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Computer Delivered – The CQIA examination is a one-part, 110-question, three-and-a-half-hour test
and is offered in English only. Of these questions, 100 are scored and 10 are unscored.Paper and Pencil – The CQIA examination is a one-part, 100-question, three-hour test
and is offered in English only.
Certification from ASQ is considered a mark of quality excellence in many industries. It helps you advance your career, and boosts your organizations bottom line through your mastery of quality skills. Becoming certified as a Quality Improvement Associate confirms your commitment to quality and the positive impact it will have on your organization.
Each certification candidate is required to pass an examination that consists of multiple-choice questions that measure comprehension of the body of knowledge.
A. Terms, Concepts, and Principles 1. Quality definitions Describe and distinguish between the common definitions of quality. (Apply)2. Quality planDefine a quality plan, describe its purpose and objectives to achieve the quality mission or policy. Identify the various functional areas and people having responsibility for contributing to its development. (Understand)3. Quality systemsUnderstand the difference and relationship between quality assurance, quality control, and continuous quality improvement. (Understand)4. Organizational cultureUnderstand how culture influences the success of process improvement efforts such as lean, Six Sigma, ISO 9001, Baldrige, and change management. (Understand)5. Employee involvement and empowermentDefine and distinguish between employee involvement and employee empowerment. Describe the benefits of both concepts. (Understand) 6. Systems and processesDefine and distinguish between a system and a process and describe the interrelationships between them. Describe the components of a system – supplier, input, process, output, customer (SIPOC) – and how these components impact the system as a whole. (Analyze)7. VariationDefine and distinguish between common and special cause variation in relation to quality measures. (Understand)8. StandardizationDescribe how quality systems provide consistency and standardization (e.g. ISO 9001). (Remember)Topics in this body of knowledge (BoK) include subtext explana-tions and the cognitive level at which the questions will be written. This information will provide useful guidance for both the test Development Committee and the candidate preparing to take the exam. The subtext is not intended to limit the subject matter or be all-inclusive of material that will be covered in the exam. It is meant to clarify the type of content that will be included on the exam. The descriptor in parentheses at the end of each entry refers to the maximum cognitive level at which the syllabu will be tested. A complete description of cognitive levels is provided at the end of this document. BODY OF KNOWLEDGECertified Quality Improvement Associate (CQIA)
B. Benefits of Quality Describe how using quality tools, techniques, and concepts can Strengthen processes and deliverables (including products and services), and how each benefit all parts of an organization. Describe what quality means to various stakeholders (e.g., employees, organizations, customers, suppliers, community, and interested parties) and how each can benefit from quality. (Understand)C. Foundations of QualityUnderstand the key concepts and teachings of the foundational quality thought leaders including 1) Walter Shewhart, 2) W. Edwards Deming, 3) Joseph Juran, 4) Kaoru Ishikawa, 5) Philip Crosby, and 6) Armand Feigenbaum. (Understand)II. Team Basics (16 Questions)A. Team Organization 1. Team purpose Describe why teams are an effective way to identify and solve problems, and describe when, where, why, and how teams can be used effectively. (Apply)2. Types of teamsDefine and distinguish between various types of teams: process teams, continuous improvement teams, workgroups, self-managed teams, ad hoc project teams, cross-functional teams, and virtual teams. (Apply)3. Value of teamsExplain how a teams efforts can support an organizations key strategies and effect positive change throughout the organization. (Understand)
B. Roles and Responsibilities Describe the roles and responsibilities of various team stakeholders: (Understand) 1. Sponsor 2. Champion3. Facilitator4. Leader5. Member6. Scribe7. TimekeeperC. Team Formation and Group Dynamics 1. Initiating teams Apply the elements of launching and sustaining a successful team, including establishing a clear purpose and goals, developing ground rules and schedules, gaining support from management, and obtaining commitment from team members. (Apply)2. Selecting team members Describe how to select team members based on knowledge, skill sets, and team logistics, such as an adequate number of members in relation to the size or scope of the project, appropriate representation from affected departments or areas, and diversity. (Apply)3. Team stages Describe the classic stages of team development: forming, storming, norming, performing, and adjourning. (Understand)4. Team conflict Identify the value of team conflict and recognize how to resolve it. Define and describe groupthink and how to overcome it. Determine how good logistics, an agenda, and effective training facilitate team success. (Analyze)
5. Team decision-making Describe and use different decision-making models, such as voting (majority rule, multi-voting) and consensus. Use follow-up techniques to clarify the issue to be decided, to confirm agreement on the decision, and to achieve closure. (Apply)III. Continuous Improvement Techniques (40 Questions)A. Process Improvement 1. Six Sigma concepts and toolsCompare Six Sigma concepts, tools, and techniques. Understand the DMAIC phases: define, measure, analyze, improve, and control. (Understand)2. Lean concepts and toolsCompare lean concepts, tools, and techniques. Understand lean tools used to reduce waste, including set-up and cycle-time reduction, pull systems (kanban), continuous improvement (kaizen), just-in-time (JIT), 5S, value stream mapping, and error-proofing (poka-yoke). (Understand) 3. BenchmarkingDefine benchmarking and describe how it can be used to develop and support best practices. (Understand)4. Incremental and breakthrough improvement Describe and distinguish between these two types of improvements, the steps required for each, and the type of situation in which either type would be expected. (Understand)
B. Improvement Techniques Select and utilize improvement opportunity techniques and/or methodologies: (Apply) 1. Brainstorming2. Plan-do-check-act (PDCA) cycle3. Affinity diagrams4. Cost of poor quality (COPQ)5. Internal audits C. Improvement Tools Select, interpret, and apply the basic improvement tools: (Apply) 1. Flowcharts 2. Histograms 3. Pareto charts4. Scatter diagrams5. Check sheets6. Control charts7. Decision trees D. Root Cause AnalysisUtilize root cause tools such as the 5 Whys and fishbone diagram to implement correction and corrective action. (Apply)E. Risk Management Understand the tools and techniques used to identify and communicate risks, including failure modes and effects analysis (FMEA) and Strengths, weaknesses, opportunities, threats (SWOT). Understand prioritization of activities and projects based on risk. (Understand)IV. provider Relationship (7 Questions)A. provider selectionIdentify the provider selection criteria and approval process. (Remember)B. provider relationshipUnderstand provider relationships, associated challenges, and effects of a diverse supply base. (Understand)C. provider PerformanceIdentify provider performance measures, including quality performance, on-time delivery, and level of service. (Apply)V. Customer Relationship(7 Questions)A. Customer IdentificationDistinguish between internal and external customers. Describe their influence on products, services, and processes. (Understand)B. Voice of the Customer (VOC)1. Data gathering and useDescribe various methods for collecting customer satisfaction feedback, including formal surveys, informal feedback, warranty claims, and focus groups. Understand the importance of using customer satisfaction feedback to drive continuous improvement. (Understand)2. Complaint processDefine and identify a customer complaint. Understand and apply the complaint handling process including documentation, action taken, and providing resolve to the customer. (Apply) 3. Customer needsUnderstand the key elements of quality function deployment (QFD) and how it identifies and prioritizes customer expectations and needs. (Understand)
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clinical equipment & Diagnostic industry MagazineMDDI Article Index
An MD&DI September 1999 Columnsubstances dealing with
John E. Lincoln
The technology, manage, transportation, and disposition of hazardous biocontaminated cloth is a becoming environmental concern. a great deal of attention has been concentrated on how hospitals get rid of physique fluids, the decontamination or disinfection of reusable medical contraptions,1â€“three the disposal of packaging and spent devices in-apartment or via commercial capabilities, and the effect on the environment. however, one enviornment that has obtained noticeably little consideration is the control of product this is suspected or popular to be biologically contaminated, essentially with blood or body fluids, and is lower back to a company for failure investigation. tactics should still be established at both ends of the provide chain for the transport, handling, processing, and disposition of such product.
constructing a company coverage
constructing guidelines and methods to correctly tackle the handle of doubtless contaminated returned product should still be completed to reduce liability and enhance public, environmental, and worker security. equipment manufacturers may superior be served by means of organising a coverage that daunts the informal return of any potentially contaminated product.
now and again the problem is getting the product returned at all. This circumstance puts the brand at a disadvantage as a result of there are times when the reason for the failure cannot be discovered by using any skill apart from product evaluationâ€”product historical past evaluation, work order documentation evaluation, simulation, and many others.â€”necessitating the return of the contaminated equipment for investigation. alas, many end-user facilities, essentially hospitals, have internal necessities or protocols for the destruction of used single-use medical contraptions, making it difficult, if no longer inconceivable, to gain such product for an investigation.
