01.iatf 16949 Awarness

P S QUALITY CERTIFICATIONS IATF 16949:2016 AWARNESS TRAINING

IATF 16949: 2016 Automotive Quality Management Systems

What is IATF? • IATF – INTERNATIONAL AUTOMOTIVE TASK FORCE • It is Based On ISO 9001 :2015 Standard with additional enhancements • The organization in automotive industry seeking IATF 16949 Certification must also comply with ISO 9001:2015 • Specifically for automotive industries • Primary focus on development of QMS that provides for continual improvement ,emphasizing defect prevention and the reduction of variation and waste in supply chain

Why IATF ? •IATF is a group of automotive manufacturers which aims at providing improved quality products to automotive customers worldwide.

•Credibility and image •Process efficiency improvement and cost savings

•Elimination of waste throughout the supply chain •The organization wants to demonstrate its ability to consistently provide products that meet customer and applicable statutory ,regulatory and product safety requirements

HISTORY OF IATF 16949 •ISO /TS 16949 was originally created in 1999 (1st edition) With aim of harmonizing the different assessment and certification systems worldwide in the supply chain for automotive sector •2nd edition was created in 2002 •3rd edition was created in 2009 •In preparation for migrating from ISO/TS 16949: 2009 to this Automotive QMS Standard IATF 16949 :2016, which cancels and replaces ISO 16949: 2009 (3rd edition)

ISO/TS 16949:2009 VS IATF 16949:2016

ISO/TS 16949:2009

IATF 16949:2016

8 Clauses

10 clauses

Based on ISO 9001:2008

Based on ISO 9001:2015

Requirement of ISO 9001:2008 inlcuded in the standard itself.

Included only supplemented requirement ISO 9001 requirement are only been referred.

Approach of IATF 16949  Key is to engage all 3 gears

Risked based thinking

PDCA approach Process approach

Process Approach implementation

identification

process

improvement

management

Risk Based Thinking

Effect of uncertainty on an expected result

PDCA CYCLE

P-D-C-A Plan - Clause No 4,5,6,7

Do - Clause No 8 Check – Clause No 9

Act – Clause No 10

Structure of IATF 16949 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Scope Normative references Terms and definitions Context of the organization Leadership Planning Support Operation Performance evaluation Improvement

IATF16949 Requirements

“Such as” guidance only

“Should” recommendation

“Note” guidance or clarification

“shall” mandatory Requirements

Scope Automotive supplemental to ISO 9001:2015

Includes products with embedded software also

Applicable to production part, service part and accessory.

Normative References Annex A(Control Plan) is a normative part of this automotive QMS standard. Annex B(Bibliography) –automotive supplemental

Terms and definitions Accessory part Aftermarket part Advanced product quality planning(APQP) Customer specific requirements(CSRs) Design for assembly(DFA) Design for manufacturing(DFM) Error proofing Escalation Process Fault tree analysis(FTA) No trouble found Etc…

4.Context of the organization

4.2 Interested parties

4.3 scope

4.1 understanding context

4.4 QMS

CONTEXT

4 context contd 4.4.1.1 conformance of product and services (applicable statutory and regulatory requirements ) 4.4.1.2 Product safety 1. special approval for DFMEA and PFMEA 2. Product safety characteristics 3. Control of product safety at the point of manufacture

CONTEXT EXTERNAL

INTERNAL

Legal

Values

Technological

Cultural

Competitive market cultural Social and.

Economic environment

knowledge

Performance of the organization

Interested Parties

5.Leadership 5.1 Leadership and commitment 5.1.1 General 5.1.1.1 Corporate responsibility 5.1.1.2 Process effectiveness and efficiency 5.1.1.3 Process owners 5.1.2 Customer focus 5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities. 5.3.1 supplemental 5.3.2 Product requirements and corrective actions

Leadership and commitment

Communicati on for quality management importance That the system achieve its intended results

Promotion of improvement

Top management to ensure Supporting for other relevant management roles

Engaging directing and supporting persons Availability of resources for QMS implementati on

Corporate responsibility

At a minimum An anti-bribery policy.

