Sample Reference Documents for

IATF16949:2016

By: Subhransu Sekhar Mohanty

Clause/Sub-
Document Type Description
Clause

4.3 Scope of QMS Scope of the quality management system

Processes, inputs, outputs, sequences, and
4.4.1 Quality Management System
interactions
5.2 Quality Policy Documented quality policy
Quality objectives and plans to achieve
6.2.2 Quality Objectives
them
Records of calibration and verification of
7.1.5.1.1 Calibration Records
tools
Evidence of competence, training, and
7.2 Competence Records
qualification
General documented information
7.5.1 Documented Information
required for QMS
Process for creating, updating, and
7.5.2 Control of Documents
controlling documents
Retention, storage, and protection of
7.5.3 Control of Records
records
Documented feasibility analysis for new
8.2.3.1.2 Feasibility Study Records
projects
Design and Development Design and development plans and
8.3.2
Planning reviews
Design output records, including
8.3.4 Design Outputs
validation
8.3.5 Design Changes Documented records of design changes
Clause/Sub-
Document Type Description
Clause
Records of supplier selection,
8.4.1.2 Supplier Control Records
development, and monitoring
8.5.1.1 Control Plans Control plan for products and processes
Documented work instructions for
8.5.2 Work Instructions
operations
Records of changes in production and
8.5.6 Control of Changes
processes
Documented records of nonconformity
8.7.2 Nonconformity Records
and corrective actions
9.1.1.1 Monitoring & Measurement Evidence of product/process monitoring
Records of internal audit results and
9.2.2 Internal Audit Records
reports
9.3.3 Management Review Records Records of management reviews

10.2.2 Corrective Action Records Documented corrective actions

Documented evidence of continual
10.3 Continual Improvement
improvement plans
Sample Document of “Scope of QMS” document in alignment with IATF 16949:2016 Clause 4.3.

Document Title: Scope of Quality Management System

Document No.: QMS-001

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of 1

1. Purpose

This document defines the scope of the Quality Management System (QMS) established by
[Company Name] in accordance with IATF 16949:2016 and ISO 9001:2015 standards.

2. Scope of the QMS

The Quality Management System of [Company Name] applies to the design, development,
manufacturing, and supply of [product names or description, e.g., lead-acid batteries, electronics,
automotive components] for the automotive industry.

2.1 Boundaries of the QMS

• Processes Covered:
o Design and Development
o Manufacturing
o Quality Assurance
o Supplier Management
o Logistics and Customer Service
• Locations Included:
o [Factory/Plant Location, e.g., Plot No. XX, Industrial Area, Baddi, Himachal Pradesh]
o [Any additional locations that apply]

2.2 Relevant Interested Parties

The QMS considers the needs and expectations of relevant interested parties, including:

• Customers
• Employees
• Suppliers
• Regulatory Bodies
• Shareholders

2.3 Exclusions (if applicable)

As per IATF 16949:2016 Clause 8.3 (Design and Development), exclusion has been applied because
[provide justification, e.g., design activities are not performed in-house].

3. Justification

This scope is determined considering:

 • Internal and external issues relevant to the organization’s context.
• Customer-specific requirements (CSR) applicable to the automotive industry.
• The organization’s capability to meet applicable statutory, regulatory, and IATF 16949 requirements.

4. References

• IATF 16949:2016 Standard

• ISO 9001:2015 Standard

5. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

Document Control

Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

This sample aligns with IATF 16949:2016 Clause 4.3 and provides clear justification, boundaries,
and process coverage for the QMS.

Sample document for Quality Management System: Processes, Inputs, Outputs, Sequences, and
Interactions as per IATF 16949:2016 Clause 4.4.1.
Document Title: Quality Management System Processes, Inputs, Outputs, Sequences, and
Interactions

Document No.: QMS-002

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of 3

1. Purpose

This document defines the processes, their inputs, outputs, sequences, and interactions within the
Quality Management System (QMS) of [Company Name] in accordance with the requirements of
IATF 16949:2016 Clause 4.4.1.

2. QMS Processes and Interactions

The Quality Management System of [Company Name] consists of interrelated core, supporting, and
management processes. Each process has defined inputs, outputs, responsibilities, and interactions.

2.1 QMS Process Map

Below is a high-level process map showing the key processes and their relationships:

Customer Requirements
│
▼
Sales and Marketing
│
▼
Design and Development
│
▼
Supplier Management
│
▼

Manufacturing
│
▼
Quality Assurance
│
▼

Logistics & Delivery

│
▼
Customer Satisfaction

2.2 Processes, Inputs, Outputs, and Interactions

Process Inputs Outputs Interactions

Customer inquiries, RFQs, Customer requirements, Design, Supplier

Sales and Marketing
contracts contracts Management
 Process Inputs Outputs Interactions

Design and Customer requirements, Design plans, product Sales, Manufacturing,

Development CSR, contracts specifications Quality Assurance

Supplier Supplier inputs, material Approved suppliers, raw Manufacturing, Quality

Management requirements materials Assurance

Design specifications, Finished product,

Manufacturing Quality Assurance, Logistics
materials production records

Product samples, process Inspection reports, NCRs, Manufacturing, Logistics,

Quality Assurance
data approvals Design

Finished products, Delivered products, Sales, Quality Assurance,

Logistics & Delivery
customer orders delivery records Customers

Management QMS performance data, Improvement plans,

All Processes
Review audits corrective actions

3. Process Descriptions

3.1 Sales and Marketing

• Purpose: To capture and communicate customer requirements.

• Owner: Sales Manager
• Key Activities:
o Respond to RFQs and customer inquiries
o Contract review and acceptance
o Communicate requirements to relevant departments

3.2 Design and Development

• Purpose: To design products meeting customer and regulatory requirements.

• Owner: Design Head
• Key Activities:
o Design and development planning
o Prototype development and testing
o Design verification and validation

3.3 Supplier Management

• Purpose: To ensure supplier quality and on-time delivery.

• Owner: Purchase Manager
• Key Activities:
o Supplier selection and approval
o Supplier monitoring and evaluation
o Procurement of materials

3.4 Manufacturing

• Purpose: To produce products as per specifications.

