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I. Contents of quality management system sample ////////////////// laboratory accreditation. 0s each is MOTIVA has introduced a series of information videos on laboratory developed, it is added to the list shon on this page. These videos are in Flash video format . hey are an ecellent start point to learn about accreditation and ho to prepare and implement a laboratory quality system system conformant to I&'I4 15(2$. 0s soon as the ebinars ebinars have provided someone ith the learning in 6est +ractice they need, they may come bac" to this page and donload the documents and forms needed. Sample Documents and Procedures
hese documents are provided free of charge to anyone ho ishes to create a quality manual that conforms to I&'I4 I&'I4 15(2$. hey may also be used for part of the creation of quality manuals required by the other technical competence standards used by Inspection 6odies 7I&'I4 15(2(8, +roduct 4ertification 6odies 7I&'I4 15(-$8, +roficiency esting esting +roviders 7I&'I4 15()38, and 9eference :aterial +roducers 7I&' ;uide 3)8. he manual and its associated procedures are based on the approach identified in MOTIVA s ystem for these types of technical training courses for the creation of a conformant quality system conformity assessment bodies 7406s8. he approach is based on tried and true true strategic planning processes. In essence, the quality policy is epanded into <*ey 9esult 0reas< 0reas< hich are
the obectives at the beginning of each of ten chapters and the remainder of each chapter is dedicated to the processes by hich the laboratory meets the obective of that chapter. =aboratories, Inspection 6odies and other types of 406s may ma"e use of these approaches in their on Q:& by simply simply donloading the documents and implementing them them directly. hese approaches represent best practice in 406 Q:& implementation. hese documents are presented in pdf format for ease of donloading. •
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MOTIVA Sample Quality Qual ity Manual Man ual . his document forms forms the basis of the MOTIVA Quality Manual Template ourse and provides a straighforard approach that meets or eceeds current requirements for quality system components. It includes a co mprehensive quality policy and a sample document structure. structure. >ote that it is not ritten in the the clause structure of any of the technical competence standards. here are other quality manual templates offered on the eb that are structured in that fashion. ethics for MOTIVA Sample ode of !thics . his document details a code of ethics implementation ithin a laboratory that meets or eceeds the impartiality requirements, including conflict of interest and confidentiality requirements of I&'I4 15(2$ and the other technical competence standards. MOTIVA Sample "ocument ontrol and ontrol of #ecords $rocedure . his document details an comprehensive approach for the control of laboratory documents and records. It is based primarily primarily on the control of paper based documents and electronic records. It meets or eceeds the the requirements in I&'I4 15(2$ for these to disciplines disciplines as detailed in clauses ).3 and ).13 as ell as the associated clauses for the other technical competence standards. Its companion Master "ocument %ist Form 7described belo8 is also available in$"F or !&!%. MOTIVA Sample ontinual ont inual Improvement Im provement $rocedure . his document details a comprehensive continual improvement approach for use in 406s that ish to meet or eceed the requirements detailed in the applicable clauses of the technical competence standard that governs their on on operation. his approach allos for the the identification of non!conformances, potential!non conformances, and opportunities for improvement from all of these source clauses and describes a congruent approach to addressing them as prescribed more and more in later revisions of the technical completence standards. It contains all the elements required for a 406 to trac" all non!conformances, potential non! conformances and opportunities for improvment from identification through root cause analysis 7here this is actually required8 to solution and follo up. Included are suggested forms and root cause analysis techniques specifically aimed at supporting 406 operations. &imple yet effective approach that is the basis of the MOTIVA #oot ause ourse and the other continual improvement disciplines. disciplines. :eets or eceeds all the requirements of all technical competence standards, including I&'I4 15(2$ clauses ).%, ).1(, ).11 and ).12. MOTIVA Sample Feed'ac( $rocedure . his document contains a comprehensive approach in acquiring and addressing feedbac", both positive 7compliments8 and negative 7complaints8 in a single procedure that includes sample forms that can be used by lab staff from reception to determination determination of impact on operations. &imple yet effective approach that is the basis of the :'I?0 training in this specific Q:& discipline. :eets all the requirements of I&'I4 15(2$ clauses ).5 an d ).# and the applicable a pplicable clauses in the
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other technical competence standards. 6ased, in part, on I&'+0 I&'+0& & 15((3 !Conformity ! Conformity assessment — Complaints and appeals appea ls — Principles and requirements requirements.. MOTIVA Sample onflict of Interest and onfidendiality )uideline . his document contains a comprehensive committment that has been referenced in the &le 4ode of thics regarding integrity. integrity. his guideline is separate separate from both the Sample Quality Manual and theSample ode of !thics , but is refered to in the &le & ample 4ode of thics hich allos for committment to both the 4ode and these ;uidelines by staff signature. his approach meets all the requirements of I&'I4 15(2$ clauses ).1 and ).2, and the applicable clauses of the other technical competence standards regarding these issues. 6ased, in part, on o n I&'+0& I&'+0& 15((1 ! Conformity assessment — Impartiality — Principles and requirements and I&'+0& I&'+0& 15((2 ! Conformity assessment — Confidentiality — Principles and requirements. requirements. MOTIVA Sample Internal Interna l Audit and Management #evie* #evi e* $rocedure+ his document forms the basis of the MOTIVA MOTIVA Internal Audit ourse and provides a straighforard approach that meets or eceeds the requirements provided in applicable clauses of all the technical competence standards, I&'I4 15(2$. he procedure describes a process based approach for internal auditing au diting and contains reference to the forms need ed for such activity ac tivity.. MOTIVA Sample ,o' , o' -a.ard Assessment $rocedure . his document forms the basis of the :'I?0 :'I?0 @ob AaBard 0ssessment 4ourse and provides a straighforard approach that meets or eceeds current 'A&0 guidelines regarding the need to inform laboratory staff of potential haBards and have them participate in appropriate solutions.
