Summarized presentation vda 6.3 2016 (serial production)

kiranwalimbe@live.com 2
While auditing the Serial Production, we will first look at the guidelines of
Red Book. We will give due importance to star questions. Thereafter, we will
use Turtle Diagram to identify process specific risks.
After covering the specific requirements of the Red Book, we will look at
some of the commonly discovered risks which are revealed by the Turtle
diagrams & which need to be added to the auditor’s basket of open ended
questions and assessed additionally, by the auditing team.
(This series of presentations will give you an idea of what is involved in these
audits. However, the expertise can come, only after undergoing an
authorized training, followed by sufficient practise.)

P5 Supplier management
•7 questions
•2 Star Questions
•5 questions for potential analysis
•Minor changes only in the content of the requirements

5.1) Are only approved/released and quality capable suppliers selected?
• An evaluation as per documented procedure of the qualification capability of the
supplier must be available.
• Audits done by CFT and also by other OEMs.
• Upgrading programs for non performing suppliers; Also applies to suppliers of research
and development , prototype, software, equipment, machinery, tools, Service providers
(eg. Sorting companies),
• External testing labs, Suppliers in outsourced processes
5.2) Are the customer’s requirements taken into consideration in supply chain?
o The communication of customer requirements must be regulated and traceable.
o Change management must be audited;
o QAA (quality assurance agreements)
o Legal, regulatory requirements

5.3) Have target agreements for the delivery performance been agreed with supplier &
implemented?
 Measurable targets for quality, delivery quantity (batches), punctuality, must be checked
and evaluated within a defined period.
 QM agreements includes escalation mechanisms.
5.4*) Are the necessary releases / approvals available for out sourced products and services?
 Approvals, releases, PSW & PPAP for build samples & trials.
 Evidence of change management from Customer to sub-supplier.
 Compliance with EU safety data sheets, MSDS, IMDS & REACH.

5.5*) Is the quality of the outsourced products & services ensured?
 Deviations from the supplier quality;
 Evaluation of main failures, ppm evaluations,
 8D reports,
 testing in accordance with ISO/IEC 17025) for raw materials (material certificates) and
finished parts.
5.6) Are incoming goods stored appropriately?
 FIFO, Identification & batch traceability, no wrong identification,
 Labelling (traceability / test status / work sequence / use status);
 the transport and storage conditions must be defined and verified;
 Secure storage for suspect & quarantined products.

5.7) Are personnel qualified for the various tasks & responsibilities defined?
 “Qualification requirements” rather than “training requirements” must be determined
for each employee;
 Knowledge must be available Of previous complaints regarding out sourced material,
Product / specifications / special customer requirements,
 Foreign language.

Additional risks likely to get discovered thru’ Turtle Diagram
1. Evidence of supplier discussions & regular support.
2. Supplier audit must actually be done by a CFT & not by a single person.
3. Inspection and measuring records of improved components.
4. Workshops, reducing defects & inventory.
5. Information flow in case of non-conformity or loss.
6. Emergency strategy in case of supply bottlenecks
7. Kanban, Pull system, JIT, FIFO & traceability
8. Safety against mix ups.
9. Audits, statistics, 8-D methods & Customer satisfaction.

P6 Process analysis production
•Total of 26 questions in 6 groups – 6.1, 6.2, 6.3, 6.4, 6.5 & 6.6
•8 Star Questions
•Transport and handling of parts is separately evaluated
•No structural changes in the elements only adjustments to content

P6.1 Process analysis => Input to the process
•5 questions
•1 Star Question different allocation
•Content revised
•Allocation for evaluation of transport and handling of parts unchanged
•Embedded software (6.1.5)

6.1.1) Has the project been transferred from development to serial production and is a
reliable start guaranteed?
• A complete production process / product release must take place
• All un-resolved issues must get closed before the first production shipment;
• PSW is signed
• Process transfer sign off is available.
6.1.2) Are the necessary quantities / production batch sizes of incoming materials available at
the agreed upon time and at the correct storage / work-station?
o The correct incoming product, quantity, packing, with the correct documentation, at the
agreed time and at the agreed place.
o Evidence of PULL system with FIFO, return of the residual quantity after the batch gets
over,
o Change status indication &
o Special requirements (ESD protection etc.) of packaging for the product.

