility and authority for product requirements and
corrective actions
personnel responsible for conformity to product requirements
have the authority to stop shipment and stop production to
5.3.2 correct quality problems
production operations across all shifts are staffed with personnel
in charge of, or delegated responsibility for, ensuring conformity
to product requirements

6.1 Actions to address risks and opportunities


6.1.1 Risk & Mitigation Control, FMEA, Contingency Plan
6.1 6.1.2 The organization shall plan:
Linkage of Risk & Mitigation control with QMS
6.1.2.1 Risk analysis
6.1.2.1 Risk & Mitigation, FMEA, Contingency Plan
6.1.2.2 Preventive action
6.1.2.2 potential nonconformities identification & prevention
6.1.2.3 Contingency plans
6.1.2.3 contingency plan with review/test frequenccy

6.2 Quality objectives and planning to achieve them


6.2.1 List of quality objectives at relevant functions, levels and
processes needed for the quality management system.
6.2
6.2.2 - what will be done, what resources will be required, who will
be responsible, when it will be completed, how the results will be
evaluated (4W-1H)

6.2.2.1 Quality objectives and planning to achieve them –


supplemental
6.2.2.1 Quality objectives at relevant functions, processes, and levels
throughout the organization.

6.3 Planning of changes


6.3 Chanages in QMS system, Documented Information Change Note

7.1 Resources
7.1.1 General
7.1 7.1.2 People - Organization Chart & required Resources

7.1.3 Infrastructure
7.1.3 Maintain the infrastructure necessary for the operation of its
processes
7.1.3.1 Plant, Facility, and equipment planning
7.1.3.1 Risk identification and control, master list of machines, euipments,
resources, etc.

7.1.4 Environment for the operation of processes


The organization shall determine, provide and maintain the
7.1.4 environment necessary for the operation of its processes and to
achieve conformity of products and services. (Humidity,
temperature, ventilation, etc.)

7.1.4.1 Environment for the operation of processes- supplemental


The organization shall maintain its premises in a state of order,
7.1.4.1 cleanliness, and repair that is consistent with the product and
manufacturing process needs. 5S Audits, records, etc.

7.1.5 7.1.5 Monitoring and measuring resources


7.1.5.1 General
7.1.5.1 List of monitoring and measurement devices
7.1.5.1.1 Measurement System Analysis
7.1.5.1.1 MSA Plan, readings & action plan
7.1.5.2 Measurement traceability
7.1.5.2 Calibration identificaation & Traceability of Measurement
7.1.5.2.1 Calibration/Verification Records
7.1.5.2.1 Calibration Plan with verification records
7.1.5.3.1 Internal laboratory
7.1.5.3.1 Scope of internal laboratroy with qualified personnel
7.1.5.3.2 External laboratory
7.1.5.3.2 calibration service provider accredited to ISO/IEC 17025
7.1.6 Organizational knowledge
7.1.6 Competency Matrix

7.2 Competence
7.2 competency matrix - including education, experience, skills, etc.

7.2.1 Competence --- supplemental


7.2.1 Training needs documented process
7.2.2 Competence --- on the job training
7.2.2 OJT (including contractual workers)
7.2.3 Internal auditor competency
7.2.3 List of internal auditor and their competency
7.2.4 Second-party auditor competency
7.2.4 List of second party auditors and their competency

7.3 Awareness
Awareness for quality policy, relevant quality objectives, their
contribution to the effectiveness of the quality management
7.3 system, including the benefits of improved performance, the
implications of not conforming with the quality management
system requirements.

7.3.1 Awareness – Supplemental


7.3.1 Documented information for customer requirements and the risks
involved for the customer with non-conforming product.

7.3.2 Employee motivation and empowerment


7.3.2 Documented process for employee motivation and empowerment

7.4 Communication
7.4 Communication Matrix with defined responsibilities

7.5 7.5 Documented information


7.5.1 General - Quality Manual, Process Interaction, Personnel
7.5.1 Competency
7.5.1.1 Quality management system documentation
7.5.1.1 Quality Manual, Procedures, Master List of Documented
Information - Forms & Formats
7.5.2 Creating and updating
7.5.2 Master list of documented information with responsibility
7.5.3 Control of documented Information
7.5.3 7.5.3.1 Documentation identification, numbering system &
responsibilities
7.5.3.2 Documented information of external origin like customer
7.5.3.2 drawings, toolings, etc.
7.5.3.2.1 Record Retention
7.5.3.2.1 Documented Information Retention & disposition
7.5.3.2.2 Engineering Specifications
7.5.3.2.2 Documented Process for Engineering changes review and
implementation, ECN Note, register, review
8.1 Operational planning and control
8.1 Production Planning, Manufacturing & Control Process, List of
Outsourced Process/ Vendors and it's control
8.1.1 Operational planning and control — supplemental
customer product requirements and technical specifications,
8.1.1 logistics requirement, manufacturing feasibility, project planning ,
acceptance criteria
8.1.2 Confidentiality
8.1.2 confidential agreement (if any)

