IAS Presentation at Kuwait Labs 2017 2nd Kuwait Conference for Laboratory Quality and Accreditation Empowering Laboratory Personnel September 26, 2017 Kuwait City Lawrence J. O Connor, P.E., L.S., F. NSPE IAS Representative
The important role of lab staff in Assuring Impartiality of the lab and Scientific Validity of Testing. Lawrence J. O Connor, P.E., L.S., F. NSPE IAS Representative
About IAS The International Accreditation Service is a US-based Accreditation Body that provides accreditation services around the world for twenty- two categories of Conformity Assessment Bodies. Providing accreditation services since 1975. A non-profit subsidiary of the International Code Council. Our largest accreditation program provides accreditation for Testing Laboratories and Calibration Laboratories under ISO/IEC 17025.
Accreditation Verifies Competence Accreditation is used worldwide to verify the competence of companies and organizations. Accreditation involves a formal assessment performed by a thirdparty (accrediting organization) to determine if a company or entity has demonstrated competence and meets specified requirements to perform specific tasks. Provides global recognition through ILAC and APLAC 4
Global Recognition IAS accreditation programs are recognized globally through agreements with international accreditation bodies: IAS is a signatory to the International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APLAC) Mutual Recognition Arrangements (MRA) for Testing, Certification and Inspection. IAS is a Multilateral Recognition Arrangement (MLA) signatory of the Pacific Accreditation Cooperation (PAC) for Product Certification. 5
Lab info on IAS Website Link to Accreditation Certificate
Empowering Laboratory Personnel The theme of this conference is Empowering Laboratory Personnel. This talk is about The important role of lab staff in assuring the Impartiality of the lab and Scientific Validity of the testing. Exploring Aspects of how the people working for Testing Labs can assure the quality of testing and provide AWEsome service. Copyright IAS 2017 L. J. O Connor - Slide 7
Empowering Laboratory Personnel Accreditation of Laboratories is an important step toward Empowerment. The accreditation process provides basic assurances to the laboratory s clients and the general public that the lab has: Commitment to Quality. Organization Structure Management Practices Facilities Equipment Staff Laboratory Procedures Quality Control Practices Copyright IAS 2017 L. J. O Connor - Slide 8
Empowering Laboratory Personnel Why become accredited? You want to create a lab that has a good reputation known for the reliability and validity of test services. Laboratory accreditation is an important step in demonstrating to the world that your lab is committed to providing quality testing services. Your clients will have assurance that the specifications are being met and safety or other performance related factors are being achieved. Copyright IAS 2017 L. J. O Connor - Slide 9
Empowering Laboratory Personnel Why become accredited? Accreditation leads to adoption of global best practices for laboratory operation. Good laboratory practices result in good science and valid test results. Reliable testing benefits the health and safety of our friends, neighbors and the citizens of your region and in some cases the whole world. Copyright IAS 2017 L. J. O Connor - Slide 10
Execution Matters So, you have a newly accredited lab. All the parts are in place. Now the question is What do you do? Building a vibrant quality organization takes constant care. Skill and wisdom are required. Execution matters. Copyright IAS 2017 L. J. O Connor - Slide 11
IMPARTIALITY and SCIENTIFIC VALIDITY Two important requirements for a successful lab are IMPARTIALITY and SCIENTIFIC VALIDITY. Both are necessary to the provision of results that are: Reliably Accurate Sufficiently Precise. Copyright IAS 2017 L. J. O Connor - Slide 12
Various Types of People are Needed What are the groups of people that can affect the quality of laboratory services? We first think of the Scientists and Lab Technicians that actually perform tests as having the most important role but others have an equally important role. Copyright IAS 2017 L. J. O Connor - Slide 13
Various Types of People are Needed What other groups of people affect the quality of laboratory services? Next there are the Scientists, Engineers and Doctors that supervise the testing and manage the laboratory. Copyright IAS 2017 L. J. O Connor - Slide 14
Various Types of People are Needed What other groups of people affect the quality of laboratory services? The Administrative support staff are key in creating an environment that allows the Technical staff to focus on the science while they manage important business and logistical duties. Copyright IAS 2017 L. J. O Connor - Slide 15
Various Types of People are Needed What other groups of people affect the quality of laboratory services? Lab assistants, laborers and drivers all provide necessary physical and logistical support and their diligence is also important to quality. But there is still one more group to consider! Copyright IAS 2017 L. J. O Connor - Slide 16
Various Types of People are Needed What other groups of people affect the quality of laboratory services? The Owners of the lab also have a key role in creating and sustaining an environment that is conducive to quality results. So, our focus in not just the Lab Technician but the several groups of people that can affect quality. Copyright IAS 2017 L. J. O Connor - Slide 17
Ability, Will and Empowerment Do the Right Thing, The Right Way, Every Day. Copyright IAS 2017 L. J. O Connor - Slide 18 - Larry O Connor
