ROOT CAUSE ANALYSIS FOR MEDICAL EQUIPMENT CALIBRATION LABORATORY NONCONFORMITIES

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1 ROOT CAUSE ANALYSIS FOR MEDICAL EQUIPMENT CALIBRATION LABORATORY NONCONFORMITIES M. Abdel Wahed 1, M. Montaser 2, S. A. Sam 1 1 Systems and Bomedcal Engneerng Department, Faculty of Engneerng, Caro Unversty, Gza, Egypt 2 Medcal Equpment Calbraton Lab, Faculty of Engneerng, Caro Unversty, Gza, Egypt. e-mal: manalaw2003@yahoo.com Abstract- Solvng problems effectvely s part of beng an effectve organzaton. Beneath every problem s a cause for that problem. In order to solve a problem one must dentfy the cause of the problem and take steps to elmnate the cause. Root Cause Analyss (RCA) s a method that s used to address a problem or non-conformance, n order to get to the root cause of the problem. One of the man requrements of medcal equpment calbraton laboratory accredtaton process s the laboratory polcy to address the problem of nonconformance of ts actvty. Ths paper presents an establshed and accredted procedure for the control of nonconformng calbraton work and/or results. The procedure s based on the experence of the Medcal Equpment Calbraton Lab (MECL) of the Systems and Bomedcal Engneerng Department (SBME), Caro Unversty. A descrpton of some nonconformty problem cases reports and ther root cause analyss s also provded. Keywords - RCA; Accredtaton; EGAC; MECL. I. INTRODUCTION The Egyptan Accredtaton Councl (EGAC) [1] operates under the terms of the Presdental Decree number 312/1996. EGAC s the sole Egyptan natonal body for the assessment and accredtaton of all conformty assessment bodes undertakng certfcaton, nspecton and testng. EGAC accredtaton s granted to laboratores that have shown that they meet, and contnue to meet, the requrements of ISO/IEC 17025:2005. EGAC requrements for the competence of calbraton and testng laboratores, ISO/IEC 17025, Secton 5.6, contan requrements for measurement traceablty and calbraton. It has been prepared to ensure that laboratores comply wth both the measurement and traceablty requrements of ISO/IEC and the relevant requrements for calbraton and testng equpment not already covered by ISO/IEC that are set out n ISO One of the man requrements by EGAC s that; the laboratory shall have a system that ncludes arrangements to prevent errors that are outsde specfed lmts of permssble error, and to provde for rapd detecton of defcences and mmedate correctve acton as requred by ISO/IEC and 4.9 [1]. To fulfll ths requrement, the Medcal Equpment Calbraton Lab (MECL) of the Systems and Bomedcal Engneerng Department (SBME), Caro Unversty [2], has establshed and mantaned a polcy and procedure mplemented when any aspect of ts calbraton work, or the results of ths work, does not conform to ts own procedures or the agreed requrements of the customer. The polcy and procedures ensure that: a) The responsbltes and authortes for the management of nonconformng work are desgnated and actons (ncludng haltng of work and wthholdng of calbraton reports, as necessary) for authorzng the resumpton of work are defned. b) An evaluaton of the sgnfcance of the nonconformng work s made. c) Correctve actons are taken mmedately, together wth any decson about the acceptablty of the nonconformng work. d) Where necessary, the clent s notfed and work s recalled. To solve a problem, one must frst recognze and understand what s causng the problem. Accordng to Wlson et al. [3], a root cause s the most basc reason for an undesrable condton or problem. If the real cause of the problem s not dentfed, then one s merely addressng the symptoms and the problem wll contnue to exst. For ths reason, dentfyng and elmnatng root causes of problems s of utmost mportance [4]. Root cause analyss (RCA) s an approach for dentfyng the underlyng causes of why an ncdent occurred so that the most effectve solutons can be dentfed and mplemented. Wthn an organzaton, problem solvng, ncdent nvestgaton and root cause analyss are all fundamentally connected by three basc questons: What's the problem? Why dd t happen? And what wll be done to prevent t? Understandng why an event occurred s the key to developng effectve recommendatons. Tools that help groups and ndvduals dentfy potental root causes of problems are known as root cause analyss tools. It s to be mentoned that; the use of RCA n the nvestgaton of clncal errors was mandated n 1997 for hosptals accredted by the US Jont Commsson on Health Care Safety [5]. Ths paper presents an establshed and accredted procedure for the control of nonconformng calbraton work and/or results. The procedure s based on the experence of the Medcal Equpment Calbraton Lab (MECL) of the Systems and Bomedcal Engneerng Department (SBME), Caro Unversty. The paper provdes a descrpton of some nonconformty cases reports n the MECL and ther RCA. II. MATERIALS AND METHODS 2.1 Non Conformty Report: When a problem encountered durng the lab work that does not conform to ts own procedures or a customer feedback complants, any team member can ssue a "Non conformty Report", Fg. 1 shows a blank form of ths report, the followng s the procedure for handlng, controllng and curng ths report: 1. Calbraton Engneers, Qualty Manager and Techncal Manager shall fll n reasons for, and area of nonconformng work n "Non conformty Report Form" and hand t to the Qualty Manager f nonconformty case s encountered durng test or calbraton work.