8.2 8.2 Requirements for products and services


8.2.1 8.2.1 Customer communication, MOM, specific requirements

8.2.1.1 Customer communication — supplemental


Organization ability to communicate necessary information,
8.2.1.1 including data in a customer-specified computer language and
format (e.g - computer-aided design data, electronic data
interchange).
8.2.2 Determining the requirements for products and services
8.2.2 Customer Specific requirements, drawings, special characteristics,
MOM

8.2.2.1 Determining the requirements related to products and


services - supplemental
Manufacturing feasibilty / contract review to include
requirements of recycling, environmental impact, and
8.2.2.1 characteristics identified as a result of the organization's , any
applicable government, safety, and environmental regulations
related to acquisition, storage, handling, recycling, elimination, or
disposal of material.

8.2.3 Review of requirements related to products and services


8.2.3 8.2.3.1 Contract review
8.2.3.1 8.2.3.2 results of the review & decision

8.2.3.1.1 Review of the requirements for products and services


8.2.3.1.1 — supplemental
customer-authorized waiver evidence (if any)
8.2.3.1.2 Customer-designated special characteristics
8.2.3.1.2 customer requirements for designation, approval documentation,
and control of special characteristics.
8.2.3.1.3 Organization manufacturing feasibility
8.2.3.1.3 Manufacturing feasibilty study
Results of the review, any new requirements for the products and
8.2.3.2 services, mom
8.2.4 Changes to requirements for products and services change
8.2.4 management
8.3 Design and development of products and services
8.3.1 General
8.3, 8.3.1 design and development documented process

8.3.1.1 Design and development of products and services –


supplemental
8.3.1.1 manufacturing process design and development and shall focus on
error prevention rather than detection.

8.3.2 Design and development planning


8.3.2 Master Development Schedule, Micro Plan & Tracking of progress

8.3.2.1 Design and development planning --- supplemental


8.3.2.1 CFT Appraoch, Use of APQP Method

8.3.2.2 Product design skills


8.3.2.2 Competency for Person with Product design skills

8.3.2.3 Development of products with embedded software


8.3.2.3 Software development assessment methodology (where applicable)

8.3.3 Design and development Inputs


8.3.3 Customer drawings, customer requirements, MOM, etc

8.3.3.1 Product design input


product drawings, specifications, requirements for identification,
traceability, and packaging, including preservation, reliability,
8.3.3.1 durability, serviceability, health, safety, environmental,
development timing, and cost;
g) applicable statutory and regulatory requirements of the
customer-identified country of destination, etc.

8.3.3.2 Manufacturing process design input


Product design output data, targets for productivity, process
capability, timing, and cost, customer requirements, experience
8.3.3.2 from previous developments, new materials, product handling and
ergonomic requirements; and design for manufacturing and design
for assembly.

8.3.3.3 Special characteristics


8.3.3.3 - special characteristics and deployment down the line
- documented information like fmea, control plan, etc
8.3.4 Design and development controls
8.3.4 Design and development reviews, verification and validation records

8.3.4.1 Monitoring
8.3.4.1 Tracking & Progress Sheet, review and monitoring
8.3.4.2 Design and development validation
8.3.4.2 Vlalidation documented information
8.3.4.3 Prototype programme
8.3.4.3 When required by the customer, the organization shall have a
prototype program and control plan.
8.3.4.4 Product approval process
8.3.4.4 PPAP documented information
8.3.5 Design and development outputs
8.3.5 Documented information on design and development outputs, final
drawings
8.3.5.1 Design and development outputs – supplemental
Design risk analysis (FMEA), reliability study results, product
8.3.5.1 special characteristics, packaging and labeling requirements for
shipping, etc.

8.3.5.2 Manufacturing process design output


specifications and drawings, special characteristics for product and
8.3.5.2 manufacturing process, manufacturing process flow charts/layout,
manufacturing process FMEA, control plan, standard work and
work instructions, etc.

