Laboratory Environment Monitoring - Are there any "universally accepted" conditions?

D

Doug Lemon

#1
We are currently preparing for our QS 9000 Audit and are struggling a bit with the new Lab Requirements (4.10.6).

Are there any "universally accepted" conditions that we should be striving to maintain? If not ... should we set our own? ie: Temperature & Humidity.

We are currently monitoring and logging both of these in our lab but are a little leary of setting a limit for ourselves ie: 68°F ± 2°(Auditor Ammo).

We are a machine shop and are often measuring to within .0001". Any feedback you have would be most appreciated.

Thanks
 
Elsmar Forum Sponsor
B

Batman

#2
If your measurements are affected by temperature changes, meaning accepting rejectable product or vice versa, you have to control the environment.

Our product is stable relative to the tolerances and amount of temperature changes and humidity changes experienced in our neck of the woods. For the general procedures, we state that all parts to be checked will be acclimated to the local conditions, and measurement devices will be calibrated or standardized prior to measurement if not residing in the environment.

A specific example of a measurement device not appropriate to the general statement is our CMM. We state "office comfortable" conditions and in the event more than 6 degrees difference we recalibrate. This is within our abilities with no real difficulties or hardships and the auditors were happy.

We also work with .0001 measurement devices, but or print and tool drawing tolerances are for the most part no less than .001". So we have little concerns here.
 
M

Mike525

#4
Check with NIST and ASTM - they might have standards or guidelines for lab environments. Also, if your customer is doing any receiving inspection, you'll want to make sure you're both testing under the same conditions / environment.
 
Thread starter Similar threads Forum Replies Date
M IQ OQ PQ in Laboratory vs. Manufacturing Environment Other Medical Device and Orthopedic Related Topics 1
V Calibration Laboratory Environment and Instrument Tolerances General Measurement Device and Calibration Topics 15
M Grade D Laboratory Environment Airlock Requirements Manufacturing and Related Processes 3
M Ambient vs. controlled test laboratory environment Test Method Evaluation Plan Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Marc Calibration Environment - Micrometers - NCSL RP 7 - Laboratory Design General Measurement Device and Calibration Topics 5
A Help required in establishing Laboratory Information Management System as per ISO 17025, Cl.7.11.2 ISO 17025 related Discussions 0
S Is design and development clause 8.3 applicable for laboratory ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Is Good Laboratory Practice (GLP) Required in ISO 17025? ISO 17025 related Discussions 4
D IATF16949 7.1.5.3.2 External Laboratory IATF 16949 - Automotive Quality Systems Standard 17
A Laboratory scope on the IATF IATF 16949 - Automotive Quality Systems Standard 5
J 7.1.3.5.2 External laboratory - CIPM MRA IATF 16949 - Automotive Quality Systems Standard 3
W 7.1.5.3.2. External laboratory Sanctioned Interpretation IATF 16949 - Automotive Quality Systems Standard 4
G Audit & Agreements for "Test Laboratory" Supplier? US Medical Device Regulations 4
D Laboratory Refrigerator Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
C Internal Laboratory (7.1.5.3.1) IATF 16949 - Automotive Quality Systems Standard 3
E 17025 Accredited Microbiological Testing Laboratory ISO 17025 related Discussions 3
X Looking for 17025 auditor to perform internal audit on IT software testing laboratory ISO 17025 related Discussions 3
F Internal Laboratory Manual IATF 16949 - Automotive Quality Systems Standard 5
R Laboratory Developed Tests EU Medical Device Regulations 2
G Internal Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 10
V Is periodic-requalification relevant for laboratory instruments Qualification and Validation (including 21 CFR Part 11) 1
E Organisational Chart-ISO 17025 Laboratory ISO 17025 related Discussions 3
D INTERNAL LABORATORY IATF 16949 - Automotive Quality Systems Standard 4
C ISO 80601-2-56 Laboratory accuracy Other Medical Device Related Standards 7
D IATF 16949 M&TE Laboratory scope IATF 16949 - Automotive Quality Systems Standard 7
X ISO 17025 certification for Laboratory for online gambling products ISO 17025 related Discussions 3
B Laboratory KPIs ISO 17025 related Discussions 13
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
T Laboratory Verification after validation ISO 17025 related Discussions 3
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
G ITAR Registration for Metrology Laboratory? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S Laboratory Environmental Conditions Outside of limits ISO 17025 related Discussions 4
I Laboratory Fridge / Freezer Inventory - Requirement(s) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Definition of "Critical Laboratory Equipment"? General Measurement Device and Calibration Topics 1
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 16
DMLqms Material for laboratory use or Medical Device? EU Medical Device Regulations 2
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
B Accredited laboratory or not under MDD 93/42/EEC IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 6
Casana IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration IATF 16949 - Automotive Quality Systems Standard 8
A Information on good laboratory practices (GLP) for the non-medical or food industry wanted Manufacturing and Related Processes 1
D Internal audit forms or checklists for a medical/veterinary laboratory General Auditing Discussions 5
N IATF 16949 7.1.5.3.2 External Laboratory - Calibration of Nikon machine in factory IATF 16949 - Automotive Quality Systems Standard 24
Q Calibration laboratory scope - Include software such as Gagetrak or Mini tab used? General Measurement Device and Calibration Topics 3
B IATF 16949 7.1.5.3.2 FAQ #7 Audit Finding - External Calibration Laboratory IATF 16949 - Automotive Quality Systems Standard 7
P Procedure for maintaining Confidentiality And Impartiality in a Laboratory Quality Management System (QMS) Manuals 2
sswaim IATF 16949 7.1.5.3.2 External Calibration Laboratory Requirelents IATF 16949 - Automotive Quality Systems Standard 15
J Good Laboratory Practice: online training course recommendations? US Food and Drug Administration (FDA) 0

Similar threads

Top Bottom