MA-PU-402 Rev 2 Date 11 02 2018 ISO TS 16949 2009 Gap Analysis Work Sheet

Minth North America
IATF 16949:2016 Gap Analysis Checklist
This gap analysis worksheet is intended to identify an organization’s gaps against the criteria of
ISO/TS16949:2009. Since IATF 16949:2016 requires process-based audits; this gap analysis checklist is
not designed to substitute for your audit worksheets. Persons using this Checklist shall also have a copy of
the IATF 16949:2016 with them when undertaking an evaluation. There are some spaces on the checklist
that you will need to fill in from the Standard. You will see these as you review the checklist. You will see
questions on the checklist that refer to the specification and highlighted in yellow are the ones that are
additions to ISO 9001 and required for IATF 16949:2016 compliance of your Quality Management System.
As you work through the checklist take notes on what is in place, and what needs to be developed.
Reference procedures or other documents that you have reviewed and that will provide information for the
new QMS. Take notes on the status of the documents, will they need to be revised for the new system? Or
can they be used as is. Also note where processes are in place, but documentation is needed.
Focus on what is in place, and what needs to be developed. While you do want to know if procedures and
processes are being complied with, compliance is not your main focus for this audit. Remember that the
final outcome of this audit should be a list of things that the organization needs to do to conform to IATF
16949:2016.
Date of Gap Analysis: ____________________________________
Minth Location or Supplier Location Analysis was undertaken: ________________________________
Name: _________________________________________________________________________
Address: _______________________________________________________________________
Reason for Gap Analysis: __________________________________________________________
Minth Staff Completing the Analysis: ________________________________________________
_______________________________________________________________________________
Supplier or Minth Location Staff supporting the Analysis: ________________________________
_______________________________________________________________________________
MA-PU-402 Rev 2 Date 11 02 2018 IATF 16949:2016 Gap Analysis Work Sheet Page 1
4 QUALITY MANAGEMENT SYSTEM
REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

(List documents or evidence) Y/N?
Estimated %
Complete
4.1 General Requirements
This clause asks you to identify how management applies the process approach to achieve the effective and efficient control of processes, resulting
in performance improvement. Specifically this section is looking for an overall process evaluation of all quality related processes and their
interrelationships. Look to see that your organizational processes are defined and that consideration is given to the items described below.
Is there a Quality Management System in
place that has been established and
documented to meet the requirements of
the IATF 16949:2016 Technical
Specification?
Look for documentation of the processes

included in the QMS
Look for information on the relationship

and sequence of the QMS processes.
Ask Management if operation and control

of processes is effective. How do they
know if it is effective?
Ask how they are able to know if

resources and information needed to
support processes have been provided.

Estimated %
Complete
Is there any information on the
effectiveness of processes?
How are improvements made to

processes?
Is there implementation of process

measure, monitoring and analysis?
What processes does your organization

outsource?
How are the process controlled?
4.1.1 General Requirements - supplemental

Do the controls over outsourced
processes ensure your responsibility to
conform to all customer requirements?
4.2 Documentation Requirements

This section addresses how you use documents and records to support effective and efficient operation of your organization. A review of your
processes, procedures, work instructions, and records will determine if the standard requirements are met.
4.2.1 General
Does your quality system documentation
include the documentation required by the
technical specification IATF 16949:2016?

Estimated %
Complete
Is the documentation sufficient to ensure
adequate operation of the QMS?
Is the documentation sufficient to ensure

adequacy for the size and type or
organization, complexity and interaction
of processes and competency of
personnel?
Does the quality management system

documentation include the following:
Documented statements of a quality

policy and quality objectives?
A quality manual?
Documented procedures required by

IATF 16949:2016? (there are seven)
Documents needed by the organization to

ensure the effective planning, operation
and control of its processes?
Records required by IATF 16949:2016?

Estimated %
Complete
Is there a list or other means of identifying
other documentation required by your
QMS?
Are the required documents available?
Does the QMS documentation include

Quality Records?
4.2.2 Quality Manual

Review the Quality Manual if available:
What is the scope of your QMS?
What processes have been excluded?

Is this appropriate?
Is a description or illustration of the

interrelation of the processes included?
Does the Quality Manual include a

scope?
Does the Quality Manual adequately

describe the QMS?

Estimated %
Complete
Does the Quality Manual document or
reference the required documented
procedures?
Do employees understand their

responsibilities and the processes they
deal?
4.2.3 Control of Documents

A documented procedure is required.
Do you have a formal procedure
regarding the control of documents for
your organization?
Are documents approved prior to

release?
Are documents updated and re-approved

prior to release?
How are changes identified?
Are documents available to those that

need to use them?
How is the most current version kept in
the correct locations?

Estimated %
Complete
Can users easily identify documents?
Can users easily read the documents?
Are the documents easy and accessible
for the employees use?
If documents such as reference books,

user’s manuals and other outside
documents are used, how are they
controlled?
How are old documents handled?

Are they removed from use?
Are they labeled?
Is a copy maintained for reference?
Is there any chance that an old document
could be used by accident?
Does the organization adequately

document (revision level, date, etc.) the
revision level, date, etc.?
4.2.3.1 Engineering Specifications

Audit the process for review, distribution
and implementation of engineering
specifications:

Estimated %
Complete
Have they been completed per the
customer schedule?
Do the reviews take place within period of

(2) working weeks?
Check for record of change

implementation into production.
Check updates to affected documents,

e.g. Work Instructions, PPAP, Control
Plan, FMEA, etc.
What is their process to ensure that the

correct revision levels are at the point of
use?
4.2.4 Control of Quality Records

A documented procedure is required by this clause of the standard.
Is there a documented procedure in place
for records control?

Estimated %
Complete
Where are records kept?
Is this identified somewhere so users can
easily find records?
Can users identify the records?
Are the records legible?
How are the retention times, storage

requirements, and their disposition
identified?
Are they stored in areas and locations are

suitable to prevent loss, damage or
deterioration?
Can they be retrieved?
How long does it take?
Are records disposed of according to the

retention times?
If the documents and or records are in the

network or Internet, can they be
changed?

Estimated %
Complete
Are records available on demand? Is
there evidence that records are easily
retrievable for the organization?
4.2.4.1 Records Retention

Does record control management satisfy
regulatory and customer requirements?
Are minimum retention times maintained?
5 MANAGEMENT RESPONSIBILITY

Estimated %
Complete
5.1 Management Commitment
This section asks you to identify how your top management demonstrates its leadership, commitment and involvement. Is management
communicating the importance of meeting customer requirements? Verify how this is being done, interview personnel to see if this is actually being
done. Is the quality policy signed off by top management, do they know it? Review management review meeting minutes. Ask how resources are
determined. Remember resources are not limited to people.
Have employees heard about the
importance of meeting customer
requirements?
What role did Top Management play in

communicating this to employees?
What role did Top Management play in

establishing the Quality Policy?
What evidence is there of their role?

Estimated %
Complete
How were the Quality Objective
established? (Have they been
established?)
What evidence is there of Top
Management involvement?
Is there a strong linkage between the

quality objectives and the quality policy?
Can you see evidence of Top

Management involvement in Management
review?
What process is used for Top

Management to identify and provide
resources necessary for the QMS?
Is the organization headed in the right

direction, do the management review
minutes show positive trends for key
measurables such as customer
satisfaction, customer returns, delivery,
and other key customer expectations
identified in 5.2 Customer Focus?

Estimated %
Complete
Does management show involvement and
take action when things are not going in
the right direction?
5.1.1 Process Efficiency

Does organization’s top management
monitor the product realization processes
and the support processes to assure their
effectiveness and efficiency?
5.2 Customer Focus

This is a requirement that may be defined in a document describing how your organization addresses this clause. If no document is available
interview top management for compliance. Top management and other personnel should be involved in this section.
Is there a process in place to identify your
customer requirements?
How is Top Management involved?
How does Top Management know if

customer requirements are being met?
Is your organization aimed at achieving

customer satisfaction?
How?

Estimated %
Complete
Are all types of customers: consumer,
client, end user, retailer, and beneficiary
identified?
Does the organization gather the type of

information that could be translated into
physical (dimensional), sensory (smell,
touch, taste), behavioral (courtesy,
honesty), temporal (punctuality,
reliability), ergonomic (linguistic,
physiological, human safety), and
functional terms?
Do you include the following expectations:

satisfaction/dissatisfaction, customer
complaints/rejects, product requirements
including regulatory and legal and product
failure information?
How do expectations translate into

requirements?
How is the organization distinguishing

between product and business
requirements?