When a brand or distributor decides to increase a coverage regarding the coping with of returned contaminated product, an contrast need to be performed on its affect on a number of departments and functions in the company. circulation charts displaying each the ancient and new process cycles can support people bear in mind the alterations.
The newly proposed technique may still be evaluated towards the excellent system laws.4,5 At a minimum, the brand new techniques should observe to quality assuranceâ€”especially complaint managingâ€”in addition to receiving, advertising and marketing, income, R&D, and engineering. other company personnel or departments coming involved with specific or suspected contaminated product also need to be aware about and comply with such techniques.
All returns from the container, primarily from hospitals and clinics, should still be dealt with as doubtlessly contaminated product except conclusive proof exists to the opposite. Such fabric should be treated below a regular precautions protocol, which can be developed the usage of this text as a suggestion.6
Ideally, devices lower back to an organization may still have been decontaminated or sterilized with the aid of the consumer before cargo and certified or labeled as such. every so often it isn't feasible or captivating to decontaminate or sterilize the product when doing so might masks the cause for the product's rejection. In any experience, a company may still never assume that a product has been decontaminated or sterilized before it turned into again.
personnel may still take delivery of access to and working towards in these methods. If no strategies are already in area, applicable written guidelines reminiscent of a copy of a typical working manner (SOP) can be supplied as quintessential to the consumers or end-clients for the coping with, decontamination, and shipment of contraptions that require servicing or that need to undergo a failure investigation.
The written directions for safe handling and return should still consist of counsel related to whom to contact on the company for advice, the method of decontamination to be used and any limitations associated with it, precautions that should be taken to prevent the inadvertent destruction of proof relating the product's failure or malfunction, directions for the documentation that may still accompany the machine, and instructions for packaging, labeling, and transport.
The company may additionally choose to provide return kits, on request, that comprise written guidelines, statistics varieties, shipping containers, and brand-handle and biohazard-image labels. supplying these substances isn't simplest effortless for the customer but helps to deliver consistent conformance to regulatory requirements and validation of the coverage offered via the packing and labeling that is equipped.
regularly occurring precautions demand that patient care items are assumed to be contaminated. When it is integral to have a contaminated machine lower back to a company or distributor, the equipment may still be placed in a securely sealed and leak-resistant simple container, and certainly recognized as contaminated material. The kit should still be labeled and shipped based on company guidelines and people of whichever predominant provider will be used (See desk I).U.S. Postal provider (USPS) U.S. department ofTransportation (DOT) Occupational protection and HealthAdministration (OSHA) medical instruments need to be sent by way of first classification in special packaging that has been classification-proven and authorized through an independent organization. DOT outlines cargo with the aid of surface (motorway), vessel, rail, or air and references international requirements. All employees who might are available contact with a contaminated equipment have to wear shielding attire. The outer equipment ought to have a USPS authorization number on a nonreturnable label that comprises a 24-hour cell number to be used in the experience of hurt or leakage (part 124.35, home mail handling). Infectious resources have their own classification (Division 6.2). All receiving, unpacking, and lab personnel must receive the necessary training per OSHA, and the practicing must be documented. Sharps require a puncture-resistant simple container placed internal a watertight secondary containment system, which can also include a couple of component. Any plastic baggage should be at least 3Â mil thick, strengthened with a fiberboard sleeve. special inner containers, their types and minimum thicknesses, and shielding intermediate and outer packaging assembly U.N. standards, together with withstanding a mentioned drop test, are required. The class of container used is stylish on the extent of the contents (49Â CFRÂ 173). certain policies and techniques to be dependent include the following: receipt of product, disposition after receipt, examination of accompanying forms, shielding apparel, disposal of all contaminated materials, environmental controlsâ€”barrier walls, room with poor airflow, environmental chamber or hoodâ€”and hand-wash facilities, machine containment as soon as un-packaged, method of transport in the course of the procedure, and checklist maintaining. The outer delivery container should be designed to prevent breakage all the way through typical processing and encompass at the least 200-lb grade corrugate or its equal. Formal, documented training of all personnel concerned in shipping is required, and the shipper is chargeable for proper packaging and labeling. Â Fluids require that the internet contents in every simple container should no longer exceed 50Â ml. There should still be ample absorbent fabric to soak up thrice the total extent of liquid in the secondary containers. For greater tips, see hazardous materials rules HM 126 and 181, Title forty nine CFR parts a hundred and seventy-one hundred eighty. Â Coolant cloth, if used, should be packaged in order that the liquid will now not escape from the outer transport container if it melts or condenses. The inner container should be immobilized so it does not shift as the coolant melts, and dry ice should be vented, its container labeled, and its weight indicated. Â Â
table I. Key transport and dealing with requirements for biologically contaminated product.
