Self Inspection - How to implement an "Operator Self Verification" program

S

Southloop

#1
I need "fresh" information on how to implement an "Operator Self Verification" program, also known as "buddy systems", or "personal Warranty", etc.
Thanks!!:D
 
Elsmar Forum Sponsor
S

Southloop

#5
I found the ARP 9162, now I am looking for "a real life" procedure that has been used to certify operators on inspecting their own work. Thanks to all!!!!!
 
N

nigaringa

#7
Re: Self inspection

In the Aviation, Space & Defense Sector, we have a Recommended Practice, dealing with the subject: ARP9162
I downloaded it, I found it unhelpful; I'd like to find a real case implementation so it can help me on my project :cfingers:
 

howste

Thaumaturge
Super Moderator
#8
Re: Self inspection

I downloaded it, I found it unhelpful; I'd like to find a real case implementation so it can help me on my project :cfingers:
I can't help with what you're asking, but I just wanted to note that ARP9162 has been cancelled and superseded by AS9162, which was published in November 2016.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#9
Re: Self inspection

I downloaded it, I found it unhelpful; I'd like to find a real case implementation so it can help me on my project :cfingers:
I don't have a procedure to offer, but I can offer a few tips, FWIW:

If you don't have the right culture in place, it will never work, period. If you have "leaders", Managers, Supervisors, whatever, who push for meeting "shipout dollar goals" or "manufacturing quotas" over all else it will fail, and fail miserably. You simply must have empowered employees who are competent, well-trained, and strongly supported by Management who are willing to speak truth to power and that "power" must never be allowed to penalize anyone in any fashion for reporting honestly the results of their measurements. What Management does will speak 100 times more loudly than what they say or write.

Perform periodic checks on the results of the self-inspectors to keep them on their toes and catch any problems that may arise (intentional or unintentional measurement errors). I used to do this for ALL Inspectors -- if there was any kind of measurement problem, I wanted to catch it before my customer did, and I as "boss" was double-checked periodically just like everyone else. It also gave Production and Customers a warm-fuzzy feeling about the quality of our measurements.

Have a certification log of who is allowed to perform self-inspection.

Treat self-inspectors as special -- because they are. A pay increase, maybe a perk like a quarterly catered luncheon for self-inspectors to recognize them, some in-person thanks from the big boss.

Not every measurement is appropriate for self-inspection.
 
Thread starter Similar threads Forum Replies Date
D Worker self-inspection - I would like to implement a first pilot experience Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
D Quality Training for Operators and Production Supervisors to do Self-Inspection Training - Internal, External, Online and Distance Learning 4
D Correct Frequence for Operator Self Inspection SPC Study Statistical Analysis Tools, Techniques and SPC 4
D Implementing Operator Product Self-Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 26
F The worth and effectiveness of Self-Inspection: Seeking Opinions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
A Self-training or Self-studying ISO 13485:2016 - Medical Device Quality Management Systems 8
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Control-self assessment Internal Auditing 5
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
E HONDA HAA QAV-1 Self Assessment General Auditing Discussions 4
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
G Self Assessment Audit from a new potential customer General Auditing Discussions 3
M CE self-certification for Class I device (face mask) EU Medical Device Regulations 9
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
K Intended Use-Class I Self Certified - Intended Use and Indications for Use statements EU Medical Device Regulations 1
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
MichaelDRoach Oganization's Self Declaration of Conformance to ISO 28000 wording example wanted Supply Chain Security Management Systems 1
M Medical Device News TGA – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018 Medical Device and FDA Regulations and Standards News 0
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
M CE self-certify, or needs testing by 3rd party? CE Marking (Conformité Européene) / CB Scheme 12
M Notified Body Involvement with Self Declared Products EU Medical Device Regulations 7
S Help: Need Control Self Assessment Questionnaire for HR Departmental Functions Process Audits and Layered Process Audits 0
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 9
R Documenting Self-Training and Effectiveness - ISO 13485:2016 Training - Internal, External, Online and Distance Learning 4
K ISO 13485:2016 Self Certification for Class I (annex 9) Stand-Alone Software? ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO9001:2015 and ISO14001:2015 Readiness/Self Evaluation Checklists wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N MDD Class I Medical Device Self Declaration Articles/Supplementary Documents EU Medical Device Regulations 1
A Self-study plan to improve fluency in English speaking, writing After Work and Weekend Discussion Topics 3
Crusader Interval for Self-Calibrating Measurement Device? Calibration Frequency (Interval) 15
T Transition Time for Self Declared IVDs EU Medical Device Regulations 3
Z IVD Self Test Pregnancy - Assessment Route? EU Medical Device Regulations 5
S Anyone know the self-selection study for home use medical device Other US Medical Device Regulations 2
D Off-Label Self Promotion - What to do EU Medical Device Regulations 3
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
S Creating goals and objectives with targets and measurables for self-evaluations Management Review Meetings and related Processes 2
C Help with Risk/Benefit Analysis Self-help Device for Diabetics ISO 14971 - Medical Device Risk Management 3
B Self Contained Biological Indicators as internal PCD Other Medical Device Related Standards 2
T Self Declaration for CE Class I, Non-Invasive Medical Device EU Medical Device Regulations 10
R Self-Certification Is Not a Real Thing - an IAF article Registrars and Notified Bodies 13
T Should a supplier self assessment form be a controlled document? Document Control Systems, Procedures, Forms and Templates 9
C Vendor Self-Survey to Qualify Vendors/Suppliers - AVL Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Annex III self declared IVD to be in use with Annex II List B IVD EU Medical Device Regulations 1
S SAE AS9015 Supplier Self Verification Process - Delegation Programs. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B FDA Product Classification - Self Treatment Software Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Changing from contract manufactured to self manufactured 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom