How does the assessor analyse the sequence and interactions processes?

R

rangotango

How does the assessor analyse the sequence and interactions processes?
 
H

Helmut Jilling

Auditor / Consultant
rangotango said:
How does the assessor analyse the sequence and interactions processes?
Click to expand...


That is a very broad question. I assume you believe have met the requirements.

If so,
1. I begin with a review of what processes you have defined.
2. How did you describe the sequencing of the key processes (some people call them COPs).
3. I will ask you to show me the inputs and outputs from each process, and where these links go.
4. I will review the supporting processes.
5. I will look for any holes that are apparent.
6. I will review the criteria of effectiveness and metrics you have defined for these processes.
7. I will evaluate these metrics to determine an initial idea as to their effectiveness.
8. I will then commence to audit the processes themselves in a logical sequence.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Egypt: Does egypt allows Multiple Registrations of the Same Product? Other Medical Device Regulations World-Wide 3
R When Does Remediation Make Sense? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Does a Pass or Fail IP test need UoM on the report? Measurement Uncertainty (MU) 0
T What does "fully verify" mean exactly in process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D What does a contract manufacturer have to do to comply with for MDR? EU Medical Device Regulations 2
U Does Medical Device training video falls under labeling requirement ? Other US Medical Device Regulations 4
C GTIN & GS1 - what does the law say ? CE Marking (Conformité Européene) / CB Scheme 5
R Does anyone know how ASQ exam requirements are verified? Professional Certifications and Degrees 3
P Does cybersecurity apply to my product? EU Medical Device Regulations 5
Q Does a gage used for a visual verification need to be calibrated? Manufacturing and Related Processes 7
M Does any one know if company is allowed to submit appeal for rejected registration file Other Medical Device Related Standards 0
B Does TUS require load thermocouples? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
S Why does GAGEpack drop the temperature and humidity readings out of the verification event card? Quality Assurance and Compliance Software Tools and Solutions 0
C Determining an as received OOT condition during calibration does not affect measurements taken prior to calibration. General Measurement Device and Calibration Topics 16
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
G When does containment event not require 100% sort? Nonconformance and Corrective Action 5
H Does this clause mean i must be in compliance with AS9100 or is 9001 enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 2
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 5
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
G Does TPI agencies comes under outsourced process as per Q1 Oil and Gas Industry Standards and Regulations 11
N FPY requested for an industry that does not have rework IATF 16949 - Automotive Quality Systems Standard 4
William55401 21 CFR 11 Password Aging - What does "periodically" revised mean in your org? Qualification and Validation (including 21 CFR Part 11) 3
I CQI-15 Welding System Assessment 2nd edition - Does not require Ultrasonic Welding anymore? Customer and Company Specific Requirements 0
Ajit Basrur Does "Refurbishment" fall under "Service"? ISO 13485:2016 - Medical Device Quality Management Systems 13
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen? Other US Medical Device Regulations 0
T What does VW mean by annual requalification? Customer and Company Specific Requirements 4
I Does BSI require suppliers to be ISO 9001 Certified? EU Medical Device Regulations 12
Watchcat Does Regulatory Affairs put the "no" in innovation? Other US Medical Device Regulations 14
Q Does anyone know what this call out means? Manufacturing and Related Processes 3
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
D What does a level 1 (PSW) PPAP actually promise? APQP and PPAP 19
R GS1 DataMatrix code does not meet GS1 Specification EU Medical Device Regulations 0
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3

Similar threads

Top Bottom