Estimated %
Complete
How are customer requirements
prioritized?
Are customer expectations gathered at

least once a year with the business
planning cycle?
Is the information gathered suitable for

converting into requirements, setting
objectives, identifying processes, and for
improvement?
Does the process provide confidence that

fulfilling the requirements will achieve
customer satisfaction?
Is the process conducted from a narrow

compliance viewpoint or is it conducted
with the idea that customer satisfaction is
the goal?
5.3 Quality Policy

Review the quality policy, management, personnel, management review meeting minutes and other documents that might apply to this clause for
compliance. Evaluate how the quality policy leads to improvements.

Estimated %
Complete
Is the quality policy appropriate for the
organization and aligned with customer
expectations, business environment, and
management goals?
Does the quality policy include a

“commitment to meeting requirements
and to continual improvement”?
How does the quality policy provide a

framework for establishing and reviewing
quality objectives?
What is the relationship between the

quality policy and the objectives that are
set?
How is it communicated and deployed to

be understood at “appropriate” levels of
the organization?
Is the quality policy reviewed at a

minimum once a year and do the
management reviews evaluate the need
for change to the quality policy reference?

Estimated %
Complete
Does the quality policy inspire and lead
organization forward?
5.4 Planning
5.4.1 Quality Objectives
Review your defined quality objectives. Do your quality objectives translate your quality policy into measurable goals? Are they documented so all
personnel knows what they are and how the objectives apply to their processes? Are the quality objectives being reviewed? Are they measurable?
Do the objectives contain commitment to the continual improvement of the QMS?
Review Quality Objectives:
Where are objectives defined for meeting
product requirements?
At what levels have quality objectives

been established?
Department?
Process?
How are objectives measured?
How do they contribute to meeting the

quality policy?
How are the objectives deployed?

Estimated %
Complete
Do the quality objectives show continual
improvement?
If not, why not?
Do the organization’s objectives target the

areas that are important to the customer
(refer to 5.2 Customer Focus)?
5.4.1.1 Quality Objectives - supplemental

Are deployed objectives included in the
organization’s business plan?
5.4.2 Quality Management System Planning

Review the documents or evidence in the QMS complying with this clause. Verify planning includes requirements for continual improvement
specified in clause 8.1. Verify quality planning includes resources and takes into account the needs of your organization as changes occur.
What quality planning process is in place?
a) How does the planning process

address quality objectives for new
processes or products?

Estimated %
Complete
b) How are business and external
changes evaluated and approved?
c) Does this take into account how

changes will affect the QMS?
Is there evidence of planning for

customer-oriented processes and support
processes?
Is there Analysis for each process?
Is there evidence that top management is

involved in quality planning?
Do the QMS planning records show a

continual improvement plan for the
objectives and the QMS?
Is the QMS planning driven and linked to

the Management Review process?
Is there a process for controlling changes

from QMS planning?

Estimated %
Complete
Does the planning include all the
appropriate processes? (such as:
Customer Oriented Processes-COPS,
Management Oriented Processes-MOPS,
Support Oriented Processes-SOPS)
Are the improvement targets appropriate

to achieve customer satisfaction?
Will the plan accomplish the task of

meeting the customers’ needs and
expectations expressed in 5.2 Customer
Focus?
5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority
Verify how top management has defined responsibilities and authorities. This information could be in the form of an organizational chart.
Review documentation on responsibility
and authority.
Is it defined?
Do employees clearly understand their

roles and the organizational lines of
authority?

Estimated %
Complete
5.5.1.1 Responsibility for Quality
What is the process to notify
management with responsibility and
authority for corrective action about
nonconforming products and processes?
Do personnel responsible for quality have

the authority to stop production to correct
problems?
Are all shifts staffed with personnel

responsible for ensuring product quality?
5.5.2 Management Representative

Verify the appointment of the management representative. The management representative is now responsible for implementing and establishing
the QMS. Verify how customer requirements are communicated throughout the organization. If more than one management representative is
appointed, how are the responsibilities and authorities handled?
Is the management representative a
direct report to the CEO / President /
General Manager and a part of top
management?
Is the management representative

actively involved in the implementation
and maintenance of the QMS?

Estimated %
Complete
Does he/she ensure that the processes of
the QMS are established and
maintained?
Is the Management Representative

knowledgeable of the QMS?
Does he/she report to top management

on the performance of the QMS and the
need for improvement?
Does he/she promote awareness of

customer requirements throughout the
organization?
Are there meeting minutes, meeting

notices, bulletins, and / or newsletters?
Is he/she promoting the correct/important

5.5.2.1 Customer Representative

Estimated %
Complete
Verify that Top Management has
designated personnel to represent the
needs of the customer in different areas
of the organization (engineering, quality,
sales, etc.).
5.5.3 Internal Communication

Verify the internal communication processes of your organization. It could be in the form of internal memos, bulletin boards, or meetings. Assess
the communication for information on the QMS, effectiveness of the processes, and changes to the system. Verify this information is communicated
to all levels within the organization.
Has the organization established
communication processes?
Do the communications include the

effectiveness of the QMS?
What tools does the organization use for

internal communication?
Does the communication communicate

both process information and its
effectiveness?
What processes are they communicating?

Estimated %
Complete
How are they communicating
effectiveness of processes? Is it
appropriate?
Do employees understand the status and

effectiveness of the QMS, where the
organization is headed, and their role and
contribution?
5.6 Management Review

5.6.1 General
Review your management review records for conformance. The requirements for management review input could be presented in an agenda or
written in a document. Verify the input requirements are discussed and recorded in your management review record. Review the management
review record for compliance to the requirements. If there is a document defining the management review process then this will need to be
assessed for conformance. Also management is required to identify customer needs. If new customer needs are identified does management
review identify the improvements made to meet these new customer needs?
Is there a schedule for management
review?
Does the review frequency ensure the

QMS’s suitability, adequacy, and
effectiveness?
Are there records or management

reviews?

Estimated %
Complete
Do the organization’s management
reviews include assessing opportunities
for improvement and the need for
changes to the quality management
system, including the quality policy and
quality objectives?
Are the organization’s records from

management reviews maintained?
5.6.1.1 Quality Management System Performance

Do the management reviews include all
elements of the quality management
system and its performance trends as an
essential part of the continual
improvement process?
Are they monitoring quality objectives and

cost of poor quality?
Is there evidence of achievement of

quality policy and business plan
objectives?
Do the plans include customer

satisfaction with product supplied?

Estimated %
Complete
5.6.2 Review Input
Does the Management Review Process
address all the required Inputs?
a) Results of audits
b) Customer feedback
c) Process performance and product

conformity
d) Status of preventative and corrective

actions
e) Follow-up actions from previous

management reviews
f) Changes that could affect the quality

management system
g) Recommendations for improvements
5.6.2.1 Review Input - supplemental

Estimated %
Complete
Is the analysis of actual and potential
field-failures and their impact on quality,
safety or the environment included as
inputs?
5.6.3 Review Output

Does the output of management review
include actions related to improvement of
the QMS?
Does the output of management review

include processes, improvement of
product related to customer requirements,
and resource needs?
Is there evidence that resources are

allocated to meet customer satisfaction
and QMS objectives?
How are resources allocated?
Are management review inputs presented

in such a fashion that management can
easily identify the current performance
and improvement opportunities of each of
the items presented?

Estimated %
Complete
If the current performance is inadequate,
are actions identified in the output to
address improvements needed?
6 RESOURCE MANAGEMENT

Estimated %
Complete
6.1 Provision of Resources
Verify that resources are available for the QMS. Assess resources for addressing customer satisfaction, implementing and improving the QMS
processes. Are resources available in a timely manner? Resources can be people, information, supplies, equipment, facility, work environment, or
financial resources.
Is there evidence to show that resources
are being provided as needed to develop,
maintain and improve the QMS?
Are resources sufficient to meet customer

requirements?
Does the resource allocation process

provide resources in a timely manner to
implement and improve the processes
and to address customer satisfaction?
Has management provided adequate

resources to meet the continual
improvements targeted?
6.2 Human Resources

6.2.1 General
Verify the training records of personnel, especially as related to sections 4.0, 5.0, 6.0, 7.0, & 8.0 of the standard. If you have a training document,
assess the document for compliance to the standard.

Estimated %
Complete
Evaluate the competence of personnel:
Do the records indicate that the

employees are competent to perform the
job based upon education, training, skills
and experience?
6.2.2 Competence, Training and Awareness

If there is a training document, verify conformance to the requirements below. If there is no document, determine how personnel know their
activities. The standard places great emphasis on competency. Assess how your organization evaluates the effectiveness of training and how
personnel know the importance of their activities. This clause applies to all personnel at all levels.
How is the necessary competence of
personnel determined and defined?
Has the determined training been

provided?
Is there on-going continual education

training?
And is this training documented in the

employees’ training records?

Estimated %
Complete
Is the effectiveness of the training
evaluated?
How?
Is there sufficient evidence?
Are personnel aware of the relevance and

importance of their activities and how they
contribute to the achievement of the
quality objectives?
Are appropriate records maintained

describing employees’ education, training,
skills and experience?
Are there competency requirements

defined for all types of jobs?
Make sure all types of employees are

sampled
Have the competency needs of

employees affecting quality been
identified?