An employee code of conduct

An ethics escalation policy(“whistleblowing policy”)

Process effectiveness and efficiency, Process owners •Management review the the product realization process and support process effectiveness and efficiency •Management identify the process owners with roles to perform activities

5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities .as per ISO 9001: 2015 5.3.1 supplemental Assign responsible person to ensure the customer requirements are met.( product design and development ,capacity analysis, logistics information etc) 5.3.2 Product requirements and corrective actions (That responsible person have the authority to stop shipment and stop production to correct quality problems )

6.Planning 6.1 Actions to address risks and opportunities . 6.1.2.1 Risk analysis 6.1.2.2 Preventive action 6.1.2.3 Contingency plan 6.2 Quality objectives and planning to achieve them....... 6.3 Planning of changes

6.1 Actions to address risks and opportunities .as per ISO 9001: 2015 6.1.2.1 Risk analysis (Product audits , field returns and repairs , scrap and rework) 6.1.2.2 Preventive action (Potential non conformities ,impact of negative effect of risk) 6.1.2.3 Contingency plan (Risk and impact to the customer ) 6.2 Quality objectives and planning to achieve them....... 6.3 Planning of changes (Resources , resp and authority, Qms )

7.Support 7.1 Resources 7.1.1 General (Internal and external resources) 7.1.2 People 7.1.3 Infrastructure (Building and associated utilities, equipments include hardware and software, transportation etc) 7.1.3.1 Plant,facility,and equipment planning (Plant layout, matrial flow and material handling ,floor space)

7.1.4 Environment for the operation of process (ISO 45001 or personal safety ) 7.1.5 Monitoring and measuring resources (Calibration plan and list of instruments ,quality persons capability) 7.1.5.2.1 Calibration /verification records 7.1.5.3 Laboratory requirements (internal lab and external lab) Internal: lab facility ,competent persons and procedures External: ISO/IEC 17025 or NABL lab 7.1.6 Organizational Knowledge Internal: knowledge gained from experience, lesson learned from failures etc External : conferences, knowledge from customer, books or standards

Support contd…. 7.2 Competence 7.2.1 Competence – supplemental (Training needs to be identify all individuals ) 7.2.2 on the job training (If any new employee or modified responsible persons ) 7.2.3 Internal auditor competency Internal auditors list with competency report ( ISO 19011) 1.QMS Auditors 2. mfg process auditors 3. product auditors 7.2.4 Second party auditor competency Supplier audit

7.3 Awareness (Quality policy, objectives and QMS ) 7.3.2 Employee motivation and empowerment (motivating the employees towards continual improvements ) 7.4 Communication (What ,when ,how, whom, who)

7.5 Documented information (Quality manual with relevant details such as : Process and their interactions ,justification of exclusions etc)

7.5.2 Creating and updating 1. identification and description (Title,date, ref number) 2.format (rev no and date) 3. Review and approvals 7.5.3 Control of documented information (Master copy, obsolute copy, controlled copy, distribution access retrival and retention ) 7.5.3.2.1 Record Retention (Production part approvals, tooling records, design records,Purchase orders ,contracts related retention policy )

8. Operations 8.1 Operational planning and control (Process flow diagram ,control Plan, SOPs, outsource process controls )

8.1.2 Confidentiality (Customer –contracted product ,projects ,under development etc) 8.2 Requirements for the products and services 8.2.1 customer communication ( Enquiries ,feedback, complaints ,Customer property etc)

8.2.2 Determining the requirements for products and services (Any applicable statutory and regulatory requirements ) 8.2.3 Review of the requirements for products and services (special characteristics, organizational manufacturing feasibility)

8.Operation contd 8.3 Design and development of products and services 8.3.1 General (Design and development process flow ) 8.3.2 Design and development planning (Duration ,process stages, verification ,validation, Resp & authorities, Internal and external resources ,subsequent provision etc)

8.3.2.1 Supplemental (APQP) (DFA , DFM alternative designs and mfg process ,DFMEA)

8.3.2.2 Product design skills (Competent in application of digitized mathematically based data ) 8.3.2.3 Development of products with embedded software (Software development capability self assessment )

8.3.3 Design and development inputs (Functional and performance , standards ,codes ,statutory etc)

8.3.3.1 Product design input (Product specifications, boundary , reliability, health safety environmental) 8.3.3.2 Manufacturing process design input (Product design output including spl characteristics, customer requirements if any, previous developments etc) 8.3.3.3 Special characteristics (Symbols ,conversion table )

