Clause 8.5.1 -- Is non Identification evidence of ineffective control of production

Golfman25

Trusted Information Resource
So we are looking at a non-conformance against 8.5.1 Control of production and service provision. Supporting evidence is: open containers of waste oil and good oil side-by-side with no identification (don't ask me how he knew one was waste and one good if not identified), lubricants kept by parts where one is used for parts and one for dies (not identified), liquids in water and spray bottles observed throughout production.

So the back story is we use several oils (probably 5-7) in our forming processes (metal stamping) and in our machines. Oils are ordered in bulk 55 gal drums and 5 gallon buckets. All have manufacturers information on them. As we run parts, our operators distribute said oils to their workstations via smaller containers (my guys love to recycle the plastic coffee containers) -- maybe a cup to a quart at a time. While there is no specific written identification on these containers, the operators know what it is and what it is used for as they fill the containers and use the product. In the event there could be confusion, the oil is easily identifiable via its color, viscosity, etc. and in the event it can't be distinguished can be scrapped out and fresh product used. Identification of the smaller containers is easier said than done as the oil likes to "eat" any labels, marker ink, etc. and is quickly made illegible. Oh, and the liquids in water bottles are the operators drinks.

Any thoughts? Discussion. Thanks in advance.
 
So the oil is strictly for maintenance (and the water too), it has nothing to do with the product. I don't see a big issue, maybe OSHA might (unmarked containers), but thats about it. Lets see what the experts say...
 

Randy

Super Moderator
OK here's what there is....Depending on location the waste oil not being labeled could or could not be an environmental violation (definitely a CAL EPA one). Both types of oil are most definitely contrary to OSHA 29CFR1910.1200 Hazard Communication Standard, Seconday containers ( your safety guy should know that and if not, get a new safety guy cause that's Basic Safety 101

Now, how the auditor fits that into 8.5.1 Control of production and service provision is dicey and grasping. There has to be a direct connection formed between the oil and whatever he was looking at, kinda like a quality auditor looking at daily inspections of forklifts.
 

Golfman25

Trusted Information Resource
OK here's what there is....Depending on location the waste oil not being labeled could or could not be an environmental violation (definitely a CAL EPA one). Both types of oil are most definitely contrary to OSHA 29CFR1910.1200 Hazard Communication Standard, Seconday containers ( your safety guy should know that and if not, get a new safety guy cause that's Basic Safety 101

Now, how the auditor fits that into 8.5.1 Control of production and service provision is dicey and grasping. There has to be a direct connection formed between the oil and whatever he was looking at, kinda like a quality auditor looking at daily inspections of forklifts.
Thanks for you input. I appreciate it. Lest we turn this into an OSHA thread, lets assume we are not dealing with Hazardous chemicals (we eliminated 95% of them years ago) or they are subject to the immediate use exception.

As for the auditor, I'm trying to figure it out as well. :)
 

Randy

Super Moderator
lets assume we are not dealing with Hazardous chemicals
Trust me when I say by federal law even oil is considered a hazardous chemical in the workplace, as is distilled water, IPA and Simple Green.

"lets assume we are not dealing with Hazardous chemicals (we eliminated 95% of them years ago) or they are subject to the immediate use exception."

As you described them they are not for immediate use, but go ahead, whatever
 

Golfman25

Trusted Information Resource
Trust me when I say by federal law even oil is considered a hazardous chemical in the workplace, as is distilled water, IPA and Simple Green.

"lets assume we are not dealing with Hazardous chemicals (we eliminated 95% of them years ago) or they are subject to the immediate use exception."

As you described them they are not for immediate use, but go ahead, whatever

Definition: "Immediate use" means that the hazardous chemical will be under the control of and used only by the person who transfers it from a labeled container and only within the work shift in which it is transferred." That's pretty much what I described.

And I don't know, but the simple green people may disagree about applicability under Hazardous communication requirements.
https://cdn.simplegreen.com/downloads/SDS_EN-US_SimpleGreenAllPurposeCleaner.pdf
But we digress. Again, thanks for your input.
 

mattador78

Quite Involved in Discussions
Here the Uk under COSHH any oils in cans on a bench next to bottles of water would be a huge no no. As for the labelling i suppose if the tubs are being recycled could different oils be put in at different times causing contamination? What you could do is make a holder/holster for theses cans out of aluminium or mild steel and engrave on the holster what goes in there then each time they can just fill the can and pop it back in its slot readily identified. then just keep the MSDS sheets readily available.
 

John Predmore

Trusted Information Resource
Getting back to the OP question about ISO 8.5.1...
Many auditors have pet peeves they look for. This guy's might be the sin of unlabeled containers.
Best practice would be "the implementation of actions to prevent human error" which happens to be 8.5.1.g.

To judge whether product quality is potentially affected, you would have to assess what bad things could happen if waste oil is accidently used instead of good oil, or the wrong oil is used. You mentioned metal stamping and "one is used for parts and one is used for dies", so I would think the quality of oil matters. If there is a risk of poor product quality, then 8.5.1 requires commensurate level of control to mitigate risk. Your company gets to decide what level of risk and what level of control, subject to scrutiny of your decision by the auditor. Of course, if evidence shows product quality problems caused by mixed or expired lubrication occurred, the auditor will conclude the controls you chose are ineffective.
 

Mike S.

