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PCP R&D QMS Process Updates Q1-2025 Safety

· 18 min read
  • Changes to the PCP R&D QMS website and OnePCP DMS templates in Q1-2025 (Functional Safety Focus).
  • Changes to the DMS guidelines from safety handbook reference list between Q2-2024 to Q1-2025.

Major changes


Update of Certifications Page

2025-03-10, Dietmar Overhoff (PR-59584)

Changed pages:

Description of change:

Artifacts:

  • Pollution degree removed from Directives, its not a directive
  • Electrical Safety standards revised and listed for different world regions
  • Explosion protection requirements revised and listed for different world regions
  • Overvoltage category and Equipment class removed, since it is included in and part of the Electrical safety certification
  • Ex Quality Management rephrased

Related work items: #366224


Outsourcing for Functional Safety Product Development

2025-03-04, Chengyu Huang (PR-59153)

Changed pages:

Description of change:

  • Updated Functional-Safety.md to update the functional safety outsourcing process, solving #318806
  • Updated Functional-Safety.md to add the reference document 2PAA121280_en List of Documents sent to TUV, solving #337284
  • Updated Functional-Safety.md to clarify the QMS baselines will be sent to ISA on a quartely basis. #283733

Pull request template updates

2025-02-05, Per Branger (PR-58659)

Changed pages:

Description of change:

  • Changed title and filename to "Pull Request Software Template" and "Pull Request Documentation Template"
  • Updated the "Pull Request Documentation Template" and added bullets for "Full" and "Focused"
  • Moved "Pull Request Software Template" to the "Software Development" category and "Pull Request Documentation Template" to the "Documentation" category. See the "List of Markdown Templates" page.

Related work items: #338211


Update of how review a PR

2025-01-17, Nicolas Martin-Vivaldi (PR-58119)

Changed pages:

Description of change:

  • Added a section on how to review PR

Related work items: #349702


Updates of Functional Safety Process

2025-01-23, Josefin Henriksen, (PR-57036)

Changed pages:

Description of change:

The Functional Safety Process page is updated according to informal review by the Safety Team. The agreed updates can be found in details in RR for Functional Safety process wiki page.xlsx which is attached to the pull request.


Minor changes


Updated Safety-Handbook-Ref-List.md

2025-03-24, Chao Xia (PR-60604)

Changed pages:

Description of change:

Update the reference link Updated Safety-Handbook-Ref-List.md

Related work items: #378460


Updated How-to-conduct-FSM-audits.md

2025-03-21, Chao Xia (PR-58799)

Changed pages:

Description of change:

  • Integrate information on FSM Audit from the Functional Safety Process page with How-to conduct internal FSM Audits in PCP R&D

Related work items: #334736


Updated Certifications.md

2025-03-19, Chao Xia (PR-59960)

Description of change:

Link to Functional Safety Process article. In RACI, product owner (PO) should be I. Add a reference to the TUV certificates page.

Related work items: #178325


Updated How-to-conduct-FSM-audits.md to update the acceptance criteria for findings

2025-03-17, Josefin Henriksen (PR-60271)

Changed pages:

Description of change:

  • Added to section "Findings & Follow-up" that the Acceptance criteria for each finding shall contain the listed bullets from the guideline How to conduct FSM audits. Note that there are one list for Internal Audits and one list for External Audits
  • Smaller cosmetic changes such as altering some grammar, removing empty rows, changing to capital letters in names etc.

Related work items: #373532


Add review protocol note to safety certification documents guideline

2025-03-07, Stuart Shirran (PR-59866)

Description of change:

Added a note as a bubble to cover handling of TUV review protocols.

Not sure how the 800xA-Learn-1.md file has been included in this branch. I have not made any changes here so why it is included with the result that a merge conflict is created I don't know. Will discus with Per B. how to resolve if I can't fix it myself.