Estimated %
Complete
Is there a training plan to satisfy these
needs?
Is it followed?
Is there new employee orientation and

training?
Does it cover relevance and importance

of employee activities, and how they
relate to the quality objectives?
Are there records for all employees

indicating their training, skills education
and experience?
Are competent personnel “effectively”

carrying out activities and providing
results for the organization through
improvement?
Are there weaknesses?
6.2.2.1 Product Design Skills

Estimated %
Complete
Does the organization ensure that
personnel with product design
responsibility are qualified to achieve
design requirements and are skilled in
applicable tools and techniques?
Has the organization identified applicable

tools and techniques needed for product
design?
6.2.2.2 Training
A documented procedure is required by this clause. Review records to confirm conformance.
Is there a documented procedure for
identifying training needs and achieving
competence?
Check personnel records against job

qualification requirements.
Do they indicate that the employees are
competent to perform the job based upon
education, training, skills and experience?
Audit qualifications of laboratory

personnel.

Estimated %
Complete
Audit qualifications of personnel making
appearance item evaluations.
Audit internal auditor qualifications and

servicing personnel training.
Are the Quality Management System

responsibilities of personnel involved in
general responsibilities?
6.2.2.3 Training on the Job

Is on-the-job training provided for new
and modified jobs?
Is there a process to inform personnel

about the consequences to the customer
of nonconformities?
6.2.2.4 Employee Motivation and Empowerment

Is there a process for employee
motivation?
Is the process helping employees achieve

objectives?

Estimated %
Complete
Is there promotion of quality and
technological awareness?
Is there process for measuring awareness

of the importance of the activities and
contributions to achievement of quality
objectives?
Interview personnel in different areas and

audit trails to verify awareness (ask with
quality policy).
6.3 Infrastructure
This clause addresses how your organization ensures that the infrastructure is appropriate for the achievement of your objectives. Verify the
facilities are maintained to achieve the conformity of the product. Safety, maintenance, management review, and meeting minutes are some of the
records to review. Different processes within the organization may have different requirements.
What is your infrastructure?
Does product or service meet

requirements when produced or delivered
using this infrastructure?
Is there adequate space for non-

conforming materials or returned product
from customer?

Estimated %
Complete
Are there adequate facilities (lab) for
returned product analysis?
Review the maintenance and prevention

maintenance process that is used to
maintain the facilities. Is it adequate?
6.3.1 Plant, Facility and Equipment Planning

Does the organization use a
multidisciplinary approach for developing
plant, facility and equipment plans?
Is the organization’s plant layouts

optimized for material travel, handling and
value-added use of floor space and shall
facilitate synchronous material flow?
Has the organization developed and

implemented methods to evaluate and
monitor the effectiveness of existing
operations?
6.3.2 Contingency Plans

Estimated %
Complete
Check contingency plans.
Do they consider all possible scenarios?
(such as utility interruptions, labor

shortages, key equipment failures and
field failures)
6.4 Work Environment

Examples to look at for compliance would be work methods, safety, ergonomics, and temperature and humidity controls. Elements that may also be
included in work environment are information, suppliers and partnerships, natural and financial resources.
What work environment is needed to
meet product or service requirements?
Has this work environment been

provided?
Has the organization identified the human

and physical factors of their work
environment?
Physical factors include heat, noise, light,
hygiene, humidity, cleanliness, vibration,
pollution, and airflow.

Estimated %
Complete
Has the organization identified work rules
for people involvement, safety rules, and
ergonomics?
What process do they use to manage the

human and physical factors?
Do records show work environment as a

root cause for non-conformances?
While walking through the facility, monitor

the level of housekeeping. Is there oil on
the floor, chips & dirt, cigarette butts, etc?
What is the general work environment as

it relates to noise, air quality, etc?
6.4.1 Personnel Safety to Achieve Conformity to Product Requirements

Does the organization’s quality policy and
practices address product safety and
means to minimize potential risks to
employees, especially in design and
development process and in the
manufacturing process activities?
6.4.2 Cleanliness of Premises

Estimated %
Complete
Is there a process for maintaining
premises in a state of order, cleanliness
and repair?
(e.g., housekeeping / 5S audits)
7 PRODUCT REALIZATION

Estimated %
Complete
7.1 Planning or Product Realization
This section may be addressed in a documented procedure or in the quality manual. Does your organization understand the processes needed to
meet product requirements? The planning activity for the processes related to product realization must address the requirements in section 4.1.
For each product/project or contract
sampled study the planning of the
realization process:
Is there a quality plan for the process?
Does the plan include appropriate quality

objectives?

Estimated %
Complete
Do the objectives relate to customer

requirements and the business goals
established in 5.4 Planning?
Was the need to establish new processes

and/or change existing product realization
process, documentation, resources, and
facilities for product identified?
Does the plan specify verification and

validation and criteria of acceptability of
the product as it goes through each
process?
Does the plan identify the records

necessary for process and product
conformance?
Is the plan output appropriate to the

operation?
7.1.1 Planning of Product Realization - supplemental

Have the customer requirement and
references to its technical specifications
been included in the planning of product
realization as a component of the quality

Estimated %
Complete
plan?
How well was the standardized new-

product development and manufacturing
process customized to meet the specific
needs of the particular product?
7.1.2 Acceptance Criteria

Is acceptance criteria defined and
approved by the customer if required?
Is acceptance criteria for attributes data

sampling at zero defects?
7.1.3 Confidentiality
Look at the processes to ensure product
and project confidentiality (limited access,
password protection, etc.).
How is computer hardware and software

controlled?
What is the process to dispose of

hardware and software that may have
customer information?
Is there a process to protect customer
intellectual property?

Estimated %
Complete
7.1.4 Change Control

Is there evidence of assessment of
change impact and change validation
before implementation?
Are manufacturing changes included?
Has proprietary designs, impact on form,

fit and function been reviewed for
proprietary designs?
Are there any additional

verifications/identification requirements?
Has the customer been notified about the

changes?
7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product
If customer requirements are not understood there is the possibility of not meeting the customer needs. A review of customer complaints, surveys,
and reports will denote any problems. Also look at any contract, logs, or orders to see if any amendments have been made. If so, is the reason for
the amendment documented? This requirement also includes recycling, environmental impact and characteristics identified as a result of the
organization’s knowledge of the product and manufacturing processes.
determined?

Estimated %
Complete
Are product requirements (physical,
functional, ergonomic, etc.) identified from
the customer including delivery and post-
delivery activities determined?
Does the organization add requirements

that they identified that were not specified
by the customer, but necessary for
intended or specified use?
Is there a process for this to happen?
Are obligations related to the product,

including regulatory and legal, identified?
Are additional requirements determined

by the organization?
Are these requirements input into 5.2

Customer Focus?
Are product requirements gathered only

during contract stages?
Does the organization try to analyze /

summarize product requirements
gathered between customers, by product

Estimated %
Complete
family, etc… as to input the planning
process?
7.2.1.1 Customer-Designated Special Characteristics

Have special characteristics been
identified per customer requirements?
Are the special characteristics identified

on drawings, FMEA’s, Control Plans and
Work Instructions with customer-
designated symbols?
Do employees related to manufacturing

and quality understand special
characteristics and can identify what they
are and how they should be treated?
7.2.2 Review of Requirements Related to the Product

When looking at the documents (records, procedure, and work instructions) consider required delivery dates, applicable standards, and any
organizational requirements. Is the same process being followed for verbal orders?
How does your organization review
What information is reviewed?
What records are maintained?

Estimated %
Complete
confirmed on a verbal order?
How is your ability to meet order

requirements confirmed?
How are changes to orders handled?
Does the organization review product

requirements for the products sampled
from 7.2.1?
Are the product requirements from 7.2.1

reviewed before the commitment to
produce is made?
Are differing requirements resolved?
Does the review make sure that they

have the ability to meet all requirements
before commitment to supply?
Is the review and subsequent actions

documented?
When customer requirements or product

requirements are changed, are relevant

Estimated %
Complete
personnel made aware of the change?
Is each order reviewed, documented and

approved prior to commitment to the
customer?
When the customer provides little to no

documented requirements, does the
organization review the requirements
from 7.2.1 with the customer?
7.2.2.1 Review of Requirements Related to the Product - supplemental

Waiving the requirement of the formal
review requires customer authorization.
If formal review not performed, is their

customer authorization?
7.2.2.2 Organization Manufacturing Feasibility

Does the organization investigate, confirm
and document the manufacturing
feasibility of the proposed products in the
contract review process including risk
analysis?
7.2.3 Customer Communication

Estimated %
Complete
If there is no document available regarding customer communication then the questions below should be asked to determine compliance to this
clause. Customer requirements are important and usually involve different levels in the organization. Ask different levels to see if the answers are
consistent and do they agree with the organizations policy and objectives.
How do you communicate product
information to customers?
What process is used for customer

enquiries, contracts or order handling,
including amendments?
What mechanism is in place to collect

customer feedback, including complaints?
Is the language specified by the customer

used for communications?
7.2.3.1 Customer Communication - supplemental

Does the organization have compatible
systems to communicate data and
information?
(Such as CATIA, IDEAS, EDIFACT, etc.)?
7.3 Design and Development

Does product and manufacturing process
design focus on error prevention rather
than detection?