6.1.3) Are incoming materials stored appropriately and are the means of transport means /
packing facilities suitable for the special characteristics of the incoming materials?
 How is the suitability of Store areas /work-stations / containers ensured?
 Are suitable transportation units used to protect the products from damage and
contamination?
 Storage times & Use-by dates.
6.1.4) Are the necessary identifications / records / approvals available and allocated
appropriately to the incoming materials?
 Customer specific regulations for the identification & traceability,
 Documentation of special releases,
 “Test results of characteristics” with special requirements regarding documentation

6.1.5*) Are the changes to the product or the process in the course of serial production
tracked & documented?
 Management of ECR & ECNs,
 Ensuring at all times the correct design level is used – also for software,
 Up-dates of the FMEA (Product and Process)

1. Sufficient & suitable transport means.
2. Minimal / no intermediate storage, management of holding stores & quarantine
store
3. Only transfer of satisfactory parts.
4. Labels, tags & latest revision number.
5. Likelihood of environmental influences.

P6.2 Process analysis=> Management of Process
•5 questions
•2 Star Questions – different allocation
•4 questions for potential analysis – different allocation
•Allocation for evaluation of transport and handling of parts not changed
•Content revised
•Question 6.2.3 (2010) – suitability of manufacturing facilities – moved to 6.4.1
•Embedded software (6.2.5)

6.2.1) Are the requirements of the control plan complete and have they been effectively
implemented?
• Process parameters & Tolerances influencing product characteristics and/or quality must
be fully stated in control plans;
• The production and test/inspection documents are complete and available and based on
the production control plan;
• Required action plan for process disturbances are known, initiated and documented.
6.2.2*) Does a repeat release for the restart of production take place?
o Defined criteria for triggering a production repeat release;
o Deviations and measures taken are documented;
o Tooling layout / master parts / setting pieces / red rabbit.

6.2.3) Are special characteristics managed in the production?
 SPC / pre control charts for critical & significant characteristics,
 Cpk, Cmk, machine capability checks
 Records of deviations with action taken;
 Proof of inspection process with Inspection results.
6.2.4*) Are non-approved and / or defective parts managed?
 Scrap and parts for reworking are separated and safely removed; Labelling of scrap,
rework & setting parts and also for the quarantine area;
 Reworking criteria / testing are defined, known and approved by customer.
 Setting pieces & masters are labelled and protected against accidental use.

6.2.5) Is the flow of materials and parts secured against mixing / wrong items?
 Material and parts flow;
 Risk Analysis,
 Poka Yoke against mix ups.
 The reuse of residues, separated parts, reworked parts, reusable parts from audits,
inspected items, outsourced processed (e.g. sorting service) etc. must be clearly
defined (including regulations for traceability).

1. Inspection frequency, Red Rabbit validation frequency,
2. Confirmation of process parameters like Pressures, timing, temperature and CNC
programs.
3. Tool layout, sister tool compatibility and tools pre-setters
4. Tool inserts their grades & geometry.
5. Changed production parameters.

P6.3 Process analysis => Personnel resources
• 3 questions
•1 Star Question
•Content revised and reorganised

6.3.1*) Are the employees able to fulfil their given tasks?
• Authorities, responsibilities, job description
• Qualification matrix for all.
• Induction training & knowledge of problems and their effects,
• Evidence of qualifications & capabilities like forklift driving license, welding certificate,
soldering certificate, vision test, hearing test;
• Applies to internal and external temporary employees.
6.3.2) Do the employees know their responsibilities and authority in the monitoring of
the product and process quality?
o Responsibilities, duties and authority of the employees like process release,
employee self-inspections, stopping the process;
o Tasks / function of the product and what happens when it malfunctions.
o Employees receive regular information on the current quality, both internally and
with the customer.
o Applies to internal and external / temporary employees.

6.3.3) Are the necessary personnel resources available?
 Shift plans with balance of qualification matrix.
 A scheme exists for supporting areas that are not continually in use like laboratory,
standards room etc.
 Fluctuations in on call staff and through absences (e.g. illness, holidays, training) are
taken into account in the schedule.

1. Co operation & contribution to improvement programs,
2. Interpretation of control charts & control plans.
3. Ability & authority to stop production.
4. Tidiness, cleanliness & 5 S.
5. Participation in JH pillar of TPM.
6. Instructions for handling products having special requirements.
6. Quality circles & their effectiveness.
7. Self assessments.