• Owner: Production Manager
 • Key Activities:
o Production planning and execution
o Process control and monitoring
o Reporting production data

3.5 Quality Assurance

• Purpose: To ensure product conformity to customer requirements.

• Owner: Quality Manager
• Key Activities:
o Incoming, in-process, and final inspection
o Nonconformance management and corrective actions
o Monitoring of KPIs and customer feedback

3.6 Logistics & Delivery

• Purpose: To ensure timely delivery to customers.

• Owner: Logistics Manager
• Key Activities:
o Packaging and dispatch
o Logistics planning and shipment tracking
o Customer satisfaction monitoring

4. References

• IATF 16949:2016 Standard

• Customer-Specific Requirements (CSR)

5. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

6. Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

Sample Quality Policy document aligned with IATF 16949:2016 Clause 5.2.

Document Title: Quality Policy

Document No.: QMS-003

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of 1
1. Purpose

The purpose of this document is to establish, implement, and communicate the Quality Policy of
[Company Name] in alignment with the requirements of IATF 16949:2016 Clause 5.2.

2. Quality Policy

At [Company Name], we are committed to:

1. Consistently meeting and exceeding customer requirements through the delivery of high-quality
products and services.
2. Continually improving our Quality Management System (QMS) and processes to enhance customer
satisfaction.
3. Complying with all applicable statutory, regulatory, and customer-specific requirements.
4. Promoting a culture of quality, teamwork, and innovation across all levels of the organization.
5. Empowering our employees through training, development, and involvement to ensure competence
and commitment to quality.
6. Achieving operational excellence by focusing on defect prevention, waste reduction, and process
efficiency.

This policy is communicated, understood, and applied throughout the organization and serves as the
framework for establishing and reviewing quality objectives.

3. Quality Policy Statement

"Delivering Quality, Enhancing Customer Satisfaction, and Driving Continuous

Improvement."

4. Responsibilities

• Top Management is responsible for reviewing and approving the Quality Policy and ensuring it is
aligned with organizational goals.
• All Employees are responsible for understanding, implementing, and adhering to the Quality Policy in
their daily activities.

5. Communication of Quality Policy

The Quality Policy is:

• Displayed at prominent locations throughout the facility.

• Communicated to all employees during training and orientation programs.
• Made available to relevant interested parties, such as customers, suppliers, and auditors, upon
request.

6. References

• IATF 16949:2016 – Clause 5.2

 • Quality Manual

7. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

8. Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

This Quality Policy is concise, clear, and aligns with IATF 16949:2016 requirements. It includes the
organization's commitment to customer satisfaction, continual improvement, and regulatory
compliance, while serving as the foundation for quality objectives.

Sample Calibration Records document aligned with IATF 16949:2016 Clause 7.1.5.1.1.

Document Title: Calibration Records

Document No.: QMS-004

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of 2

1. Purpose

The purpose of this document is to establish a systematic approach for maintaining calibration records
of all measuring and monitoring equipment to ensure compliance with IATF 16949:2016 Clause
7.1.5.1.1.
2. Scope

This document applies to all measuring and monitoring equipment used within the organization for
production, inspection, testing, and quality assurance processes.

3. Calibration Record Format

Equipment Equipment Calibration Due Reference
Location Calibrated By Status
ID Name Date Date Standard

XYZ Calibration 2025- Traceable to

EQP-001 Vernier Caliper QC Lab 2024-06-01 OK
Co. 06-01 NIST

Production Line 2024- ISO 17025

EQP-002 Micrometer In-House 2024-06-05 OK
1 12-05 Standard

Pressure ABC 2025-

EQP-003 Assembly Area 2024-05-20 OK NABL Certified
Gauge Calibrations 05-20

Digital Maintenance XYZ Calibration 2025- Traceable to

EQP-004 2024-05-15 OK
Multimeter Room Co. 05-15 NABL

4. Responsibilities

• Calibration Coordinator: Ensures all measuring equipment is calibrated and records are updated.
• Quality Control (QC) Department: Verifies calibration status during inspections.
• Production Team: Ensures equipment used for production is calibrated and tagged properly.

5. Calibration Process

1. Identification of Equipment:
o All monitoring and measuring equipment are uniquely identified.
2. Calibration Schedule:
o A calibration schedule is maintained for all equipment based on:
▪ Manufacturer’s recommendations
▪ Frequency of use
▪ Customer and regulatory requirements
3. External Calibration:
o Calibration services provided by external agencies must be traceable to international or
national standards (e.g., ISO 17025, NABL, NIST).
4. In-House Calibration:
o In-house calibration is performed using certified master instruments.
5. Calibration Status:
o Calibrated equipment must be labeled/tagged with:
▪ Calibration Date
▪ Next Due Date
▪ Status (OK, Rejected, or Out of Tolerance)
6. Out-of-Tolerance Equipment:
o If any equipment is found out of tolerance, affected processes and products are reviewed,
and appropriate corrective actions are initiated.
6. Retention of Records

Calibration records are retained for a minimum period of [Insert Duration, e.g., 3 years] or as per
customer-specific requirements.

7. References

• IATF 16949:2016 – Clause 7.1.5.1.1

• ISO 10012:2013 – Measurement Management Systems
• ISO 17025:2017 – General Requirements for the Competence of Testing and Calibration Laboratories

8. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

9. Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

Sample Competence Records document aligned with IATF 16949:2016 Clause 7.2.

Document Title: Competence Records

Document No.: QMS-005

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of 2

1. Purpose

The purpose of this document is to establish a process for maintaining Competence Records to
ensure that personnel performing work affecting product quality are competent based on appropriate
education, training, skills, and experience, as required by IATF 16949:2016 Clause 7.2.