Related work items: #367777


Updated DoD-for-L4-Bugs.md

2025-02-28, Massimo Marongiu (PR-59831)

Changed pages:

Description of change:

Age count modified to detail how to stop age counting, considering the new L4 bugs management

Related work items: #367579


Update of PRO role description, new PRO Handbook

2025-02-25, Daniela De Vincenzi (PR-59006)

Changed pages:

Description of change:

  • Update of "Responsibilities"
  • New PRO Handbook in PowerPoint (linked to from role description). Review PPT by clicking on link.

Related work items: #362201


Update the PO role

2025-02-20, Nicolas Martin-Vivaldi (PR-58826)

Changed pages:

Description of change:

  • Modified intro text and some responsibility bullets

Related work items: #357065


Smaller updates to Safety Handbook

2025-02-20, Josefin Henriksen (PR-58868)

Changed pages:

Description of change:

  • Updated Safety-Handbook.md to clarify that ABB PCP R&D does not have a specific Safety Plan and that the contents of such an artifact is included in the Quality Plan
  • Updated Safety-Handbook-Add-On.md to add missing "." to headlines 18 & 19
  • Updated Functional-Safety.md to correct links to align with updates to Safety Handbook Artifacts
  • Commit bbd49b49: Updated Safety-Handbook-Ref-List.md to fix a broken link to Cyber Security Guideline

Related work items: #348083, #360936


Updated Hardware-Development.md

2025-02-12, Anders Larsson (PR-59126)

Changed pages:

Description of change:

The link and name to this document are changed to the correct one.

For document reviews use 3BSE052207 Document Review Guideline

HW Process

Related work items: #363585


Updated Calibration.md

2025-02-12, Anders Larsson (PR-59121)

Changed pages:

Description of change:

Deleted names and telephone numbers to specific persons.

Related work items: #361899


Updated How-to-Manage-Stop-and-Start-Orders.md

2025-02-10, Anders Larsson (PR-58990)

Changed pages:

Description of change:

Updated How-to-Manage-Stop-and-Start-Orders.md

Related work items: #362327


Updated How-to-Manage-Certification-Documents.md to align with PCR 338409

2025-02-10, Josefin Henriksen (PR-58840)

Changed pages:

Description of change:

Updated How-to-Manage-Certification-Documents.md to align with PCR 338409, i.e. to clarify when to use the external life cycle for documents.

Related work items: #338409


Add Safety relevant

2025-02-05, Chao Xia (PR-58816)

Changed pages:

Description of change:

The term safety relevant shall be added to Safety Handbook | PCP R&D QMS.

Related work items: #332006


Clean up after updates to Functional Safety Process

2025-02-04, Josefin Henriksen (PR-58723)

Changed pages:

Description of change:

Links to the Safety Handbook has been re-directed to wiki page and process owner tag has been updated to Functional Safety Team for all safety-related pages.

Related work items: #332007, #332013


Updated Guideline-for-HAZOP.md to add reference to  7PAA010740_en Safety Tool Selection for ABB SafetyInsight

2025-02-04, Josefin Henriksen (PR-58772)

Changed pages:

Description of change:

Updated Guideline-for-HAZOP.md to add reference to 7PAA010740 to Guideline for HAZOP. Included updates related to ongoing pull request 58723 to avoid merge conflict.

Related work items: #331384


Info about periodic process update

2025-01-31, Daniela De Vincenzi (PR-58684)

Changed pages:

Description of change:

  • A sentence in Governance was added to clarify that periodic updates are required.

