Regulatory Open Forum

Hi RAPS experts,

could you please advise on the following.

how can we deal with the case where we have purchased critical materials from unapproved supplier (not in our approved supplier list)? as per our procedure, critical materials have to sourced from approved supplier only. is this a non-conformance? if yes, what is the root cause that I can attribute this to? we do not have any additional controls to ensure materials conformity in such case.

the problem is that purchasing department keeps buying critical materials from this supplier even after realizing it is not on our approval list. not sure if we need to raise CAPA or NC is sufficient?  we are currently at the last stage of approval process for this supplier.

we are a small RUO manufacturer company with ISO-13485 CERT.

any help and advice on this are highly appreciated.

Thanks.

This is a non-conformance because your company, purchasing, has failed to follow your company's procedure.

There is no such thing as "root cause" in quality. You won't find the term in either ISO 13485:2016 or ISO 9000:2015. It is a concoction of the Department of Redundancy Department. The correct term is "cause".

It is hard to determine the cause without a little more information. For example, the purchasing procedures could be deficient in that they don't have this requirement. Perhaps, the purchasing agents have not been trained. Perhaps, they just choose to ignore the procedure because they are under pressure to bring in inventory. You need to conduct an investigation.

There is no such thing as a CAPA. In this case, because you have a detected nonconformance, a corrective action is appropriate. A preventive action doesn't enter consideration.

The corrective action includes an investigation to determine the cause and actions to prevent recurrence.

Is there some reason why the supplier is unapproved? Does the company use the material anyway? If so, you might have a bigger problem.<o:p></o:p>

Hi RAPS experts,

could you please advise on the following.

how can we deal with the case where we have purchased critical materials from unapproved supplier (not in our approved supplier list)? as per our procedure, critical materials have to sourced from approved supplier only. is this a non-conformance? if yes, what is the root cause that I can attribute this to? we do not have any additional controls to ensure materials conformity in such case.

the problem is that purchasing department keeps buying critical materials from this supplier even after realizing it is not on our approval list. not sure if we need to raise CAPA or NC is sufficient?  we are currently at the last stage of approval process for this supplier.

we are a small RUO manufacturer company with ISO-13485 CERT.

any help and advice on this are highly appreciated.

Thanks.

 @Dan O'Leary Thank you for taking time to answer.

purchasing people were not aware that this supplier is not approved. it came to their attention when IQC department informed them that they received the wrong material! a NC was opened for the wrong incoming material  and through this the supplier was identifies as unapproved one.  The wrong material was quarantined and the supplier was informed. it was decided to keep the material in quarantine to check if we need it for another application!
purchasing department placed another order (to get the required material) with this supplier while working on approval process!

Regards,
 

This is a non-conformance because your company, purchasing, has failed to follow your company's procedure.

There is no such thing as "root cause" in quality. You won't find the term in either ISO 13485:2016 or ISO 9000:2015. It is a concoction of the Department of Redundancy Department. The correct term is "cause".

It is hard to determine the cause without a little more information. For example, the purchasing procedures could be deficient in that they don't have this requirement. Perhaps, the purchasing agents have not been trained. Perhaps, they just choose to ignore the procedure because they are under pressure to bring in inventory. You need to conduct an investigation.

There is no such thing as a CAPA. In this case, because you have a detected nonconformance, a corrective action is appropriate. A preventive action doesn't enter consideration.

The corrective action includes an investigation to determine the cause and actions to prevent recurrence.

Is there some reason why the supplier is unapproved? Does the company use the material anyway? If so, you might have a bigger problem.<o:p></o:p>

Hi RAPS experts,

could you please advise on the following.

how can we deal with the case where we have purchased critical materials from unapproved supplier (not in our approved supplier list)? as per our procedure, critical materials have to sourced from approved supplier only. is this a non-conformance? if yes, what is the root cause that I can attribute this to? we do not have any additional controls to ensure materials conformity in such case.

the problem is that purchasing department keeps buying critical materials from this supplier even after realizing it is not on our approval list. not sure if we need to raise CAPA or NC is sufficient?  we are currently at the last stage of approval process for this supplier.

we are a small RUO manufacturer company with ISO-13485 CERT.

any help and advice on this are highly appreciated.

Thanks.

Hi Anon

It sounds like you don't really know the cause yet. As part of the investigation, it would be good to talk with the people in the purchasing department and hear their thoughts. Why didn't they know the supplier is not approved? How do they usually know if a potential supplier is approved or not? Could there be a better way to make the information available, that works with their process, so they can be confident in knowing when it's ok or not ok to buy from any supplier?

 @Dan O'Leary Thank you for taking time to answer.

purchasing people were not aware that this supplier is not approved. it came to their attention when IQC department informed them that they received the wrong material! a NC was opened for the wrong incoming material  and through this the supplier was identifies as unapproved one.  The wrong material was quarantined and the supplier was informed. it was decided to keep the material in quarantine to check if we need it for another application!
purchasing department placed another order (to get the required material) with this supplier while working on approval process!

