Self Calibration of Measurement Tools

R

RiverSteel

#1
I currently have in place a tool calibration program that requires an extreme effort on a periodic basis to calibrate/verify our measurement tools. The number of tools involved makes it an exceptionally time consuming task-and like many others on this forum I work for a relatively small company and wear a multitude of hats, making it difficult at best to perform the task in a timely manner.
My question is this-I would like to go to a system that allows the tool user to calibrate/verify the tools themselves on a prescribed schedule. (The tools we use here are very basic-tape measures, squares, levels, etc. with the exception of a couple of machinists with calipers, mics, etc.) Is this an acceptable method of calibration/verification as long as I can show evidence that the employee has received the necessary training? I envision a calibration/verification station that includes the necessary equipment, along with the procedure and work instruction for the task.
The main hang up I have is how to identify the tool as calibrated/verified-we currently apply a tag to the tool itself. I'd like to go to a checkoff log, but am not sure how to enable the user to be aware of when thier tools are due.
Any help on this would be greatly appreciated.
BTW-We are in the process of obtaining ISO 9001:2008 & several AISC certifications at the same time...:mg:
 
Elsmar Forum Sponsor
S

Sorin

#2
My question is this-I would like to go to a system that allows the tool user to calibrate/verify the tools themselves on a prescribed schedule. (The tools we use here are very basic-tape measures, squares, levels, etc. with the exception of a couple of machinists with calipers, mics, etc.) Is this an acceptable method of calibration/verification as long as I can show evidence that the employee has received the necessary training? I envision a calibration/verification station that includes the necessary equipment, along with the procedure and work instruction for the task.
And as long as the references (standards) used are calibrated there should be no problem....
 
J
#3
While I agree with Sorin here that there should be no problem, the acid test will be whether this change will adversely effect outgoing quality.

This could be a good thing in a mature, quality oriented, company culture, and a dangerous thing if the culture of the company is not mature.

Peace
James
 
R

RiverSteel

#4
That is, of course one of my concerns as well-I have been gradually transforming an old school, shoot from the hip mentality into a quality oriented culture. Not easy going, but we're getting there.
I would be performing closely scheduled audits on this process out of the gate. My intent here is threefold-to take the load off myself and one other quality person, make sure that the tools are done when due, and to further instill a sense of ownership in the quality process.
Again, my concern here is how to notify the user that thier tools are due...I am thinking of having them continue to tag the individual tool, and provide them with a date chart (i.e. if calibrating 5/1, next cal/ver date is 8/1). The tool number would be signed off on the list as completed, but not assigned to a specific person.
 

BradM

Staff member
Admin
#5
Hi there!:bigwave:

There are two (at least two:tg:) long-standing arguments within your issue. First, should tape measures be calibrated, and 2-should calibration labels be applied. So since those two are carried on in other places:D, let's make assumptions that you do want to calibrate those measuring instruments, and you don't want to put on calibration labels.

One of the main concerns that you will need to drive into the users is the need to have control over the instruments. This means not "pulling out" just anything and measuring stuff. They need to use calibrated instruments, and they need to be in the system.

Second of all, they will need to keep good control over the standards. This means keeping up with them, handling properly, noting any wear spots on the gauges, etc.

That said, there are a number of ways you can do this. You could have reports for each workstation. It could list all the standards and due dates, and they should check the list prior to using instruments.

You could post a master list of instruments due for calibration. Then, each user would be responsible for calibrating the instrument, and return the paperwork to you (or whatever).

Also, you might want to buy everyone some sandwiches for lunch, and ask them their opinions.:) Show them the issue, and ask them how they can help with this; how everyone can work together for a solution.

Main thing: just assure the system is effective. There should be no use of non-calibrated instruments (for the calibrated needs), no past due stuff, and that the calibration activities are properly documented and noted.:)
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#6
Brad is correct.

I have dealt with Master Machinists and Prototype Machinists and know how they value and care for their tools. Having stated that, calibration generally is no what they do well. Not because they can't, but metrology is a science for a reason. A good calibration requires both science and skill.

Calibration also requires traceability and uncertainty calculations. Hence, if you want to calibrate internally you need to know how to calculate uncertainty. Otherwise it is verification only.

The best option is to find an accredited calibration provider and have them manage your calibration and provide service on site at your place. The external cost is likely to actually be a bit less than the true internal cost.
 
Thread starter Similar threads Forum Replies Date
R Self (In-House) Calibration of Measuring Tools (vernier, micrometers etc.) General Measurement Device and Calibration Topics 17
R Self Calibration of Dimensional Measuring Tools General Measurement Device and Calibration Topics 3
Crusader Self-Calibrating Furnace does not require calibration General Measurement Device and Calibration Topics 15
A Need to send out for Calibration or Self-calibration? HP model# 35670A analyzer General Measurement Device and Calibration Topics 4
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
A R2 Certification vs Self Declaration to ISO 14001 and OHSAS 18001 ISO 14001:2015 Specific Discussions 3

Similar threads

Top Bottom