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| SHORT DESCRIPTION |
 General management processes enabeling functional safety compliant development activities |
| PERSON RESPONSIBLE |
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| INPUT |
See below |
| OUTPUT |
See below |
| PROCESS OBJECTIVES |
Ensure and anable safety-related development compliant to ISO 26262 series of standards |
| PERFORMANCE INDICATORS |
The corresponding functional safety audit is without critical findings |
| MODIFIED BY |
Franz Montowski |
| MODIFIED ON |
11.05.2020 |
| WORK STEPS | PERFORMER | REFERENCE |
| SAFETY CULTURE (ISO 26262-2 | 5.4.2) | ||
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Project Functional Safety Manager |
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Development and implementation of organisation-specific rules and processes to achieve functional safety for entire safety lifecycle. Processes may be tailored for general use (project independent).
 ISO 26262-2 | 5.4.2 (Handbook chapter 2.1.1).
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Project Functional Safety Manager |
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Communication of relevant divisions of the project like FS, cyber security and similar ones shall be planned and frequently performed to enhance the overall safety of the product as well as the FS.
ISO 26262-2 | 5.4.2 (Handbook chapter 2.1.1).
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Project Functional Safety Manager |
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The project manager shall ensure availability of all resources necessary for achievement of FS. This includes money as well as time and personnel.
ISO 26262-2 | 5.4.2 (Handbook chapter 2.1.1).
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Project Functional Safety Manager |
 Rules Processes |
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Project Functional Safety Manager |
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| MANAGEMENT OF SAFETY ANOMALIES (ISO 26262-2 | 5.4.3) | ||
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Identified FS anomalies shall be surely (by defined process) communicated to responsible persons (might be same division, customer or supplier) during entire safety lifecycle.
ISO 26262-2 | 5.4.3 (Handbook chapter 2.1.2).
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Project Functional Safety Manager |
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Identified FS anomalies shall be surely (by defined process) resolved by either evaluating it as not relevant (with justification) or handling it with an implemented safety measure which is proven as effective.
ISO 26262-2 | 5.4.3 (Handbook chapter 2.1.2).
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Project Functional Safety Manager |
Safety anomalies |
| COMPETENCE MANAGEMENT (ISO 26262-2 | 5.4.4) | ||
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Project Functional Safety Manager |
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Personnel involved in the safety lifecycle shall have competences corresponding to their responsibility.
ISO 26262-2 | 5.4.4 (Handbook chapter 2.1.3).
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Project Functional Safety Manager |
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To give evidence of competence, the personnelīs competence and the requirements for their task shall be documented, e.g. in competence matrices.
ISO 26262-2 | 5.4.4 (Handbook chapter 2.1.3).
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Project Functional Safety Manager |
Competence management |
| QUALITY MANAGEMENT (ISO 26262-2 | 5.4.4) | ||
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Project Functional Safety Manager |
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To support achievement of FS, a well-known and accepted standard for QM (e.g. IATF 16949) shall be implemented and application is to be proven.
ISO 26262-2 | 5.4.5 (Handbook chapter 2.1.4).
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Project Functional Safety Manager |
Quality management |
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Project Functional Safety Manager |
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Appointment of a project manager responsible for achievement of functional safety during concept phase and development phase. PM may appoint a competent FS manager. Further responsibilities shall also be documented.
ISO 26262-2 | 6.4.2 (Handbook chapter 2.2.1).
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| IMPACT ANALYSIS (ISO 26262-2 | 6.4.3) | ||
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Project Functional Safety Manager |
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Distinction between modification and new development. In case of modification of item or environment, perform impact analysis.
ISO 26262-2 | 6.4.3 and 6.4.4 (Handbook chapter 2.2.2 and 2.2.3).
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Project Functional Safety Manager |
Impact analysis |
| Documentation of distinction result and, if applicable, result of further impact analysis. | ||
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Project Functional Safety Manager |
Impact analysis |
| PROVEN IN USE ARGUMENT (ISO 26262-8 | 14) | ||
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Project Functional Safety Manager |
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The candidate to be proven in use shall be described with a minimum set of information listed in ISO 26262‑8 14.4.3.
ISO 26262-8 | 14.4.2 and 14.4.3 (Handbook chapter 8.10.1 and 8.10.2).
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Project Functional Safety Manager |
Candidate |
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Project Functional Safety Manager |
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Modifications to candidates and their environment shall be identified and comply with ISO 26262‑2 6.4.2 or 6.4.3.
ISO 26262-8 | 14.4.4 (Handbook chapter 8.10.3).
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Project Functional Safety Manager |
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Evidence of continuous application of change- and configuration management of candidate shall be provided. A suitable observation period shall be applied to candidates for proven in use argument. Field data shall be analysed regarding compliance of candidate with all safety requirements.
ISO 26262-8 | 14.4.5 (Handbook chapter 8.10.4).