Regards,
 

This is a non-conformance because your company, purchasing, has failed to follow your company's procedure.

There is no such thing as "root cause" in quality. You won't find the term in either ISO 13485:2016 or ISO 9000:2015. It is a concoction of the Department of Redundancy Department. The correct term is "cause".

It is hard to determine the cause without a little more information. For example, the purchasing procedures could be deficient in that they don't have this requirement. Perhaps, the purchasing agents have not been trained. Perhaps, they just choose to ignore the procedure because they are under pressure to bring in inventory. You need to conduct an investigation.

There is no such thing as a CAPA. In this case, because you have a detected nonconformance, a corrective action is appropriate. A preventive action doesn't enter consideration.

The corrective action includes an investigation to determine the cause and actions to prevent recurrence.

Is there some reason why the supplier is unapproved? Does the company use the material anyway? If so, you might have a bigger problem.<o:p></o:p>

Hi RAPS experts,

could you please advise on the following.

how can we deal with the case where we have purchased critical materials from unapproved supplier (not in our approved supplier list)? as per our procedure, critical materials have to sourced from approved supplier only. is this a non-conformance? if yes, what is the root cause that I can attribute this to? we do not have any additional controls to ensure materials conformity in such case.

the problem is that purchasing department keeps buying critical materials from this supplier even after realizing it is not on our approval list. not sure if we need to raise CAPA or NC is sufficient?  we are currently at the last stage of approval process for this supplier.

we are a small RUO manufacturer company with ISO-13485 CERT.

any help and advice on this are highly appreciated.

Thanks.

It is interesting that Dan notes that there is no root cause in quality. The following is from the BSI nonconformity report:

It is essential that the CAP includes the following elements:
1. The unique identifier (the Finding Reference as detailed in this report and where applicable, any internal identifier assigned within your organisation).
2. Statement of non-conformity.
3. Root Cause Analysis. You must clearly indicate if this is a single site issue, or exists across all or other named sites as applicable.
4. Relevant Immediate Correction (where applicable). Please clearly indicate where the corrections are across single or all or other named sites.
5. Relevant and Proportionate Corrective Action. Please clearly indicate where the corrective actions are across single or all or other named sites.
6. Person/s responsible.
7. Time for completion of all identified actions, and where necessary, across all affected sites.

Regards,

Hi Anon

It sounds like you don't really know the cause yet. As part of the investigation, it would be good to talk with the people in the purchasing department and hear their thoughts. Why didn't they know the supplier is not approved? How do they usually know if a potential supplier is approved or not? Could there be a better way to make the information available, that works with their process, so they can be confident in knowing when it's ok or not ok to buy from any supplier?

 @Dan O'Leary Thank you for taking time to answer.

purchasing people were not aware that this supplier is not approved. it came to their attention when IQC department informed them that they received the wrong material! a NC was opened for the wrong incoming material  and through this the supplier was identifies as unapproved one.  The wrong material was quarantined and the supplier was informed. it was decided to keep the material in quarantine to check if we need it for another application!
purchasing department placed another order (to get the required material) with this supplier while working on approval process!

Regards,
 

This is a non-conformance because your company, purchasing, has failed to follow your company's procedure.

There is no such thing as "root cause" in quality. You won't find the term in either ISO 13485:2016 or ISO 9000:2015. It is a concoction of the Department of Redundancy Department. The correct term is "cause".

It is hard to determine the cause without a little more information. For example, the purchasing procedures could be deficient in that they don't have this requirement. Perhaps, the purchasing agents have not been trained. Perhaps, they just choose to ignore the procedure because they are under pressure to bring in inventory. You need to conduct an investigation.

There is no such thing as a CAPA. In this case, because you have a detected nonconformance, a corrective action is appropriate. A preventive action doesn't enter consideration.

The corrective action includes an investigation to determine the cause and actions to prevent recurrence.

Is there some reason why the supplier is unapproved? Does the company use the material anyway? If so, you might have a bigger problem.<o:p></o:p>

Hi RAPS experts,

could you please advise on the following.

how can we deal with the case where we have purchased critical materials from unapproved supplier (not in our approved supplier list)? as per our procedure, critical materials have to sourced from approved supplier only. is this a non-conformance? if yes, what is the root cause that I can attribute this to? we do not have any additional controls to ensure materials conformity in such case.

the problem is that purchasing department keeps buying critical materials from this supplier even after realizing it is not on our approval list. not sure if we need to raise CAPA or NC is sufficient?  we are currently at the last stage of approval process for this supplier.

we are a small RUO manufacturer company with ISO-13485 CERT.

any help and advice on this are highly appreciated.

Thanks.

John,

The term root cause is one of those terms that have crept into the quality lexicon. Unfortunately, it is a term with no meaning.

Consider FDA QSR, ISO 13485:2016, and ISO 9000:2015. The term does not appear in any of these documents.

I suspect that the term came from a misunderstanding when somebody said we "we must get to the root of the problem". This led, in my theory, to somebody believing  this must be the root cause.

Over the years the problem has gotten worse. I often hear people say that we must find the "true root cause". Have we been finding false root causes all these years?