Related work items: #356764


Document Template Updates

NameDocument IDRevisionLifecycle StatusApproved By PersonApproval Date
3BSE039313_en_TPF Names on RACI.xlsx3BSE039313YApprovedAndre Ekfeldt2025-04-08
7PAA003087_en_TPF Quality report.pptx7PAA003087GApprovedDaniela De Vincenzi2025-03-21
7PAA019377_en OnePCP DMS Template Management.pptx7PAA019377AApprovedKamil Brutkowski [EXT]2025-03-14
3BSE046924_en_TPF Checklist for temporary correction.xlsm3BSE046924JApprovedAndre Ekfeldt2025-02-25
7PAA001404_en_TPF Word Template TC and Rollup Release Notes.docx7PAA001404HApprovedAndre Ekfeldt2025-01-13

Hint on how to find the revision history of templates:

  • for Excel template, right click on the worksheet tab, where all worksheets are present. Click unhide to reveal the "Template Revision history"
  • for Word template, click "show all" to reveal the "Template information and revision history"
  • for PowerPoint template, scroll down to "Revision History -Template"

3BSE039313_en_TPF Names on RACI.xlsx

363991

377883

366968

Description of change:

Columns AH-AI (”Document only applicable for safety products” respectively “Mandatory for Safety Projects”) have not been mapped yet to Names on RACI. Safety Team should discuss internally and update these columns if they are applicable. Current states as "Not Applied".

Other updates for Safety related artefacts: Impact Analysis Report. G4 for New Functionality, G5 for Error handling DoF, DD, IfD & SVTD sent to TUV Static Code Analysis Report. Approved G5, Draft G4 Traceability Report. Approved G5, Draft G4 Test Summary and Final Conclusion of Test (Detailed Test Plan). Approved G4.

7PAA003087_en_TPF Quality report.pptx

Description of change:

Mainly updated cyber security artefacts. see template revision history on page 34

7PAA019377_en OnePCP DMS Template Management.pptx

This is a general tool instruction for process owners on how to update/withdraw template in OnePCP DMS.

3BSE046924_en_TPF Checklist for temporary correction.xlsm #360891

Description of Change

Worksheet: Release(G5) Task 6: Added ? No significant changes have been introduced and the Product Security Assessment <Add PSA reference> is still valid. ? Have you changed any 3rd party component? If so, have you analyzed and handled any related risks (license, vulnerabilities, obsolescence)? OSS changes shall be analyzed and managed with Black Duck.

7PAA001404_en_TPF Word Template TC and Rollup Release Notes.docx #327675

Description of change:

Put place holder for personal information or risk that it needs to be constantly checked/updated, e.g. lists telephone numbers or email addresses.

"If the hardware or software versions used are not yet listed in the latest available Annex to the TÜV Certification Report, see <Add name and document id of relevant certificate annex> in ABB Library, please contact your local ABB sales representative or TÜV Süd directly for confirmation. ABB contact details can be found in this document or via myABB/myControlSystem. TUV Süd contact details are found in the relevant Annex to the TÜV Certification Report or associated TUV Safety Certificate, both available in ABB Library."


OnePCP DMS Process Guideline Updates

NameDocument IDRevisionLifecycle StatusApproved By PersonApproval Date
3BSE082892_en Configuration Change Control in Azure DevOps (Scrum).docx3BSE082892PApprovedManuela Mantione2025-04-08
3BSE039245_en ABB approach to IEC61508 2nd Ed, Test.docx3BSE039245FApprovedStuart Shirran2024-11-26
3BSE052207_en_Formal_Review_Process_Guideline.pptx3BSE052207JApprovedTomasz Halajda2024-06-25
3BSE045438_en ABB Approach to avoid common cause failures in PM SM.docx3BSE045438FApproved Stefano Lanata2024-09-27
7PAA001404_en ABB Approach to IEC 61508 failure classification and probability calculations for AC800M HI3BSE068757CApproved Stuart Shirran2024-11-22

3BSE082892_en Configuration Change Control in Azure DevOps (Scrum).docx

245472

318832

292974

Description of change:

  • Added explanation on how to handle impact analysis fields in Bug/Feature
  • Updated reference table to the latest Status
  • Added recommendation on tracking mandatory safety impact analysis fields using data descipline dashboard in Azure DevOps
  • Added recommendation on adapting the existing review record template to perform impact analysis review in Azure DevOps

3BSE039245_en ABB approach to IEC61508 2nd Ed, Test.docx

221110

Description of change:

Updated to replace reference to 3BSE044017 HW and SW development with reference to Safety Handbook instead. Note that the reference had the wrong title listed in this document.