Estimated %
Complete
If your organization does not have a PRODUCT DESIGN and DEVELOPMENT function, the elements associated with PRODUCT DESIGN
will not be applicable and exclusion should be noted. However, all MANUFACTURING PROCESS DESIGN cannot be excluded.
7.3.1 Design and Development Planning
This section for planning is done to the level necessary to achieve the design/development objectives. Planning could be in the form of a flow chart
(GANTT chart, PERT chart) to give the information. A review of projects and records will determine how this is being done and if consistent with
the clause. Advanced Product Quality Planning (APQP) is one acceptable method to develop products and/or manufacturing processes.
How does your organization plan and
control the design and development of
product?
Sample various products.
For each product that was designed or

developed check the following:
Was there a plan for the design and

development of the product?
Were the stages of design and or

development determined?
Were reviews, verification, and validation

activities conducted for each stage?
Were the responsibilities and authorities

for these activities identified?

Estimated %
Complete
How was the interface between the
different groups managed for effective
communication and clarity of
responsibilities?
Was the output of the plan updated as the

design or development progresses?
7.3.1.1 Multidisciplinary Approach

Does the organization use a multi-
disciplinary approach to prepare for
product realization that includes:
- Development/ finalization and

monitoring of special characteristics?
- Development and review of FMEAs

including actions to reduce potential
risks?
- Development and review of control

plans?
7.3.2 Design and Development Inputs

Although the standard does not specifically require it, consider preparing a document to address the input requirements in order to avoid any
misunderstandings. Review any document or paperwork that addresses this clause.
Continue the same product samples from

Estimated %
Complete
7.3.1 Design and/or Development
Planning:
Were inputs relating to product

requirements defined and documented?
Did they include functional and

performance requirements?
Did they include applicable regulatory and

legal requirements?
Did they include applicable information

derived from previous similar designs?
Did they include other requirements

essential for design and /or development?
Is there evidence that the inputs were

reviewed for adequacy?
Is there evidence that incomplete,

ambiguous, or conflicting requirements
were resolved?
7.3.2.1 Product Design Input

Do documented product design inputs

Estimated %
Complete
include customer requirements such as
identification, traceability, special
characteristics, and packaging?
Do design inputs include information from

previous designs, feedback, field data,
and other sources?
Do design inputs include functional and

performance requirements?
Does the organization identify, document

and review the product design inputs
requirements including:
- Customer requirements (contract

review)?
- Use of information (the organization

shall have a process to deploy
information gained)?
- Targets for product quality, life,

reliability, durability, maintainability,
timing, and cost?
7.3.2.2 Manufacturing Process Design Input

Estimated %
Complete
Were inputs for the manufacturing
process requirements identified,
documented and reviewed?
Does the organization identify, document

and review the manufacturing process
design input requirements, including:
- Product design output data?
- Targets for productivity, process

capability and cost?
- Customer’s requirements if any?
- Experience from previous

developments?
7.3.2.3 Special Characteristics

Do documents include identification of
special characteristics?
Does the organization identify special

characteristics and:
- Comply with customer specified

definitions and symbols?

Estimated %
Complete
- Identify process control documents

including drawings, FMEAs, control
plans, and operator instructions with
the customer’s special characteristic
symbol or the organization’s
equivalent symbol or notation to
include those process steps that affect
special characteristics?
7.3.3 Design and Development Outputs

Verify the outputs of the design/development satisfy the design/development inputs. Assess the documents that apply to this clause for
compliance. This clause does not require a quality record, but to demonstrate compliance some form of quality records should exist.
Continue the same samples from 7.3.1
Design and/or Development Planning:
Were the design outputs documented in a

manner that enables verification against
the inputs?
Was the output reviewed prior to release?
Did the outputs meet the input

requirements?
Did the output provide appropriate

information for production and service

Estimated %
Complete
operations (read as process control, i.e.
ongoing functional testing, product
characteristics etc.)?
Did it contain or reference product

acceptance criteria?
Did it define characteristics of the product

essential for safe and proper use?
7.3.3.1 Product Design Outputs -supplemental

Is the organization’s product design
output expressed in terms that can be
verified and validated against product
design input requirements?
Does the organization’s product design

output include:
- Design FMEA, reliability results?
- Product special characteristics,

specifications?
- Product error proofing, as

appropriate?

Estimated %
Complete
- Product definition including drawings?
- Product design reviews results?
- Diagnostic guidelines where

applicable?
7.3.3.2 Manufacturing Process Design Output

Were process design outputs expressed
in a manner that enables verification and
validation against the inputs?
Does the organization’s manufacturing

process design output include:
- Specifications and drawings?
- Manufacturing process flow chart /

layout?
- Manufacturing process FMEAs?
- Control plan?
- Work instructions?
- Process approval acceptance criteria?

Estimated %
Complete
- Data for quality, reliability,
maintainability and measurability?
- Results of error-proofing activities, as

appropriate?
- Methods of rapid detection and

feedback of product/manufacturing
process non-conformities?
7.3.4 Design and Development Review

Verify the design review record to confirm compliance. Confirm the reviews are taking place, done according to the plan, appropriate attendance at
the reviews, and follow up action has taken place. The standard does not require the number of design reviews that should be conducted. The
review is intended to confirm internal and external needs have been taken into consideration or addressed.
How do project managers identify the
stages of design where design review is
required?
What is covered in design review?
Continue to follow the same product

samples from 7.3.1 Design and/or
Development Planning:
Were design reviews conducted at

suitable frequencies?

Estimated %
Complete
Were they conducted as per the
“planned” schedule?
Did the review evaluate the ability to meet

the requirements needed at the stage,
and identify problems and proposed
follow up actions?
Are they accomplishing what is required

at the stage?
Did they identify problems and propose

action?
Did the review include representatives of

the functions involved in that stage of the
design?
Was the review well documented

including follow-up actions?
7.3.4.1 Monitoring
Does the organization define and analyze
measurements at specified stages of
design and development and summarize
a report of results as an input to
management review?

Estimated %
Complete
7.3.5 Design and Development Verification

Verification considers the product after it is finished. Verification makes the determination that the product meets the stated requirements. This can
be done by review of test data, calculations, or additional testing. For verification the capability of the product must meet the specified requirements
and there must be objective evidence available to demonstrate it. Assess the records for compliance.
How is verification planned?
What does verification include?

Planning:
Was the output of the design or

development verified to ensure that it met
the inputs?
Did it “ensure” that the output meets the

input without any ambiguity?
Were results of the validation and any

subsequent follow-up actions recorded?
7.3.6 Design and Development Validation
Validation assures that the design/development output conforms to defined user needs and is capable of meeting the requirements for the intended
use. Validation is usually performed after verification. Verify that the requirements of this clause are met by reviewing the validation records.

Estimated %
Complete
Planning:
How is validation planned?
What is included in validation?

Was the output of design or development
validated to test whether the product is
“capable of meeting the requirements for
the specified or intended use or
application”?
Note: the validation should be testing the

product as close to real use as possible.
It should be testing the product under the
various conditions or worst conditions
that it will be put to use by the customer.
Was the validation completed before

delivery or implementation of the product
whenever “practicable”?
If full validation was impractical prior to

delivery or implementation, was partial
validation performed to the extent
applicable?
Were the results of the validation and any

Estimated %
Complete
subsequent follow-up actions recorded?
Does the validation process include an

analysis of field reports for similar
products?
Does verification and validation evident

for both product and manufacturing
processes?
7.3.6.1 Design and development validation - supplemental

Was the validation completed according
to customer requirements and program
timing?
7.3.6.2 Prototype Program

When required by the customer, does the
organization have a prototype program
and control plan?
Wherever possible, does the organization

use the same suppliers, tooling and
manufacturing processes as will be used
in production?
Does the organization monitor all

performance testing activities for timely

Estimated %
Complete
completion and conformance to
requirements?
Does the organization take responsibility

for the subcontracted services, including
technical leadership?
7.3.6.3 Production Approval Process

What is the organization and supplier
product and process approval procedure?
Does the organization conform to a

product and process approval procedure
recognized by the customer?
Does the organization apply a product

and process approval procedure
recognized by the customer to its
suppliers?
7.3.7 Control of Design and Development Changes

Some of changes that may take place are omissions, errors or inconsistencies in the design or requirements, changes in statutory or regulatory
requirements, or issues raised during reviews. It is important that changes be documented and actions taken to prevent any possible effect on the
product. Assess the design/development records for compliance and verify that changes have been communicated to all parties.
How are changes to the design recorded
and implemented?

