Safety Function Model for Requirement Specification in Critical Systems: A Case Study of Generic Patient Controlled Analgesia Pump Model (CGPA)
Abstract
Developing safety-critical systems (SCS) involves a systematic method for assuring and providing safety and dependability. Conventional approaches rely on expert intervention, which can introduce bias, cause delays, and promote inconsistency. This work proposes a model that enhances efficiency and accuracy by extracting safety functions from requirements specifications. The model is made up of three main steps: (1) preprocessing, which involves getting rid of stop words; (2) string selection and matching using a database of safety properties variables based on literature and expert knowledge; and (3) putting safety and non-safety functions into a structured safety function log. The model was trained and tested with the CGPA insulin pump and got a 94% F1 measure score, which means it was 91% accurate, 96% accurate, 92% precise, and 96% recall. This shows that it is good at making things clearer and less biased when finding functions for safety against failures, malfunctions, operational hazards, and inconsistencies in safety-critical specifications. All these enhancements contribute towards Sustainable Development Goal (SDG) 11: Sustainable Cities and Communities, aiming to develop safer, resilient, and sustainable infrastructure in safety-critical regions.
Keywords
References
K. Hobbs, M. Mote, M. Abate, S. Coogan, and E. Feron, “Run Time Assurance for Safety-Critical Systems: An Introduction to Safety Filtering Approaches for Complex Control Systems,” IEEE Control Syst., vol. 43, no. 2, pp. 28–65, Jun. 2022, doi: 10.1109/MCS.2023.3234380.
L. Buysse, I. Habli, D. Vanoost, and D. Pissoort, “Safe autonomous systems in a changing world: Operationalising dynamic safety cases,” Saf. Sci., vol. 191, p. 106965, Nov. 2025, doi: 10.1016/J.SSCI.2025.106965.
X. Wang, J. Yang, C. Liu, Y. Yan, and S. Li, “Safety-Critical Disturbance Rejection Control of Nonlinear Systems With Unmatched Disturbances,” IEEE Trans. Automat. Contr., vol. 70, no. 4, pp. 2722–2729, Apr. 2025, doi: 10.1109/TAC.2024.3496572.
W. H. Organization, “Improving the Quality of Health Services - Tools and Resources,” WHO Serv. Deliv. Saf. Dep., pp. 1–59, 2018.
T. Purchase, P. Bowie, P. Hibbert, R. G. Krishnan, and A. Carson-Stevens, “Human Factors to Improve Patient Safety,” Patient Saf. A Case-based Innov. Playb. Safer Care Second Ed., pp. 45–60, Jan. 2023, doi: 10.1007/978-3-031-35933-0_4.
S. Thukral et al., “Diagnosis of Safety Problems Using Safety Analyst for Efficient and Effective Safety Management,” 2013.
M. Mohamad, J. P. Steghöfer, E. Knauss, and R. Scandariato, “Managing security evidence in safety-critical organizations,” J. Syst. Softw., vol. 214, p. 112082, Aug. 2024, doi: 10.1016/J.JSS.2024.112082.
R. Sadeghi and F. Goerlandt, “A proposed validation framework for the system theoretic process analysis (STPA) technique,” Saf. Sci., vol. 162, p. 106080, Jun. 2023, doi: 10.1016/J.SSCI.2023.106080.
X. Chen et al., “Empowering Domain Experts With Formal Methods for Consistency Verification of Safety Requirements,” IEEE Trans. Intell. Transp. Syst., vol. 24, no. 12, pp. 15146–15157, Dec. 2023, doi: 10.1109/TITS.2023.3324022.
A. Ait Wakrime and Y. Ouhammou, “Advances in modeling, verification and testing of safety-critical software architectures,” Innov. Syst. Softw. Eng., vol. 18, no. 4, pp. 483–484, Dec. 2022, doi: 10.1007/S11334-022-00493-Z/METRICS.
A. Cimatti, M. Roveri, A. Susi, and S. Tonetta, “Formalization and Validation of Safety-Critical Requirements,” Electron. Proc. Theor. Comput. Sci. EPTCS, vol. 20, pp. 68–75, Jun. 2012, doi: 10.4204/EPTCS.20.7.
J. Fox et al., “Expert systems for safety-critical applications: theory, technology and applications,” in IEE Colloquium on Knowledge-Based Systems for Safety Critical Applications, 1994, pp. 5/1-5/5.
T. Segreto, “Knowledge-Based System,” CIRP Encycl. Prod. Eng., pp. 997–1001, 2019, doi: 10.1007/978-3-662-53120-4_6557.
J. P. Steghöfer, E. Knauss, J. Horkoff, and R. Wohlrab, “Challenges of Scaled Agile for Safety-Critical Systems,” Lect. Notes Comput. Sci. (including Subser. Lect. Notes Artif. Intell. Lect. Notes Bioinformatics), vol. 11915 LNCS, pp. 350–366, 2019, doi: 10.1007/978-3-030-35333-9_26.
J. Fox and D. Robertson, “Industrial use of safety related expert systems,” Heal. Saf. Exec., vol. 296, 2000.
S. G. Tzafestas, A. I. Kokkinaki, and K. P. Valavanis, “An Overview of Expert Systems,” Expert Syst. Eng. Appl., pp. 3–24, 1993, doi: 10.1007/978-3-642-84048-7_1.
