IATF 16949 Overview

ISO/TS 16949 (01st Edition) was originally created in 1999 by IATF (International Automotive Task Force) with the aim of harmonizing different assessment of Customer requirements and Certification Systems worldwide, in the Automotive Supply Chain. 

Three Editions of ISO/TS 16949 were released, as below:

1st Edition - 1999

2nd Edition - 2002

3rd Edition - 2009

In preparation for migrating from ISO/TS 16949:2009 (3rd Edition) to the latest Automotive QMS Standard, IATF 16949, feedback was solicited from the Certification Bodies, Suppliers, Auditors & OEMs to create 1st edition of IATF 16949, which cancels & replaces 3rd edition of ISO/TS 16949:2009.

So, the evolution of IATF can be summarized as per below:

Goal:

The Goal of New Automotive QMS Standard is the development of Quality Management System that provides Continual Improvement, emphasizing defect prevention rather than detection and reduction in variation & waste in Supply Chain, incorporating Risk based approach.

The adoption of Quality Management System is the strategic decision of Organization that can help to improve its overall performance & provide a sound basis of sustainable development initiatives.

PDCA:

IATF employs Process Approach, which incorporates PDCA (Plan-Do-Check-Act) Cycle and Risk based thinking.

The Process Approach enables an Organization to plan its processes and their interactions.

PDCA cycle enables the Organization to ensure that its defined processes are adequately resourced and managed & that opportunity for improvement are determined , acted on and monitored for its effectiveness.

Risk Based Thinking:

Risk based thinking enables an Organization to establish a basis for increasing the effectiveness of a Quality Management System achieving the improved results, preventing & mitigating negative effects.

Opportunities may arise as a result of a situation favorable to achievement of intended results. A Positive deviation arising from a Risk can provide an opportunity which can be further utilized up to its optimum level.

Quality Management Principles:

The IATF Principles:

Changes from ISO/TS 16949 to IATF (Clause Ref.):

IATF 16949 Requirements:

Mandatory Procedures in IATF 16949:

There are total 21 mandatory Procedures which needs to be documented & implemented in an Organization. These are listed as below:

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Risk Management

Hi Friends,

Greetings !!

Today, we will understand the "Risk Management", typically, what is the Risk and how to deal with them opting a Response Strategy, in order to make our Project successful without affecting the planned Outcome or Deliverables in terms of T,Q,C,D i.e. Technical, Quality, Cost & Delivery of a Project.

Risk: 

So, the Risk is always considered if it is identified before the Occurrence of the Event, else becomes the News and considered as an Issue, if reported after it has occurred.

Risk Quantification & Prioritization:

A Risk can be quantified or the Impact of Risk can be evaluated as per below equation:

Risk can be assessed & quantified as per below Probability & Damage (Consequence) Table:

Below is the Risk Matrix based on "What will Happen & What would be its Impact"

Risk Impact:

A Risk can Impact following Major Deliverables of a Project and the amount of Impact is based on the product of Probability of Occurrence & the Damage if it occurs.

Risk Identification Techniques:

Risk Response Strategies:

Below are the Strategies defined to "Overcome or to Respond" the Risks (Negative Risks) in a Project:

Action Plan Development:

So, after deciding the Response Strategy from above, Action Plan is made with defined Responsibilities along with Target Dates and those actions are further monitored for their completion & effectiveness.

For managing the Positive Risks, there are some other defined Strategies adopted, achieve the maximum benefits of these risks e.g. Exploit, Enhance, Share & Accept. All these details would be shared in the upcoming articles.

Note: There is a Standard template also attached herewith which can be used & implemented in your Organization in Managing the Risks effectively. If you need it in editable form of Excel, Please do contact me through email.

Risk Assessment Template

  

Thank You 🙏

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Types of QMS Audits

Hello Friends, 

Today, I am writing this blog to share the "Audit Types" in QMS i.e. Quality Management System in various types of Industries, Globally. 

Before going ahead, let's understand what the 'Quality Management System Audit' is: 

What is an Audit: By definition, "Audit is a documented, systematic and independent process of gathering Audit evidences and to assess it objectively to reach a conclusion to the degree to which the Audit Criteria is met." 

Audit evidence includes all verifiable records, statement of facts & other information pertaining to Audit Criteria. And the Audit Criteria comprises of the applicable ISO Standards, Organization's Policies & Procedures and requirements which are used as references to compare the collected Audit evidences. 

An Audit should not be confused with "Surveillance" or "Inspection" activities performed for the sole purpose of Process Control or Product acceptance. In fact the Audit is an Information gathering activity so that the need for Improvement or Corrective Action may be evaluated. 

There is total absence of a witch hunt or apportioning blames for deficiencies. This fact is fed firmly amongst Auditees because defensiveness will not encourage the correct & actual information flow, during the Audit.