Estimated %
Complete
Are the changes verified, validated and
approved prior to implementation?
Are the changes evaluated for the effect

on constituent parts and delivered
products?
Are the results of the review of changes

and any necessary actions recorded?
Do design and development changes

include all changes during the product
program life?
7.4 Purchasing
7.4.1 Purchasing process
This clause asks your organization to base the type and extent of control of suppliers on the effect of the purchased material on both the product
realization processes and products produced. Assess the records of supplier evaluations and follow up actions.
Is there a process in place to ensure that
purchased product conforms to
requirements?
Is the control appropriate to effect the

purchased product has on the
subsequent or final product?
Is there a method of controlling the

Estimated %
Complete
suppliers?
How are suppliers selected?
What criteria are there for evaluating

suppliers?
Are evaluation and any necessary actions

being recorded?
Is there a list of approved suppliers?
Does the list include all the appropriate

types of suppliers?
Were the suppliers evaluated and

selected based upon their ability to supply
product in accordance with requirements?
Was there a criteria for their selection?
Were the suppliers periodically

evaluated?
Were their criteria for their periodic

evaluation?

Estimated %
Complete
Did they base their purchasing
commitments on supplier evaluation?
Are there records of supplier selection

and evaluation?
Does the organization’s purchasing

process include all products and services
that affect customer requirements such as
sub-assembly, sequencing, sorting,
rework and calibration services?
When there are mergers, acquisitions or

affiliations associated with suppliers, the
organization should verify the continuity of
the supplier’s quality management system
and its effectiveness.
7.4.1.1 Statutory and Regulatory Conformity

Do purchased products satisfy applicable
statutory and regulatory requirements?
7.4.1.2 Supplier Quality Management System Development

Is there evidence of supplier development
towards conformance to IATF
16949:2016?

Estimated %
Complete
Are suppliers registered to ISO
9001:2008?
Sanctioned Interpretation 5: Is the

organization’s second party audit process
consistent with the automotive process
approach, including evidence of planning,
supplier readiness and supplier
performance?
7.4.1.3 Customer-Approved Sources
Where specified by the contract, does the
organization purchase products, materials
or services from approved sources?
Does the organization demonstrate

responsibility for ensuring the quality of
purchased products supplied by
customer-designated sources, including
tool/gage suppliers?
7.4.2 Purchasing Information

Assess how the organization describes the products, materials or services that are purchased.
What does purchasing information
include?
How do your purchasing personnel

confirm that the purchase requirements

Estimated %
Complete
are complete and correct before the order
is placed?
Does the organization use purchase

orders?
Do the purchase orders include

information describing the product?
Do the P.O.’s include requirements for

approval or qualifications (as appropriate)
for approval of products, procedures,
equipment and personnel?
Do the P.O.’s include quality

management system requirements?
Does the purchasing process include an

evaluation to ensure the adequacy of
specified requirements prior to release?
7.4.3 Verification of Purchased Product

Assess how the organization has defined the inspection process for compliance and verify evidence of product acceptance. Verification of
purchased product performed at the supplier’s premises is seldom used. If being done assess the process for compliance.
Is inspection used to verify that
purchased product meets requirements?

Estimated %
Complete
What other methods are used in addition
to inspection?
Are the activities for verification of

purchased product identified and
implemented?
If the customer performs verification

activities on the supplier’s premises, are
the methods of verification and release
specified?
Is there evidence that purchased product

quality, delivery, or cost is affecting in-
process, delivered product, and /or
customer satisfaction/customer
dissatisfaction?
7.4.3.1 Incoming Product Conformity to Requirements

Does the organization have a process to
assure the quality of purchased product
utilizing one or more of the following
methods:
- Receipt of, and evaluation of,

statistical data by the organization?

Estimated %
Complete
- Receiving inspection and/or testing
such as sampling based on
performance?
- Second or third party assessments or

audits of supplier sites, when coupled
with records of acceptable quality
performance?
- Part evaluation by a designated

laboratory?
- Another method agreed with the

customer?
7.4.3.2 Supplier Monitoring

Does the supplier list include all products
and services that affect customer
requirements?
Does the organization monitor supplier

performance through the following
indicators:
- Delivered part quality performance?
- Customer disruptions including field

Estimated %
Complete
returns?
- Delivery schedule performance

(including incidents of premium
freight)?
Does the organization promote supplier

monitoring of their manufacturing
processes’ performance?
7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision
The requirements noted below cover process control, inspection and testing, inspection and test status, and servicing and requirements for the
release, delivery, and post-delivery of the product.
How are production and service provision
controlled?
Where are the product characteristics

documented?
How do personnel know what equipment

to use for a process?
Does documentation identify what

monitoring and measuring equipment
should be used, and when?

Estimated %
Complete
Select a representative sample of the
processes of the organization.
Is there a quality plan or other document

that identifies the characteristics
controlled in each step of the process?
Is enough information available to specify

the characteristics of the product?
Are work instructions available for each

process step or are operators able to
explain how to perform that step of the
process?
Is the equipment suitable for the work
performed and do records show that
maintenance is planned and being carried
out?
Do they have the necessary gauge and/or

monitoring equipment for process and
product monitoring?
Do records indicate that the monitoring

activities are properly implemented and
that all persons operating the process are
following it?

Estimated %
Complete
Do they have defined processes for

release, delivery and post-delivery
activities?
Does the organization control the

provision of product and service so that it
is meeting or exceeding customer
expectations?
Does monitoring and measurement data

show that the organization is meeting
objectives set for the product?
7.5.1.1 Control Plan

Does the organization:
- Develop control plans at the system,

subsystem, component and/or
material level, for the product
supplied, including those for bulk
materials produced by the
organization and all purchased
products and materials?
- Have a control plan for pre-launch and

production that take into account the

Estimated %
Complete
design FMEA and manufacturing
process FMEA outputs
Does the organization’s control plan:
- List the controls used for the

manufacturing process control?
- Include methods for monitoring and
recording results of control exercised
over special characteristics defined by
both the customer and the
organization?
- Include the customer required

information, if any?
- Initiate the specified reaction plan

when the process becomes unstable
or non capable?
Does the organization review and update

control plans when any change occurs to
affect product, manufacturing process,
measurement, logistics, supply sources or
FMEA?
7.5.1.2 Work Instructions

Estimated %
Complete
Has the organization prepared
documented work instructions for all
employees having responsibilities for the
operation of processes?
Are the organization’s work instructions

accessible for use at the work-station?

derived from sources such as the quality
plan, the control plan and the product
realization process?
7.5.1.3 Verification of Job Set-ups

Does the organization verify job set-ups
whenever performed?

available for set-up personnel?
Does the organization use statistical

methods of verification of job set-ups
where applicable?
7.5.1.4 Preventive and Predictive Maintenance

Does the organization identify key
process equipment and provide resources

Estimated %
Complete
for machine/equipment maintenance and
develop an effective planned total
preventive maintenance system?
Does the organization’s preventive

maintenance system, (at a minimum)
include the following:
- Planned maintenance activities?
- Packaging and preservation of

equipment, tooling and gauging?
- Availability of replacement parts for

key manufacturing equipment?
- Documenting, evaluating and

improving maintenance objectives?
Does the organization utilize predictive

maintenance methods to continually
improve the effectiveness of its preventive
system?
7.5.1.5 Management of Production Tooling

Does the organization provide resources
for tool and gauge design, fabrication and

Estimated %
Complete
verification activities?
Does the organization establish and

implement a system for tooling
management including:
- Maintenance and repair facilities and

personnel?
- Storage and recovery?
- Set-up?
- Tool-change programs for perishable

tools?
- Tool design modification

documentation, including engineering
change level?
- Tooling identification defining the

status?
Has the organization implemented a

system to monitor its tooling management
activities if any work is outsourced?

Estimated %
Complete
7.5.1.6 Production Scheduling
Is production scheduled in order to meet
Does it include just-in-time delivery and

information systems that support an order
driven system?
7.5.1.7 Feedback of Information from Service

Has the organization established and
maintained a process to communicate
information on service concerns to
manufacturing, engineering and design
activities?
7.5.1.8 Service Agreement with Customer

When there is a servicing agreement with
the customer, does the organization verify
the effectiveness of:
- Any organization service centers?
- Special purpose tools or

measurement equipment?
- Training of servicing personnel?

