Clause 6.3 Infrastructure - Clearing the Confusion

[Jen Kirley]

Good day CATERAF,

As my colleagues here have pointed out, there is no clear requirement for planned maintenance. The standard is asking for your system to have control.

So the handling of your infrastructure depends on your needs. If you have a clean room, you will probably have a HEPA filtration system to monitor for accurate performance as well as maintain for uninterrupted performance. If you have temperature/humidity needs for a laboratory, your infrastructure needs for that will probably also include some monitoring as well as maintenance to help make sure the controlled conditions are uninterrupted for production. Pneumatic and chill water systems might be needed to serve your production equipment, so you might need to maintain that if you want to control down time.

That's what it's generally about, you see. Meeting your goals, whether they be production or process control. Figure out what you need to do that, and get it done. The list of what to do PMs on, the type of work to do and when is not a record (it's a plan or tool), but evidence of completion would be.

 

[CATERAF]

Attempting to list every last conceivable piece of production equipment and set up a maintenance schedule for each one could be gross overkill and become a boondoggle to administer.

I agree! However, I'm thinking that some control is necessary. They have equipment out in the workshop that's blunt or not working and there's definite room for improvement.

Good day CATERAF,

As my colleagues here have pointed out, there is no clear requirement for planned maintenance. The standard is asking for your system to have control.

The list of what to do PMs on, the type of work to do and when is not a record (it's a plan or tool), but evidence of completion would be.

Thanks very much Jennifer (and all other posters!) - that clears it up immensely.

So, it would seem that we need to make sure we're controlled. Having a list of items to maintain may be useful for planning and control, but we don't need to show everytime we update it (e.g., sharpen a blunt tool).
In saying that, it may be useful recording it (seeing as I'm trying to get the staff used to that for everything else, we mightaswell be consistent!).
Time to speak to the manager and get this written!

Thanks for all your posts - very much appreciated

 

[RMain]

All we have in our manual is:

XXXX Company will determine, provide and maintain the infrastructure needed to achieve conformity to product and regulatory 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).

I've been Audited by ISO/FDA/Customers etc... and it's never been a problem.

My 2 cents

 

[Stijloor]

All we have in our manual is:

XXXX Company will determine, provide and maintain the infrastructure needed to achieve conformity to product and regulatory 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).

I've been Audited by ISO/FDA/Customers etc... and it's never been a problem.

My 2 cents

I am also an auditor and I am not interested what WILL happen, but more what is ACTUALLY happening.
I am not so impressed with a rehash of ISO Standard verbiage either.

 

[RMain]

I leave what will be happening to support the infrastructure in the related Procedures guided by training and written text with ties to objective evidence in the forms related to work instructions i.e. Forms / Templates / Data Collection.

I've always been able to show support of infrastructure with out creating seperate lists of equipment etc..., I've only created equipment listed for Calibration and Maintenance as part of ISO 7.6 etc.... as part of supporting infrastructure for example.

Again my 2 cents

 

[Jen Kirley]

All we have in our manual is:

XXXX Company will determine, provide and maintain the infrastructure needed to achieve conformity to product and regulatory 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).

I've been Audited by ISO/FDA/Customers etc... and it's never been a problem.

My 2 cents

Since there is no requirement for a documented procedure for planned maintenance in ISO 9001, this verbiage doesn't do much for me either; like Stijloor, I am more interested in what is being done and how effective it is in helping you achieve your goals, at least one of which may be impacted by unscheduled machine downtime. When I say things like "list" it is with the idea that some means is in place to know what you have as PM needs go, and a way to make sure they get done.

 

[Hanr3]

I too am an auditor, and don't really care if they recurgitate the standard. It comes down too; Can you show me evidence that you are meeting this requirement? I don't really care how you do it, as long as your doing it.




I keep my personal feelings out of the eqaution. I am there to audit thier processes to the Standard, not give them my two cents about what I like or don't like. Seen way too many processes modified to suit the auditor, what value does that add to the company?