2. Scope

This document applies to all employees whose work directly or indirectly affects product quality,
including production, quality assurance, maintenance, logistics, and other support departments.
3. Competence Record Template
Trainin Evaluat
Emplo Required Train Compet
Emplo Designat Departm Education/Exp g Trainer/Pr ion
yee Compete ing ence
yee ID ion ent erience Receiv ovider Metho
Name nce Date Status
ed d

Machin
Producti Process e Written
EMP- John on Producti Control, Diploma in Operati 2024- Test, Compet
In-House
001 Smith Supervis on Machine Engineering on 06-01 Practica ent
or Setup Trainin l
g

Product
Inspecti Practica
Quality Quality Inspectio ABC
EMP- Jane on 2024- l Compet
Inspecto Assuranc n, Graduate Training
002 Doe Techni 05-20 Assess ent
r e Reportin Co.
ques ment
g

Equipme
TPM & Practica
Mainten nt B.Tech
EMP- Mark Mainten Safety XYZ 2024- l Compet
ance Mainten Mechanical
003 Wilson ance Worksh Trainers 04-15 Assess ent
Engineer ance, Engg.
op ment
Safety

Dispatc
Packagin
h
Sarah Logistics g,
EMP- Handlin 2024- Written Compet
Thoma Executiv Logistics Dispatch Graduate In-House
004 g 06-10 Test ent
s e Procedur
Trainin
es
g

4. Responsibilities

• HR Department: Maintains and updates competence records for all employees.

• Department Heads: Identify required competencies, approve training plans, and ensure evaluations
are performed.
• Training Coordinator: Organizes and tracks training programs.
• Employees: Participate in training and assessments to achieve competence.

5. Competence Management Process

1. Identification of Competence Requirements

o Required competencies for each role are defined based on job descriptions, customer
requirements, and applicable standards.
2. Training and Development
o Training needs are identified during employee onboarding, annual performance reviews, and
internal/external audits.
o Training methods include:
▪ On-the-job training
▪ Classroom training
▪ External workshops/seminars
3. Evaluation of Competence
o Employees are evaluated through:
 ▪ Written tests
▪ Practical demonstrations
▪ Interviews or feedback from supervisors
4. Competence Status and Records
o Competence status is updated based on evaluations.
o Records are maintained in both soft and hard copies for traceability.
5. Retention of Records
o Competence records are retained for the duration of employment + [Insert Retention
Period] years.

6. References

• IATF 16949:2016 – Clause 7.2

• ISO 9001:2015 – Clause 7.2
• Training Needs Analysis Document

7. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

8. Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

This document provides a structured approach for maintaining competence records, ensuring
compliance with IATF 16949:2016 Clause 7.2.
Sample Control of Documents procedure aligned with IATF 16949:2016 Clause 7.5.3.

Document Title: Control of Documents

Document No.: QMS-006

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of 3

1. Purpose

The purpose of this document is to establish a process for the control of documents within the Quality
Management System (QMS) as required by IATF 16949:2016 Clause 7.5.3. This ensures all
documents are approved, updated, communicated, and properly controlled to prevent unintended use.

2. Scope

This document applies to all QMS documents, both internal and external, including:

• Quality Manual
• Procedures
• Work Instructions
• Forms and Records
• Customer-Specific Requirements (CSRs)
• External Standards and Technical Specifications

3. Document Control Process

3.1 Document Creation and Approval

1. All documents are prepared by the respective process owners.

2. Documents are reviewed for accuracy and completeness by relevant department heads.
3. Documents are approved by authorized personnel (e.g., Quality Manager, Top Management).

Document Type Prepared By Reviewed By Approved By

Quality Manual Quality Dept. Quality Manager Management Rep.

 Document Type Prepared By Reviewed By Approved By

Procedures Process Owner Department Head Quality Manager

Work Instructions Process Owner Supervisor Department Head

Records/Forms Relevant Staff Process Owner Quality Manager

3.2 Document Identification

All QMS documents shall include the following identification:

• Document Title
• Document Number
• Revision Number
• Effective Date
• Page Numbers (e.g., Page 1 of 3)
• Prepared By, Reviewed By, and Approved By

3.3 Document Distribution

1. Controlled copies of documents are distributed as required to relevant departments.

2. Electronic versions are stored in a secure server with controlled access.
3. Obsolete documents are removed from points of use to prevent unintended use.

3.4 Document Changes (Revisions)

1. Document changes are initiated when:

o Process improvements occur
o Customer or regulatory requirements change
o Internal/external audit findings require changes
2. Revision records are maintained in a Document Revision Log:

Revision No. Date Description of Change Approved By

01 2024-06-01 Initial Release Quality Manager

02 2024-06-15 Added control for external documents Management Rep.

3. All changes are communicated to users, and obsolete versions are marked "OBSOLETE" and archived.

3.5 Control of External Documents

1. External documents (e.g., standards, specifications) are identified and controlled.

2. Updated versions of external documents are obtained from authorized sources and reviewed for
impact on the QMS.

3.6 Retention of Documents

1. Documents are retained as per the Document Retention Schedule:

 Document Type Retention Period Location

Quality Manual Current + 5 Years QMS Server

Procedures Current + 3 Years Departmental Records

Work Instructions Current + 3 Years Production Area

Forms and Records As specified Record Storage Area

2. Documents older than the retention period are disposed of in a controlled manner (e.g., shredding).

4. Responsibilities

• Quality Manager: Oversees the control of documents and ensures compliance.

• Process Owners: Create, review, and update documents.
• Document Controller: Maintains the master list of documents and controls distribution.
• Employees: Use only the latest approved versions of documents.

5. Document Control Master List

Document Title Document No. Revision No. Effective Date Owner

Quality Manual QMS-001 01 2024-06-01 Quality Manager

Control of Documents QMS-006 01 2024-06-10 Quality Manager

Calibration Records QMS-004 01 2024-05-30 Quality Manager

6. References

• IATF 16949:2016 – Clause 7.5.3

• ISO 9001:2015 – Documented Information
• Documented Information Procedure

7. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

8. Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

This document outlines the process for controlling QMS documents, ensuring compliance with
IATF 16949:2016 Clause 7.5.3.
Sample Control of Records document aligned with IATF 16949:2016 Clause 7.5.3.2.

Document Title: Control of Records

Document No.: QMS-007

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of 3

1. Purpose

The purpose of this document is to define the procedure for identification, storage, protection,
retrieval, retention, and disposition of records to ensure compliance with IATF 16949:2016 Clause
7.5.3.2. This ensures records remain legible, identifiable, and traceable.