Estimated %
Complete
7.5.2 Validation of Processes for Production and Service Provision
If special processes are part of your organization’s scope the above requirements will be assessed for compliance. Define conditions and the
criteria for revalidation. If you have no special processes, identify that in the quality manual.
Does your organization have any
processes for production and service
where the output cannot be verified by
monitoring or measurement?
Do you validate these processes?
How is validation performed?
If the process being audited is a special

process, how is validation performed?
Does validation demonstrate the ability to

achieve planned results?
Does the validation process include

defined criteria for review and approval of
the process?

validation of processes?

validation of equipment and personnel?

Estimated %
Complete
Does the validation process include use

of defined methodologies and
procedures?

requirements for records?
Does the validation process include Re-

validation?
Does the organization validate all of its

processes for all its production and
service provision where the resulting
output cannot be verified by subsequent
monitoring or measurement?
7.5.2.1 Validation of Processes for Production and Service Provision - supplemental

Does the organization apply the
requirements for validation of processes
to all processes for production and
service provision?
7.5.3 Identification and Traceability

Product need to be identified in such a way as to know its status, that is, is good, bad, or don’t know?
How is product identified?

Estimated %
Complete
How is measuring and monitoring status
identified?
Does your organization control and record

the unique identification of the product,
where traceability is required?
Is the product identified throughout the

process until it is shipped?
Is the identification clear and legible?

Is each form or tag to be filled out
completely?
Is the status of the product in relationship

to measurement and monitoring clearly
discernible?
How does the operator know what has

and has not been checked?
To what level is traceability required?
How do they track the product to the

traceability level required?
7.5.3.1 Identification and Traceability - supplemental

Estimated %
Complete
Does the organization consider the above
requirements of 7.5.3 as appropriate?
7.5.4 Customer Property

Property provided by the customer can include intellectual property, as well as tooling, information, software, containers, or materials. Remember
to include all these items in the review of customer property.
Is there any customer property used in
the process?
How is the customer property identified,

verified, protected and maintained?
Do they have a process of recording and

reporting to the customer any lost,
damaged, or otherwise unsuitable
product?
Is there evidence that this is happening?
7.5.4.1 Customer-Owned Production Tooling

Is customer owned tooling permanently
marked so that ownership of each item
can be determined?
7.5.5 Preservation of Product

Products need to be protected in order to preserve conformity to requirements

Estimated %
Complete
How do you make sure that product
quality is maintained during processing
and delivery?
Is any product on the floor, misplaced,

mishandled?
Are packaging specs defined and

understood?
Are they being followed?
Are there customer complaints related to

improper packaging?
Are there customer complaints for

damage products during transport?
Are there opportunities where something

may go wrong?
7.5.5.1 Storage and Inventory

Is the condition of product in stock verified
periodically?
Ask the operator questions regarding

identification, handling, packaging,
storage, and protection to ensure proper

Estimated %
Complete
controls are being followed.
Check inventory management system

and inventory turns matrix.
Is FIFO being used to replenish

inventory?
Is obsolete product controlled as if it were

nonconforming?
Does the organization handle product in a

fashion that ensures that the product is
preserved?
Are constituent parts handled in a fashion

that ensures that they are preserved?
7.6 Control of Monitoring and Measuring Equipment

. Review procedures, work instructions and records for compliance.
Has your organization established a
mechanism to ensure monitoring and
measuring is performed consistent with
requirements?
What action is taken if equipment is found

to be out of calibration?

Estimated %
Complete
Does your organization take appropriate

action on the equipment and any product
affected above?
How is software used for measuring and

monitoring verified prior to use and
reconfirmed as necessary?
Has the organization identified

measurements to be made and the
measurement and monitoring equipment
required for conformity of product?
Audit the gages: (check quality,

manufacturing prototype lab and
maintenance department gages)
Accuracy, precision?
How chosen?
Identification?
Acceptance criteria?

Estimated %
Complete
Handling, storage and preservation of

inspection, measuring and test
equipment?
Environmental conditions?
Location?
Corrective actions?
Frequency of checks?
Audit the calibration program.
NOTE: Monitoring and measuring

equipment should be trailed from
processes audited in Production and
Service Provision (7.5)
Sample several pieces of equipment used

in the organization for the following:
Are they calibrated to International or

National Standards?
Are results recorded?

Estimated %
Complete
Daily/weekly mastering of gages before

use (usually during plant audit)?
Where no International Standard exists, is

the basis of the calibration recorded?
Are they adjusted periodically or before

use?
Is calibration status identified?
Are they safeguarded from adjustment

that would invalidate the calibration?
Are they protected from damage and

deterioration during handling,
maintenance, and storage?
Does the organization have a process to

re-assess previous results if equipment is
found to be out of calibration and have
corrective action taken?
What action is taken when equipment is

found to be out of calibration?

Estimated %
Complete
Audit backtracking of product when gage
is found to be bad?
Have they recorded the results of

calibration?
7.6.1 Measurement System Analysis

Does organization conduct statistical
studies to analyze the variation present in
the results of each type of measuring and
test equipment system?
Do the studies include GRR, bias

linearity, stability and discrimination and
test equipment?
Does the organization conduct

measurement system analysis for
measurement systems referenced in the
control plan?
Does the organization use measurement

system analytical methods and
acceptance criteria that conform to those
in customer reference manuals on
measurement systems analysis?

Estimated %
Complete
7.6.2 Calibration/Verification Records
Do calibration records for organization
and customer-owned gauges, measuring
and test equipment include:
- Equipment identification, including the

measurement standard against which
the equipment is calibrated
- Revisions following engineering

changes
- Any out-of-spec readings as received

for calibration/verification
- An assessment of the impact of out-

of-spec condition
- Statements of conformity to spec after

calibration/verification
- Notification to the customer if suspect

product or material has been shipped
7.6.3 Laboratory Requirements

7.6.3.1 Internal Laboratory
If organization conducts in-house

Estimated %
Complete
calibration, then they need to have a
capable in-house laboratory that includes:
- Laboratory scope
- Adequate lab procedures
- Qualified laboratory personnel
- Evidence of proper testing
- Tests traceable to element standards
-A review of quality records
7.6.3.2 External Laboratory

If outside laboratories are used, are the
laboratories certified to ISO/IEC 17025.
Are the tests/calibrations performed