8.3.6 Design and development changes


8.3.6 Engineering Change Note, review , monitoring & implementation

8.3.6.1 Design and development changes - supplemental


8.3.6.1 Validated of changes against customer requirements and
approved internally, prior to production implementation.
8.4 Control of external provision of goods and services
8.4 8.4.1 General
Master list of externally provided goods and services
8.4.1.1 General - supplemental
Master list of externally provided goods and services (vendors) to
8.4.1.1 include sub-assembly, sequencing, sorting, rework, and calibration
services
8.4.1.2 Supplier selection process
8.4.1.2 Documented Process for Supplier selection process
8.4.1.3 Customer-directed sources (also known as “Directed–
Buy”)
8.4.1.3 customer directed vendors/ sources (MOM, E-Mails, agreement,
etc)
8.4.2 Type and extent of control
8.4.2 Supplier Evaluation & Monitoring documented process
8.4.2.1 Type and extent of control – supplemental
8.4.2.1 Supplier Evaluation & Monitoring documented process - type of
control, inspection, audit plan, etc.
8.4.2.2 Statutory and regulatory requirements
8.4.2.2 P.O, communication to external service provider for special and
regulatory requirements

8.4.2.3 Supplier quality management system requirements


8.4.2.3 QMS status of vendor (minimum ISO 9001:2015) with
upgradation/ audit plan

8.4.2.3.1 Automotive product-related software or automotive


8.4.2.3.1 products with embedded software
Process for software quality assurance for their products (if any)

8.4.2.4 Supplier monitoring


8.4.2.4 Documented process for Supplier Monitoring, review, data and
action plan
8.4.2.4.1 Second-party audits
8.4.2.4.1 Second Party audit plan, frequency, Second party auditor
competency
8.4.2.5 Supplier development
8.4.2.5 Supplier development priority, plan, action plan
8.4.3 Information for external providers
8.4.3 Supplier Registration Form
8.4.3.1 Information for external providers - supplemental
8.4.3.1 Communication for statutory and regulatory requirements and
special product and process characteristics
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5 Partrol Inspection, Competent Personnel, periodic revalidation,
pokayoke ,etc.
8.5.1.1 Control plan with reaction plan, special characteristics,
8.5.1.1 alternate process control method (if any)

8.5.1.2 Standardized work – operator instructions and visual


8.5.1.2 standards - local language, legible, understood by personnel

8.5.1.3 Verification of job set-ups - first piece and laste part


8.5.1.3 validation (as applicable)
8.5.1.4 Verification after shutdown
8.5.1.4 Actions to ensure product compliance with requirements after a
planned or unplanned production shutdown period.

8.5.1.5 Total productive maintenance


- Prevention Plan, records, action plan
8.5.1.5 - Predictive Plan, records, action plan
- Periodic Overhaul (Analysis)
- MTTR, MTBF data and action plan

8.5.1.6 Management of production tooling and manufacturing,


8.5.1.6 test, inspection tooling and equipment
Tool life monitoring, duplication plan, maintenance, etc
8.5.1.7 Production scheduling
8.5.1.7 Producion Planning & control
8.5.2 Identification and traceability
8.5.2 Route Card, Identification Tags

8.5.2.1 Identification and traceability — supplemental


8.5.2.1 Documenting traceability plans, based on the levels of risk or
failure severity for employees, customers, and consumers.

8.5.3 Property belonging to customers or external providers


8.5.3 List of Customer Property - their identification, maintenance and
safety status

8.5.4 Preservation
8.5.4 Identification, handling, contamination control, packaging, storage,
transmission or transportation, and protection.

8.5.4.1 Preservation - supplemental


8.5.4.1 Stock Verification Checklist to avoid deterioriation
Inventory Management, Use of “first-in-first-out” (FIFO).

8.5.5 Post-delivery activities - Control of Post-delivery activities can


include actions under warranty provisions, contractual obligations
8.5.5 such as maintenance services, and supplementary services such as
recycling or final disposal. (where applicable)

8.5.5.1 Feedback of information from service


Instructions for material handling, logistics, engineering, and
8.5.5.1 design activities is established, implemented, and maintained.
(where applicable)
8.5.5.2 Service agreement with customer - verification of
8.5.5.2 effectiveness and service personnel trained in applicable
requirements
8.5.6 Control of changes
8.5.6 Change Management documented process
8.5.6.1 Control of changes - supplemental
8.5.6.1 Verification, validation records, customer authorization (where
applicable)
8.5.6.1.1 Temporary change of process controls
8.5.6.1.1 List of approved back-up or alternate process control methods.