2. Scope

This procedure applies to all quality records required to demonstrate compliance with QMS
requirements, customer-specific requirements, and statutory/regulatory requirements.

3. Definition of Records

Records are documented evidence of activities, processes, or results, including:

• Inspection and test results

• Calibration records
• Competence and training records
• Maintenance logs
• Internal and external audit reports
• Corrective action records
• Customer complaints and feedback

4. Control of Records Process

4.1 Identification of Records

All records shall include:

• Unique identification number

• Title/description
• Originating department
• Date of creation
• Retention period

4.2 Record Retention and Storage

1. Records are stored in hardcopy and/or electronic format based on organizational needs.
 2. Records are protected from damage, deterioration, or loss through:
o Fireproof cabinets for hard copies
o Password-protected servers for electronic records
3. Retention periods are defined as follows:

Record Type Retention Period Storage Location Responsible Person

Quality Department
Inspection and Test Records 3 Years Quality Manager
Archives

Calibration Records 3 Years Calibration File / Server Maintenance Head

Training and Competence Duration of Employment + 3

HR Department Archives HR Manager
Records Years

Audit Reports 3 Years QMS Server Quality Manager

Corrective Action Reports 3 Years CAPA File / Server Quality Manager

Customer Service Customer Support

Customer Complaints 3 Years
Records Head

4.3 Protection of Records

• Hard copies are protected from environmental damage (e.g., moisture, fire, and unauthorized access).
• Electronic records are backed up regularly on secure servers.
• Access to sensitive records is restricted based on departmental roles.

4.4 Retrieval of Records

Records shall be easily retrievable upon request:

• Internal users (e.g., employees)

• External parties (e.g., customers, auditors, regulatory authorities)
• Access shall be approved by the Record Custodian or relevant department head.

4.5 Disposition of Records

1. Records exceeding the defined retention period are reviewed for disposition.
2. Disposed records are destroyed using:
o Shredding (for hard copies)
o Permanent deletion (for electronic records)
3. A Record Disposition Log is maintained.

Record Type Retention End Date Disposition Method Approved By

Inspection and Test Records 2024-06-01 Shredding Quality Manager

Calibration Records 2024-06-10 Deletion Maintenance Head

Customer Complaints 2024-05-15 Shredding Customer Support Head

5. Responsibilities
Role Responsibilities

Quality Manager Ensures QMS-related records are controlled and retained.

HR Manager Maintains competence and training records.

Maintenance Head Controls and retains calibration and maintenance records.

Record Custodians Protect and manage records within their respective departments.

IT Manager Ensures electronic record security and backups.

6. References

• IATF 16949:2016 – Clause 7.5.3.2

• ISO 9001:2015 – Control of Documented Information
• Internal Document Retention Policy

7. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

8. Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

This Control of Records document ensures that all records are maintained in a systematic, secure,
and traceable manner, as required by IATF 16949:2016 Clause 7.5.3.2.

Sample Feasibility Study Records document aligned with IATF 16949:2016 Clause 8.2.3.1.3.

Document Title: Feasibility Study Records

Document No.: QMS-008

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of 3

1. Purpose

The purpose of this document is to establish a process for conducting and maintaining Feasibility
Study Records to assess the capability of the organization to meet customer-specific requirements,
product design, and process requirements as per IATF 16949:2016 Clause 8.2.3.1.3.

2. Scope

This procedure applies to all new product inquiries, changes to existing products, and any customer-
specific requirements for feasibility analysis before acceptance of an order.

3. Feasibility Study Process

3.1 Input to Feasibility Study

The following inputs are considered during a feasibility study:

• Customer requirements (drawings, specifications, standards, and volume demands)

• Product design and development requirements
• Process design and development requirements
• Available resources (machines, tools, manpower, facilities, etc.)
• Material availability
• Cost analysis and profitability
• Risk analysis (e.g., PFMEA, DFMEA)

3.2 Feasibility Study Record Template

Customer Name [Insert Customer Name] Project Name [Insert Project Name]

Inquiry Date [Insert Date] Product Code [Insert Product Code]

Feasibility Aspects Details/Observations Feasibility Status Comments

Customer Feasible/Not
[Describe Key Requirements] [Notes on Specific Gaps]
Requirements Feasible

Product Design [Design Compatibility Feasible/Not

[Areas for Improvement]
Feasibility Observations] Feasible

Process Design Feasible/Not

[Process Capability Observations] [Resource Requirements]
Feasibility Feasible

[Machines/Tools/Manpower Feasible/Not [Additional Resource

Resource Availability
Details] Feasible Needs]

Feasible/Not
Material Feasibility [Material Sources & Lead Time] [Potential Risks]
Feasible
 Feasibility Aspects Details/Observations Feasibility Status Comments

[Summarize PFMEA/DFMEA Feasible/Not

Risk Analysis [Mitigation Plans]
Results] Feasible

Feasible/Not
Cost and Profitability [Costing Analysis] [Margin Observations]
Feasible

Feasibility Status: [☐ Feasible ☐ Not Feasible]

Conclusion:

• Final decision: [Approval/Disapproval of Project]

• Comments: [Insert any relevant remarks]

Prepared By: [Name/Department]

Reviewed By: [Name/Designation]
Approved By: [Name/Designation]

Date: [Insert Date]

4. Feasibility Study Responsibilities

Role Responsibilities

Sales/Marketing Team Collect customer requirements and provide inputs.

Design Team Conduct design feasibility analysis and DFMEA.

Production Team Assess process feasibility and resources availability.

Quality Team Perform risk analysis, review PFMEA/DFMEA results.

Management Review feasibility analysis and approve/disapprove decisions.