OSHA has its personal set of necessities and requirements for worker conversation, awareness, practising, and documentation concerning place of work dangers and their mitigation, which might be required via legislations to be applied and mentioned. For extra assistance, evaluate 29Â CFRÂ 1910.1030, "Bloodborne Pathogens," and 29Â CFRÂ 1910.132, "own protecting machine regular," and include pertinent elements in the business SOPs for the managing of contaminated material.
Any transport by means of air of hazardous or contaminated product is field to the unhealthy goods regulations9 (replacing the historic restrained article laws) of the foreign Air Transport affiliation (IATA). IATA coordinates its work with the international Civil Aviation company and its technical guidance, and the U.N. Committee of consultants on the Transportation of unhealthy items.
determine 1. A trial method to developing and imposing the control method for a returned goods authorization device.
The IATA unhealthy goods (DG) regulations require review of each and every DG article or substance and its acceptability for air transport. Some articles or materials could be forbidden, or forbidden except granted specific approvals from the states concerned. If the products are allowed to ship, aspects that need to be taken into consideration encompass considerations of cargo versus passenger transport, packaging (with volume concerns), training, suitable announcement of bad goods by using the shipper, and correct reporting of incidents. The air provider should be contacted for extra selected advice.
A pattern method
The necessities enable for a number of diverse procedures, and they each can be right so long as the regulatory necessities are met. it is essential to accept as true with each factor of those requirements, evaluate latest enterprise practices, and strengthen a gadget that optimal blends both. The discussion that follows comprises just one feasible approach (determine 1).
birth with some class of formal lower back-items authorization (RGA) gadget. At a minimal, the RGA system should still require that any end-person, expecting a product return, have to achieve acclaim for the return from the brand or distributor earlier than shipment, and that an RGA quantity be assigned. The RGA number should still be prominently displayed on the outer container of the cargo. The company's or distributor's SOP should still include a sequential numbering device and a log or varieties to doc the client contact, product description, lot quantity (if accessible), amount, explanation for return, and so forth. The RGA should have a provision for review and inclusion within the company's complaint equipment. This RGA device would then serve three key functions. it would:
On receipt at the device brand's web page, the equipment containing the probably contaminated gadget should be instantly routed, unopened, to a defined protecting enviornment, might be beneath plant first-rate assurance manage. All suspect product should still be viewed the equalâ€”as if it be contaminatedâ€”and handled with established precautions. consequently, all receiving and again-product coping with personnel ought to be knowledgeable in company tactics involving the disposition of suspect productâ€”always all opened product bought back from a customer, except certain advice to the contrary is commonplace.
The dependable receiving department will make certain that the machine is correctly and certainly identified and that it is handled and kept segregated from acceptable or different quarantined product. The branch will then be sure that the machine is decontaminated based on written technique (each time viable), in advance of examination or contrast. This step may also be delayed if decontamination or sterilization would bog down the investigation; it may possibly even be eradicated if it can be tested that the sender followed centered protocol in having already accomplished the process.
exceptional assurance routes the productâ€”either in the container it was mailed in or in a extra suitable box, labeling it as "engineering test sample," "contaminated," or "biohazard"â€”and routes or hand carries it to fabric handling. There, the product should still undergo a predefined sterilization system validated to worst-case circumstances. independent test labs have protocols using lab soils that might form the groundwork of a contaminated-product disinfection, decontamination, or sterilization protocol.10â€“12
If the product is included in an organization's sterile load, an analysis or validation of the product's impact on the burden's configuration and bioburden should still be brought to the acceptable documentationâ€”surely, the sterilization validation equipment. The formula or methods chosen for decontamination, disinfection, or sterilization should permit the equipment to be safe for contact despite which category or types of pathogens may have contaminated it.
