Determining what are, and are not, Outsourced Processes

[somashekar]

Re: Determining what are and are not Outsourced Process

Ajay has not come back here after his November 2012 opening post. I hope he does.
John. Do you mean to say that a SLA in itself is a control on the process outsourced ?
I feel it forms the basis over which process begins to get outsourced. However the ongoing controls are actually the evidences of what stuff as stated in the agreement begins to happen, and are reviewed at appropriate times and agreed to be in order, and hence outsourced process is in order.

 

[John Broomfield]

Re: Determining what are and are not Outsourced Process

somashekar,

Yes, SLAs specify the requirements of the service and the agreed upon responsibilities for ensuring the requirements are fulfilled including any required records.

John

 

[ehoqa]

Re: Determining what are and are not Outsourced Process

Outsourced processes are typically related to the product/service that you sell to your customers.

This discussion has been helpful, as we have a minor finding from our surveillance audit for not identifying our outsourced processes. While they exist and are controlled, we didn't have them identified anywhere. The auditor told us it's a simple fix since we can meet the requirement by calling out which are outsourced on our approved supplier list. He mentioned that pest control, external calibration, and external lab testing are considered outsourced processes.

The outsourced processes directly related to the product are easy for me to identify. We outsource some cutting and painting processes in making our products. And sure, we use external calibration services for our measuring instruments and other external testing services.

But I wouldn't have thought of including pest control. Any hints on how to identify those not-so-directly-related to the product/service?

Some specific questions I have: We buy labels with our logo/address on it and then we print the product information in-house. Is the labeling (of just our logo/address) an outsourced service? If we have used a staffing agency to hire temps, should we include that as an outsourced service?

I might be thinking too much into it. Hope someone can help guide me in the right direction in identifying outsourced processes.

 

[Big Jim]

Re: Determining what are and are not Outsourced Process

This discussion has been helpful, as we have a minor finding from our surveillance audit for not identifying our outsourced processes. While they exist and are controlled, we didn't have them identified anywhere. The auditor told us it's a simple fix since we can meet the requirement by calling out which are outsourced on our approved supplier list. He mentioned that pest control, external calibration, and external lab testing are considered outsourced processes.

The outsourced processes directly related to the product are easy for me to identify. We outsource some cutting and painting processes in making our products. And sure, we use external calibration services for our measuring instruments and other external testing services.

But I wouldn't have thought of including pest control. Any hints on how to identify those not-so-directly-related to the product/service?

Some specific questions I have: We buy labels with our logo/address on it and then we print the product information in-house. Is the labeling (of just our logo/address) an outsourced service? If we have used a staffing agency to hire temps, should we include that as an outsourced service?

I might be thinking too much into it. Hope someone can help guide me in the right direction in identifying outsourced processes.

There is no requirement to list your outsourced processes.

What the standard says is:

"Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to those processes shall be defined within the quality management system."

I don't see list in there anywhere.

You should appeal that nonconformance. The auditor appears to have fallen into "requirement creep".

I would view buying labels as simply making a purchase, not outsourcing.

The Auditing Practices Group has published guidelines on outsourcing that you may find useful. Google TC-176 and look on their site for Auditing Practices Group and look for information on outsourcing. TC-176 is the technical committee within ISO that is responsible for ISO 9001:2008.

 

[ehoqa]

Re: Determining what are and are not Outsourced Process

Hi Big Jim,

Thanks for your reply. The requirement is actually from ISO 13485... I did a search for "outsourced processes" and ended up on this thread. I figured the topic is similar enough.

ISO 13485 says under 4.1 "Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system"

It says we need to identify the outsourced processes. While this can be done in several ways, we already have an approved supplier list, and the auditor brought up that by marking them in our existing supplier list, it would satisfy the requirement. But that's besides the point. I was having trouble actually identifying the outsourced processes besides the ones directly related to our product.

 

[harry]

Re: Determining what are and are not Outsourced Process

...............I was having trouble actually identifying the outsourced processes besides the ones directly related to our product.

1. Have you check ISO's guidance document on this topic?

2. This article gives a list of examples - not sure if it helps.

 

[John Broomfield]

Re: Determining what are and are not Outsourced Process

Hi Big Jim,

Thanks for your reply. The requirement is actually from ISO 13485... I did a search for "outsourced processes" and ended up on this thread. I figured the topic is similar enough.

ISO 13485 says under 4.1 "Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system"

It says we need to identify the outsourced processes. While this can be done in several ways, we already have an approved supplier list, and the auditor brought up that by marking them in our existing supplier list, it would satisfy the requirement. But that's besides the point. I was having trouble actually identifying the outsourced processes besides the ones directly related to our product.

ehoqa,

You've listed the processes directly related to your product.

Now list the processes that affect product conformity to requirements.

This may include outsourced processes that indirectly are related to your product such as processes that are part of maintaining the work environment so it is conducive to quality (6.4).

Without knowing your product and your production facility it is difficult to be more helpful.

John

 

[Big Jim]

Re: Determining what are and are not Outsourced Process

Hi Big Jim,

Thanks for your reply. The requirement is actually from ISO 13485... I did a search for "outsourced processes" and ended up on this thread. I figured the topic is similar enough.

ISO 13485 says under 4.1 "Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system"

It says we need to identify the outsourced processes. While this can be done in several ways, we already have an approved supplier list, and the auditor brought up that by marking them in our existing supplier list, it would satisfy the requirement. But that's besides the point. I was having trouble actually identifying the outsourced processes besides the ones directly related to our product.

I'm not sure how I wandered into 13485 land where I have very little knowledge so I apologize.

Still, even with the somewhat different wording, it doesn't look like it is requiring a list, rather that you need to identify the controls over outsourcing.

 

[maris1]

Re: Determining what are and are not Outsourced Process

In accordance with ISO, All process that affects the quality of the product or service should be included. The outsource process as external calibration services should be controlled.

 

[ehoqa]

Thanks for all your help! (Love this place!)

The examples from the link Harry provided helped: "However, some outsourced processes are often overlooked, including hiring and training, internal auditing, calibration, lab testing, customer surveys, call centers, purchasing, field service, equipment preventive maintenance, installation, and records archiving."

I'm pretty new to this so the links and all your responses will give me something to work with. Appreciate it much!