included in the laboratory scope?
Is there evidence that the external lab is

acceptable to the customer?
NOTE 1:
Such evidence may be demonstrated by

Estimated %
Complete
e.g. customer assessment, or by
customer approved second party
assessment that the laboratory meets the
intent of ISO/IEC 17025 or national
equivalent.
NOTE 2:
Where a qualified laboratory is not
available for a given piece of equipment,
calibration services may be performed by
the equipment manufacturer. In such
cases, the organization should ensure
that the requirements listed in 7.6.4.1
have been met.
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
REQUIREMENTS
CURRENTLY IN PLACE
(List documents or evidence)
CONFORMING Y/N?
Estimated % Complete
ITEMS NEEDED
8.1
General
Verify that your organization is monitoring, measuring, and improving the processes. How this is being done is defined by your organization. This may
be written in procedures, although there is no requirement for this clause to have a procedure. Assess if your organization has determined the need
for, and use of statistics.
How is product conformance demonstrated?
Is there a measuring and monitoring process in place?
How is the conformity of the QMS ensured?
Is there a measuring and monitoring process in place?
Does measuring and monitoring allow continual improvement of the effectiveness of the QMS?
Does the process include identification of methods, including statistical techniques for the measuring and monitoring?
Have measurement and monitoring activities been defined? What do they involve?
Have measurement and monitoring activities been planned?
How?
Have measurement activities been implemented?
Do they employ applicable methodologies?
8.1.1
Identification of Statistical Tools
Do they employ applicable statistical techniques?
Are statistical techniques included in the control plan?
Have measurement and monitoring activities been defined? What do they involve?
Have measurement and monitoring activities been planned? Have statistical concepts been determined during Advanced Quality Planning?
8.1.2
Knowledge of Basic Statistical Concepts
Are basic statistical concepts understood and used by the organization, such as variation, control (stability), process capability and over-adjustment?
Have measurement activities been implemented?
Do they employ applicable methodologies?
8.2
Monitoring and Measurement
8.2.1
Customer Satisfaction
This clause does not define how your organization is to monitor information on customer perceptions. For compliance to this clause, verify how your
organization monitors the customer information, follow through on the methods being used. Are the methods being used consistent with the quality
policy and quality objectives?
What methods does your organization use to monitor information on customer perception regarding fulfilling customer requirements?
Is there a defined process with documented methodologies for obtaining customer satisfaction and dissatisfaction?
Are all the types of customers surveyed / interviewed?
Is the number of customers surveyed/interviewed enough to provide good information, i.e. statistically valid?
Are they surveying/interviewing different departments within the customer who affect the buying decision?
How is this information used when determining customer expectations?
What is the quality of the information gathered? Is the information gathered useful in improving the organization?
Can they provide evidence of using this information for continual improvement?
Does the customer satisfaction process provide a true picture of the perception (opinion) of the organization’s customers? Is the information gathered
useful in improving the organization?
Are the performance indicators headed in the right direction?
Does it show correlation to customer satisfaction?
Is the information gathered being used to improve customer satisfaction?
Is there an evaluation of the realization process indicators, in order to better understand the correlation between customer satisfaction and the product
realization performance indicators?
Is the manufacturing process performance monitored?
Do trends show conformity with customer requirements?
8.2.1.1
Customer Satisfaction - supplemental
Are the organization’s performance indicators for customer satisfaction based on objective data and include, but not be limited to:
- Delivered part quality performance?
- Customer disruptions including field returns?
- Delivery schedule performance (including incidents of premium freight)?
- Customer notifications related to quality or delivery issues?
8.2.2
Internal Audit
A documented procedure is required for this clause. Assess the internal audit procedure for conformance to the requirements below. Verify the
auditors have determined the QMS has been effectively implemented. It is management’s responsibility to make sure actions are taken in a timely
manner.
Is an internal audit system in place?
Are they being performed on time?
Are they effective?
Do they identify good improvements and eliminate non-conformances?
How is the audit schedule prepared?
What measures are in place to ensure the audits and auditors are objective and impartial in the audit process?
Is there a documented procedure and does the procedure define the responsibilities and requirements for planning and conducting audits, including
audit reports and maintaining records?
How does the management responsible for the area audited take timely action to eliminate nonconformities and their causes?
Do follow up activities include verification of the corrective action and the reporting of those results?
Is there an audit schedule that takes into account the status, importance of areas and activities, and the results of the previous audit?
Does the audit frequency change?
Do the records show that the schedule is being followed?
Does the internal audit cover the full scope of the standard as well as any customer specific requirements?
Do the audit schedule and the audit process indicate that the current auditing process audits effective implementation and maintenance of the
system?
Have audits, scope and frequency, and methodologies been defined?
Are the auditors independent of the area audited?
Are audit questions comprehensive?
Are they focused on the performance of the process meeting planned objectives?
Is the objective evidence recorded for each question?
There should be objective evidence for both conformance and non-conformances.
Do the questions and the evidence indicate that the audit is checking whether the QMS is effectively implemented and maintained?
Are there non-conformances identified in the audit reports?
Are the non-conformances well written, that is, are requirement cited (is it correct); is there objective evidence, and the nature of the non-
conformance?
Are all the elements audited?
If not, check to see that all the elements are audited by a combination of the entire year’s audits?
Are the nonconformities closed out in a timely manner?
Does the organization go back and audit the problem?
Is there objective evidence of verification results?
Is the internal audit generally finding the same type of problems as the current audit?
Are the problems well documented?
Is there objective evidence for areas of conformance and nonconformity?
Are the non-conformances closed out on a timely basis (three-month window at the most)?
Are the problems repeating?
Are the number and type of problems going down?
Are the summary results of the audits communicated to their respective process owners and Management?
8.2.2.1
Quality Management System Audit
Is there evidence of QMS audits to IATF 16949:2016 and any additional requirements (e.g. customer-specific requirements, industry specific
supplements)?
8.2.2.2
Manufacturing Process Audit
Is there evidence of manufacturing process audits?

Are there corrective actions in the case the process audits yield non-conformances?
Does your customer require you to perform layered process audits? If so;
Is there evidence of layered process audit records?
Is there a layered process audit procedure?
Are there corrective actions for layered process audit non-conformances?
Is there evidence of manufacturing process audits?
8.2.2.3
Product Audit
Is there evidence of product audits at different stages of production and delivery?
8.2.2.4
Internal Audit Plans
Does the plan cover all quality management processes, activities and shifts?
Is the internal audit scheduled according to an annual plan?
Is audit frequency increased after internal/external nonconformities or customer complaints?
8.2.2.5
Internal Auditor Qualification
Are there internal auditor training and qualification records?
Are the organization’s internal auditors qualified to audit the requirements of IATF 16949:2016?
Do the organization’s internal auditors meet the qualification requirements of your customer, if they are stated?
8.2.3
Monitoring and Measurement of Processes
Verify that your organization has defined and is performing the measuring and monitoring activities needed to confirm product conformity. Looking at
the process data will provide evidence if process parameters or specifications have been identified. If not, was corrective action taken? Compliance
would also include observing the measurement and monitoring processes.
How are QMS processes monitored? Where are appropriate measurements identified?
Are results evaluated to determine if the QMS processes are achieving the planned results?
When the results are not achieved, are corrective actions taken to confirm conformity of the product?
Are the policies, procedures or requirements (i.e. process characteristics) clearly identified?
Are the characteristics related to customer or product requirements for the processes identified?
What are the criteria and methods used to control the processes?
Are the methods suitable?
How do they ensure that the process is operating effectively and that the necessary resources and information are available to support operation and
measurement of processes?
How are the processes measured, monitored and analyzed?
Is there evidence to show that the measurement and monitoring of the process is satisfactory in meeting customer requirements?
Are actions taken to achieve process goals and for continual improvement?
Do the criteria and methods used effectively control the process?
Are the process metrics related to customer requirements and organizational objectives?
Is the process improving and is it benefiting the customer?
8.2.3.1
Monitoring and Measurement of Manufacturing Processes
Does the organization perform process studies to verify process capability and to provide additional input for process control?
Are there objectives for manufacturing process capability, reliability, maintainability, availability and acceptance criteria?
Is ongoing manufacturing process capability studied and improved per PPAP requirements.
Does the organization document the results of process studies with specifications where applicable for means of production, measurement and test,
and maintenance instructions?
Is the control plan being followed?
Is the organization using the control plan reaction plan for unstable and non-capable processes?
Does the organization initiate the appropriate reaction plan from the control plan for characteristics that are either unstable or non-capable?
Does the organization’s reaction plans for characteristics that are either unstable or non-capable include containment of product and 100% inspection
as appropriate?
Does the organization establish a corrective action following the initiation of reaction plans, indicating specific timing and assigned responsibilities to
assure that the process becomes stable and capable?
Are the organization’s corrective action plans reviewed with and approved by the customer when so required?
Does the organization maintain records of effective dates of process changes?
Are there records for significant process events, such as tool change or machine repair?
8.2.4
Monitoring and Measurement of Product
This section includes all measurement activities from receiving inspection to product delivery. Assess work instructions, procedures, and records to
verify compliance. Verify that the records provide evidence that product criteria are met. Do the records also identify the person responsible for
release?
Are the policies, procedures or requirements (i.e. process characteristics) clearly identified?
Are the characteristics related to customer or product requirements for the processes identified in General Requirements (4.1) and Planning of
Product Realization (7.1)?
Is product measured and monitored to verify that product requirements are met?
Where are planned measurements identified?

Do they show conformance with acceptance criteria?
Who is authorized to release product? Is the appropriate person releasing product?
Is there evidence that product release and service delivery does not proceed until all activities have been completed (unless otherwise approved by a
relevant authority or customer)?
What are the criteria and methods used to control the process?
Are the methods suitable?

How do they ensure that the process is operating effectively and that the necessary resources and information are available to support operation and
measurement of processes?
How is the process measured, monitored and analyzed?
Is there evidence to show that the measurement and monitoring of the process is satisfactory in meeting customer requirements?
Are actions taken to achieve process goals and for continual improvement?
Do the criteria and methods used effectively control the process?
Are the process metrics related to customer requirements and organizational objectives?
Is the process improving and is it benefiting the customer?
8.2.4.1
Layout Inspection and Functional Testing
Does the organization perform a layout inspection and a functional verification to applicable customer engineering material and performance
standards for all products at a sufficient frequency as specified in the control plan?
Does the organization have layout inspection and functional testing results available for customer review?
Does customer require an annual layout inspection? If so, are records indicating annual layout inspection has been performed?
8.2.4.2
Appearance Items
Sample products for appearance items, if applicable:
Is there appropriate lighting to perform appearance evaluations?
Are there masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI) as appropriate? etc.
Is there maintenance/control of appearance masters and evaluation equipment?
What are the qualifications of personnel making appearance evaluation?
8.3
Control of Nonconforming Product
A documented procedure is required for this clause. Verify the correction of nonconforming product and the re-verification by review of the records.
How has your organization ensured that product which does not conform to requirements is identified and controlled to prevent unintended use?
Is there a procedure that identifies responsibilities for taking action?
Does the procedure identify the ways that nonconforming product can be handled?
Is nonconforming product re-verified after correction to demonstrate conformity to requirements?
What action does your organization take when a nonconformity is detected after delivery or use has started?
Is there a documented procedure for dealing with nonconforming product?
Is the organization following the procedure?
Is non-conforming product (including product thought to be non-conforming) stored separately so that it does not get mixed with conforming product?
Does the organization promptly dispose of product that prevents a large accumulation of non-conforming product? Is there evidence of this?
How does the organization deal with non-conforming product?
Check log or file for deviation or concession records
Are records maintained of the nature of nonconformities and subsequent action?
What actions are taken if product non-conformance is discovered after shipping?
Are there customer complaints or rejects due to non-conforming product being shipped to customers?
Based on internal and external reject and rework data, are there problems indicated related to handling, packaging, storage and delivery?
8.3.1
Control of Nonconforming Product -supplemental
Does the organization classify unidentified or suspect status product as nonconforming product?
8.3.2
Control of Reworked Product
Are rework instructions available to personnel?
Is reworked product re-inspected per instructions?
8.3.3
Customer Information
Is the customer informed promptly?
Is there evidence that the customers are informed promptly?
Are there requirements for reporting “rectification” of nonconforming product to the customer, end user, regulatory body, or other body?
Is it being done?
8.3.4
Customer Waiver
Are concessions or deviations obtained from the customer if products or processes are different than those approved?
Waivers can be initiated by customer, supplier or the organization.

