AS9100 Rev C - Determining, Providing and Maintaining" Infrastructure

  • Thread starter Mario Alberto83
  • Start date
M

Mario Alberto83

#1
Hello colleagues

I would be very grateful for your point of view related to the 6.3 clause in the standard, I have a proposal of how to comply with "determining, providing and maintaining" infrastructure.

I am working on the QMS for the company I work for and I always try to interpret the clauses and requirement by myself and propose instead of going asking and asking. I would like you guys to provide me your valuable feedback and guidance.

I decided to meet this clause with a work instruction, please see the very basic draft in the attachment.

Thank you all in advance for your contributions.
 

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Hodgepodge

#4
Hello colleagues

I would be very grateful for your point of view related to the 6.3 clause in the standard, I have a proposal of how to comply with "determining, providing and maintaining" infrastructure.

I am working on the QMS for the company I work for and I always try to interpret the clauses and requirement by myself and propose instead of going asking and asking. I would like you guys to provide me your valuable feedback and guidance.

I decided to meet this clause with a work instruction, please see the very basic draft in the attachment.

Thank you all in advance for your contributions.
There isn’t really a necessity for a work instruction to meet the requirements of 6.3. If you look at 6.3 requirement by requirement you may see what I mean.

AS9100C Section 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).​
The requirement is to provide and maintain. The provision of the infrastructure should be self evident. For example: if you don’t have the proper machinery to manufacture a specific item, it isn’t likely (though not impossible) that your price will be competitive, so you probably won’t receive a contract/order. This may be over-simplifying it, but don't go to extra lengths to over-complicate it. Determining the need for new or additional workspace, machinery, etc. could be part of manufacturing engineering and/or contract review. Do we have what we need to get the job done? No. Build a new fixture, buy a new machine or inspection equipment, add on to the building, build a controlled environment lab, etc. Sometimes these are “big picture” business decisions made by top management. It is doubtful that a standalone work instruction will be of value for these types of decisions.​

Maintenance of the infrastructure should be determined department by department or item by item. The shipping department can have its own instructions for how often to have the delivery vehicle serviced. Production equipment should be maintained per the manufacturer’s instructions. The production department or maintenance department can maintain instructions as appropriate for these items. The recall of inspection equipment and tooling can be planned for by a calibration process instruction. A company-wide adoption of 5S principles can be a big help to maintaining the work environment. Each department would then determine responsibilities and maintain records.​

Instead of having a separate instruction for 6.3, have the planning of the other parts of your Quality Management System include the requirements for appropriate provision and maintenance. Provision and maintenance should be considered general requirements for the planning of the QMS. The approval process for changes to your QMS could determine, instruction by instruction, what aspects of 6.3 needs to be addressed in an instruction. For verification, an internal quality audit could be planned with the goal of determining compliance to section 6.3. process by process. Seeing a process in action and talking to employees is a great way to determine how effective a company is at provision and maintenance of its infrastructure.​

Instead of creating an instruction for each clause of the standard, build the requirements into the instructions/procedures you will actually use.​
 
M

Mario Alberto83

#5
Hello Hodgepodge, I am a little late on the reply, just wanted to thoroughly review your input provided and now I am clearer, thanks a lot.

- In case of buildings, workspace and utilities, they are maintained per the process we have for 7.5.1 (j) "Control of production and service Provision"

- In case of process equipment (hw and sw), they are maintained per the process we have for 7.5.1.3 "Control of production equipment, tools and software programs" for production and Per 7.6 "Control of monitoring and measuring equipment" for product acceptance.

I just have a question related to supporting services (comunication, IT, etc.), they can not be met or considered within other clauses of the standard because product conformity do not depend on them, supporting services are determined as per organization operation.

Based on this, I would think of generating a document that covers maintenance to supporting services not covered in other clauses.

What would you recommend? Do you think I am on the way? Do you think it is the ideal way to face this?

Thank you and regards
 
H

Hodgepodge

#6
You certainly could create a document to control these items. It may not be necessary based on the size of your company, how these ancillary services are related to production and/or you company's ability to function, the competence of personnel, etc.

If the culture of your company is such that the lines of communication between people, processes, and departments is open and flowing, the communication would be self evident. Depending on your company, IT may be very interconnected with production. For instance, are all programs available to users even if some of your computers or servers go down? You know your company. If you understand how IT is interrelated to your other processes, you will be the best judge of how much control you need to exercise over it. If you feel the process may easily go out of control, document some guidelines, otherwise, don't worry about it. You can ask this question, "Will IT ever use the document?" If the answer is yes, then create it. If not, find out why. If you can be convinced that the process will remain under control without it, don't document it.
 

Big Jim

Super Moderator
#7
It is worth noting that the standard calls for neither a documented procedure or records for element 6.3.

That said, many if not most companies would not want to operate without them. Bear in mind that once you say that you have a written procedure (or work instruction) or that you will keep maintenance records, you will need to do so.

If you are a small company and have no trouble keeping after maintenance, you may not want to encumber yourself in that manner. If you see value in it, do it.
 
M

Mario Alberto83

#8
Thank you guys for your input, they all are useful for me.

I think I will cover this in our documentation for 7.5.1 maybe including some general statements for supporting services maintenance. 7.5.1 requires control for utilities and supplies to the extent they affect conformity to product requirements. This clause does not exclude other types of utilities/supplies such as communication devices, servers, etc. I think they all can be managed the same way as long as I meet 7.5.1 intend. I think QMS should be suitable for the current operation and consider further situations if feasible; the company I work for is small but the projection is to have an important growth and expand service scope so we should be prepared in some way and avoid future gaps. QMS should be aligned to company plans and objectives.

Best Regards and thanks again.
 
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