2 2. The Qualty Manager shall check the occurrence of nonconformty and shall fll Secton 2 n the "Nonconformty Report" that descrbes shown symptoms and suggested reasons. 3. The Qualty manager s responsble for revewng the delvered Nonconformty Report and shall have all the authortes for management of nonconformng work by takng one or more of the followng actons: a) Halt work n area of non conformty: a Meetng Mnutes wll be held as soon as possble to resolve the nonconformty. b) Customer Notfcaton: The Qualty or Techncal Manager shall ssue a "Customer Notfcaton" to notfy the customer about the nature of non-conformty & how the results obtaned and delvered were affected. c) Retestng: the the techncal Manager shall ssue new "Work Order" to repeat the part of, or all test whose results were affected by the non-conformty. d) Document Edtng: the "Qualty Document Issue Procedure" wll be ssued 4. The Qualty Manager shall apply the proper procedures to mplement a Correctve Acton. When a non-conformty report s ssued by any of lab members a commttee ncludng all of (lab drector, Qualty Manager and Techncal manager) s to be held to dscuss the non-conformty and make the root cause analyss for t and decde the correctve acton needed. 2.2 Root Cause Analyss (RCA): Root cause s the fundamental breakdown or falure of a process whch, when resolved, prevents a recurrence of the problem. Root causes are underlyng causes, can be reasonably dentfed and controlled by managers, and for whch effectve recommendatons can be generated [6]. RCA s a systematc approach to get to the true root causes of a process problem. Tools that assst groups and ndvduals n dentfyng the root causes of problems are known as root cause analyss tools [7]. Three root cause analyss tools frequently dentfed n the lterature as vable mechansms for problems solvng and decsons makng these are: 1. Cause-and-effect dagram (CED): CED (also known as fshbone dagram) s a tool for breakng down potental causes nto more detaled categores so they can be organzed and related nto factors that help dentfy the root cause [8]. Usng CED whle branstormng possble causes; helps a group of people to focus on varous possbltes. 2. Interrelatonshp dagram (ID): ID s a tool to quantfy the relatonshps between factors and thereby classfy potental causal ssues or drvers [9]. 3. Current realty tree (CRT): CRT s a tool to fnd logcal nterdependent chans of relatonshps between undesrable effects leadng to the dentfcaton of the core cause [10]. A detaled descrpton, recommendaton, and nstructon for ther constructon and use of those tools are provded n the lterature [11], [12], [13]. The lterature confrmed that these three tools do, n fact, have the capacty to fnd root causes wth varyng degrees of accuracy, effcency, and qualty [14]. III. RESULTS AND DISCUSSION We have appled the MECL procedure for non conformty control on two problems. The two problems were selected to cover one techncal problem, and one manageral problem. The cause-and-effect root cause analyss tool was used by the responsble commttee to analyze the problems. 3.1 Techncal problem: The followng are the data of secton 1 n the non conformty report: NCR ssued by: Techncal manager. Reason for non conformty: Customer complant. Area of non conformty: Calbraton & work nstructons. Descrpton of non conformty: Measurng the temperature nsde the baby ncubator s shfted 1 degree hgher than the nomnal value. The analyss requred for secton 2 n the report s presented n Fg. 2. The evaluaton of non conformty s Retestng. After nvestgatng all causes; the commttee found that the powerng system of the specfed test equpment s the root cause of ths problem. 3.2 Manageral problem: The followng are the data of secton 1 n the non conformty report: NCR ssued by: Qualty manager. Reason for non conformty: Internal Audt. Area of non conformty: QM & Procedures.. Descrpton of non conformty: Empty customer feedback fle. The analyss requred for secton 2 n the report s presented n Fg. 3. The evaluaton of non conformty s Documents Edt. After nvestgatng all causes; the commttee found that ths problem has two root causes. The frst cause s mscommuncaton between team members, and the second cause s the msapplcaton of work nstructons by the project manager. IV. CONCLUSION The MECL fulflled the requrements of EGAC accredtaton process. The MECL manageral procedures nclude: Qualty documents control, Revew of customer requests, tenders and contracts, Customer care, Purchasng servces and supples, Record control, Control of nonconformng calbraton work or results, Correctve/Preventve actons, Team communcaton, Internal audts, and Management revews. The polcy and procedure for non conformty control establshed by the MECL was presented n ths paper. The complexty of calbraton of medcal equpments requres approaches that are more sophstcated. Effectve problem solvng requres the dentfcaton of specfc and reasonable root causes. Two of the MECL non conformty