Ability, Will and Empowerment There are three key factors that influence QUALITY. Ability Will Empowerment When these three come together you have the potential of creating an AWEsome lab. Copyright IAS 2017 L. J. O Connor - Slide 19
Ability, Will and Empowerment Scientists and Lab technicians must have the ABILITY to perform tests correctly. Intellect Education Training Experience Copyright IAS 2017 L. J. O Connor - Slide 20
Ability, Will and Empowerment Lab Managers Lab Supervisors Scientists Lab Technicians All need to have the WILL and dedication to do things correctly day-in, day-out. Copyright IAS 2017 L. J. O Connor - Slide 21
Ability, Will and Empowerment Administrative staff Lab assistants Drivers Laborers All provide the support necessary to create an environment that EMPOWERS and enables the Professional, Scientific and Technical core to do good Science. Copyright IAS 2017 L. J. O Connor - Slide 22
Ability, Will and Empowerment Owners and Business Managers have crucial roles to play to EMPOWER the lab s management and technical staff. The Owner has to have both the ABILITY and the WILL to put all the necessary components in place. Copyright IAS 2017 L. J. O Connor - Slide 23
Ability, Will and Empowerment Owners and Business Managers have crucial roles to play to EMPOWER the lab s management and technical staff. The Owner has to have both the ABILITY and the WILL to put all the necessary components in place. Copyright IAS 2017 L. J. O Connor - Slide 24
The Owner s Duty to Empower Owners and Business Managers provide: Executive Commitment to Quality. Organization Structure that Supports Impartiality. A Management System in accordance with ISO best practices. Adequate Facilities for the proper, safe and efficient conduct of testing. Copyright IAS 2017 L. J. O Connor - Slide 25
The Owner s Duty to Empower Owners and Business Managers: Purchase and provide maintenance for Measurement and Test Equipment Hire Qualified Lab Managers, Supervisors, Scientists and Technicians. Assure that the Technical Staff create appropriate Laboratory Procedures Provide adequate resources to support the necessary Quality Control Practices. Copyright IAS 2017 L. J. O Connor - Slide 26
Threats to Impartiality 1. Technicians know and understand the principles of proper sampling and must be vigilant against being directed by others in such manner that non-random sampling occurs. Management must support the Technician s role vs external pressures. (A, W & E) Copyright IAS 2017 L. J. O Connor - Slide 27
Threats to Impartiality 2. Direct interference on Technical Staff from external influences is relatively unlikely in the Gulf but more possible in smaller operations. (W) 3. Managers and Supervisors must hold to high standards of independence. (W, E) Copyright IAS 2017 L. J. O Connor - Slide 28
Threats to Impartiality 4. Is Management sufficiently independent of external influences and pressure? (E) Note: On-going evaluation of threats to impartiality and documented actions to mitigate threats will be required in the upcoming revision to ISO/IEC 17025. Copyright IAS 2017 L. J. O Connor - Slide 29
Scientific Validity of Testing Factors that affect the Scientific Validity of Testing: 1. Inadequate Education, Training and Experience of newly hired Technical Staff. (A) 2. Inadequate in-house training capability / commitment. (W) 3. Insufficient QC practices. (W, E) 4. Absence of written Lab Procedures. (A, W, E) Copyright IAS 2017 L. J. O Connor - Slide 30
Scientific Validity of Testing Factors that affect the Scientific Validity of Testing: 5. Calibration Practices. (W, E) 6. Absence of relevant intermediate checks. (A,W,E) 7. Poor repeatability / reproducibility (Precision/Accuracy). (A, W) 8. Lack of Proficiency Testing and Interlaboratory Comparisons. (Bias). (W, E) Copyright IAS 2017 L. J. O Connor - Slide 31
Scientific Validity of Testing Factors that affect the Scientific Validity of Testing: 9. Incomplete Uncertainty of Measurement Calculations & and no on-going analysis. (A,W,E) 10. Inadequate time allowed to technicians. (E) 11. Logistics for sample handling, storage and management. (E) 12. Sampling procedures that fail to obtain random, representative samples. (E) Copyright IAS 2017 L. J. O Connor - Slide 32
Scientific Validity of Testing Factors that affect the Scientific Validity of Testing: 13. Samples provided to the lab by the client. (E) 14. Improper reagents and CRMs. (E) 15. Poor handling and storage of reagents and CRMs. (A,W) 16. Skill and Diligence in following the standard method and properly using equipment. (A,W) Copyright IAS 2017 L. J. O Connor - Slide 33
Ability, Will and Empowerment This analysis is drawn from my experience with numerous labs and from my personal commitment to quality: Do the right thing, the right way, every day. Copyright IAS 2017 L. J. O Connor - Slide 34
Ability, Will and Empowerment Quality laboratory services depend on everyone that works for the lab, not just the technical staff. People may have the ABILITY to do the test and the diligence and WILL to do it the right way but they also need to be EMPOWERED and provided with a suitable environment to do good science. Copyright IAS 2017 L. J. O Connor - Slide 35
Ability, Will and Empowerment So, when you are thinking about the various roles and factors that affect Quality you have a simple way to be sure that you have an AWEsome lab. Do your people have the ABILITY to do the test right? Do your people have the WILL to persevere and do it right every day? Are staff EMPOWERED to perform good science? Copyright IAS 2017 L. J. O Connor - Slide 36
Questions / Contact Info Lawrence J. O Connor, P.E., L.S., F. NSPE IAS Representative loconnor@iasonline.org +1 (646) 504-0556 +974 3397 7179 +966 5 4297 2342 Copyright IAS 2017 L. J. O Connor - Slide 37