The components of decontamination may still be documented, as smartly as the concerned brokers or personnel and the date and time. If sterilized, the merchandise may still be logged in the sterilization batch list, together with the tips mentioned above. When the product is back, it's routed by way of the fabric dealing with branch lower back to excellent assurance, the place it's both scrapped, placed in a new container, or labeled. The container or label should still point out that decontamination has been performed. youngsters, personnel handling or testing the sterilized product should still, to the diploma viable, treat it as suspect. first-class assurance personnel may still route the decontaminated product to the correct department for evaluation.
If the decontamination procedure or chemical substances might have an effect on the investigation effects, the product could have to be evaluated just before decontamination. In such circumstances, evaluating personnel ought to put on appropriate defensive attire and observe procedural and engineering controls, validated and described by SOPs, earlier than handling any contaminated product. After the evaluation is achieved and previous to disposal, the product ought to be decontaminated or treated as hazardous, crimson-bag waste.
employee safety MEASURES
Personnel must be trained in all defense measures. protecting attire, in line with the diploma of possibility, may still be worn by anyone thinking in coping with or investigating the product, including housekeeping and waste-disposal personnel. Such apparel includes gloves, gowns, lab coats, head and foot coverings, face shields or masks, and eye and respiratory protection. Reusable gadgets require a validated cleansing system after each use. Such apparel should still periodically be checked, repaired, or reconditioned as vital, or retired from use. facts of protective-apparel safety exams and their effects should be maintained. If items should be customized-geared up, equivalent to a sealed face masks or respirator, a documented, periodic fit check, along with training, may still be carried out with the particular individual who uses the machine.
a corporation may still Strengthen a application that makes it possible for personnel who risk coming in contact with suspect or contaminated product to receive a hepatitis vaccine. these employees who want to decline should still do so in writing so that their instructions can be filed of their personnel records.
Hand-washing amenities or antiseptic towels should be provided within the enviornment or areas where contaminated-product managing happens. ingesting, drinking, the use of cosmetics or lip balm, and the dealing with of contact lenses are all prohibited in these detailed areas. Wipe-down strategies are also required.
Product in a position to generating potentially infectious aerosols ought to be transported in leakproof, sealed containers and evaluated in biological safeguard cabinets or actual-containment contraptions. Such critiques may still simplest be carried out in closed-door work areas with restricted entry, frequently a biological lab or R&D enviornment. Such enviornment doors are marked with a familiar biohazard image.
events investigations should be performed within the confined-entry enviornment, with an additional enviornment, about three ft in radius from the work surface or sink, delineated by means of cones or roped off when in use and prior to decontamination. After the investigation is accomplished, the sink and surrounding work surfaces have to be washed with an authorised disinfectant. Any surfaces uncovered to the contaminated product have to even be handled as if they have been contaminated except they are decontaminated or disinfected. The cleansing processes should still be validated and periodically reviewed, reverified, revalidated, and documented. suitable disposal of disinfecting options may still also be practiced. This may contain overview by using the cognizant native water/sewer district, which should even be documented.
Precautions may still be taken against spills or other accidents. When an accident does turn up, the probably infectious materials ought to immediately be cleaned up. There are industrial kits that help increase the protected handling of such spills and aid in the assortment and disposal of the material.
RECORDING INVESTIGATIVE information
Investigators engaged on contaminated product should still listing their observations and findings into nonhandheld recorders or dictate to a 2nd grownup, as a way to steer clear of the illness from being circulated to other departments.
just before disposal, all contaminated product may still be decontaminated or sterilized. gadgets coming involved with such contaminated product, comparable to sponges, utensils, and cloths, should even be decontaminated or sterilized just before disposal (or reuse) except a provision exists or is implemented for business pink bag waste dealing with. businesses should still confer with state-selected groups for disposal guidelines and document the findings.
