The Role of the Laboratory Quality Assurance Officer Kenneth Osborn, Aun Rosecrance, Hil Niven The role of the enviontnental labor tory is 0 produce mea’ 1 based information for its clients, the value of is direetly related to its teliability. snce( QA) program. which optimizes the reliability of the measure through quality control practices. is ministered hy laboratory QA increasing demands on environ: laboratories to produce scientifi cally valid and legally defensible data necessitates having «laboratory QA off cer more than ever before, In fact, many QA project plans sand govertunent con tracts require a QA officer position in Iaboratory organization, Even wit absence of project or repulatory require: ments for aQa olficer. it ts goed labo tory practice to includeoncon the labora tory staff Butbeforediscussing the QA offi sole,one must under: quality assurance. What is Quality Assurance? Qh isa set of syster essary t0 provide adequate confidence that a product or service will saisty a given requirement for quality. Some- times QA is classified as, activity used to generate quality data. ‘According o Standard Methods “quality assurance is a vet of operating principles that, if suictly followed during sample collection and analysis, will produce data of known and defensible quality.” In- ‘cluded in QA is quality control and qual- ity asvensment QC consists of operational or func- ‘ional techniques that are used wo provide 44 quality product. Standard Methods identifies seven elements in an effective OC program, They include certification of operator competence, recovery of known additions, analysis of extemally plied standards, analysis of | wl of duplicates, and the ue of control cha Quality aoressincnt 1s the measure ment of laboratory perforinauce and data quality. The mezrsures typically include perforinance evaluation ssinple labora tory inter-comnparivan scunph forinanne ail, and pr OA Officer Responsibilities The demands and complexiti Odand QC program that i latory requirements snd market place ex pectations require an individual wbo hi ‘overall responsibility for laboratory QA and QC functions. The QA officer (or er) plays the major role in the ‘of the QA and QC functions in ve, partici uvdatory ony, haratory operation, how pation by the entine staff is, ng on the size of the the QA officer may be involved seas, Developinent, 0 ordination of the QA many QC pr of duty of the QA offi- cer, Ifa standard documented QA anid QC programm does not exist, the frst goal of a QA officer is to develop one, This would include writing a laboratory QA. manual and documenting cach labora tory activity in standard operating proce dures, The QA manual serves as the n chester fon the Yabora: on paniT ae quality prog tony defining, its ponpanes. its tion. and itsoperating principles. Sidocu- ments the policies, objectives, and procedures that describe herw the labora ory will produce data of known apd cepted quality Standard operating procedures ate those step-by-step instructions tha allow experienced » obtain ace le results with a new oF unfamiliar procedure, Laboratory activities requir: ing written standard operating procedures ¥y include sample receigA. cample log. ody. rainple preparation reduction. data vali- dation. repon preparation. document con: trol, preventive maintenance, and corres ral tive action ‘AQA progran is never completed--it tantly evolves. The QA manual pro- vides the guidelines used in this evolu- tion, The QA officer should review the OA manual regularly and revise it as nocded to ensure that it conforins with changes in regulations and changes in client needs, The QA officer should audit the laboratory's performance. The audit should involve the evaluation of indi- vidual laboratory analysts. laboratory sections, or laboratory systems (such as sample custody). The QA officer (or assistants of the QA officer) may be in- volvedin validating data. Data validators determine whether the laboratory data meet each client's data quality objec- tives. Additionally. the QA officer should prepare regular reports to management ‘on the status of the QA and QC program. Today, laboratory accreditation and analystcenification are prominentissues. ‘These programs may be administered by aclient or a government agency. Many states have their own accreditation pro- ‘grams, which may include acombination ‘of performance evaluation sample analy- sis, on-site audits, and QA system ac- ‘creditation. In some cases, the laboratory may be involved in a multitude of ac~i @ isin cases, he OA ote isn toring Systems Laboratory. The pro | fram. called the Discharge Monitoring Report--Quality Assurance program, Quires the periodic analysis of perio mance evaluation samples, Ensuring that the laboratory accredi- | tation is maintained. that performance evaluation samples are analyzed and Ported on time, that audits are scheduled and carried out professionally, and th outside reports identifying problems are | addressed without delay areresponsibili- ties of the QA officer. As a liaison to outside auditing agencies (such as state, federal, and industrial auditing groups) the QA officer is highly visible and es. sential. One of the difficult roles the QA offi- Cer must undertake is idemifying deti- Ciencies and implementing comectiveac tion. The QA officer's interpersonal skills will be tested when communicating these deficiencies and when instituting correc: tive action. It is necessary, however, for the QA officer to work closely with th individuals situated in the problem iv and a a team. find the best solution, Sometimes the QA officer isinvolved instaff waining. Thismay beascomplex asrunninga lab-wide training program or as simple as providing training sessions ‘on QC sample analysis or QC chart con- struction, information source. Analysts and super- visors should use the Qa officer'sexper- {ise in resolving difficult obstacles that ‘might affect data quality or data integrity ‘and in providing guidance ostaffon how to incorporate quality standards into all aspects of their work Organizational Structure The QA officer may or may not be involved in the daily or routine QC ac- ions. The size and organization of the laboratory will determine if the QA offi- Cet prepares control charts. produces QC samples, resolves data outliers, or inves- tigates analytical problems. Forexample. inalarge laboratory the combined effors of the analyst, work supervisor. and QA THE BENCH SHEET olficer may he required to track and re solve an instrument or analytical prob Jem. Inasmall laboratory. the QA officer may be an added responsibility ta su Pervisor or an analyst For small laboratories that are part of larger organization, the QA officer po sition might be shared by several facil fies. A small innovative organization may allow the QA officer roll to be pe formed by a part-time contractor that is anexpert in QA and QC. For laboratories that have multiple medium-sized or large quality are large organization should have a QA policies and procedures for all labo: ralories with QA officersat each location who develop laboratory-specifie proce- dures to meet the quality progriun stan: dards and poticies. Both consistency in quality objectives and individual fex- meeting those objectives should tated in a multiple-location labo- tory organization, Whether thy of QA officer is added responsi- laboratory position, it is he or she have sufficient cally. the QA officer re st level of laboratory important th authority, Ty, ports 10 the hig! ‘management, Characteristics of an Etfective QA Officer ‘What makes a good QA o education to understand what strong desire to do it right, and the expe- rience to suppor the desire are necessary characteristics. A Qa officer need not be anexpedtinall laboratory areas, butshould have a broad perspective and a compre- hensive laboratory background. A BS in laboratory science is necessary, includ- ing course work in statistics, ‘To breastof changes in the field, continuing ‘education through seminars and confer ences is advisable for the QA officer, Effective interpersonal skills are also important, The QA officer interacts with 4 variety of people including analysts, supervisors, clients, agency repress Skills in com- municating, listening, resolving conflict, and team building are essential to encour. ‘age innovation and initiative, and to cre In open, positive, problem solving working environment, and regulatory ratives, Changing Expectations The role of the QA officer. like the QA ‘manual, is changing. Changes in regula- tions, client expectations, and laboratory operations are transforming the QA offi- cet position from one that monitors labo- ratory performance to one that directs the achievement of overall quality Today. many work places are imple- menting the total quality management Philosophy. Emphasis on improving products and services based on the input {rom every employee is a major ingredi- ent of thisphilosophy. Any organization that hopes to build competitive advan- tage by working to improve quality will seizetheconceptof total quality manage- ‘ment, This will mean an evolution of the QA officer's ole. Quality improvement will become the entire staff"s responsi- bility, not one lone employee's. For a laboratory to implement total ment a transformation ‘must take place, It means the laboratory ange from controlling ‘oseiting direction: from giving orders to coaching or facilitating change; from ‘mandating decisions to providing guid- ance, information, and support. As a leader in the laboratory organization, the responsibility for implementing change willlikely fll upon the QA officer. How- ever. this change cannot be mandated. It can only be accomplished through the thorough cooperation of the entire Labo ratory staff. The laboratory staff must work together toachieve the laboratory's quality objectives and performance stan- dads. Kenneth Osborn is the quality assur~ ‘ance officer with East Bay Municipal Utility District in Oukland. Calif. Ann Rosecrance is the corporate quality as- surance director with Core Laboratories. in Houston, Tex. Bill Nivens is editor of ‘The Bench Sheet, a