L. E. G. Martins and T. Gorschek, “Requirements Engineering for Safety-Critical Systems: An Interview Study with Industry Practitioners,” IEEE Trans. Softw. Eng., vol. 46, no. 04, pp. 346–361, 2020, doi: 10.1109/TSE.2018.2854716.
J. Wu, X. Zhang, M. Song, and M. Lind, “Challenges in Functional Modelling for Safety and Risk Analysis,” in Proceeding of the 33rd European Safety and Reliability Conference, 2023, pp. 1892–1899.
B. Hendrix, T. E. Lewis, M. Emery, and B. Rachele, “Model Based Functional Safety – How Functional Is It?,” J. Syst. Saf., vol. 57, no. 2, pp. 32–38, Jun. 2022, doi: 10.56094/JSS.V57I2.192.
A. Nouri, B. Cabrero-Daniel, F. Torner, H. Sivencrona, and C. Berger, “Engineering Safety Requirements for Autonomous Driving with Large Language Models,” Proc. IEEE Int. Conf. Requir. Eng., pp. 218–228, 2024, doi: 10.1109/RE59067.2024.00029.
J. G. Sheehan, J. L. Howe, A. Fong, S. A. Krevat, and R. M. Ratwani, “Usability and Accessibility of Publicly Available Patient Safety Databases,” J. Patient Saf., vol. 18, no. 6, pp. 565–569, Sep. 2022, doi: 10.1097/PTS.0000000000001018.
S. Gupta et al., “Industrial Expectations of a Pure Component Database for Thermodynamic and Transport Properties,” Ind. Eng. Chem. Res., vol. 61, no. 42, pp. 15514–15553, Oct. 2022, doi: 10.1021/acs.iecr.2c01642.
M. B. McKinnon and G. T. Bellamy, “Fire Safety Research Institute Materials and Products database—A resource to support fire modeling,” J. Fire Sci., vol. 42, no. 3, pp. 175–216, May 2024, doi: 10.1177/07349041241235566/ASSET/9B5829C4-6322-403A-90CD-3A5D5335B63E/ASSETS/IMAGES/LARGE/10.1177_07349041241235566-FIG16.JPG.
A. Maurya and D. Kumar, “Reliability of safety-critical systems: A state-of-the-art review,” Qual. Reliab. Eng. Int., vol. 36, no. 7, pp. 2547–2568, Nov. 2020, doi: 10.1002/QRE.2715.
V. Nguyen Tran, L. Vu Tran, V. Nguyen Tran, and D. Ngoc Vu, “Hazard Analysis Methods for Software Safety Requirements Engineering,” ACM Int. Conf. Proceeding Ser., pp. 11–18, Jan. 2022, doi: 10.1145/3520084.3520087;PAGE:STRING:ARTICLE/CHAPTER.
D. C. Jensen and I. Y. Tumer, “Modeling and Analysis of Safety in Early Design,” Procedia Comput. Sci., vol. 16, pp. 824–833, Jan. 2013, doi: 10.1016/J.PROCS.2013.01.086.
K. Hamidi, O. Malasse Dr., and J. F. Aubry Prof., “Contribution to an improvement of quantitative evaluation model for reliability of safetv-related functions,” IEEE Int. Symp. Ind. Electron., vol. 1, pp. 115–120, 2004, doi: 10.1109/ISIE.2004.1571792.
A. Abdullah, R. A. Bakar, K. Gunaratnam, F. Hujainah, and M. F. Abdul Farid, “Safety Property Attributes in Critical Systems for Requirement Specification: A Review,” 8th Int. Conf. Softw. Eng. Comput. Syst. ICSECS 2023, pp. 481–486, 2023, doi: 10.1109/ICSECS58457.2023.10256294.
F. Barez, H. Hasanbieg, and A. Abbate, “System III: Learning with Domain Knowledge for Safety Constraints,” no. NeurIPS, pp. 1–10, Apr. 2023, Accessed: Aug. 28, 2025. [Online]. Available: https://arxiv.org/pdf/2304.11593.
Y. Liu, J. M. Wu, M. Avdeev, and S. Q. Shi, “Multi-Layer Feature Selection Incorporating Weighted Score-Based Expert Knowledge toward Modeling Materials with Targeted Properties,” Adv. Theory Simulations, vol. 3, no. 2, p. 1900215, Feb. 2020, doi: 10.1002/ADTS.201900215;SUBPAGE:STRING:FULL.
I. Babeshko, O. Illiashenko, V. Kharchenko, and K. Leontiev, “Towards Trustworthy Safety Assessment by Providing Expert and Tool-Based XMECA Techniques,” Math. 2022, Vol. 10, Page 2297, vol. 10, no. 13, p. 2297, Jun. 2022, doi: 10.3390/MATH10132297.
“UMN Critical Systems Group (CriSys).” https://crisys.cs.umn.edu/gpca.shtml (accessed Aug. 28, 2025).
“The Generic Infusion Pump (GIP).” https://rtg.cis.upenn.edu/gip/#Publications (accessed Aug. 28, 2025).
DOI: https://doi.org/10.52088/ijesty.v5i3.1370
Refbacks
- There are currently no refbacks.
Copyright (c) 2025 Azma Abdullah, Rohani Abu Bakar, Fairus Abdul Farid, Mansoor Abdulhak




