8.6 Release of products and services


8.6 Pre Dispatch Inspection Standard & Records with traceability of
person doing inspection
8.6.1 Release of products and services — supplemental
8.6.1 PDIR standard linkage with Control Plan
Initial
8.6.2 Layout inspection and functional testing
8.6.2 Layout and functional testing plan & records

8.6.3 Appearance items


Standard Instruction for apperance items, master sample
verification and change frequency, Verification that personnel
8.6.3 making appearance evaluations are competent and qualified to do
so.

8.6.4 Verification and acceptance of conformity of externally


provided products and services
8.6.4 Incoming Inspection standards, Reports or any other alternate
arrangement
8.6.5 Statutory and regulatory conformity
8.6.5 Inspection reports with ensuring confirmation to any statutory and
regulatory conformity
8.6.6 Acceptance criteria - Sampling plan for variable and attribute
8.6.6 data
8.7 Control of nonconforming outputs
8.7.1 8.7.1 control of non conforming documented process
8.7.1.1 Customer authorization for concession
8.7.1.1 Deviation Note, Deviation Register, Customer authorrization
(where applicable)
8.7.1.2 Control of nonconforming product – conformance with
8.7.1.2 customer-specified controls
8.7.1.3 Control of suspect product
8.7.1.3 Appropriate manufacturing personnel receive training for
containment of suspect and nonconforming product.
8.7.1.4 Control of reworked product
8.7.1.4 Rework documented process, rework instructions, records and
action plan
8.7.1.5 Control of repaired product
8.7.1.5 Repair documented process, repair instructions, records and
action plan, deviation, customer approval, MOM

8.7.1.6 8.7.1.6 Customer notification for non conforming shipment

8.7.1.7 Nonconforming product disposition


8.7.1.7 documented process for disposition of nonconforming product not
subject to rework or repair.
8.7.2 documented information for nonconformity, actions taken,
describes any concessions obtained,
8.7.2 identifies the authority deciding the action in respect of the
nonconformity.

9.1 Monitoring, measurement, analysis and evaluation


9.1.1 General
9.1.1 MIS (Quality Objectives including process and product effectiveness
and efficiency parameters)

9.1.1.1 Monitoring and measurement of manufacturing processes


- Measurement techniques, sampling plans, acceptance criteria,
9.1.1.1 reaction plans
- 4 M Change recording system

9.1.1.2 Identification of statistical tools


9.1.1.2 Special characteristics, spc plan, readings & action plan
9.1.1.3 Application of statistical concepts
9.1.1.3 Knowledge & application of statistical concepts by concerned
personnel
9.1.2 Customer satisfaction
9.1.2 Customer Survey, customer score cards, customer complaints

9.1.2.1 Customer satisfaction – supplemental


MIS of customer disruptions, field returns, recalls, and warranty
9.1.2.1 (where applicable), delivery schedule performance (including
incidents of premium freight), customer notifications related to
quality or delivery issues

9.1.3 Analysis and evaluation


9.1.3 MIS (Quality Objectives) review, analysis & action plan for
improvement
9.1.3.1 Prioritization
9.1.3.1 Review of quality objectives as per target & prioritization of
actions for improving customer satisfaction.
9.2 Internal Audit
9.2.1 Internal Audit Plan
9.2 9.2.2 List of Internal Auditors, NC records, action plan, closure &
effectiveness monitoring
9.2.2.1 Internal audit programme
9.2.2.1 Documented internal audit process with frequency of audit
9.2.2.2 Quality management system audit
The organization shall audit all quality management system
9.2.2.2 processes over each three-year calendar period with sample audit
of CSR (customer specific requirements)

9.2.2.3 Manufacturing process audit


9.2.2.3 Manufacturing processes audit plan, records and action plan

9.2.2.4 Product audit


9.2.2.4 Product Audit Plan, records and action plan
9.3 Management review
9.3 9.3.1 9.3.1 General
MRM Plan
9.3.1.1 Management review - supplemental
9.3.1.1 Management review frequency (shall be conducted at least
annually)
9.3.2 Management review Inputs
9.3.2 MRM Agenda
9.3.2.1 Management review inputs – supplemental
MRM Agenda (cost of poor quality , measures of process
9.3.2.1 effectiveness, new facilities,customer scorecards, identification of
potential field failures identified through risk analysis - such as
FMEA)