Do you see evidence of all three?
Is expiration date or quantity authorized recorded?
Is the temporary nature of deviation communicated to avoid confusion on plant floor?
How does compliance to expiration date or quantity occur?
Does material shipped documentation clearly identify deviation material?
Does the organization apply the customer waiver requirements for production product to purchased product as well?
Does the organization agree with any product concession requests from suppliers before submission to the customer?
8.4
Analysis of Data
Assess the methods used to collect and analyze the data required below. Confirm the analysis of the data is used to demonstrate the suitability and
effectiveness of the QMS and the system continues to improve.
How is data from measuring and monitoring activities used to demonstrate suitability and effectiveness of the QMS?
How is it used to continually improve the QMS?
Does the organization analyze data for improvement?
How often?
Does the data provide information on customer satisfaction and/or dissatisfaction?
Does the data presented clearly indicate the trend in customer satisfaction?
Is the data analyzed to understand things gone right or things gone wrong?
Does the organization trace success or failure to projects performing well or poorly?
Does the organization study opportunities for improvement and use techniques such as Pareto analysis or critical requests from customers to decide
on new opportunities?
Does the organization analyze non-conformance data, customer complaints and customer returns?
Data analyzed should be collected to allow analysis of all customer requirements.
Is the data available in a form to allow analysis and identification of projects?
Is information on characteristics of processes, product and their trends analyzed?
Is process and product data tracked and trended?
What is the process when a process or product is found not meeting customer requirements?
Does the organization identify improvement opportunities for the characteristics?
Does the organization gather and analyzing information on suppliers?
Does the organization track supplier data as it relates to deliveries and receiving inspection?
Is this data used for selecting and evaluating suppliers?
How is the information used to identify improvement?
Does the data analysis clearly show what is happening to customer satisfaction, conformance to customer requirements, characteristics of processes,
product and their trends, and suppliers?
Does the data point to improvement opportunities?
Does the organization determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management
system and to evaluate where continual improvement of the effectiveness of the quality management system can be made?
Does the organization’s data analysis include data generated as a result of monitoring and measurement and from other relevant sources?
Is data compared to competitors or benchmarks?
8.4.1
Analysis and Use of Data
Check for characteristics of processes, product and their trends:
What do they do when a process or product is found not meeting customer requirements?
Is process and product data tracked and trended?
Do they identify improvement opportunities for the characteristics?
Is data compared to competitors or benchmarks?
Does the organization compare trends in quality and operational performance compared with progress toward objectives and lead to action to support
the following:
- Development of priorities for prompt solutions to customer-related problems?
- Determination of key customer related trends and correlation to support status review, decision-making and longer term planning?
- An information system for the

timely reporting of product
information arising from usage?
8.5
Improvement
8.5.1
Continual Improvement
This clause contains many of the requirements already specified in previous clauses. Verify that the requirements are being used to plan for continual
improvement.
How does your organization, continually improve the effectiveness of the QMS?
Does the organization continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives,
audit results, analysis of data, corrective and preventive actions and management review?
8.5.1.1
Continual Improvement of the Organization
Has the organization defined a process for continual improvement?
Are continuous improvement projects identified using the quality policy, objectives, audit results, analysis of data, corrective and preventive action,
and management review?
Is there performance evidence?
How does the organization allocate resources to these projects?
What types of techniques are used for continuous improvement?
Is there evidence of improvement resulting from improvement project completion?
How are projects tracked and their completion?
Are improvement projects assigned to individuals and are deadlines established?
Are there projects for reduction of variation and waste in capable and stable manufacturing processes
Is there evidence of continual improvement?

Are the trends positive in performance measures related to quality objectives?
8.5.1.2
Manufacturing Process Improvement
Does the organization’s continual improvement focus upon control and reduction of variation in products characteristics (special characteristics)?
Does the organization’s continual improvement focus upon control and reduction of variation manufacturing process parameters (process special
characteristics)?
8.5.2
Corrective Action
A documented procedure is required for this clause. Review your records to confirm conformance.
What is identified as corrective action?
Are the actions taken appropriate to the impact of the problems encountered?
Is there a documented procedure for corrective action, and is there objective evidence that they follow it?
Sample several corrective actions:
Was the non-conformity (i.e. problem) identified?
Was the cause of non-conformity determined?
Was the need for actions to ensure problem do not repeat evaluated?
Was corrective action implemented?
Were results of the corrective action recorded?
Was the corrective action taken?
Does the data show that the corrective action is effective?
Do problems repeat?
Are corrective action performance trends monitored, analyzed and improved?
8.5.2.1
Problem Solving
Does the established problem solving process include root cause identification and elimination?
If required, do they follow the customer prescribed problem-solving format?
8.5.2.2
Error-Proofing
Are error-proofing methods used?
Do FMEA’s demonstrate greater implementation of prevention controls rather than only detection controls?
Do error-proofing methods implemented in corrective action initiate changes to the PFMEA and Control Plan?
Check for linkage.
8.5.2.3
Corrective Action Impact
Was the corrective action applied to similar processes and products?
8.5.2.4
Rejected Product Test/Analysis
Does the organization analyze parts rejected by the customer's manufacturing plants, engineering facilities, and dealerships?
Does the organization minimize the cycle time of its rejected product test/analysis process?
Does the organization keep records of its rejected product test/analyses and make available upon request?
Does the organization perform analysis and, initiate corrective action to prevent recurrence?
8.5.3
Preventive Action
A documented procedure is required by this clause. Review records to confirm conformance.
Has your organization established a procedure to eliminate the cause of potential nonconformities to prevent their occurrence?
Is there objective evidence it is followed?
What does the organization identify as preventive action?
Are the actions taken appropriate to the impact of the problems encountered?
Sample preventive actions:
Was a potential non-conformity (i.e. problem) identified?
Was it determined that preventive action was needed?
Were the results of action taken recorded?
Was preventive action taken reviewed?
Does the data show that the preventative action is effective?
Are problems eliminated before they occur?
Additional Notes:
Additional Notes:

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Minth North America

IATF 16949:2016 Gap Analysis Checklist

Date of Gap Analysis: ____________________________________

Minth Location or Supplier Location Analysis was undertaken: ________________________________

Reason for Gap Analysis: __________________________________________________________

Minth Staff Completing the Analysis: ________________________________________________

Supplier or Minth Location Staff supporting the Analysis: ________________________________

4 QUALITY MANAGEMENT SYSTEM

REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

Look for documentation of the processes

Look for information on the relationship

Ask Management if operation and control

Ask how they are able to know if

REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

How are improvements made to

Is there implementation of process

What processes does your organization

4.1.1 General Requirements - supplemental

4.2 Documentation Requirements

REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

Is the documentation sufficient to ensure

Does the quality management system

Documented statements of a quality

Documented procedures required by

Documents needed by the organization to

Records required by IATF 16949:2016?

REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

Are the required documents available?

Does the QMS documentation include

4.2.2 Quality Manual

What processes have been excluded?

Is a description or illustration of the

Does the Quality Manual include a

Does the Quality Manual adequately

REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

Do employees understand their

4.2.3 Control of Documents

Are documents approved prior to

Are documents updated and re-approved

How are changes identified?

Are documents available to those that

REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

If documents such as reference books,

How are old documents handled?

Does the organization adequately

4.2.3.1 Engineering Specifications

REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

Do the reviews take place within period of

Check for record of change

Check updates to affected documents,

What is their process to ensure that the

4.2.4 Control of Quality Records

REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

How are the retention times, storage

Are they stored in areas and locations are

Can they be retrieved?

How long does it take?

Are records disposed of according to the

If the documents and or records are in the

REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

4.2.4.1 Records Retention

REQUIREMENTS CURRENTLY IN PLACE CONFORMING ITEMS NEEDED

What role did Top Management play in