Happy to be Alive
Trusted Information Resource
Aside from debate over what exact clause may best apply, I think the auditor has identified a problem area for you. Using old, unlabeled coffee containers to transfer oil? Unidentified spray bottles?

No offense intended but it sounds like practices used in a fast and loose garage-shop operation - or my garage.
 

Randy

Super Moderator
No offense intended but it sounds like practices used in a fast and loose garage-shop operation - or my garage.
Yep, but what the heck, I've only a BS in Occupational Safety and 35+ years in the field with current specialization in Responsible Care
 
Thread starter Similar threads Forum Replies Date
eternal_atlas Identification of ISO 9001 Clause to a specific Non-Conformity General Auditing Discussions 7
D AS9100 Rev D - Clause 8.7 Control of Non conforming outputs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
somashekar Justification for Non-applicable clause at Stage 2, in clause 4. ISO 13485:2016 - Medical Device Quality Management Systems 11
S What's meant by ISO9001 clause 8.7 non conforming output? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P IATF 16949 Clause 8.4.2.3 - Justification for non-certified suppliers IATF 16949 - Automotive Quality Systems Standard 14
qualprod Only manufacturing, non applicable - ISO 9001 Clause 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
qualprod Is it a NC, if a clause is not declared as non applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
N ISO 17025 clause 5.8.3 Records of Non-Conforming Test Items ISO 17025 related Discussions 3
T Clause 7.4.1.2 - Evidence of annual assessments for all non-TS Suppliers IATF 16949 - Automotive Quality Systems Standard 16
Y Accurately applying a specific clause to a Non Conformance Internal Auditing 10
M Supplier Quality Statement - Clause that our non-certified suppliers could sign Supplier Quality Assurance and other Supplier Issues 14
L How to apply the clause "control of non-conforming product" on services company ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M TS Clause 7.6.3.2 - Can Non-Accreditated External Laboratory Carry out Calibration? IATF 16949 - Automotive Quality Systems Standard 14
P Interpreting the Process Gap - Open Non-Conformances & ISO Clause ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Sampling - Clause 8.2.4 - What do the words "known non conformities" mean here? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
M Record Falsification - What clause to raise a non-conformity? Records and Data - Quality, Legal and Other Evidence 20
A ISO 9000:2000 Clause 8.3 - Control of Non-Conforming Product Nonconformance and Corrective Action 7
Z How to interpret and apply IEC60601-2-54, clause 203.6.4.3.104.3 Accuracy of X-RAY TUBE VOLTAGE, second para. IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
G ISO 17025.2017 Clause 7.8.4.3 Certificate of Calibration Label ISO 17025 related Discussions 5
M IEC 60601-1-8 clause 6.4.1 (statistics of the distribution of the sum of the maximum ALARM CONDITION + SIGNAL GENERATION DELAY) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F Clause 7.4 Communication Compliance Evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F IATF 16949 Clause 8.5.1.5 - OEE, MTTR, and MTBF Calculation IATF 16949 - Automotive Quality Systems Standard 2
B ISO 9001Exclusion of clause 8.5.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
B Clause 4.4.1 c) vs. Clause 9.1.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
R Can an organization be ISO certified if it doesn't comply with each clause? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Feedback process ISO 13485:2016 clause 8.2.1 ISO 13485:2016 - Medical Device Quality Management Systems 2
G Clause 7.5.3 and Required Work Instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 41
LincolnQA AS9100D, Clause 8.4.1.1d - actions to take when external providers do not meet requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
H IEC 61010-1:2010/A1:2016 - Clause 10.5.3 - (b) - Interpretation CE Marking (Conformité Européene) / CB Scheme 6
E Clause 15.4.2.1 d) - Loss of ESSENTIAL PERFORMANCE IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Clause 7.5.2 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
S Is design and development clause 8.3 applicable for laboratory ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Clause for use of expired quality alerts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
H DIN 12880:2007-05 Clause 7.2 Test Equipment Description CE Marking (Conformité Européene) / CB Scheme 0
D API Q1 clause (1.0) Scope Oil and Gas Industry Standards and Regulations 1
D API Q1 clause (5.6.3) Verification of Purchased Products or Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R 9001 and 9004 clause misalignment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
L 60601-2-10 clause 201.12.4.103 Output Indicator (itself in SFC?) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B IATF 16949 clause 10.2 - requirements following a customer complaint. IATF 16949 - Automotive Quality Systems Standard 9
R Clause 8.5.1.2 - Y1 Capacitors in Series IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
eule del ayre Clause 7.1.5 Monitoring and measuring resources IATF 16949 - Automotive Quality Systems Standard 14
P AS9100D clause 8.6 - Documentation required to show evidence of conformity AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
H IEC 61010-1 Clause No. 10.5 Resistance to Heat - Sub Clause 10.5.3 Insulating Material CE Marking (Conformité Européene) / CB Scheme 6
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
J Iso 9001 Clause 7.1 - Advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
T Need help understanding AS6174 clause 3.1.5. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
H Required explanation of sub clause 7.2.101.2 (Exception) of IEC 61010-2-020:2006 CE Marking (Conformité Européene) / CB Scheme 5
J ISO 9001:2015 Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Integrated Management System (IMS) - Process Vs Clause Based Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
D IATF 16949 Clause 7.2.2 - On the job training IATF 16949 - Automotive Quality Systems Standard 2

Similar threads

Top Bottom