 

[John Broomfield]

Hi,
I've been reading through the many many threads on Clause 6.3 Infrastructure to try and get a better understanding of how we are going to address this clause.
However, there seems to be a lot of difference in the way people have approached this clause.

On the one hand, there are those who think that the clause calls for a list of items that are needed to achieve product conformity, and then maintenance procedures and logs are a good idea to go with that (although records are not required by the clause).

In the other pool, there are those who don't think it's necessary to give a list of items, but rather it is sufficient that people within the organisation know to maintain items, or, if an item can be 'fixed' quickly then there is no need for maintenance at all.

This is the first time I've really examined this clause though and am quite confused as to what I need to do.

We do engineering and production for hardware and software.

Currently I'm thinking I need to draw up a list of the equipment that is essential for us to maintain. The criteria for being essential could be like that which was posted in another forum - "equipment that cannot be replaced within a day that would cause significant delays in processes should be considered for a preventive maintenance program".

These items could be those that are general, or those items we already have. Then, for each product developed, if there are additional items we could add them to the list. Another suggestion was to review it at management review meetings.

How does this sound as a way to go?
Would you advise stating the preventive maintenance (and records of when it needs to be done and when it's done) that we would do for these things? I mean, records aren't required, but it seems strange that they aren't.. they want you to maintain it, but how do you do that in a company (that's got more than a few people) without things being missed (e.g., missing things while maintaining something, or not maintaining something at all?)?

I welcome your thoughts please! I'm intrigued as to what one must do..

CATERAF,

If your organization is into 5S and TPM, the results would be plain for everyone to see.

You could also analyze and capture your management system's process for: Maintaining Facilities and Equipment including the objective(s) of this process. Some organizations add Utilities to this process. Critical infrastructure such as Cleanrooms would have their own process and process objective.

Then you have a basis for continually improving the infrastructure on which your organization depends.

John

PS, You may also need to include: Maintaining the Information Network too.

 

[Mikishots]

Hi,
I've been reading through the many many threads on Clause 6.3 Infrastructure to try and get a better understanding of how we are going to address this clause.
However, there seems to be a lot of difference in the way people have approached this clause.

On the one hand, there are those who think that the clause calls for a list of items that are needed to achieve product conformity, and then maintenance procedures and logs are a good idea to go with that (although records are not required by the clause).

In the other pool, there are those who don't think it's necessary to give a list of items, but rather it is sufficient that people within the organisation know to maintain items, or, if an item can be 'fixed' quickly then there is no need for maintenance at all.

This is the first time I've really examined this clause though and am quite confused as to what I need to do.

We do engineering and production for hardware and software.

Currently I'm thinking I need to draw up a list of the equipment that is essential for us to maintain. The criteria for being essential could be like that which was posted in another forum - "equipment that cannot be replaced within a day that would cause significant delays in processes should be considered for a preventive maintenance program".

These items could be those that are general, or those items we already have. Then, for each product developed, if there are additional items we could add them to the list. Another suggestion was to review it at management review meetings.

How does this sound as a way to go?
Would you advise stating the preventive maintenance (and records of when it needs to be done and when it's done) that we would do for these things? I mean, records aren't required, but it seems strange that they aren't.. they want you to maintain it, but how do you do that in a company (that's got more than a few people) without things being missed (e.g., missing things while maintaining something, or not maintaining something at all?)?

I welcome your thoughts please! I'm intrigued as to what one must do..

When addressing these requirements, start by describing the infrastructure you currently have, then outline how maintenance (operations and IT areas) and capital expenditures programs keep the existing infrastructure in good shape (and also how it may add to it). When you're done, your description should convince the reader that you have all the capital investment in place to fill orders from your customers and satisfy their needs.

A lot of people ask me about why I include IT/IS in this area; typically, I see that many companies exclude IT from their QMS, but they should NOT, since everything they do has an immediate and direct impact on a company's ability to operate the business and satisfy the customer's needs.

Keep in mind that just because a record isn't stated as being required, it doesn't mean that you cannot keep one. In addition to the required records, you need to keep the ones you need, in order to maintain control and maintain the effectiveness of your QMS.