Systematic Approach to Process Safety

Asia Pacific Journal of Management and Education

Johnson & Johnson was founded in 1886, which is a multinational medical device, pharmaceutical and consumer packaged goods manufacturing company. This company has 250 subsidiary companies which operate in 60 countries and their products are sold over 175 countries. The company was performing well since their establishment; however, J&J is facing numerous quality issues in later years. The first product safety issues arose in 1982, seven individuals died in Chicago, after ingesting cyanide-laced Tylenol capsules, and the company make a large recall of the capsules from retailers and it was known as the first major recalls in the American history. In 2010, a subsidiary of Johnson and Johnson has recalled children's medicine after an inspection which claim that the products were not meet with the required manufacturing specification. Over the year 2016-2018, this company faced with numerous lawsuits related to its talcum powder products-Johnson's Baby Powder and Shower-to-Shower body powder. The latest issue associated with this company was the powder contain harmful substances which might cause cancers. These issues had caused the public lost trust over the brand and the reputation was affected throughout the year. The purpose of this paper aims to analyse the product quality and safety issue and to discuss way to ensure pharmaceutical quality regarding Johnson & Johnson's products. Besides quality control, company management also play a big role when facing this issue. Besides, we aim to find ways in which J&J could maintain its brand image and reputation as a trusted family company.

KEYWORDS: Multi-product plant, safe chemical process steps, holistic approach for process risk analysis, process modules, safety modules, risk modules, modular fault tree analysis. Abstract The outsourcing of chemical productions with all its technologically sophisticated process steps is a big business today. This involves the manufacture of chemicals that have been produced for several years already, as well as new developed chemicals that never have been produced on large scale. Most of these are realized batch wise in Multi-product plants, expensive specialty chemicals as well as cheap chemicals. That is why; custom synthesis is of economic interest. However, with all their advantages, Multi-product plants have system-inherent drawbacks with respect to safety. For each process step one must prove with the systematic approach whether the existing plant and the existing organisation are capable to control the risks of the process. Thus, the challenge for Multi-product chemistry is not only to avoid disastrous accidents but also production losses.

