Understanding and Certification Series:
This course was developed to cover all requirements of the ISO 9001:2015 standard. Group exercises and case studies will be used to develop the required skills. Other topics covered are from ISO 19011 and include the auditing process and methodologies, e. g. planning and conducting an audit, writing nonconformity statements, preparing an audit summary and report, and verifying corrective actions. Auditing case studies to develop skills for identifying nonconformities will be used. Best practices and techniques for leading audit teams will also be discussed.
All modules can be valuable for Quality Assurance Managers, ISO 9001 implementation and transition team members, management representatives, and all others who would like to develop competency in ISO 9001 and the auditing process for first, second, and third-party auditing.
- Understanding the requirements of the QMS standard
- Application of quality management principles in the context of ISO 9001
- Relation of the quality management system to the organizational products, services, and operational processes
- Organization’s context and interested party needs and expectations related to the planning and implementation of a quality management system
- Application of the principles, procedures and techniques of auditing
- Personal attributes necessary for the effective and efficient conduct of an audit
- How to establish, plan and task the activities of an audit team
- Effective communication with the auditee and audit client
- Organization and direction of audit team members
- How to prevent and resolve conflicts with the auditee or within the audit team
- Preparation and completion of the audit findings and writing non-conformities
- Guiding the audit team to successful conclusion of the audit objectives
- Prevent and resolve conflict with the auditee and/or within the audit team
- Prepare and complete the audit report
APQP: Advanced Product Quality Planning | 1 day
The seminar explains the process of Advanced Product Quality Planning (APQP) within an organization. An overview of the five phases of APQP is given, comparing the APQP approach with VDA 6.3, internal management systems and IATF 16949.
Those who have direct responsibility for introducing new products and/or a new manufacturing processes and systems would benefit from this seminar. This includes program/product managers, quality managers, design engineers, manufacturing engineers, APQP team members and others who have direct responsibility for process standardization and improvement.
- The five phases of APQP and the benefits of the APQP strategy
- Inputs and outputs of the five phases of APQP
- Process elements and key requirements of VDA 6.3 in relation to APQP
- APQP and the specifications for „product realization“ according to IATF 16946
- Connections between APQP, VDA 6.3 and IATF 16949
- The training may include requirements of the company quality management system.
Design FMEA | 1-2-3 days
The seminar enables the participants to work in an FMEA team. The participants learn about the structure and development of a design FMEA, as well as how to use the corresponding tools.
Leaders responsible for design activities, design engineers, NPI development teams, process engineers, quality engineers.
- System and design FMEA: block diagrams, the use of an interaction matrix to identify the connection between components and higher-level systems
- Product development and quality
- Implementation of a design FMEA: Identification of functions, malfunctions, causes as well as avoidance and discovery measures, documentation
- Implementation of the results of the Design FMEA into a Design Verification Plan (DVP&R)
- Determination of functional failure modes and errors, and their significance
- Incorporating Special Characteristics and features in product design
- Using FMEA risk assessments as the basis for the continuous improvement process
Process FMEA | 2-3 days
The training provides practical knowledge on the development and linking of process flow diagrams, P-FMEA and production control plans in order to improve and standardize processes.
Leader responsible for process design and development and process engineers, APQP team members, manufacturing engineers, quality representatives as well as PPAP coordinators and project managers.
- Performance of a P-FMEA
- Requirements and special features
- Risk assessment
- Types of defects, prevention and detection
- Production control plan
- Work instructions
Special features: D-FMEA and P-FMEA
- If desired, the use of the corresponding software can be integrated into the training; the training duration is thus increased by one day.
- The FMEA training can be conducted according to the specifications of AIAG, VDA or the new harmonized FMEA. Training on the new FMEA necessarily includes software training, as the use of corresponding programs is specified by the standard.
Note: After Daimler has announced that from now on only FMEAs according to the new standard will be accepted, it is expected that the other OEMs will follow suit. It is certainly recommended to train according to the new standard.
For FMEA-experienced employees Omnex also offers trainings that focus on the differences and changes (training material currently in English; German as training language is still possible).