8.3.4 Design and development controls (Review of result ,verification of design outputs) 8.3.4.1 Monitoring (Quality risks ,costs ,leadtime,critical paths,) 8.3.4.2 Design and development validation 8.3.4.3 Prototype Programme (All performance testing activities monitor for timely completion )

8.3.4.4 Product approval process ( customer approval document)

8.3.5 Design and development outputs 8.3.5.1 supplemental (Reliability study results, 2d drawings spl characteristics etc)

8.3.5.2 Manufacturing process design output (Specifications and drawings, control plan, work instructions, flow charts, capacity analysis) 8.3.6 Design and development changes (Revision records )

8.4 Control of externally provided processes, products and services 8.4.1.2 supplier selection process (Suppliers risk, delivery performance ,supplier QMS,financial stability ,manufacturing capability) 8.4.1.3 Customer directed sources 8.4.2 Type and extent control 8.4.2.2 Statutory and regulatory requirements (Country of receipt, country of shipment ) 8.4.2.3 Supplier quality management system development 8.4.2.4 Supplier monitoring (Supplier performance ) 8.4.2.5 Supplier development (Second party audit findings, QMS status, risk analysis ) 8.4.3 Information for external providers

8.5 Products and services provisions (Suitable infrastruture, equipment and instruments required for control of production and service ) 8.5.1.1 Control plan 8.5.1.2 Standardized work ( operator instructions and visual standards) 8.5.1.3 Verification of job set ups (Set up approval or first off) 8.5.1.4 verification after shutdown ( planned or unplanned shutdown period)

8.5.1.5 Total productive maintenance (OEE-overall equipment effectiveness, MTBF –mean time between

failure MTTR – mean time to repair )

8.5.1.6 Management of production tooling and manufacturing ,test, inspection tooling and equipment (tool history card) 8.5.1.7 Production Scheduling

(Customer orders ,supplier on time delivery performance, capacity,lead time,inventory level,preventive maintenance ,calibration )

8.5.2 Identification and traceability (Location of product in the production flow with identification) 8.5.3 Property belonging to customer or external providers (Materials, components,intellectual property ,and personal data ) 8.5.4 Preservation (FIFO, Storage place, container, storage environment)

8.5.5 Post delivery activities (Warranty provisions ,maintenance services, service agreements etc) 8.5.6 Control of changes production trials,Verification , validation )

8.6 Release of products and services (Approval of releasing person with document ) 8.6.2 layout inspection and functional testing (Complete measurement of all product dimension shown on the design records) 8.6.3 Appearance items (Colour,texture,and lighting and competent resources )

8.6.4 verification and acceptance of conformity of externally provided products and services 8.6.5 statutory and regulatory conformity 8.6.6 Acceptance criteria (zero defect , sampling plan)

8.7 Control of nonconforming outputs 8.7.1.1 Customer authorization for concession ( Deviation permits ) 8.7.1.2 Control of nc product ( customer specified process) 8.7.1.3 Control of suspect product (Unidentified product) 8.7.1.4 Control of reworked product (Rework register – qty,date,traceability information) 8.7.1.5 Control of repaired product (Rejection or repaire record) 8.7.1.6 Customer notification 8.7.1.7 Non conforming product disposition (Prior approval from customer before disposition)

9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1.1 monitoring and measurement of manufacturing processes 9.1.1.2 Identification of statistical tool 9.1.1.3 Application of statistical concepts 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation

9.2 Internal audit 9.2.2.1 Internal audit programme 9.2.2.2 QMS audit 9.2.2.3 Manufacturing Process Audit 9.2.2.4 Product Audit

9.3 Management Review 9.3.2 Management review inputs ( ISO 9001:2015) 9.3.2.1 Management review inputs 9.3.3 Management review outputs

10. Improvement 10.1 General 10.2 Nonconformity and corrective action 10.2.3 Problem solving 10.2.4 Error proofing 10.2.5 Warranty Management Systems 10.2.6 Customer complaints and field failure test analysis 10.3 Continual improvement

QUESTIONS

Slideshow based on ISO Central Secretariat and ISO/PC 288 generic presentations