The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Google
  Web Elsmar.com
*Please be aware that SOME RECENT forum threads may not yet be indexed by Google.

View Full Version : Identification of ISO 9001 Clause to a specific Non-Conformity


eternal_atlas
26th January 2009, 03:29 AM
Kindly go through the non-conformity finding which we have found during the internal audit. We had a small debate internally among our auditors team in relating this nonconformity to the ISO clause no. I need you guys opinion. Tell me which clause no. we can relate.(6.3,6.2.2,7.5,4.2.4 or any other clause)

Non Conformity Description :The following discrepancies were noted in the maintenance activities.


Preventive maintenance jobs for the machines listed out in the check list are general and not specific to the particular machine (example: Hydraulic Press Brake, CNC press, Rolling Machine etc.)
The preventive maintenance jobs recommended by the manufacturer of the equipment are not carried out during maintenance (example: The preventive maintenance for Rolling Machine FACCIN model HAV/S -3172, Equipment Sl.No: RM/01 does not cover manufacturer’s recommendations for the preventive maintenance
Break down reports are prepared; however, these reports are not included as a standard attachment of the procedure and brought under the control of records.
Equipment history is not available for any machine to analyze the break down summary and machine availability.


Thank you in advance

Howard Atkins
26th January 2009, 03:46 AM
If you are talking about ISO 9001 then there is no non conformacy to the standard.
6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product
requirements. Infrastructure includes, as applicable,
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport, communication or information systems).


No requirement for PM, records and analysis.

There may be to your procedures.

If you are talking about ISO/TS 16949 then the situation is different

7.5.1.4 Preventive and predictive maintenance
The organization shall identify key process equipment and provide resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system. As a minimum, this system shall include the
following:
 planned maintenance activities;
 packaging and preservation of equipment, tooling and gauging;
 availability of replacement parts for key manufacturing equipment;
 documenting, evaluating and improving maintenance objectives.
The organization shall utilize predictive maintenance methods to continually improve the effectiveness and the
efficiency of production equipment.

eternal_atlas
26th January 2009, 04:29 AM
Dear Mr. Howard,

I am trying to relate this non-conformity to the ISO 9001 Clause. I had a doubt. Can you please explain more on the phrase " maintain the infrastructure". Its very generic.

And If I raise a non-conformity against the maintenance procedure established then which clause i can address. 7.5??

Here are my auditors opinions:

6.2.2 - Since process owner is not aware of the maintenance process.
6.3- Since equipments are not maintained properly.
4.2.4 - Since maintenance records are not maintained.
7.5 (f) - Since maintenace procedure is not implemented effectively by the process owner

Please clarify me more

Howard Atkins
26th January 2009, 06:37 AM
The non conformance that you refer to if I understand correctly is that of:
"there is no effective method of ensuring the implementation of a procedure"
The objective evidence is the fact that maintenance was not performed according to your procedure XYZ.

If maintenance is a defined process then the NC is
"The process of implementing actions necessary to achieve planned results and continual improvement is not effective"

4.1
The organization shall
a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
e) monitor, measure where applicable, and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
ISO 9001:2008 Changes

It could be
"The process of communicating responsibility is not effective"
5.5.1 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.

In fact you could use both clauses. I personally do not see the need in internal audits to use clauses.
The standard requires for the Internal Audit 8.2.2
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization,
I would not use 7.1 as it is product orientated.

The important aspect is that you find the correct root cause and implement corrective actions in respect to the NC which by chance was in the maintenance area.

Big Jim
26th January 2009, 08:28 AM
Writing a nonconformance for not keeping records of equipment maintenance should be weighed against the interpretation from TC176 on that topic. Element 6.3 does not include a requirement to maintain records. Here is a link to the interpretation.

http://www.tc176.org/pdf/rfi003_final6_3.pdf

howste
26th January 2009, 08:48 AM
If you choose to write it against an ISO 9001 clause, then pick the one that will help to get the desired result.

Preventive maintenance jobs for the machines listed out in the check list are general and not specific to the particular machine (example: Hydraulic Press Brake, CNC press, Rolling Machine etc.) It sounds like the instructions given are not enough to let the personnel know what should be done. I'd suggest maybe 4.2.1d - shall have documents necessary for the effective planning, operation and control of processes. Or it could possibly be 7.5.1b - controlled conditions include work instructions as necessary.
The preventive maintenance jobs recommended by the manufacturer of the equipment are not carried out during maintenance (example: The preventive maintenance for Rolling Machine FACCIN model HAV/S -3172, Equipment Sl.No: RM/01 does not cover manufacturer’s recommendations for the preventive maintenance The equipment is not being properly maintained. As Howard suggested, 6.3b, or 7.5.1c - suitable equipment is required. Poorly maintained equipment is may not be suitable for producing conforming product.
Break down reports are prepared; however, these reports are not included as a standard attachment of the procedure and brought under the control of records.I don't see a requirement in ISO 9001 for this. If it's required, it's in your system.
Equipment history is not available for any machine to analyze the break down summary and machine availability.
Again, not required by ISO 9001. It may fall under 8.2.3 or 8.4 depending on how you've defined your processes and metrics.

AndyN
26th January 2009, 09:33 AM
Suresh:

These are poorly worded non-conformances, to begin with. None of these relate to ISO, as a result. Just like your auditors, we can debate them here, indeed it has started. If there is debate, something is wrong with the findings! Auditors need facts, not opinion! If I were the Maintenance Supervisor I would find a reason for all these situations! The auditors would go away feeling foolish!

The auditors must include your own qms requirements for these actions - the recording etc. in their findings. To write an nc against the standard is not enough.

The auditors have no evidence of any effects on the process regarding these findings - one can respond to each of them as "So what?" Without having some details about the effects of these non-conformities, Management will not treat them seriously.

Your auditors need help.......

JaneB
26th January 2009, 11:53 PM
Non Conformity Description :The following discrepancies were noted in the maintenance activities.

What were the audit criteria? ie, against what were you auditing? You refer to 'discrepancies' - discrepancies from what? Your opinion? Written procedures? etc etc.

For example, is it a problem to have preventive maintenance jobs not being specific to a particular machine? If so, what's the evidence of the problem or risk? And where is the requirement stated in your system?

As Andy says:

one can respond to each of them as "So what?" Without having some details about the effects of these non-conformities, Management will not treat them seriously.

First, your system needs to address the requirements. Then, write NCs against your own system. If you absolutely must pick a clause (why?), pick one that you think suits. But I think it's pretty much a waste of time a bunch of internal auditors arguing about which clause/s of a Standard to write NCs against. There are much more valuable activities.