5. Retention of Records
Record Type Retention Period Location

Feasibility Study Records 3 Years after project end QMS Server / Archives

6. References

• IATF 16949:2016 – Clause 8.2.3.1.3

• Customer-specific requirements
• Design and Process Development Procedures

7. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

8. Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

This document provides a systematic approach for maintaining Feasibility Study Records, ensuring
compliance with IATF 16949:2016 Clause 8.2.3.1.3

Control Plan in tabular form with document and other relevant details as per IATF 16949:2016
Clause 8.3.4:

Document Title: Control Plan

Document No.: QMS-009

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of 3

Control Plan Template

Measurement Frequency of
Process Step Control Feature Control Limits Reaction Plan
Method Monitoring

Visual Inspection / Reject material

Receiving Raw Material Each Lot Material
Dimensional outside spec, notify
Inspection Integrity Received Specifications
Measurement supplier
 Measurement Frequency of
Process Step Control Feature Control Limits Reaction Plan
Method Monitoring

Re-calibrate
Cutting Length, Edge Micrometer, Visual
Each Batch ±0.5 mm machine, recheck
Process Quality Inspection
material

Recheck tools,
Assembly Torque Wrench / Every 10th
Fastener Torque ±5 Nm adjust torque
Process Digital Torque Meter Unit
settings

Re-calibrate paint
Painting
Paint Thickness Thickness Gauge Each Lot 50 - 80 microns sprayer, adjust
Process
spray pressure

Visual Defects, Reject product,

Final Optical Measurement,
Dimensional Each Unit ±0.2 mm investigate
Inspection Caliper
Checks production process

Control Plan Process

1. Purpose: The Control Plan outlines the control measures to ensure processes are monitored and meet
specified quality requirements.
2. Scope: Applies to all processes during production, from design to final inspection.
3. Frequency of Monitoring: Monitoring is done based on batch, unit, or production lot depending on
the process.
4. Reaction Plan: Actions are taken when a product or process deviates from the specified control limits
(e.g., re-calibration, investigation, rework).
5. Measurement Method: Measurement tools and techniques for inspecting process control features.

Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

Work Instructions template aligned with IATF 16949:2016 Clause 7.5.1.1:

Document Title: Work Instructions

Document No.: WI-001

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of X

1. Purpose

To provide step-by-step Work Instructions for [insert process name] to ensure process
standardization, consistency, and compliance with customer requirements and quality standards.

2. Scope

This document applies to all personnel involved in [insert process name or department] and covers all
related activities.
3. Work Instructions Template
Step Safety
Process Step Tools/Equipment Specifications/Standards Control Method
No. Requirements

Preparation:
Material checklist, BOM, Material Wear PPE (Gloves,
1 Verify Visual Inspection
ERP system Specifications Safety Shoes)
materials

Cutting Cutting Machine, Dimensional Ensure machine

2 ±0.5 mm on Length
Process Micrometer Measurement guard is engaged

Assembly Torque Wrench, Fastener Torque: 5 Nm Torque Wrench Follow ergonomic

3
Process Fasteners ±0.5 Nm Reading guidelines

Painting Spray Gun, Paint Paint Thickness: 50–80 Thickness Use respirator
4
Process Thickness Gauge microns Measurement mask, ventilation

Dimensional Report
Final Caliper, Visual Critical Dimensions,
5 Check & Visual nonconformance
Inspection Inspection Tools Surface Finish
Inspection immediately

4. Responsibilities
Role Responsibilities

Operators Follow the work instructions and report abnormalities.

Supervisors Ensure work instructions are followed and updated as required.

Quality Inspectors Verify compliance with standards through inspections.

Process Engineers Update work instructions when processes or standards change.

5. Safety Precautions

• Wear appropriate Personal Protective Equipment (PPE) at all times (e.g., gloves, safety shoes,
goggles).
• Ensure all tools and machines are in proper working condition before starting.
• Follow all lockout/tagout procedures where applicable.
• Maintain a clean and organized workstation to minimize risks.

6. References

• Process Flow Diagram (PFD)

• PFMEA (Process Failure Mode and Effects Analysis)
• Control Plan
• Customer-Specific Requirements (if applicable)

7. Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

8. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

Control of Changes document template aligned with IATF 16949:2016 Clause 8.5.6.

Document Title: Control of Changes

Document No.: QMS-010

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of X

1. Purpose

The purpose of this document is to define the process for controlling changes to products, processes,
and services to ensure compliance with customer requirements and quality standards, as per IATF
16949:2016 Clause 8.5.6.

2. Scope

This procedure applies to all product, process, and documentation changes within the organization
that may affect:

• Product performance
• Process capability
• Customer requirements
• Regulatory compliance

3. Definitions

• Change: Any modification to product design, production processes, equipment, materials, suppliers,
or control methods.
• Temporary Change: Changes implemented for a limited period or emergency changes.
4. Change Management Process
Step
Activity Responsibility Description
No.

Identify the need for change (design, process,

1 Initiation of Change Process Owner
material, or equipment).

Change Request Submit a Change Request Form (CRF) with details of

2 Requestor
Submission the proposed change.

Quality, Engineering Analyze potential risks, impacts on process, product

3 Impact Assessment
Teams quality, and customers.

Management Approve or reject the change based on impact

4 Approval of Change
Representative analysis and justification.

Implementation of Implement the approved change following Control

5 Process Owner
Change Plans, PFMEA, and Work Instructions.

Validation and Verify the effectiveness of the change through

6 Quality Team
Verification testing, inspection, or audits.

Communication of Quality, Production Notify relevant internal teams, customers, and

7
Change Teams suppliers as applicable.

Documentation Document Control Update related documents (e.g., Control Plan, PFMEA,
8
Update Team Work Instructions, etc.).

Monitoring and Process Owner, Monitor the change to ensure stability and record the
9
Review Quality results for review.

5. Documentation for Control of Changes

The following documents shall be updated when changes are implemented:

Document Type Examples

Control Plans Product/process control parameters

Process Flow Diagrams Steps in production process

PFMEA (Process Failure Modes) Risk analysis for process steps

Work Instructions Operator instructions and controls

Design Documents Drawings, specifications, BOM

Inspection Records Testing/inspection methods

Supplier Documentation Supplier process/material changes

6. Responsibilities
Role Responsibilities

Process Owners Initiate change requests and implement changes.

Quality Team Assess risks and validate changes for effectiveness.

Management Approve changes and provide oversight for implementation.

Document Control Update relevant documents and ensure proper version control.