Other updates made: Updated to new template.

Removed mentioning of Q & Safety plan and Test Plan in 1.2 Scope, since figure 1 is not included in current Quality Plan nor in Test Plan. Referred to Safety Handbook instead.

Added Stream Owner, Cluster Lead and Stream Member as terms to chapters 1.3.1 and 1.3.2.

Added information on which verification techniques and measures are described in ABB approach to IEC61508 2nd Ed, Design instead to align with how that document is structured.

Updated term skeleton to template in chapter 3.2.

3BSE052207_en_Formal_Review_Process_Guideline.pptx

Updated according to PCR #195409 to align with new tool OnePCP DMS.

Description of change:

Larger changes A separate workflow for documents not based on Microsoft Office has been introduced, both for full review and for minor review DMS tool tips on how to create a new document/update a template have been removed. There are linking to the OnePCP DMS User Manual instead where applicable. Process Orientation (slide 2): New slide to visualize where in the QMS this process is situated and its sources. All help boxes have been color aligned to the process triangle described on slide 2. Formal review – Two types: Full review and Minor review (slide 3): This now only contains information on formal review types for 800xA safety development (full formal and minor). Informal reviews have no requirements on documenting review comments and the author is directly responsible for the review, approval and release. “Best practice for reviewing” both for before and during review meeting has been integrated into the workflow instead of being separate slides as in the previous version(s), see slides 11-12.

Smaller changes All instances of “TFS work item” have been changed to “ADO work item” All instances of “NextECM” have been changed to "DMS” Wording such as “Approve” and “Abort” has been changed to “Accept” respectively “Cancel/Reject” in order to align with the OnePCP DMS terminology. Wording such as “Reviewer” and “Approver” has been changed to “Approvers” in order to align with OnePCP DMS functionality of assigning a workflow. The references have been updated and structured into types “General” and “800xA Development” for document review process guideline. Unused references have been removed: 3BSE025114 Document Management for Projects: Any relevant information is already included in this document 3BSE038862 Safety Handbook: Safety handbook refers down, not needed for the other way around 3BSE045565 Test Summary and Final Conclusion of Test (Template): What template to use is stated elsewhere DMS tool tips “How to find information about workflow comments and actions for a document” removed and WI raised to add the information into the OnePCP DMS user manual instead. DMS tool tips How to cancel a workflow that you started” removed since the DMS user manual applies and there is a link to the user manual on all reference instances in the PowerPoint.

3BSE045438_en ABB Approach to avoid common cause failures in PM SM.docx

DU [228482] (https://tfsa.abb.com/tfs/OCS_3/CIT_CMS/_search?text=228482&type=workitem&pageSize=25&filters=Projects%7BCIT_CMS%7D )

Description of change:

Noticed when reviewing Impact Analysis of Feature 178081: Product Feature: 3rd party PROFIsafe in AC 800M that a minor update is needed 3BSE045438, Ch 6.4, as the section is currently specifically addressing Select I/O and v2.6.1 of the standard.

The approach as such is still valid, also for 3rd Party, but text needs to be amended or generalized to cover 3rd Party as well. (Compare ABB Approach to PROFIsafe, 3BSE076543-063)

7PAA001404_en ABB Approach to IEC 61508 failure classification and probability calculations for AC800M HI

221111

Description of change:

Updated to replace reference to 3BSE044017 HW and SW development with reference to Safety Hand-book instead. Note that the reference had the wrong title listed in this document. Other updates made: Updated to new template. Added Stream Owner, Cluster Lead and Stream Member as terms to chapters 1.2.1 and 1.2.2. Changed MIN to MAX for chapters 3.2.1.5 and 3.3.1.4 to align with DUs 126278 and 223293.