What is the purpose of authorizing the lab activities

#1
Hi,
I am interested to clarify certain things:
1. What is difference between 'authority' and 'authorization' of a lab personnel to perform a specific lab activity, as standard has mentioned them both in separate clauses;

2. I have another confusion, and that is related to authorization of personnel. Consider a scenario where a person 'A' who is competent and can perform a lab activity but there is a possibility that he may not perform it due to availability of other lab personnel who are also competent and authorized to perform the same activity, The question is, why I should not authorize the person 'A to preform this lab activity which he is not performing in his routine, but he is competence enough and can do it?

3. In our laboratory, chemists are responsible for reviewing the work of lab analyst and head of lab is responsible for release/ reporting of test results but the chemists and head of lab are not authorized to preform the lab activities which they are reviewing and reporting to the customer, only lab analyst is authorized to perform analysis. Now how and unauthorized personnel can review and report the work performed by an authorized person? is it not necessary to first authorize the chemist and lab head to perform the lab activity and then additionally they are authorized to review and report the test results?


Thanks
 
Last edited:
Elsmar Forum Sponsor

dwperron

Trusted Information Resource
#2
Good questions.

1) The Authority is the person(s) determined by your organization to determine those who are competent at performing some function. Often there is a skill related document that is used to verify the competency of the person for the task.
Authorization is the written document that declares that a person has been determined competent to perform a function.

2) You can declare multiple people to be authorized to perform a function. You want to have more than one person to avoid having a single point of failure.

3) I have seen instances where people who are not trained to perform a test are trained to analyze the results provided from a test, to be able to determine if the results are complete and adequate. They would be Authorized to review the test results.
 
Thread starter Similar threads Forum Replies Date
dgrainger Informational Draft for comment - "reclassification of products without an intended medical purpose" EU Medical Device Regulations 6
placebo_master What is the difference between "Fitness for Purpose" and "Calibration/Verification"? General Measurement Device and Calibration Topics 6
dgrainger Informational DRAFT - Common specifications for the groups of products without an intended medical purpose listed in Annex XVI. EU Medical Device Regulations 0
Dan Pare Density Column setup for Measuring General Purpose ABS General Measurement Device and Calibration Topics 0
T Intended purpose for devices that might not fit the IP criteria EU Medical Device Regulations 0
B Nasal Saline Solution for Irrigation purpose classification EU Medical Device Regulations 0
A Intended Purpose on device label EU Medical Device Regulations 7
M ISO 13485 for general purpose disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Records required for ISO 9001 clause 7.1.5.1 - Fitness for purpose of the monitoring and measurement resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A A purpose of a Stage 1 audit - Off site document review Registrars and Notified Bodies 3
A Audit purpose - case study - What is the role of SQE in such case? General Auditing Discussions 3
A True purpose of doing EST (Electrical Safety Test) on medical device Other Medical Device Related Standards 3
T Informational What is the purpose of Internal Audits? Internal Auditing 27
K QMS Improvement - Analyze the systemic weaknesses of the QMS for improvement purpose Quality Tools, Improvement and Analysis 6
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
SK13485 Can a literature alone be used for the purpose of Clinical Evaluation of a device? EU Medical Device Regulations 6
E IATF 16949 Cl. 7.1.5.1 - Documented information as evidence of fitness for purpose IATF 16949 - Automotive Quality Systems Standard 3
R Auditing Fitness of Purpose for Monitoring and Measuring Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Are dermal fillers & PDO sutures for aesthetic purpose under CE MDD? EU Medical Device Regulations 6
somashekar Electronic data Back-up procedure, for Medical device QMS and regulatory purpose. ISO 13485:2016 - Medical Device Quality Management Systems 4
P Purpose of calculating Ta, Tb & R Square in Linearity Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
P Purpose of calculating Uncertainty value in calibration study Measurement Uncertainty (MU) 5
Q IEC 60601 for Non-Medical Research Purpose Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D UV Absorption Test - What is it's purpose and what specifically is it looking for? Other Medical Device Related Standards 10
A ISO/IEC 20000 Toolkit For Academic Purpose IT (Information Technology) Service Management 6
L What is, and the purpose of, ISO STATS recording ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
x-files Hardcopy and Electronic Forms for same purpose vs. Naming and Numbering System Document Control Systems, Procedures, Forms and Templates 1
N How to qualify (IQ, OQ, PQ) a multi-purpose equipment ? Imported Legacy Blogs 1
V The Purpose of Basic Dimensions on Prints APQP and PPAP 6
Q Beginner's Understanding - The Purpose and Applications of QMS/ISO Standards Philosophy, Gurus, Innovation and Evolution 12
J How to qualify (IQ, OQ, PQ) a multi-purpose equipment ? Qualification and Validation (including 21 CFR Part 11) 5
S Logo Marking for Marketing purpose - ISO 9001, ISO 14001 and OHSAS 18001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P What is the latest version of ISO 10021 used for Certification purpose? Other ISO and International Standards and European Regulations 3
N Export & Import of Unapproved Device in USA for Service Purpose Only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Purpose of the Quality Manual for an Organisation Quality Management System (QMS) Manuals 4
M TS 16949 Clause 7.5.1.8 - Special-Purpose Tools or Measurement Equipment IATF 16949 - Automotive Quality Systems Standard 2
A FDA: Label Requirements for General Purpose Reagents IVD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A What is the purpose of using AQL (Acceptable Quality Level) for Sampling? AQL - Acceptable Quality Level 3
S What is the purpose of ON HOLD Labels Food Safety - ISO 22000, HACCP (21 CFR 120) 5
Q How to write Statement of Purpose for a Law School Admission Career and Occupation Discussions 9
C FDA Approval Process for Device that can also be used for Veterinary Purpose 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
R Can some one share JIS B7502/7507 or DIN862 with me for study purpose? General Measurement Device and Calibration Topics 2
C What is the Purpose of or Requirement for having a Gage Glossary? IATF 16949 - Automotive Quality Systems Standard 2
P What is the purpose and use of Chart Stickers Labels? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Auditor suggested company find a higher purpose for Internal Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Purpose of using different Distributions to solve Reliability Problems? Reliability Analysis - Predictions, Testing and Standards 2
Z CMM Measuring Instruction - Example needed for translation purpose Document Control Systems, Procedures, Forms and Templates 17
L Please share some practical SPC exercises for training purpose Statistical Analysis Tools, Techniques and SPC 4
thisby_ Intended Use vs. Intended Purpose vs. Intended by the Manufacturer - Doubts ISO 13485:2016 - Medical Device Quality Management Systems 9

Similar threads

Top Bottom