P6.4 Process analysis => material resources
•5 questions
•2 *-Questions
•4 questions for potential analysis – different allocation
•Content revised
•No questions to transport and handling of parts
•New question: Suitability of manufacturing facilities – previously in 6.2 (2010)

6.4.1*) Can the product-specific requirements from the customer be met with the
manufacturing equipment?
• Do the products meet the customer specifications;
• Evidence of machine / process capability for spl. characteristics / process determining
Parameters (e.g. pressure, time, temp.);
• Layout and condition of the equipment, tools, fixtures and handling facilities meet the
requirements under real production conditions;
• Capability of replacement tools / reproducibility of fixtures, specifications.
6.4.2) Is the maintenance of the mfg. equipment & tools controlled?
o Scheduled / unplanned maintenance activities have been carried out & analysed for
improvements;
o Process for analysing & optimization of utilization of machine tools etc;
o Key processes and critical equipment are identified and preventive as well as proactive
maintenance activities are carried out;
o Tool life and conditions are monitored;

6.4.3*) Can the quality requirements be effectively monitored with the measurement and
testing facilities in use?
 The test, inspection and measurement facilities used are suitable & as per control plan;
 The test, inspection and measurement facilities used are suitable;
 Proof of the capability of inspection equipment and Processes;
 Identification & calibration system of the equipment;
 Comparison of in-house results with those at customer’s.
6.4.4) Are the work and inspection stations appropriate for the needs?
 Ergonomic suitability of work stations;
 Lighting, Cleanliness and tidiness, Climate control, Noise pollution;
 Clean rooms;
 The work-place layout is adapted ergonomically to the process;
 Also applies to permanent and temporary established rework, sorting and inspection
stations.

6.4.5) Are tools, equipment and testing equipment stored properly?
 Tools, equipment and testing equipment (including gauges, tools, equipment and test
equipment not in use or not yet released) must be stored and managed properly.
 Change history,
 Defined storage location;
 Status identification.
 Identification showing customer's property, products /tools / devices provided on
loan.

1. Monitoring of MTBF / MTTR and steps taken for their improvement.
2. Maintenance of conveyors, chutes, trolleys & trucks.
3. Health & safety at work.
4. Standstill of the process / equipment, it’s analysis, corrective and preventive action.
5. Managing 5 S & Visual workplace.
6. Revision to PM plan after major breakdown.

P6.5 Process analysis => Effectiveness, efficiency, waste avoidance
•4 question
•1 Star Question
•Content revised

6.5.1) Are there targets set for the manufacturing process?
• Target requirements are defined, agreed, achievable based upon Customer requirements
and up-to date.
• Targets include Number of parts produced per unit of time; Rework, scrap, production runs
with no reworking, first time through quality, first pass yield;
• Quality metrics include failure rates, audit results;
• Process metrics (process capability);
• Reduction of waste of energy and process materials).
• Audit of A, P & Q factors of OEE.

6.5.2) Is quality and process data collected and analysed?
o Defect frequency cards; Control charts; Special characteristics;
o Process parameters (temp, time, pressure);
o Factory data collection, Special incidents are documented in shift / equipment book.
o Fault signals like plant standstill, power failure, programme error message;
o Parameter changes are analysed for improvement.
o SPC, Pareto analyses, Cause & effect diagrams, Risk analysis (FMEA, FTA).
o Wherever applicable, FMEA is revisited & cascading document changes take place.

6.5.3*) In the case of deviations from product & process requirements, are the causes
analysed and corrective actions checked for effectiveness.
 Corrective & preventive actions for failures are immediate, effective and known to all
concerned;
 Knowledge & successful use of Cause & effects diagram- Taguchi, Shainin - 5 W
method;
 Nonconformities that affect the properties of the delivered product are
communicated to the customer.
6.5.4) Are processes & products audited regularly?
 The process and product audits carried out effectively at regular frequency;
 Root causes are analysed for deviations discovered;
 Process audits cover parameters and capabilities;
 Product audit to cover specified characteristics, Labelling, packaging;
 Capacity of the test equipment, Software version.

1. Data acquisition & use of I O T.
2. Recorders & their status / adequacy,
3. Analysis Corrective / preventive action for Plant Standstill / Power off.
4. Cost of poor quality
5. Cost optimization and control of 7 wastes.
6. Re-occurrence of same NCs in subsequent audits.
7. Auditor qualifications.

P6.6 Process analysis => Result/Output
•4 questions
•1 Star Question
•3 questions to transport and handling of parts (separate evaluation)
•Content revised

6.6.1) Do the quantities/production batch sizes match needs and are they systematically
directed to the next process step?
• Audit of ‘D’ type characteristics
• Dock audits for customer requirements; audit Millipore ratings,
• Tests, checks and inspection procedures are agreed with customer and documented,
• Audit of Endurance tests and of Production tests under peak production conditions.
• Communication in the event if shipment is blocked / hold.