The term also carries the connotation that every nonconformance has a single cause, the root cause. This is seldom true. Usually there is a chain of things that must go wrong, i.e., a sequence of events. It is a rare case that there is one and only one cause.

The fact that BSI uses the term only shows how pervasive the misconception is.

My recommendation is that we, as quality practitioners, don't use the term. Instead recognize that cause is the correct term and it includes chains of occurrences.<o:p></o:p>

It is interesting that Dan notes that there is no root cause in quality. The following is from the BSI nonconformity report:

It is essential that the CAP includes the following elements:
1. The unique identifier (the Finding Reference as detailed in this report and where applicable, any internal identifier assigned within your organisation).
2. Statement of non-conformity.
3. Root Cause Analysis. You must clearly indicate if this is a single site issue, or exists across all or other named sites as applicable.
4. Relevant Immediate Correction (where applicable). Please clearly indicate where the corrections are across single or all or other named sites.
5. Relevant and Proportionate Corrective Action. Please clearly indicate where the corrective actions are across single or all or other named sites.
6. Person/s responsible.
7. Time for completion of all identified actions, and where necessary, across all affected sites.

Regards,

Hi Anon

It sounds like you don't really know the cause yet. As part of the investigation, it would be good to talk with the people in the purchasing department and hear their thoughts. Why didn't they know the supplier is not approved? How do they usually know if a potential supplier is approved or not? Could there be a better way to make the information available, that works with their process, so they can be confident in knowing when it's ok or not ok to buy from any supplier?

 @Dan O'Leary Thank you for taking time to answer.

purchasing people were not aware that this supplier is not approved. it came to their attention when IQC department informed them that they received the wrong material! a NC was opened for the wrong incoming material  and through this the supplier was identifies as unapproved one.  The wrong material was quarantined and the supplier was informed. it was decided to keep the material in quarantine to check if we need it for another application!
purchasing department placed another order (to get the required material) with this supplier while working on approval process!

Regards,
 

This is a non-conformance because your company, purchasing, has failed to follow your company's procedure.

There is no such thing as "root cause" in quality. You won't find the term in either ISO 13485:2016 or ISO 9000:2015. It is a concoction of the Department of Redundancy Department. The correct term is "cause".

It is hard to determine the cause without a little more information. For example, the purchasing procedures could be deficient in that they don't have this requirement. Perhaps, the purchasing agents have not been trained. Perhaps, they just choose to ignore the procedure because they are under pressure to bring in inventory. You need to conduct an investigation.

There is no such thing as a CAPA. In this case, because you have a detected nonconformance, a corrective action is appropriate. A preventive action doesn't enter consideration.

The corrective action includes an investigation to determine the cause and actions to prevent recurrence.

Is there some reason why the supplier is unapproved? Does the company use the material anyway? If so, you might have a bigger problem.<o:p></o:p>

Hi RAPS experts,

could you please advise on the following.

how can we deal with the case where we have purchased critical materials from unapproved supplier (not in our approved supplier list)? as per our procedure, critical materials have to sourced from approved supplier only. is this a non-conformance? if yes, what is the root cause that I can attribute this to? we do not have any additional controls to ensure materials conformity in such case.

the problem is that purchasing department keeps buying critical materials from this supplier even after realizing it is not on our approval list. not sure if we need to raise CAPA or NC is sufficient?  we are currently at the last stage of approval process for this supplier.

we are a small RUO manufacturer company with ISO-13485 CERT.

any help and advice on this are highly appreciated.

Thanks.

This is a non-conformance because your company, purchasing, has failed to follow your company's procedure.

There is no such thing as "root cause" in quality. You won't find the term in either ISO 13485:2016 or ISO 9000:2015. It is a concoction of the Department of Redundancy Department. The correct term is "cause".

It is hard to determine the cause without a little more information. For example, the purchasing procedures could be deficient in that they don't have this requirement. Perhaps, the purchasing agents have not been trained. Perhaps, they just choose to ignore the procedure because they are under pressure to bring in inventory. You need to conduct an investigation.

There is no such thing as a CAPA. In this case, because you have a detected nonconformance, a corrective action is appropriate. A preventive action doesn't enter consideration.

The corrective action includes an investigation to determine the cause and actions to prevent recurrence.

Is there some reason why the supplier is unapproved? Does the company use the material anyway? If so, you might have a bigger problem.<o:p></o:p>

Hi RAPS experts,

could you please advise on the following.

how can we deal with the case where we have purchased critical materials from unapproved supplier (not in our approved supplier list)? as per our procedure, critical materials have to sourced from approved supplier only. is this a non-conformance? if yes, what is the root cause that I can attribute this to? we do not have any additional controls to ensure materials conformity in such case.

the problem is that purchasing department keeps buying critical materials from this supplier even after realizing it is not on our approval list. not sure if we need to raise CAPA or NC is sufficient?  we are currently at the last stage of approval process for this supplier.

we are a small RUO manufacturer company with ISO-13485 CERT.

any help and advice on this are highly appreciated.

Thanks.