Implementation of the service / service development (D4)

Process Element D4: Implementation of the service / service development Minimum requirements relevant for assessment: Examples for implementation D4.1* Are the actions which were defined in the development plan for the service implemented?

In the development phase a FMEA must be used to ensure that the service will comply with the customer requirements.

When carrying out the FMEA for the provision of service, the proposed location is included.

Special characteristics are identified, noted in the FMEAs and secured through implemented

measures.

The out-sourced products and services are taken into account. The implementation of the service /service development is ensured in the supply chain.

The documentation of the findings from the devel-opment of the service are available for reference in the serial phase.

The requirements for the test equipment are defined and implemented.

- Methods to minimize risk (QDF, FMEA)

- Statistical design of expire-ments (for example: DoE, Shainin, Taguchi…) - Poka-Yoke Principles - Control plan / inspection

plan

D4.2* Are human resources available and are they qualified to ensure the start of the series?

A general personnel plan must be available.

Personnel must be qualified for the relevant tasks.

This also applies to the staff of external service pro-viders. Appropriate certification must be available.

Needs assessments will be carried out regularly dur-ing service development with regard to possible emerging bottlenecks and additional requirements.

Personnel resources are planned and personnel are qualified in accordance with the project plan.

Processes that have been outsourced have also been considered.

- Customer requirements - Requirements profile for

the relevant position - Determine the need for

training

- Proof of training

- Knowledge of methods and foreign languages

- Appropriate behaviour for the quality of service

D4.3 Are the material resources available and suitable to ensure the start of the series?

A process to determine resources has been estab-lished.

Resource determination refers to the availability of the production facility, warehouses, storage areas, test equipment, laboratory equipment, machinery, equipment, and their utilization. Supporting process-es must be considered.

Within the resource determination the necessary in-frastructure is taken into account.

Regular needs assessment must be carried out dur-ing the service development with regard to possible emerging bottlenecks and additional requirements.

Material resources are planned and provided in ac-cordance with the project plan.

Outsourced processes must be considered.

The resources must be available with a suitable lead time before the start of customer’s serial production.

- Customer requirements - Technical interface to

cus-tomer and suppliers

UProduct development - Test planning

UProcess Development - Facility planning - Facility layout - Transport routes

- Transport, containers, stor-age

- Supporting processes for example from logistics und IT should be considered.

D4.4* Are the required approvals and releases for the service / service develop- ment available?

The releases and verification of suitability is con-firmed for all services and procurement volumes in accordance with development schedules.

The actions from the FMEA have implemented and their effectiveness has been confirmed

A release procedure is coordinated with the custom-er.

The release of the service must be available at the time agreed upon with the customer.

The verification and validation of the product and process are ensured before the customer SOP.

- Test reports, protocols

- Supporting documents for pur-chased parts / suppliers - Sampling results

- Specifications, requirement specifications

- FMEA IMDS, REACH, RoHS - Confirmation of conformity with

legal requirements

- Development releases from customers.

- Logistics concept (e.g. suitabil-ity of packaging through sam-ple shipping)

- Proof of capability of special characteristics

- Capacity studies

D4.5 Are the service specifications derived from the product and process development and are they implemented?

The service and inspection specifications contain all inspection characteristics from the service develop-ment (including special characteristics).

Results of the risk analysis are considered.

The specifications include information for control of the service, methods and response plans and correc-tive actions.

Process / service audits are defined.

The specifications must be available for all phases.

U

Product development - Risk analysis (FMEA,

FTA,…)

- Service control plan

- Process / Service audit plan - Inspection plan

- Response plan

D4.6 Is a performance test for the developed service defined and performed to ensure that the service will withstand the stress of working conditions?

A production trial run of the service must be carried out in order to assess all production factors and in-fluences at the appropriate time and make any nec-essary corrections.

The production trial run has provided evidence that the quality capability of the entire process for the provision of the service is given under serial produc-tion condiproduc-tions.

- Packaging requirements - Customer requirements - Determination of minimum

quantities (intended production rate and flexibility as agreed upon)

- Process capability study - Measurement capability - Equipment and infrastructure

are ready for start of series (measurement reports) - Personal concept for serial

production

- Work/inspection instructions - Service tests according to

customer schedule

D4.7* Is there a controlled method for the product handover from development to serial production?

A process exists for transferring work results from the project to the production.

Prerequisite for project delivery is a successful inter-nal approval and a successful customer approval.

Releases for procurement volumes are available.

Resulting actions from the releases are implemented on time.

Ensure that the service delivery takes place under controlled conditions.

The human resources are available in accordance with the planning and are qualified.

The material resources include buildings, test facili-ties, laboratory facilifacili-ties, equipment, facilifacili-ties, etc.

These are available and have been released.

Measures to safeguard the initial provision of service are specified and introduced when necessary.

Product / Process Development - Customer requirements - Handover protocols/

check-lists with handover criteria - Acceptance reports

- Production control plan - inspection plans

- Part history

- A method has been deter-mined to carry out failure analysis and to introduce corrective measures

- Production metrics such as OEE, rejects,…

- Experience from the ongo-ing project

- Measurement capability