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Project Functional Safety Manager |
Analysis reports |
| SAFETY ACTIVITIES (ISO 26262-2 | 6.4.5 to 6.4.8) | ||
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Project Functional Safety Manager |
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In general it is allowed to deviate from the safety activities as described in the ISO 26262 series of standards. Such tailoring shall be defined (in safety plan) and justified. FS achievement needs to stay ensured.
ISO 26262-2 | 6.4.5 (Handbook chapter 2.2.4).
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Project Functional Safety Manager |
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The project FS manager is responsible for planning and coordination of safety activities and thus to maintain the safety plan. Required content is to be read in references below.
ISO 26262-2 | 6.4.6 (Handbook chapter 2.2.5).
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Project Functional Safety Manager |
Safety plan |
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Project Functional Safety Manager |
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Safety related documents shall be summarised in a way presenting an argument for achievement of FS to support the FS assessment.
ISO 26262-2 | 6.4.8 (Handbook chapter 2.2.7).
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Project Functional Safety Manager |
Safety case |
| SAFETY MANAGEMENT AFTER RELEASE FOR PRODUCTION (ISO 26262-2 | 7.4) | ||
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Project Functional Safety Manager |
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Appointment of responsible organisations and persons for achievement of functional safety during production, operation, service and decommissioning. Planning of safety activities during those phases.
ISO 26262-2 | 7.4.2 (Handbook chapter 2.3).
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Project Functional Safety Manager |
SM after RfP |
| INTERFACES WITHIN DISTRIBUTED DEVELOPMENTS (ISO 26262-8 | 5) | ||
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Project Functional Safety Manager |
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Evaluation of potential suppliers regarding capability and experience for FS related development and QM.
ISO 26262-8 | 5.4.2 (Handbook chapter 8.1.2).
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Project Functional Safety Manager |
Selection report |
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Project Functional Safety Manager |
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(Jointly) planning of development responsibilities between supplier and customer, starting with appointment of FS managers on both sides.
ISO 26262-8 | 5.4.3 (Handbook chapter 8.1.3).
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Project Functional Safety Manager |
DIA |
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Project Functional Safety Manager |
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Assurance of compliance with DIA during SLC on supplierīs side.
ISO 26262-8 | 5.4.4 (Handbook chapter 8.1.4).
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Project Functional Safety Manager |
Supplier's safety plan |
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Project Functional Safety Manager |
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Planning of FS assessment execution and responsibility (which side?). If supplier assesses himself, reports shall be available for customer.
ISO 26262-8 | 5.4.5 (Handbook chapter 8.1.5).
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| [TBD] hier fehlt das FS Assessment als Work Product/ Output [TBD] |
Project Functional Safety Manager |
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Project Functional Safety Manager |
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Evidence by supplier of compliance with capability requirements of production. Addressing of responsibilities for FS issues as well as definition of communication channels for safety related events shall be documented.
ISO 26262-8 | 5.4.2 (Handbook chapter 8.1.6).
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Project Functional Safety Manager |
Supply agreement |
| CONFIGURATION MANAGEMENT (ISO 26262-8 | 7) | ||
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Project Functional Safety Manager |
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Assurance of reproducibility of work products, items, elements as well as principles and general conditions of their creation. Traceability of configurations shall be ensured.
ISO 26262-8 | 7.4.1 (Handbook chapter 8.3).
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Project Functional Safety Manager |
CM plan |
| CHANGE MANAGEMENT (ISO 26262-8 | 8) | ||
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Project Functional Safety Manager |
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General planning of change management process (including schedule) and application to each case of change before performing changes.
ISO 26262-8 | 8.4.1 (Handbook chapter 8.4.1).
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Project Functional Safety Manager |
Change management |
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A change request shall have a unique identifier and include date, reason, description and configuration. A change shall be analysed and evaluated regarding aspects listed in references below (e.g. impact on functional safety).
ISO 26262-8 | 8.4.2 to 8.4.4 (Handbook chapter 8.4.2 to 8.4.4).
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Project Functional Safety Manager |
Change request |
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Project Functional Safety Manager |
Change request plan |
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Project Functional Safety Manager |
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Implementation and verification of changes as planned. If applicable, functional safety assessment and confirmation reviews shall be updated. Changes shall be documented.
ISO 26262-8 | 8.4.5 (Handbook chapter 8.4.5).
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Project Functional Safety Manager |
Change report |
| DOCUMENTATION MANAGEMENT (ISO 26262-8 | 10) | ||
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Project Functional Safety Manager |
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Documentation management shall be planned to provide documented information throughout entire SLC.
ISO 26262-8 | 10.4 (Handbook chapter 8.6).
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Project Functional Safety Manager |
DM plan |
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Project Functional Safety Manager |
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Documents shall be uniquely identifiable and contain as a minimum set of information title, author and approver, change history and status. Further aspects are to be read in references below.
ISO 26262-8 | 10.4 (Handbook chapter 8.6).
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Project Functional Safety Manager |
Guideline requirements |
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| PROCESSES |
To our processes. |
| DOCUMENTS |
To our documents. |
| WORK PRODUCTS |
To our work products. |