Sample Forms
=aboratories may ma"e use of these forms in their on Q:& by simply donloading them and implementing them directly. directly. hese approaches represent best practice in laboratory Q:& implementation. •
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ontinual Improvement Form+ his form trac"s an identified departure from the quality system 7hether or not it has already occured8 or a potential improvement, from identification through assessment of impact, root cause analysis 7here necessary8, development and implementation of solution, to follo up 7again, here necessary8. his form is used in the MOTIVA Internal Audit ourse . It is also available in Cord Cord format here+ Feed'ac( Form ! his form trac"s both positive and negative feedba c" from any person or organisation ith respect to any aspect of the opera tion of the laboratory. It is also available in Cord Cord format here+ Internal Audit Forms . his set of forms forms allos for a laboratory laboratory to conduct an internal audit conformant to I&'I4 15(2$, clause ).1 ), using a process based approach. hese forms are used in the MOTIVA Internal Audit ourse . It is also available in Cord Cord format here+ Master "ocument %ist . Chile this appraoch to controlling documents has been phased out of the neest versions of standards such as I&'I4 15(2( and 15(-$, it still lives in
15(2$ and it provides a very simple approach to controlling the documents ithin a management system. If e understand that the the entire aim of document control control is to ensure that only the most appropriate version of a document is available to everyone ho may need it, then the :aster Document =ist approach described in ).3.2 of I&'I4 15(2$ is a pretty straightforard ay to do that. >o thin"ing required, ust list list them and trac" trac" them. his form allos a laboratory to list the status and location of all internally!generated documents and all eternally!generated documents, including the the formats of laboratory laboratory forms. It also allos the laboratory quality system personnel to record the authorities for creating and authoriBing documents, trac"ing revie dates, and indicating hen a document needs to be revieed again to determine its continued suitability in the laboratory management system. It is also available in its !/cel format here . //////////////////
III. Quality management tools
1. Check sheet he chec" sheet is a form 7document8 used to collect data in real time at the location here the data is generated. he data it captures can be b e quantitative or qualitative. Chen the information is quantitative, the chec" sheet is sometimes called a tally sheet. he defining characteristic of a chec" sheet is that data are recorded by b y ma"ing mar"s 7<chec"s<8 on it. 0 typical chec" sheet is divided into regions, and mar"s made in different regions have different significance. Data a re read by observing the location and number of mar"s on the sheet. 4hec" sheets typically employ a heading that ansers the Eive CsF
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Cho filled out the chec" sheet Chat as collected 7hat each chec" represents,
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an identifying batch or lot number8 Chere the collection too" place 7facility, room,
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apparatus8 Chen the collection too" place 7hour, shift, day of
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the ee"8
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Chy the data ere collected
2. Control chart
4ontrol charts, also "non as &hehart charts 7after Calter Calter 0. &hehart8 or process!behavior charts, in statistical process control are tools used to determine if a manufacturing or business process is in a state of statistical statistical control. If analysis of the control chart indicates that the process is currently under control 7i.e., is stable, stable, ith variation only coming from sources common to the process8, then no corrections or changes ch anges to process control parameters are needed or desired. In addition, data from the process can be used to predict the future performance of the process. If the chart indicates that the monitored process is not in control, analysis of the chart can help determine the sources of variation, as this ill result in degraded process p rocess performance.G1H 0 process that is stable but operating outside of desired 7specification8 limits 7e.g., scrap rates may be in statistical control but above desired limits8 needs to be improved through a deliberate effort to understand the causes of current performance and fundamentally improve the process. he control chart is one of the seven basic tools of quality control.G3H ypically control charts are used for time!series data, though they can be b e used for data that have logical comparability 7i.e. you ant to compare samples that ere ta"en all at the same time, or the performance of different individuals8, hoever the type of chart used to do this requires consideration.