7. Change Request Form

Change Request ID [Auto-Generated]

Change Initiator [Name, Department]

Date of Request [Date]

Type of Change Design / Process / Supplier

Reason for Change [Brief Justification]

Impact of Change [Risk Assessment Summary]

Proposed Implementation Date [Target Date]

Approval [Manager Name, Date, Sign]

8. Monitoring and Review

All changes shall be reviewed for effectiveness within [insert review period, e.g., 30 days] of
implementation. A summary of changes and results will be presented in Management Review
meetings.

9. References

• IATF 16949:2016 – Clause 8.5.6

• Control Plan
• PFMEA
• Work Instructions

10. Document Control

Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

11. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

Nonconformity Records document template aligned with IATF 16949:2016 Clause 10.2
(Nonconformity and Corrective Action).

Document Title: Nonconformity Records

Document No.: NCR-001

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of X

1. Purpose

To systematically identify, document, and resolve nonconformities in products, processes, or systems

to ensure compliance with quality standards and prevent recurrence.

2. Scope

This document applies to all nonconformities identified during:

• Incoming material inspection

• In-process production
• Final inspection
• Internal audits
• Customer complaints
• Supplier performance

3. Definitions

• Nonconformity (NC): Non-fulfillment of a requirement or deviation from specifications, standards, or

processes.
• Corrective Action: Action taken to eliminate the cause of a detected nonconformity to prevent
recurrence.

4. Nonconformity Record Template

Nonconformity Record No. [Auto-Generated]

Date of Detection [Insert Date]

Reported By [Name, Designation]

Location/Process [Process/Department/Workstation]

Nonconformity Description [Detailed Description of the NC]

Type of NC Product / Process / System / Supplier

Nonconformity Record No. [Auto-Generated]

Reference Document [Control Plan, Drawing, WI, Customer Spec]

Severity Major / Minor

5. Nonconformity Details
Root Cause Analysis [Why? Analysis, Tools: 5 Whys, Fishbone Diagram, etc.]

Containment Action [Immediate action to isolate and correct the NC]

Corrective Action Plan [Actions to eliminate root cause & prevent recurrence]

Responsible Person [Name/Department]

Target Completion Date [Insert Date]

Verification of Action [Details of verification and results]

6. Nonconformity Management Process

Step
Activity Responsibility Description
No.

Identification of Report and record nonconformity using NCR

1 Operator/Inspector/Auditor
Nonconformity form.

Process Owner/Team Implement immediate measures to isolate the

2 Containment Action
Leader issue.

Perform root cause analysis using tools like 5

3 Root Cause Analysis Quality/Process Team
Whys or Fishbone Diagram.

Develop and implement corrective actions to

4 Corrective Action Assigned Responsible
address the root cause.

Verify effectiveness of corrective actions

5 Verification of Action Quality Team
through testing or inspection.

Update Control Plan, PFMEA, and Work

6 Documentation Update Document Control Team
Instructions if necessary.

Review and close the NCR after validation of

7 Closeout and Review Quality Manager
corrective actions.

7. Documentation and Records

The following records shall be maintained as evidence of nonconformity management:

 Record Type Responsible Department Retention Period

Nonconformity Reports (NCR) Quality Assurance 3 Years

Root Cause Analysis Reports Quality/Process Engineering 3 Years

Corrective Action Reports Quality/Process Engineering 3 Years

Verification Records Quality Team 3 Years

8. Responsibilities
Role Responsibilities

Operators/Inspectors Identify, report, and record nonconformities.

Process Owners Implement immediate containment and corrective actions.

Quality Team Perform root cause analysis and verify corrective actions.

Management Approve corrective action plans and ensure their implementation.

9. References

• IATF 16949:2016 Clause 10.2

• Control Plan
• PFMEA (Process Failure Modes and Effects Analysis)
• Customer Complaint Reports

10. Document Control

Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

11. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

Here is a Monitoring & Measurement document template aligned with IATF 16949:2016 Clauses
9.1.1 (Monitoring, Measurement, Analysis, and Evaluation) and 7.1.5 (Resources for Monitoring
and Measurement).

Document Title: Monitoring & Measurement

Document No.: QMS-011

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of X

1. Purpose

To define the process for monitoring and measuring product, process, and system performance to
ensure compliance with customer requirements, specifications, and continual improvement of the
quality management system.

2. Scope

This document applies to all processes, equipment, and personnel involved in monitoring and
measuring:

• Product characteristics
• Process parameters
• Customer satisfaction
• QMS performance

3. Monitoring & Measurement Template

Monitoring /
Criteria / Measurement Responsible
Measurement Equipment/Tool Frequency Record
Parameter Method Person
Item

Incoming
Material Visual Inspection / Calipers, Incoming Inspection
Material Each Lot
Specifications Gauges Micrometers Inspector Report
Inspection

Machine
Process Manual/Automatic Every 2 Process
Settings (e.g., Digital Meters Operator
Parameters Readings Hours Control Log
RPM)

Final
Product Dimensional Vernier Caliper, Each Quality
± 0.2 mm Inspection
Dimensions Measurement CMM Batch Inspector
Report

Paint
Paint 50–80 Paint Thickness
Thickness Gauge Per Lot Production/QA Thickness
Thickness Microns Gauge
Report
Monitoring /
Criteria / Measurement Responsible
Measurement Equipment/Tool Frequency Record
Parameter Method Person
Item

Torque
Torque of 5 Nm ± 0.5 Torque Every 10th Operator /
Torque Wrench Verification
Fasteners Nm Measurement Unit Supervisor
Log

Response Customer
Customer CRM System / Quality
Time & Complaint Analysis Monthly Complaint
Complaints Records Manager
Resolution Log

Delivery & Supplier

Supplier Supplier ERP/Manual Supplier
Quality Quarterly Performance
Performance Scorecards Tracking Quality Team
Metrics Report

4. Monitoring & Measurement Resources

Calibration Responsible Calibration
Resource/Equipment Method of Calibration
Frequency Person Record

Standard Calibration Maintenance / QA Calibration

Vernier Caliper 6 Months
Block Team Certificate

ISO/Manufacturer Calibration
Paint Thickness Gauge 12 Months Quality Team
Standard Report

