Auditing the Engineering Project/CAPEX process

I've been asked to conduct an internal audit on the Engineering Project process, from the approval of finance to the delivery of the project.

We're a chemical supplier, so the engineering projects are not a service sold to a customer. The projects are designed to enable us to create the products that we supply to customers.

Auditing against the internal processes is going to be fairly straightforward. Here's the process, is it being followed?

My question is this: what parts of the ISO9001 standard should I be auditing the process against? ISO9001 goes into great depth about products and services supplied to customers, but there is little that directly references things like projects that are designed to enable the supply of products or services.

Thanks in advance...

 

Ive been involved in Engineering/project and I know what is managed, when is needed to comply with Iso,tomorrow I,ll share information about it.

 

You have to consider the internal customers as well as external customers. With a process with no clear access to the final,outside customer, I look at a process flow of the entire process. Chances are you will find several internal customers, from purchasing to design to tooling to production. Each of these are considered internal customers. When one area's inputs are outputs from another department, you have customers. The inputs for design, for example, are the outputs from the purchasing department (prints, requirements, product definitions, etc). The outputs of design form the basis of the inputs of production's process. Not all customers are outside your organization.

 

I've picked up a copy of Craig Cochran's newly published book, ISO 9001:2015 in Plain English. It does set out clearly that the internal customer is covered as Emmyd has stated. Unfortunately, this means that the audit has grown significantly, as sections 7 through 10 will all apply, at least in part. Such is life.

 

PDCA approach is the great starting point. I hope this helps.
Plan (section 6 and 7 of the ISO9001:2015)
Are methodologies defined to obtain Customer requirements? Are Customer requirements refined to indicate product requirements in objective terms?
Are Quality, Cost, Delivery measures available with operational definition?
Are targets fixed for QCD measures?
Is procedure defined for New Product initiation?
Are process deliverables defined?
Is time plan prepared based on procedure?
Are verification, validations planned as per procedure at appropriate intervals?
Are standard for Verification/Validation available and approved?
Are reviews planned at appropriate intervals?
Is the Project Organization defined, competitive and Cross functional in nature?

Do (section 8 0f ISO9001:2015 standard)
Have all above been carried out as per plan?

Check (section 9 of ISO9001:2015)
Are Verification/Validation results, Process deliverables, etc checked against planned acceptance criteria?
Are QCD results checked against planned target?
Are reviews carried out against set of criteria?

Act (section 10 of the ISO9001:2015)
Have all the gaps identified during 'Check' stage, followed up with Correction, Containment action, Corrective action, Preventive action whichever is deemed appropriate?
Are Lesson learned compiled and documented?
Are design changes planned and if so, appropriate 'Plan' points as above are adhered?

 

Then we revert to a standard checklist for Design and Development? Then we can just add the questions: How do you determine the effectiveness and how do you measure effectiveness? What is the risk to the customer and the QMS? If we cover those have we conducted an effective internal audit?

 

I think you knew what I was asking because your answers are what I wanted to hear. Thank you Andy.

 

I want to thank you for your input. It's been valuable.

I work for a chemical processing company. The engineering function is responsible for the infrastructure available on site. For this audit, we have chosen a project that involved the construction of a bulk liquid nitrogen tank, to replace a pipeline that used to supply the site. There will be some Design having gone into the project, no doubt of it.

I can see the discussion that you've been having - which it seems to me is on of process based audits against the audits that are based on the clauses of the standard. I get that. However, the circumstances in play within the company are going to force me (I suspect) to conduct a clause based audit, largely because there appear to be large gaps present in the company's processes. This will probably be the first non-conformance from the audit.

What I've been able to locate so far are procedures that revolve around safety. Specific to the engineering/CAPEX project are two: firstly there is a procedure to conduct HAZOPs, at various stages throughout the life of the project, and the second is Management Of Change, which kicks in if there are late changes in the design, after the early HAZOPs have been conducted.

There seems to be no over-arching procedure that maps out the engineering/CAPEX project process, something that should be in place.

 

I believe that the audit will show them that gaps exist. I've been considering that the company should have a Conformity Matrix (something like this one), in order to map the requirements in our QMS. Do you think it's worthwhile?

 

Andy,
Thanks for the warning. The Design requirements are certainly included in the audit - in my opinion.

The audit just forms a part of the ongoing internal audit process - business as usual. From my perspective it's unusual because I've never had to audit this area before. Some people in my line of work are heavily involved in engineering. I'm not - it's a service that another department provides and I don't tend to get involved in it.

As far as the results go, it will be business as usual as well. If there are non-conformities, they will be handled through the usual processes.

I understand your warning, but fortunately the company expects internal audits to show non-conformances here and there. The attitude is that we want to find problems before the certifying body auditors do.

 

Gentlemen,

A very interesting discussion! But might anyone be able to offer a few robust examples of a (staged) product design checklist? I am working with a medical device manufacturer and our team has been asked to revisit the current (disparate) protocols. Our task is to develop a solid product design/development checklist for the product engineers, in order to provide both specific requirements and add some needed standardization to this activity. Any help would be greatly appreciated!

 

Regarding the above matrix, it's my understanding that Improvement must be taken into consideration for every process defined as well. --continual improvement anyway.

 

After much delay, the audit is complete - well as much as I can do anyway. The problem is that the folder containing most of the work has disappeared. I don't see this as deliberate. It will be either (a) sitting on somebody's desk or (b) misfiled to the wrong area. What do I do? Ask them to locate the file? Threaten a non-conformance? Go along with their assurances that the work has been done? I will acknowledge that the project has been completed and the results are acceptable at the very least, so I have no reason to believe that the work wasn't carried out in accordance with the QMS.