Brief Bio-data of Dr.M.K.Mukundan 1. a. Name b. Date of birth & age c. Date of entry into service Dr.M.K.Mukundan. : 28.10.1949. : 30.10.1972. 2. Sex : Male. 3. Brief service details : Agricultural Research Service (ICAR, Govt. of India). Currently working as Principal Scientist & Head of Dept (past 11 years) in CIFT, Cochin – 682029. Also served as Prof & Head of Dept in KAU (3 yrs), as Jt Director (10 yrs) & as Director ( 4 months) CIFT. Currently Director, CFRD (Govt of Kerala), Konni, from 14-12-2009. 4. Educational qualifications: MSc Pharmaceutical Chemistry with First class second rank, PhD in Marine Biochemistry, Marine Science Faculty, CUSAT. Attended several national and international training programmes including advanced training in Enzyme Technology under Colombo Plan in OMTRI, Osaka University, Japan. Trained Lead Auditor, NABL ISO 17025, Trained BRC Lead Auditor, ISO 22000 FSMS and trained BIS Lead Auditor ISO 14000EMS. 5. Professional Experience: a. 41 years experience in teaching and research in Food Processing and Quality Assurance out of which 21 years as Professor and Head / Principal Scientist and Head in teaching Institutions like Kerala Agricultural University and CIFT & CMFRI affiliated to CIFE Deemed University under ICAR, Govt of India & CFRD, Govt of Kerala. Published over 129 research papers and authored 9 books. As Principal Scientist and Head Quality Assurancce and Management Division CIFT, Cochin for 12 years (i) organized over 100 training programmes on Seafood Quality Assurance, HACCP, ISO 22000 FSMS, Laboratory Quality Management System ISO17025 (ii) As project leader set up Referral Laboratory facilities at CIFT for testing quality parameters and toxic residues in sea food, process water and other ingredients used in sea food industry in India. (iii) Arranged NABL accreditation for QA Labs of CIFT (iv) Provided vital support to Sea Food Industry in India for about nine years from 1997 as Principal Member I, Supervisory Audit Team and guided around 120 sea food exporting units to achieve EU approval. As Director , CFRD set up (i) Food Quality Monitoring Lab at Konni and arranged NABL accreditation in August 2011 and (ii) Started College of Indigenous Food Technology for teaching BSc and MSc programmes in Food Technology and Quality Assurance. b. Over twenty years experience as Member Board of Studies of College of Fisheries, Kerala Agricultural University for BFSc, MFSc and PhD and CIFE, Deemed University, Mumbai for MFSc and PhD programmes & BSc and MSc programmes of M.G.University. c. More than five years experience as Chairman Board of Examiners of MSc course, University of Calicut, Examiner for MSc and PhD programmes of Cochin University of Science and Technology, University of Calicut, Mahatma Gandhi University, Kottayam and for MFSc and PhD Programmes of CIFE (Deemed University), Mumbai. d. Principal Member of Core Committee and presently Convenor Core Committee: to formulate and approve Syllabus for MSc courses in Food Science, Quality Assurance and Food Technology of Mahatma Gandhi University for the past five years. e. As Professor and Head and as Principal Scientist and Head prepared syllabus for BFSc & MFSc in Fish Processing Technology and BSc & MSc in Food Science and Technology, Food Technology and Qlty Assurance and started these courses under Kerala Agricultural University and Mahatma Gandhi University respectively. f. As approved guide of Cochin University of Science and Technology , Kerala Agricultural University and of CIFE, Mumbai guided 7 PhDs 15 MSc and MFSc thesis. g. Principal Member in several national & state level committees on Science, Technology & Education and Bureau of Indian Standards on food safety, HACCP and ISO 22000. Lead auditor for HACCP and PRPs, BRC certified as well as NABL Auditor, ISO/IEC 17025.. h. Leader first and third Indian Delegation for the ISO/TC 234 Meeting on food safety (Fisheries), October 2007, Bergen, Norway.and ISO/TC 234 Meeting Canada 2009. i. Principal member, Supervisory Audit Team, appointed by European union and Govt. of India to inspect & approve Seafood Exporting Units for export to EU countries from 1997 to 2007. In this capacity inspected & improved GMP, GHP and HACCP and approved over 100 production units all over India. j. Patents: 1. Process patent for production of fine grade absorbable surgical sutures from fish gut collagen. 2. Process patent for collagen – chitosan membrane (artificial skin). _______________

2009

Urbain Bruyere, Matt Fox and Colin Watson Operations Essentials Group Project Director, BP International, Chertsey Road, Sunbury-on-Thames, TW16 7LN, UK; e-mail: bruyereu@bp.com Partner, kineo, 100 Queens Road, Brighton, BN1 3XF, UK; e-mail: matt.fox@kineo.com Engineering & Process Safety Consultant, Watson Integrity Ltd., Arndilly, Edinburgh Road, Linlithgow, EH49 6QT, UK; e-mail: colin@ccwatson.freeserve.co.uk

Process Safety Progress, 2008

From 1985 to 2000, large western chemical and petroleum companies, collaborating through the Center for Chemical Process Safety (CCPS), developed a sophisticated level of process safety knowledge and shared this knowledge in the western world through conferences and English-language books. This approach proved satisfactory to address the process safety needs of a large proportion of global industry existing at the time. However, since 2000, the industry has been expanding significantly in developing regions of the world. Communications in these new regions are complicated by language, time zone differences, and culture. Additionally, as reported by the US Chemical Safety Board, many smaller companies, even in the west, are often unaware of the considerable resources that have been developed. Finally, new engineers entering the workplace around the world are generally unable to travel, to attend courses or technical sessions. And because of the Internet resources available to them during their formative years, they are less enthused about plowing through hardcover books to retrieve information. It is clear that traditional books, courses, and technical sessions do not always successfully reach all of these groups. CCPS has recognized that the communication paradigm must be changed and expanded. This article addresses what CCPS is doing to (a) close physical and language gaps, through on-site participation and translation of key materials, and (b) use exciting new Internet tools to facilitate interactions across distances that meet the needs of new engineers. 2007 American Institute of Chemical Engineers Process Saf Prog 27: 2-6, 2008 This article is a summary of a paper recently published. Please see Ref. 1 for a more detailed description.