Any contaminated, biohazardous spills should be treated as a hazardous fabric incident, to be dealt with per an applicable SOP. Such procedures encompass cleanup using absorbent or adsorbent fabric designed to soak up, bind, gel, or solidify the liquid, followed by disinfection using a bactericidal, viricidal, and fungicidal disinfectant confirmed useful against HIV, hepatitis B, and herpes I and II.
Hazardous cloth spills should still be pronounced to the plant protection officer, senior quality equipment or regulatory affairs supervisor, or different designated senior management grownup. tips on the containment and corrective action taken should be totally documented. Disposal of such spills and associated medical gadgets should all the time be in keeping with state-particular guidelines as to accepted remedy technologies.
helpful decontamination and sterilization requirements should still be considered all over product design or redesign. Such issues, as a part of design input, may still encompass configuration, materials, clear surfaces, biocompatibility of the disinfectant or sterilant, and the ideas of chance analysis and FMEA.
mandatory practising in approaches to make use of for contaminated product need to be blanketed in the business's periodic practising courses, with the agenda and attendance documented. A multitiered equipment may well be used during which personnel are counseled that the business may, at any time, acquire contaminated product from the field, even if it's naturally recognized or not. people that would logically receive or transport such product, even if real or suspect, should get hold of extra intensive practicing. the most thorough working towards should still be supplied to these concerned in the investigation, testing, cleansing, decontamination, sterilization, and last disposition of the product.
Written strategies should not eliminate the deserve to follow tactics dictated with the aid of typical sense and caution or exchange those suggestions mandated by using other organizations when particular biohazards are worried.
The practising and equipping of personnel, as smartly as the authorization for cargo, receipt, dealing with, storage, decontamination or sterilization, investigation, disposal, and documentation of suspect or real contaminated product, is a major business accountability. This responsibility is heightened as more clinical devices reach a worldwide market and new and more resistant sorts of pathogens seem. groups ought to implement or refine their latest methods. To lengthen simplest places their employees and the atmosphere at pointless possibility. In situations in which programs are not at present in location, personnel can take it upon themselves to follow regularly occurring precautions and Strengthen their personal techniques for managing contaminated product.
1. Designing, trying out, and Labeling Reusable clinical gadgets for Reprocessing in health Care facilities: A e book for gadget manufacturers, AAMI TIR 122 (Arlington, VA: affiliation for the development of clinical Instrumentation, 1994).
2. AF sales space, "The manufacturer's role in safe Reuse," medical equipment & Diagnostic business 19, no. 5 (1997): 127â€“134.
3. E Arscott, et al., "Validating Reusable clinical contraptions: a top level view," scientific device & Diagnostic trade 18, no. 1 (1996): 210.
4. Code of Federal regulations, 21 CFR 820.60, 820.75, 820.80, 820.90, 820.one hundred, 820.140, 820.one hundred fifty, and 820.198.
5. quality programs - model for high-quality assurance in design , ANSI/ISO/ASQ[C] QS9001 (manhattan metropolis: American national requirements Institute, 1994).
6. Code of Federal laws, 29 CFR 1910.132, 1910.1030, and booklet 3127, "Occupational exposure to Bloodborne Pathogens."
7. domestic Mail handling, USPS section 124.35 (Washington, DC: u.s. Postal provider).
8. Code of Federal regulations, 49 CFR one hundred seventy-178, HM 126, and HM 181.
9. dangerous goods rules (Geneva: international Air Transport association, 1999).
10. protected handling of Biologically Contaminated medical instruments in Non clinical and medical Settings, AAMI TIR 10 (Arlington, VA: affiliation for the advancement of scientific Instrumentation, 1993).
eleven. RR Reich, "How Design Controls have an effect on Sterilization procedure building and Validation," medical device & Diagnostic industry 19, no. 10 (1997): 107-111.
12. SL Barbee, et al. "Susceptibility of Crytospuridium paruum in Disinfection and Sterilization Processors" (paper offered at the Eighth Annual assembly of the Society for Healthcare Epidemiology of the us, Orlando, Florida, April 5-7, 1998).
John E. Lincoln is essential of J.E. Lincoln and associates (Tooele, UT).
Illustration via James Schlesinger
back to the MD&DI leading web page
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