3 reports were descrbed n ths paper wth ther analyss. Root cause analyss s valuable because t has the potental of developng new ways of thnkng. REFERENCES [1] (Cted on 2/11/2008). [2] M. Abdel Wahed, S. A. Samy, M. Montaser, "Establshng an accredted medcal equpment calbraton laboratory", The 4 th Caro Internatonal Bomedcal Engneerng Conference (CIBEC '08), Caro, Dec [3] Wlson, P. F., Dell, L. D., & Anderson, G. F., "Root cause analyss: A tool for total qualty management", Mlwaukee: ASQC Qualty Press, [4] Dew, J. R., "In search of the root cause", Qualty Progress, 24 (3): , [5] R. A. M. Iedema et al, " Turnng the medcal gaze n upon tself: Root cause analyss and the nvestgaton of clncal error", Socal Scence & Medcne 62, pp , 2006, do: /j.socscmed [6] J. J. Rooney and L. N. V. Heuvel, "Root Cause Analyss For Begnners", Qualty Progress, pp , July [7] A. M. Doggett, "Root Cause Analyss: A Framework for Tool Selecton", Qualty Management Journal, Vol. 12, No. 4, pp , [8] Ishkawa, Gude to qualty control,(2nd rev. ed.). Tokyo: Asan Productvty Organzaton, [9] Mzuno, S. (Ed.), Management for qualty mprovement: The seven new QC tools. Cambrdge: Productvty Press. 1988, (Orgnal work publshed n 1979). [10] Goldratt, E. M., What s ths thng called theory of constrants and how should t be mplemented? New York: North Rver Press, [11] Anderson, B., & Fagerhaug, T. Root cause analyss: Smplfed tools and technques. Mlwaukee: ASQ Qualty Press, [12] Dense Robtalle, Root Cause Analyss: Basc Tools and Technques, Paton Professonal, [13] Paul F. Wlson, Larry D. Dell, Gaylord F. Anderson, Amercan Socety for Qualty, [14] Doggett, A. M. "A statstcal comparson of three root cause analyss tools", Journal of Industral Technology, vol. 20, no. 2, 2004.

4 Non Conformty Report Secton1: NCR NCR No: Date: Issued By: Reason for Non Conformty Customer Complant Internal Audt Day to day operaton External Audt Management Revew Others Specfy: Record No (f exsts): Area of Non-Conformty ISO QM & Procedures Calbraton & Work nstructons Area of Actvty/ reference document Clause No: Descrpton of Non-Conformty... Secton 2: Analyss of Symptoms & Reasons... Evaluaton of Non-Conformty Halt work: Retestng: Customer notfcaton Documents Edt Others Secton 3: Correctve Actons Wth dates Descrpton of Correctve acton. Responsblty: Deadlne: Secton 4: Follow up Is Correctve acton Done? Yes No Date: (If NO) Extended deadlne: Done? Yes No Remarks. Secton 5: NC clearance Non Conformty Closed? Yes No Date: Preventve acton needed? Yes Yes Record No (f exsts): (f Yes) Internal Memo No: (If No) Management Revew: Fg. 1 A blank non conformty report form

5 Fatgue People Test procedure Desgn Applcaton Instructons Incorrect tranng Inadequate tranng Poor tranng Powerng Connecton Wrong person n job Functon Test equpment Calbraton Control Measurng the temperature nsde baby ncubator s shfted 1 degree hgher than the nomnal value Measurng Test Equpment Envronment Fg. 2 Cause-and-Effect Dagram for a Techncal problem People Desgn Instructons Incorrect tranng Inadequate tranng Poor tranng Customer feedback form desgn Mscommuncaton between team members Form ncluded n the system Customer feedback form spare copes Applcaton Customer cooperaton Empty customer feedback fle Materal Envronment Fg. 3 Cause-and-Effect Dagram for a Manageral problem