Now , coming to the types of Audits, Basically there are two main types of Audits known as:

I. INTERNAL AUDIT, also known as 1st Party Audit &

II. EXTERNAL AUDIT, may be 2nd Party or 3rd Party Audit

However, there are number of other Audits in practice which derive their names either from the specific nature or scope they have. A short description of all type of Audits are being furnished here:

I. INTERNAL AUDIT:

It is the 1st Party Audit in which an Organization looks at its own Systems, Procedures and Activities to ascertain their Compliance & Effectiveness.

It provides Management the Information on the extent to which the System is effective & the defined Policies are met, and whether any changes are required to improve the Effectiveness of the System.

Internal Audit is performed by Organization's own personnel who is competent to conduct the Audit and not having the direct responsibility in the area's being Audited. Internal Auditors are selected in a cross-functional manner.

II. EXTERNAL AUDIT:

External Audits may be 2nd Party or 3rd Party Audits:

(a) 2nd Party Audits: A second party Audit is conducted by a Customer Organization or a party designated by Customer on its own suppliers or sub-contractors against defined Management System and requirements. Through these Audits, Customer Organization can assess the potential supplier or develop & improve the Management System of existing supplier.

(b) 3rd Party Audits: A third party is performed by Certification Bodies or independent agencies recognized by an Industry or by Government, with an objective to assess the relevant management System against agreed Standard or set of requirements. These Audits would subsequently lead to a third party Certification of any Management System Standard e.g. ISO 9001, ISO 14001, ISO 45001, IATF 16949 etc. 

III. ADEQUECY AUDIT:

This is also known as "Desktop" or "Management" Audit and is an office exercise that determines the extent to which auditee's relevant Management System documentation (Quality Manual, Organization's Procedures, Guidelines, Work Standards, Records etc.) meets the agreed standard or set of requirements, and if it is adequate to satisfy the Audit objective or Scope.

This type of Audit is usually conducted by the Certification Bodies & known as 'Stage-1 Audit', during a Management System Certification Programme, of the relevant Standard.

IV. COMPLIANCE AUDIT

This is an Audit in which the extent to which the defined Documented System by the Organization  is implemented and followed in actual in day-to-day activities. The defined Procedures, Policies and Work Standards are Audited for verification of the Compliance thereof and awareness of the User as well.

V. PRODUCT AUDIT

 A Product Audit is a detailed re-examination , reinspection or retesting of a finished Product which is already accepted and passed through all Quality Checks & Test Performance.

In a Product Audit, "Reverse Approach" is followed i.e. 'Output - Process - Input', means, the Product which is to be Audited must be picked from the FG Storage under the same conditions in which the 'Product' will be received by the Customer.

Then the review of the Product's Dimensional, Functional, Appearance & Performance parameters is carried out, with the same procedures, methods and equipment that went into the manufacture the same Product or Services.

VI. PROCESS AUDIT

Process Audits focuses on the verification of the factors which directly influence the Manufacturing Process i.e.6Ms which are Man, Machine, Method, Material, Measurement & Mother Nature (Environment).

 It checks that the defined Process Control is adequate and effectively implemented during the manufacture of any Product or Service to achieve the desired outcome from the Process.

VII. JOINT AUDIT

Sometimes, Many Audit Organizations join hands to Audit a Quality and / or Environment Management System. In such cases, prior to commencement of the Audit, all the Audit Organization should reach to an agreement on their specific responsibilities, Audit Team Leader's authority, Audit methods and distribution of Audit reports etc.

VIII. COMBINED AUDIT

Combined Audit is performed when the two or more Management Systems in Integration, are audited in any Organization. For example, Quality & Environment Management Systems are audited together or the Quality, Environment & Occupational Health management Systems i.e. Integrated Management System (IMS) are audited.

IX. SNAP AUDIT

The purpose & intention of the SNAP Audit is investigative and to provide the real information to Top Management in terms of System Adherence down the line, in the Organization. As such, it is conducted without any prior intimation to the Auditees. However, in this type of Audit, some specific aspects or elements of the System are verified for its effective implementation & compliance.

X. HORIZONTAL AUDIT

In this type of Audit, one or more particular elements of the System are Audited for their implementation throughout the entire range of the Products. Means, the verification of a particular checkpoint or feature in all similar models & Products range.

XI. VERTICAL AUDIT

Unlike Horizontal Audit, Vertical Audit is a detailed verification of all the controls applied to a Particular Product. In this Audit, there is a Top-Down checklist used to verify all the Controls for ensuring Product Features, Layout, Aesthetics, Function & Performance as per the specified requirements.

XII. FOLLOW UP AUDIT

This is an Audit which consists only the verification of Implementation of the Corrective Actions taken for the non-conformities of the previously conducted Audit. It is  always a per of any Audit and never a complete one. During this Audit, all the Corrective Actions are verified which are taken against the raised NCs and post-verification NCs are closed by the Auditor. 

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