9.3.3 Management review outputs


9.3.3 MRM - Minutes of Meeting (with action plan, date, responsibility &
status)

9.3.3.1 Management review outputs – supplemental


9.3.3.1 Action plan when customer performance targets are not met.

10 Improvement
10.1 General
10.1 Correction, corrective action, continual improvement, breakthrough
change, innovation and re-organization.
10.2 Nonconformity and corrective action
10.2 10.2.1 Custsomer/ Internal complaints
10.2.2 - 8D/CAPA
10.2.3 Problem solving
Documented process for problem solving, root cause analysis,
10.2.3 methodology used, analysis, and results, 8D/CAPA with
standardization
10.2.4 Error-proofing
10.2.4 Documented process for Error-proofing, list of pokayoke and thier
status, pokayoke verification checksheet
10.2.5 Warranty management systems
10.2.5 Method for warranty part analysis, including NTF (no trouble
found).
10.2.6 Customer complaints and field failure test analysis
10.2.6 Warranty Analysis, action plan & communication with customer

10.3 Continual improvement


10.3 List of Continual improvement records, kaizen, pokayoke, etc.

10.3.1 Continual improvement - supplemental


10.3.1 Documented process for continual improvement.
Internal Audit Checklist (as per IATF 16949:2016)

Auditor :Ankur Dhir


Compliance
Observation NC Reference
Y N

RISK ANALYSIS /COTO FORMAT-AGS/F/MR/09 y

RISK ANALYSIS /COTO FORMAT-AGS/F/MR/09 y

Defined in QMS MANUAl- Assembly of PCBA with SMT


Mounting of electronics& Mechanical Components Y

Defined in QMS MANUAl- Assembly of PCBA with SMT Manual Updation


Mounting of electronics& Mechanical Components Y and Finalization

Hella manual- customer property AGS /F/NPD/21

List of processes interaction,, N


List of outsourcing processess to be made N

ESD PROTECTIVE AREA - AGS/F/IQC/05 y

Pending N

AS PER ORG CHART - AGS/F/HR/02 Y

DISPLAYED but Wrong Document No N To be ammended


AS PER ORG CHART - AGS/F/HR/02

To Update JD N To be Updated
To be added in Quality Procedure

RISK ANALYSIS /COTO FORMAT-AGS/F/MR/09


Skill Matrix AGS/F/HR/21to be upadated for quality

Contigency plan to be devolped

Objective sheet to be updated To Be updated

Objective sheet to be updated

ROLES AND RESPONSIBILTY TO BE UPDATED ?JD

List of machinery availble Doc no AGS/F/mnt/24

5s audit records available

list available
MSA PLAN TO BE MADE N

Plan and documents available y

calibration done by nabl approved lab


Skill Matrix AGS/F/HR/21to be upadated for all
departments

competence matrix to be updated


To be Planned
To be Planned To Be updated
To be Planned To Be updated
To be Planned To Be updated

Training record

Training record

Evidence of awards/recognation by management/hr


communication matrix to be devolped To Be updated

master list ok

master list ok
master list ok

master list ok
master list ok
available

available

PPC

Available
Available

Available

Available
mom available

availble

availble

availble

availble
availble
availble
availble

Procedure no AGS/DP/NPD/01

13 products

not availble

List of CFT team memebers to be created


skill devolpment - skill matrix for NPD

customer drawings availble

NPD

NPD

IDENTIFIED
tracking sheet to be updated

CP in place
po sent on mail

available

design fmea not applicable only pfmea

layout requirments

supplier list available highlight customer approved source

no outsourced activity
Supplier selection crietria AGS?F ?PUR /10

Ok evidence to be verified
Ok

ok

PO sent on mail Terrms to be added

upgradation for iATF

ok not applicable

carried out

pending
Action plan not in place
to be devolped

terms to be addedin po

available

available
available

available

predictive mtc needs updation/history card are maintained

MTC
PPC

Packing standard/WI and PDI to updated for packing


requirement

Packing standard/WI and PDI to updated for packing


requirement

WI FIFO DOCUMENT NO to be given

dispatch dept monitors same

dispatch dept monitors same


Deviation note by customer

available

pdi report available

Deviation note by customer


PDI/CUSTOMER COMPLAINTS MR

list of suspect product

rework products are not allowed by customer

reapaired products are not allowed by customer


nc procedure

nc format

nc format

Objective sheet to be updated

4m change record to be updated


spc plan to be made

SPC Training to be added in training plan


customer scorecard available/repeat order data to be
updated

customer scorecard available/repeat order data to be


updated

Objective sheet to be updated

Objective sheet to be updated

available
available

MR

QA
NPD

TO BE CONDUCTED

TO BE CONDUCTED
TO BE CONDUCTED

TO BE CONDUCTED

TO BE CONDUCTED

TO BE CONDUCTED

Displays /statuary requirments /emergency assembly


point/company name board

ok

ok

list of poka yoke

TO BE UPDATED
TO BE ANALYSED

TO BE ANALYSED
TO BE ANALYSED
IMPORTANT
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