6.6.2) Are products/components stored in an appropriate manner and are transport
facilities/packing arrangements suitable for the special characteristics of the
products/components?
o Internal packing instructions are known and implemented (not only customer-specific),
o Parts must be protected against environmental and climatic influences during storage
and transport.
o Audit of ESD protection to electronic parts.
o Monitoring of storage periods / quantities stored;
o Customer specific packaging instructions (inc. packing supplied by the customer);
Information on available stock levels;
o Substitute packaging, Requirements for cleaning packaging.

6.6.3) Are the necessary records / releases retained?
 Customer requirements for the labelling of the release status on containers / batches /
carriers / components and also on reworked parts must be implemented and
documented;
 Customer specifications, Customer's identification requirements;
 Customer’s requirements for archiving time limits, Archiving requirements/ regulations
(EDP, paper, fire protection, legibility, Last piece inspection;
 Identification of special releases.

6.6.4*) Are the customer requirements met at the delivery of the final product?
 If deviations occur, corrective actions are defined and implemented;
 Quality agreements with the customer;
 Customer specific requirements;
 Customer requirements for the identification of special characteristics;
 The planning of the shipping audit;
 Storage / recall processing / parts supply / shipping, Target agreements,

1. Evidence of Communication process in the event if shipment of product is blocked /
hold.
2. Defined storage / holding locations availability.
3. Packing WI
4. Customer requirements for identifying reworked parts.
5. Special releases/ deviation approvals, product traceability

P7 Customer care, customer satisfaction, service
• 5 questions
• 2 *-Questions – new allocation
• 4 questions for potential analysis
• Failure analysis as a general requirement is integrated into complaint‘s management
(specific question removed)
• Question 7.1 has been redefined

7.1) Are all requirements related to QM System, Product and Process fulfilled?
• Quality agreements with the Customer is fulfilled.
• Layout inspection and a functional verification concept e.g. carried out product audits,
function tests, endurance tests
• Supply guarantee after serial production
• Inclusion of sub-supplier for the supply of spare parts & Supply guarantee after serial
Production
• Certification of the QM system
7.2) Is customer service guaranteed?
o Competent contact personnel ensure communication in accordance with the customer
specifications
o Knowledge of the product application and of problems with the product and complaints
regarding the product or Transport
o Access to customer portals in accordance with the customer specific agreement is
ensured.
o World-wide customer service

7.3*) Is the supply of parts guaranteed?
 Concepts to ensure supplies including in emergency are available
 Contingency plans including for alternative production, suppliers, transport in line with
VDA’s standard for Robust Production processes, are available.
 Capacity and reaction time for sorting actions & Use of external capacity
 Procedures must be in place which guarantees that the organisation informs the customer
immediately when supply shortages are detected.
 Regulations covering authority to make decisions & escalation paths.
7.4*) If there are deviations from quality requirements, are failure analyses carried out and
corrective actions implemented effectively?
 Processing complaints & 8D process also for 0 km and field complaints.
 Procedures for failure analysis are defined.
 Internal / external analysis facilities (laboratories, comprehensive testing facilities,
personnel) & Use of problem solving methods
 Testing concept for defective parts in the field (standard test/ stress test/ NTF test) And
NTF guidelines

7.5) Are personnel qualified for the various tasks and are responsibilities defined?
 Responsibilities, duties and authorisations each employee in Org Chart
 The employees know the product and the consequences of faulty workmanship for the
supply of parts and the quality of the final product.
 Failure analysis
 - Evaluation methods (e.g. audits, statistics)
 - Quality techniques (e.g. Pareto, 8D Method, cause and effect diagram, Ishikawa)
 - Foreign language skills

1. Quality agreements
2. Agreed inspection & testing procedures.
3. Record of customer visits & deriving measures,
4. Implementation of new requirements
5. Possibilities for plant modification
6. Use of 8 D & verification of effectiveness
7. Customer packing requirements (CSR, Packing Wi),
8. Spare part production plan for after the end of serial production.
9. NTF (No trouble found) guidelines- Procedure
10. Regulations covering replacements -after sales who deal with customer)

Kiran Walimbe is a trainer attached to UBF.B
who are one of the official franchisees for
VDA trainings.
He possesses practical experience exceeding
40 years in Automotive Industry.
Besides holding several qualifications, he is
qualified by VDA to impart trainings of VDA
6.3 (2016) and also of VDA 2.
He is located at Pune in India and is available thru’ UBF.B for
delivering trainings (including pre-audit preparatory training) in
any part of the world.
(Kindly share your feedback on kiranwalimbe@live.com)

Summarized presentation vda 6.3 2016 (serial production)

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