Citing Against Requirement 7.1.4 Environment for the operation of processes

[Big Jim]

Bit of a surprise here, Jim. I agree with you.

... well up to a point. I don't really like the change to documented information but it is part of the ISO harmonized structure so we are stuck with it.

Why on earth would you want to "be stuck with it" for something that has not lived up to its use of harmonizing? It has made things more confusing. I heard that it came from the printing industry although I don't really know where it came from. I do know that of the several printing companies I have called on since introduction of the 2015 version have never heard of such a thing as "documented information". It added complexity and wide spread confusion.

I wonder if this might be considered as something that didn't live up to its mission as did "preventive action".

 

[Big Jim]

If we stick with the 7.1.5.1 clause there is a requirement for the organisation to retain records that demonstrate that the measuring equipment is capable. That on its own requires a record. The fact that the auditor preferred to reference 7.1.4 is neither here nor there.

Common sense would require that when writing a nonconformance that it be written against a requirement. It only makes sense that you can't cite a clause that doesn't have the requirement you are trying to relate to. If for no other reason than it makes it more difficult to respond to the nonconformance when citing an empty clause, that is empty to the requirement the auditor believes was missed. I does matter.

 

[Big Jim]

[QUOTE="Paul Simpson, post: 698935, member: 2702"

For the avoidance of doubt, ISO 9001 does not state against each clause where records may be required that records are required to meet the clause requirements.

Quality professionals are expected to look through their organization's own requirements and decide what records are required to demonstrate the system meets its own needs (as well as the standard requirements).

It appears you can't see that. I'm sorry that is the case.

[/QUOTE]

This is Jabberwocky.

First you state that the standard does not state against each clause where records may be required, then you go on to state that quality professionals determine what records are required.

The standard states it more clearly. It says that the quality management system shall include a) documented information required to this international Standard b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.

What is clear to me is that those are two different things. 1st that the quality management system has to include the documented information REQUIRED BY THIS INTERNATIONAL STANDARD. 2nd that the organization gets to choose what if any additional documented information NECESSARY FOR THE EFFECTIVENESS OF THE QUALITY MANAGEMENT SYSTEM.

What is clear is that the auditor does not get to determine what that additional documented information needs to be. The organization does.

Your comments seem to mix those two up.

It appears that you can't see that for which I feel sorry for you.

 

[Big Jim]

All 7.5.1 says is that all procedures and records need to be within the system and have to be covered by all the other clauses under 7.5

As written in the standard that certainly is not clear.

What is said is that you need the documented information required by the standard as well as documented information the organization has determined to be necessary need to be included in the quality management system. 7.5.1 says nothing about what follows in the rest of 7.5. What is included in the rest of 7.5 are additional requirements concerning control of documented information.

I sort of like the way you stated it better, except that you put far more into 7.5.1 than the standard states. Perhaps your wording or something more inclusive could be included in the next revision of the standard.

 

[Paul Simpson]

After re-reading some of this I think Jim and Paul bring up some good points. Go back to the original statement -- "We had some calibration equipment that had specific temperature requirements but didn't control the temperature or record it." I can see how that is 7.1.4. But sounds like there where two issues: 1) Control of the temp and 2) Records of some type regarding that temp. Which I guess begs the question. Could you have a climate controlled room without keeping records. I'm thinking a room, with a thermostat set to whatever and the room is kept at that temp. (assuming that it all within the equipment's needs).

Nicely summarized. We can only go on the information presented and my interpretation is that without evidence of control (and the OP has said there is none) the measuring equipment cannot be shown to be capable.

I'd agree with your follow up question. It could be possible to demonstrate control without a record.

 

[Paul Simpson]

Agree 1000%. When we started this journey I swore to my team we would not do something just "because the auditor required it." But 20+ years of bashing my head against the wall, trying to "fight" and/or prepare responses (root cause/corrective action) to BS "non-conformances" has taken its toll. Sometimes it's just easier to pull out a "document" and say here you go.

Totally agree. Over the years I have used the 'Show me the shall' that I learned here on the Cove to deal with a majority of BS NCs and I'll also tell auditors that I am not afraid to use the CB appeal/complaint process. I wish more companies would do this.

That said, in my work with clients, they are often less willing to challenge bogus NCs and I have to go with their wishes.

 

[Golfman25]

Totally agree. Over the years I have used the 'Show me the shall' that I learned here on the Cove to deal with a majority of BS NCs and I'll also tell auditors that I am not afraid to use the CB appeal/complaint process. I wish more companies would do this.

That said, in my work with clients, they are often less willing to challenge bogus NCs and I have to go with their wishes.

Problem is in my experience the appeal process with my CB leaves a lot to be desired. Seems it's favored to the auditor, lest they be accused of using incompetent auditors. There seems to be very little independent thought put into it. So you need to pick you poison.

 

[Randy]

A vast............VAST majority of 3rd party auditors need to learn and practice the phrase "benefit of the doubt" and the practice of "GET UP AND LOOK AT IT FROM THEIR SIDE OF THE TABLE"

 

[Mikishots]

At my old company we got written up once. We had some calibration equipment that had specific temperature requirements but didn't control the temperature or record it.

Hello!
Has anyone ever assigned or been assigned an audit finding/CAPA/etc. against 7.1.4 Environment for the operation of processes? Clause: “the organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. A suitable environment can be a combination of human and physical factors, such as: social (non-discriminatory, calm, non-confrontational), psychological (stress-reducing, burnout prevention, emotionally protective), and physical (temperature, heat, humidity, etc.).”

If so, what led to it?

I know It’s a risky clause to try and issue a corrective action for, but a non-conformity to ISO is a non-conformity, right?

It comes up occasionally in audits. Paint processes require limits for temperatures and humidities of the rooms in which paints or primers are applied. If the environments are not controlled, there is an elevated risk of paint adhesion issues.

As far as the social or psychological aspects, it came up once - I witnessed a yelling match between two operators and a manager and it got a bit ugly. I would tend not to cite 7.1.4 but rather Clause 5.1.

 

[Randy]

As far as the social or psychological aspects, it came up once - I witnessed a yelling match between two operators and a manager and it got a bit ugly. I would tend not to cite 7.1.4 but rather Clause 5.1.

Who won?