Production Part Approval Process | Production Process Approval | 1 day
The training builds on APQP and provides the participants with comprehensive knowledge of PPAP/PPA which is the final part of the APQP process: basic requirements, documentation, customer specific requirements, evaluation.
Development engineers, quality assurance officers, supplier developers, production engineers, internal Auditors.
- Introduction and overview to PPA process
- PPAP within the framework of the operational QMS
- Management of sampling documents
- Submission stages
- Archiving of records and master samples
- Representative production run
- PPAP documents for submission
- Part submission confirmation and status
- Assessment of PPAP documents
- Customer-specific documents and processes can be included in the training.
- The training can be aligned to PPAP (AIAG) or PPF (VDA), depending on your needs. In each case, differences and parallels to the other standard are taken into account.
Note: The VDA has announced a revised version of PPF for summer 2020. All changes can be considered at short notice after the document comes into force.
Statistical Process Control | 2 days
The seminar provides basic knowledge of statistics, such as mean value, range, standard deviation and their application in relation to production processes, deals with process capability and the creation and evaluation of different control charts.
Development engineers, development teams, process engineers, quality engineers, shift supervisors, team leaders in production who are entrusted with tasks related to the execution and planning of sampling inspections to determine process capability.
- Variation and its causes
- Basics of statistics: population and sample, distribution, mean value, range, standard deviation, normal distribution
- Stable processes and predictability, sporadic and systematic errors
- Overregulation and funnel experiment
- Central limit theorem
- Process capability and confidence intervals and proportion of defective products for bilateral tolerances as a function of process capability. Process capability criteria for PPAP acceptance
- Commonly used SPC Control charts
- Statistical steering with control charts
- Out-of-control signals for xbar cards, rules for pattern recognition
- Process improvements with SPC
- Stumbling blocks in the implementation of SPC
- Process capability and test process suitability
- As there is a variety of different control charts, specific operational needs can be addressed by prior arrangement in order to optimize the effectiveness of the seminar.
- The seminar contains practical exercises to illustrate the function and benefits of statistical tools.
- If desired, the use of software can also be considered.
Measurement System Analysis – 2 days
The seminar imparts practical knowledge on test process suitability, MSA objectives, procedure, MS evaluation methods. Course includes the use of the common software for some practical exercises.
Quality managers, measurement and laboratory technicians, internal auditors, persons responsible for the planning, application and maintenance of measurement systems.
- Introduction to test process suitability
- Measurements in the testing process
- Resolution and discrimination of gages
- Normal distributions
- Bias, Linearity and Stability
- GRR according to AIAG and ANOVA methods
- Procedures 1, 2 and 3 according to VDA 5
- Incapable measuring systems and conditional release
- Attributive measuring systems
- MSA 4 and VDA 5
- On the European and German market, the procedure according to VDA 5 is usually demanded. However, if required, the training can also be carried out according to MSA 4 (AIAG).
- The VDA 5 oriented training contains exercises that are evaluated with software help (Solara or Minitab, depending on the operational situation). To carry out the training, it is sufficient to have a computer with a corresponding demo version for every 4-5 participants.
Effective Team-oriented problem solving | 2 or 3 days
This course focuses on team-oriented solving for complex or chronic problems. Using the 8D methodology steps, students will learn and practice how to solve complete and 8D and ensure permanent elimination of the problematic (root) causes. This course aligns with AIAG CQI-21.
All those who participate in or lead a problem-solving team and are using 8D to report results.
- Introduction: Problem solving
- Assembling the right (size) team for problem solving
- Developing the correct problem description
- Containment: temporary measures to prevent further escapes
- Root cause (3L – error/root causes)
- Finding permanent shutdown measures
- Decision-making, and common pitfalls
- Evaluate permanent shutdown measures
- Preventing repeat defects, failures and complaints
- Ensuring team success
- Managerial Root Cause
- Use of checklists
- Internal company cases can be worked through, evaluated and discussed in the training.
- Documents of the 8D process can be integrated into the training.
- Both measures significantly increase the practical applicability of what has been learned.