0+ $areto chart
0 +areto chart, named after ?ilfredo +areto, is a type of chart that contains both bars and a line graph, here individual values are represented in descending order by bars, and the cumulative total is represented by the line. he left vertical ais is the frequency of occurrence, but it can alternatively represent cost or another important unit of measure. he right vertical ais is the cumulative percentage of the total number of occurrences, total cost, or total of the particular unit of measure. 6ecause the reasons are in decreasing order, the cumulative function is a concave function. o ta"e the eample above, in order to loer the amount of late arrivals by 5#, it is sufficient to solve the first three issues. he purpose of the +areto chart is to highlight the most important among a 7typically large8 set of factors. In quality control, it often represents the most common sources of defects, the highest occurring t ype of defect, or the most frequent reasons for customer complaints, and so on. Cil"inson 72((-8 devised an algorithm for producing statistically based acceptance limits 7similar to confidence intervals8 for each bar in the +areto chart.
). Scatter plot Method
0 scatter plot, scatterplot, or scattergraph is a type of mathematical diagram using 4artesian coordinates to display values for to variables for a set of da ta. he data is displayed as a collection of points, each having the value of one variable determining the position on the horiBontal ais and the value of the other variable determining the position on the vertical ais.G2H his "ind of plot is also called a scatter chart, scattergram, scatter diagram,G3H or scatter graph. 0 scatter plot is used hen a variable eists that is under the control of the eperimenter. If a parameter eists that is systematically incremented andor decremented by the other, it is called the control parameter or independent variable and is customarily plotted along the ho riBontal ais. he measured or dependent variable is customarily plotted along the vertical ais. If no dependent variable eists, either type of variable can be plotted on either ais and a scatter plot ill illustrate only the degree of correlation 7not causation8 beteen to variables. 0 scatter plot can suggest various "inds of correlations beteen variables ith a certain confidence interval. Eor eample, eight and height, eight ould be on ais and height ould be on the y ais. 4orrelations may be positive 7rising8, negative 7falling8, 7falling8, or null 7uncorrelated8. If the pattern of dots slopes from loer left to upper right, it suggests a positive correlation beteen the variables being studied. If the pattern of dots slopes from upper left to loer right, it suggests a negative co rrelation. 0 line of best fit 7alternatively called JtrendlineJ8 can be dran in order to study the correlation beteen the variables. 0n equation for the correlation beteen the variables can be determined by established best!fit procedures. Eor a linear correlation, the best!fit procedure is "non as linear regression and is guaranteed to generate a correct solution in a finite time. >o universal best!fit procedure is guaranteed to generate a correct solution for arbitrary relationships. 0 scatter plot is also ver y useful hen e ish to see ho to comparable data d ata sets agree ith each
other. In this case, an identity line, i.e., a y/ line, or an 1F1 line, is often dran as a reference. he more the to data sets agree, the more the scatters tend to concentrate in the vicinity of the identity lineK if the to da ta sets are numerically identical, the scatters fall on the identity line eactly.
1+Ishi(a*a diagram
Ishi"aa diagrams 7also called fishbone diagrams, herringbone diagrams, cause!and!effect diagrams, or Eishi"aa8 are causal diagrams created by *aoru Ishi"aa 71%-#8 that sho the causes of a specific event. G1HG2H 4ommon uses of the Ishi"aa diagram are product design and quality defect prevention, to identify potential factors causing an overall effect. ach cause or reason for imperfection is a source of variation. 4auses are usually grouped into maor categories to identify these sources of variation. he categories typically include • •
+eopleF 0nyone involved ith the process :ethodsF Ao the process is performed and the specific requirements for doing it, such as policies, procedures, rules, regulations and las
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:achinesF 0ny equipment, computers, tools, etc. required to accomplish the ob
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:aterialsF 9a materials, parts, pens, paper, etc. used to produce the final product
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:easurementsF Data generated from the process that are used to evaluate its quality
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nvironmentF he conditions, such as location, time, temperature, and culture in hich the process operates
-. Aistogram method
0 histogram is a graphical representation of the distribution of data. It is an estimate of the probability distribution of a continuous variable 7quantitative variable8 and as first introduced by *arl +earson.G1H +ea rson.G1H o construct a histogram, the first step is to <bin< the range of values !! that is, divide the entire range of values into a series of small intervals !! and then count ho man y values fall into each interval. 0 rectangle is dran ith height proportional to the count and idth equal to the bin siBe, so that rectangles abut each other. 0 histogram histogram may also be normaliBed displaying relative frequencies. It then shos the proportion of cases that fall into each of several categories, ith the sum of the heights equa ling 1. he bins are usually specified as consecutive, non!overlapping intervals of a variable. he bins 7intervals8 must be adacent, and usually equal siBe.G2H he rectangles of a histogram are dran so that they touch each other to indicate that the original variable is continuous.G3H
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