Internal Audit of Internal Calibration Laboratory - Inspection sample size question

#1
Hi everyone,
I usually post in the ISO17025, but now I have a question on sampling. Here is the deal:

I'm a supervisor of an internal calibration lab. I have 8 technicians that report to me. Part of their evaluations include an internal audit that I perform each month. This audit consists of sampling work performed - calibrations.

During this review of records, I look for several issues:
1. Do they have a training record on file for the calibration being performed
2. Did they follow procedure
3. Any mistakes on the calibration certificate

What I would like to know is how many records should I sample for each tech? The number of calibrations per each tech can vary monthly depending on the area they are calibrating. The average number is between 100-130. I'm currently using a 20% sample, but I feel that is overkill. I also have a couple of techs that don't make mistakes. Should they be included anyway in a sample? I rather concentrate on the ones making the most mistakes.
 
Elsmar Forum Sponsor

Tim Folkerts

Trusted Information Resource
#2
Charles,

I have two thoughts along somewhat different tracks.

First, could you remove Issue #1 (concerning training records on file) by improving the process of assigning work to techs? Do you and/or the techs not know what tasks they are currently trained to do? Perhaps posting a simple matrix with tech name and date when retraining in a topic is due would suffice to keep everyone cognizant of what calibrations they are allowed to perform.

Secondly, how you sample depends a lot on what you are trying to accomplish. For example, if you want to look for small shifts in the performance of a specific tech for a specific calibration, then 20 pieces per month per individual is probably not enough! If you want to track general trends with a goal of improving the training for calibrations that cause the most problems, then you could get by with sampling fewer records, and concentraing on those who have made the most mistakes in the past.

Just my $0.02....


Tim F
 

Hershal

Metrologist-Auditor
Trusted Information Resource
#3
I believe you may find some value in reducing the volume, at least for the top techs, and when you assess for the average or below average techs, the volume is not the most important thing, what you see and how you can use that to improve your operation is.

Also, the higher the volume, the more time required to do your review. If you are obtaining real value from the reviews for a given tech, OK, but if all the records are great, then you can reduce the volume.

It is not an easy question, but hopefully this will help shed some light on potential solutions.

Hershal
 
Thread starter Similar threads Forum Replies Date
T Robust internal audit program AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
Q AS9100:D Counterfeit internal audit questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Documenting internal audit of customer specific requirements IATF 16949 - Automotive Quality Systems Standard 7
R Looking for ISO 13485 Internal Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 8
G During internal audit - finding poor action plans ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
G Opening meeting - internal audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Mr Roo Discovered dishonesty after performing an internal audit General Auditing Discussions 4
W IATF 9.2.2.1 Internal Audit how to determine risk IATF 16949 - Automotive Quality Systems Standard 12
X Looking for 17025 auditor to perform internal audit on IT software testing laboratory ISO 17025 related Discussions 3
J 9001 Internal Audit of Client Onboarding process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Internal audit checklist Internal Auditing 5
V Internal Audit Software IATF 16949 - Automotive Quality Systems Standard 5
J Internal Audit Schedule IATF Internal Auditing 4
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
D Number of people to be interviewed during an internal audit? Internal Auditing 10
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
armani Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
C API Q1 internal audit report Internal Auditing 3
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 2
J Internal audit random sampling methodology Internal Auditing 2
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
W How do you phrase your internal audit questions? Internal Auditing 3
M IATF - Internal Audit 3 year span Internal Auditing 4
Q ISO 9001-2015 Internal audit finding Internal Auditing 14
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 20
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 8
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
salaheddine96 Internal audit planning Internal Auditing 2
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
E MDR internal audit Internal Auditing 4
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 12
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7

Similar threads

Top Bottom