Torque Calibration Maintenance Calibration

Torque Wrench 6 Months
Tool Team Certificate

Coordinate Measuring Accredited Lab CMM Calibration

12 Months QA Manager
Machine (CMM) Calibration Report

Manufacturer’s Maintenance Calibration

Digital Meters 6 Months
Standard Team Records

5. Monitoring of QMS Performance

The following key performance indicators (KPIs) shall be monitored and evaluated:

Performance Indicator Measurement Method Target Value Frequency Responsible Person

Customer Feedback, ≥ 90%

Customer Satisfaction Quarterly Quality Manager
Surveys Satisfaction

Production
Internal Rejection Rate Rejection Reports ≤ 1.5% Monthly
Manager

Supplier Nonconformance Supplier Quality

Supplier NCRs ≤ 2% Quarterly
Rate Team

On-Time Delivery (OTD) Delivery Reports ≥ 98% Monthly Logistics Team

 Performance Indicator Measurement Method Target Value Frequency Responsible Person

As
Process Capability (Cp, Cpk) Statistical Analysis Cp, Cpk ≥ 1.33 Process Engineer
Applicable

6. Responsibilities
Role Responsibilities

Quality Team Define methods, conduct measurement, and verify records.

Operators/Technicians Perform measurements, record results, and report issues.

Maintenance Team Ensure calibration and upkeep of monitoring equipment.

Process Engineers Analyze process capability and performance.

Top Management Review performance results and initiate improvements.

7. Record Retention
Record Type Retention Period Location

Calibration Certificates 3 Years Quality Department

Inspection and Test Records 3 Years QA Document Storage

Process Monitoring Logs 3 Years Production / QA

Customer Feedback Reports 3 Years Customer Care Department

8. References

• IATF 16949:2016 – Clause 7.1.5 and 9.1.1

• Control Plan
• Calibration Procedures
• Customer-Specific Requirements

9. Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

10. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

Internal Audit Records document template aligned with IATF 16949:2016 Clause 9.2 (Internal
Audit).

Document Title: Internal Audit Records

Document No.: QMS-012

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of X
1. Purpose

To define the process for planning, conducting, reporting, and maintaining records of internal audits
to ensure the quality management system (QMS) conforms to the requirements of IATF 16949:2016
and demonstrates effectiveness.

2. Scope

This document applies to all departments, processes, and personnel within the organization where
internal audits are conducted.

3. Internal Audit Schedule

Audit Planned Actual
Audit Area/Process Audit Criteria Auditor(s) Auditee(s)
No. Date Date

Incoming Material Control Plan, WI, [Auditor [Auditee

001 01/01/2024 05/01/2024
Inspection ISO/IATF Name] Name/Team]

PFMEA, Control [Auditor Production

002 Production Line A 01/02/2024 03/02/2024
Plan Name] Supervisor

Clause 7.1.5 of [Auditor Maintenance

003 Calibration Process 01/03/2024 04/03/2024
IATF Name] Engineer

Clause 7.5 of [Auditor QA Document

004 Document Control 01/04/2024 06/04/2024
IATF Name] Controller

4. Internal Audit Checklist

Conformance
Audit Question Audit Criteria Evidence/Comments
(Yes/No)

IATF 16949 Clause

Is the Control Plan being followed? Yes Control Plan available.
8.5.1.2

Are inspection records maintained IATF 16949 Clause

No Missing records for Lot 2.
accurately? 8.7.2

Are tools/equipment calibrated as IATF 16949 Clause Calibration certificates

Yes
scheduled? 7.1.5 checked.

Are nonconformities recorded and IATF 16949 Clause

Yes NCR Log verified.
addressed? 10.2

5. Internal Audit Report

Audit No. 001

Audit Area Incoming Material Inspection

Audit Criteria Control Plan, WI

Date of Audit 05/01/2024

 Audit No. 001

Auditor(s) [Auditor Name]

Auditee(s) [Auditee Name]

Nonconformities Identified 1 (See NCR-002)

Observations Records updated, minor delays noted.

Recommendations Improve documentation frequency.

Conclusion Minor NC; overall area conforms.

6. Nonconformities and Corrective Actions

NC Description of Root Corrective Target Verification
Responsibility
No. Nonconformity Cause Action Date Status

NCR- Missing inspection Human Implement a Verified on

QA Inspector 15/01/2024
002 record for Lot 2. error logbook checklist 20/01/2024

NCR- Outdated calibration Missed Set calibration Maintenance

25/01/2024 Pending
003 record for Micrometer. schedule reminders Team

7. Audit Follow-Up
Follow-Up Date Audit Area Auditor(s) Status Comments

20/01/2024 Incoming Inspection [Auditor Name] Closed Records are now maintained.

30/01/2024 Calibration Process [Auditor Name] Open Awaiting updated records.

8. Responsibilities
Role Responsibilities

Internal Auditors Plan, conduct, and report on internal audits.

Auditees Cooperate during audits and address nonconformities.

Quality Manager Approve audit reports and oversee corrective actions.

Top Management Review audit results and ensure continual improvement.

9. Record Retention
Record Type Retention Period Location

Internal Audit Reports 3 Years Quality Department

Audit Schedules 3 Years QA Document Storage

 Record Type Retention Period Location

Nonconformity Reports (NCR) 3 Years NCR Log / Document Storage

Corrective Action Reports 3 Years CAPA Folder

10. References

• IATF 16949:2016 – Clause 9.2

• Audit Plan and Checklist
• Nonconformity and Corrective Action Procedure

11. Document Control

Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

12. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

Management Review Records document template aligned with IATF 16949:2016 Clause 9.3
(Management Review).

Document Title: Management Review Records

Document No.: QMS-013

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of X

1. Purpose

To define the process for conducting management reviews to ensure the Quality Management System
(QMS) is suitable, adequate, effective, and aligned with the strategic direction of the organization.

2. Scope

This document applies to all management reviews conducted at planned intervals as per IATF
16949:2016 Clause 9.3.
3. Management Review Agenda
Agenda Item Reference Clause

Review of previous management review actions 9.3.2 (a)

Changes to internal/external issues 9.3.2 (b)

QMS performance (objectives, nonconformities) 9.3.2 (c)

Process performance and product conformity 9.3.2 (c)

Customer satisfaction and complaints 9.3.2 (c)

Audit results (internal/external) 9.3.2 (c)

Status of corrective and preventive actions 9.3.2 (c)

Supplier performance 9.3.2 (c)

QMS resource needs 9.3.2 (d)

Effectiveness of actions for risks/opportunities 9.3.2 (e)

Opportunities for improvement 9.3.2 (f)

4. Management Review Meeting Details

Meeting Date [Insert Date]

Meeting Location [Location Name]

Chairperson [Top Management Name]

Participants [List of Participants]

Facilitator [Quality Manager]

5. Management Review Inputs

Input Item Details Reviewed By

Previous management review actions [Summarize progress on actions] [Person Name/Role]

Changes to internal/external issues [Changes in risks, opportunities] [Person Name/Role]

QMS performance [KPIs, Quality Objectives] [Person Name/Role]

Customer satisfaction [Survey results, complaints] [Person Name/Role]

Audit results [Internal/External Audit Findings] [Person Name/Role]

Nonconformities and corrective actions [Status of NCRs and CAPA] [Person Name/Role]

Supplier performance [Supplier KPIs, delivery, quality] [Person Name/Role]

 Input Item Details Reviewed By

Resource needs [Staffing, equipment, training needs] [Person Name/Role]

6. Management Review Outputs

Responsible
Output Item Action Required Target Date
Person

[Person
Improvements to QMS [List actions for improvement] [DD/MM/YYYY]
Name/Role]

[Person
Updates to Quality Objectives [Any changes to objectives/KPIs] [DD/MM/YYYY]
Name/Role]

[Resource [Person
Resource Allocations [DD/MM/YYYY]
approvals/requirements] Name/Role]

[Actions to resolve [Person

Corrective Actions for NCs [DD/MM/YYYY]
nonconformities] Name/Role]

Opportunities for Improvement [Person

[List identified OFIs] [DD/MM/YYYY]
(OFIs) Name/Role]

7. Management Review Summary

Key Observations Comments

QMS performance and objectives met/not met [Summarize status]

Changes to internal/external issues affecting QMS [Summarize changes and impact]

Effectiveness of actions taken to address risks/opportunities [Summarize findings]

Resource adequacy and areas for improvement [Summarize needs]

Opportunities for improvement and decisions for continual [Summarize OFIs and actions
improvement planned]

8. Record Retention
Record Type Retention Period Location

Management Review Agenda 3 Years Quality Department

Management Review Minutes 3 Years Document Control Storage

Action Plans 3 Years CAPA Log

9. References

• IATF 16949:2016 – Clause 9.3

• QMS Objectives and KPIs
 • Audit Reports
• Customer Satisfaction Reports

10. Document Control

Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

11. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]

Corrective Action Records document template aligned with IATF 16949:2016 Clause 10.2
(Nonconformity and Corrective Action).

Document Title: Corrective Action Records

Document No.: QMS-014

Revision No.: 01
Effective Date: [Insert Date]
Prepared By: [Your Name/Department]
Approved By: [Authorized Person]
Page No.: 1 of X

1. Purpose

To document and track corrective actions taken to eliminate nonconformities and prevent their
recurrence, ensuring compliance with IATF 16949:2016 Clause 10.2.

2. Scope

This document applies to all processes, products, and systems where nonconformities are identified
and require corrective action.
3. Corrective Action Log
Source Nonconfor Root
CA Correctiv Responsibi Target Verificati Stat
Date (Audit/Process mity Cause
No. e Action lity Date on Date us
/Customer) Description Analysis

Implemen
Missing
CA- 05/01/202 Human ta 20/01/2 25/01/2 Clos
Internal Audit calibration QA Team
001 4 error calibratio 024 024 ed
records
n logbook

Retrain
Nonconfor
operators
CA- 10/01/202 Customer ming Operator Production 25/01/2 30/01/2 Ope
, add
002 4 Complaint product oversight Manager 024 024 n
inspectio
shipment
n step

Schedule
Tool wear Lack of
preventiv
CA- 15/01/202 causing tool Maintenan 28/01/2 Ope
Process Audit e Pending
003 4 product maintena ce Team 024 n
maintena
defects nce
nce

4. Corrective Action Report

CA No.: CA-002

Date: 10/01/2024

Nonconformity Description

Nonconforming product shipment identified due to inadequate final inspection.

Root Cause Analysis

• 5 Why Analysis:

1. Why did the nonconformity occur? Final inspection missed the defect.
2. Why was the defect missed? Inspection criteria were unclear.
3. Why were the criteria unclear? Operators were not properly trained on updated standards.
4. Why was training inadequate? Training plan not monitored.
5. Why was it not monitored? Responsibility for training was not clearly defined.

• Root Cause Identified: Lack of operator training and unclear inspection criteria.

Corrective Action Plan

Action Steps Responsibility Target Date Verification Date Status

Retrain all operators on updated standards Training Manager 20/01/2024 25/01/2024 Closed

Update and clarify final inspection criteria QA Team 22/01/2024 27/01/2024 Open
 Action Steps Responsibility Target Date Verification Date Status

Implement additional inspection step Production Supervisor 25/01/2024 Pending Open

Verification of Effectiveness

• Verification Method: Review updated inspection process and records. Conduct follow-up audit on
final inspection.
• Verification Date: [Insert Date]
• Verified By: [Auditor/QA Manager]
• Effectiveness Status: [Effective/Not Effective]

5. Record Retention
Record Type Retention Period Location

Corrective Action Logs 3 Years Quality Department

Corrective Action Reports 3 Years Document Control Storage

Root Cause Analysis Documents 3 Years CAPA Folder

6. References

• IATF 16949:2016 – Clause 10.2

• Nonconformity and Corrective Action Procedure
• Internal/External Audit Reports

7. Document Control
Revision Description of Change Date Prepared By

01 Initial Release [Insert Date] [Your Name]

8. Approval
Prepared By Reviewed By Approved By

[Name, Designation] [Name, Designation] [Name, Designation]

Date: [Insert Date]