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.

You have a variety of potential root causes. The first that comes to mind is inadequate training in SOPs (purchasing group); inadequate SOPs; and there are likely to be some others I cannot list as I am not familiar with your organization. The CAPA for the inadequate training is retraining and likely to include a few other points (such as scheduled refresher training). The preventive part could potentially be to improve the SOP on approved suppliers, or perhaps improve access to the list of approved suppliers. This could also be the corrective part if the root cause is an inadequate SOP.

Considering that the purchase of this critical material from an unapproved supplier persists, I would recommend that QA and regulatory meet with this group and have a "come to Jesus" talk about compliance and meeting regulatory commitments, and the potential impact of failing to do both. If all else fails it may be necessary to involve HR or executive management.

For the record, "root cause analysis" and "CAPA" are commonly used terms in both drug and device industries as well as many others; CAPA is found in 820.100 and many other locations. 

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.

Thank you all for your thoughts and clarification on this.

As I mentioned early, we are a small RUO manufacturer. we granted ISO-13485 Cert only last year. before this, there was no proper QMS system to record and document processes. the supplier issue was spotted after implementing the QMS!.

i am planning to close this NC identifying  "root cause" as lack of procedure. Correction: we have implemented supplier system management as a requirement of ISO as this is the best i can do now.

Regards.

You have a variety of potential root causes. The first that comes to mind is inadequate training in SOPs (purchasing group); inadequate SOPs; and there are likely to be some others I cannot list as I am not familiar with your organization. The CAPA for the inadequate training is retraining and likely to include a few other points (such as scheduled refresher training). The preventive part could potentially be to improve the SOP on approved suppliers, or perhaps improve access to the list of approved suppliers. This could also be the corrective part if the root cause is an inadequate SOP.

Considering that the purchase of this critical material from an unapproved supplier persists, I would recommend that QA and regulatory meet with this group and have a "come to Jesus" talk about compliance and meeting regulatory commitments, and the potential impact of failing to do both. If all else fails it may be necessary to involve HR or executive management.

For the record, "root cause analysis" and "CAPA" are commonly used terms in both drug and device industries as well as many others; CAPA is found in 820.100 and many other locations. 

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.

You have a variety of potential root causes. The first that comes to mind is inadequate training in SOPs (purchasing group); inadequate SOPs; and there are likely to be some others I cannot list as I am not familiar with your organization. The CAPA for the inadequate training is retraining and likely to include a few other points (such as scheduled refresher training). The preventive part could potentially be to improve the SOP on approved suppliers, or perhaps improve access to the list of approved suppliers. This could also be the corrective part if the root cause is an inadequate SOP.

Considering that the purchase of this critical material from an unapproved supplier persists, I would recommend that QA and regulatory meet with this group and have a "come to Jesus" talk about compliance and meeting regulatory commitments, and the potential impact of failing to do both. If all else fails it may be necessary to involve HR or executive management.

For the record, "root cause analysis" and "CAPA" are commonly used terms in both drug and device industries as well as many others; CAPA is found in 820.100 and many other locations. 

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.

While true that " 'root cause analysis' and 'CAPA' are commonly used terms in both drug and device industries as well as many others" it just means there is a common mistake. Root cause implies there is one cause for the problem investigated. This is rarely, if ever true. A problem needs a sequence of events, more than one thing, to arise. Multiple things need to go wrong at the same time. (There is a lot of work on this problem as an application of the Swiss Cheese Model.) To assume there is a "root cause" is to fail to understand how problems arise.

Note that neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term. The best approach is to stop using a term that causes confusion and leads to inadequate investigations.

"CAPA is found in 820.100 and many other locations." This is a misunderstanding. Neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term "CAPA". 820.100 is named "Corrective and preventive action", not CAPA. In ISO 13485:2016, the corresponding section is 8.5 Improvement.

In addition, GHTF/SG3/N18:2010 advises against the term saying, "The acronym 'CAPA' will not be used in this document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action."

I often hear that someone wants to "open a CAPA". This is not correct because CA and PA are two different processes with two different applications; each address a different type of problem and are not used together.

The best approach is to stop using a term that causes confusion and leads to incorrect application of the processes.<o:p></o:p>

You have a variety of potential root causes. The first that comes to mind is inadequate training in SOPs (purchasing group); inadequate SOPs; and there are likely to be some others I cannot list as I am not familiar with your organization. The CAPA for the inadequate training is retraining and likely to include a few other points (such as scheduled refresher training). The preventive part could potentially be to improve the SOP on approved suppliers, or perhaps improve access to the list of approved suppliers. This could also be the corrective part if the root cause is an inadequate SOP.

Considering that the purchase of this critical material from an unapproved supplier persists, I would recommend that QA and regulatory meet with this group and have a "come to Jesus" talk about compliance and meeting regulatory commitments, and the potential impact of failing to do both. If all else fails it may be necessary to involve HR or executive management.

For the record, "root cause analysis" and "CAPA" are commonly used terms in both drug and device industries as well as many others; CAPA is found in 820.100 and many other locations. 

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.

While true that " 'root cause analysis' and 'CAPA' are commonly used terms in both drug and device industries as well as many others" it just means there is a common mistake. Root cause implies there is one cause for the problem investigated. This is rarely, if ever true. A problem needs a sequence of events, more than one thing, to arise. Multiple things need to go wrong at the same time. (There is a lot of work on this problem as an application of the Swiss Cheese Model.) To assume there is a "root cause" is to fail to understand how problems arise.

Note that neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term. The best approach is to stop using a term that causes confusion and leads to inadequate investigations.

"CAPA is found in 820.100 and many other locations." This is a misunderstanding. Neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term "CAPA". 820.100 is named "Corrective and preventive action", not CAPA. In ISO 13485:2016, the corresponding section is 8.5 Improvement.

In addition, GHTF/SG3/N18:2010 advises against the term saying, "The acronym 'CAPA' will not be used in this document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action."

I often hear that someone wants to "open a CAPA". This is not correct because CA and PA are two different processes with two different applications; each address a different type of problem and are not used together.

The best approach is to stop using a term that causes confusion and leads to incorrect application of the processes.<o:p></o:p>

You have a variety of potential root causes. The first that comes to mind is inadequate training in SOPs (purchasing group); inadequate SOPs; and there are likely to be some others I cannot list as I am not familiar with your organization. The CAPA for the inadequate training is retraining and likely to include a few other points (such as scheduled refresher training). The preventive part could potentially be to improve the SOP on approved suppliers, or perhaps improve access to the list of approved suppliers. This could also be the corrective part if the root cause is an inadequate SOP.

Considering that the purchase of this critical material from an unapproved supplier persists, I would recommend that QA and regulatory meet with this group and have a "come to Jesus" talk about compliance and meeting regulatory commitments, and the potential impact of failing to do both. If all else fails it may be necessary to involve HR or executive management.

For the record, "root cause analysis" and "CAPA" are commonly used terms in both drug and device industries as well as many others; CAPA is found in 820.100 and many other locations. 

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.

You do make some very good points, Dan O'Leary. I notice you cite device-related sources only. I am strictly biotech and am completely unfamiliar with the device world's guidance and acronyms. 

I suspect the phrase "open a CAPA" comes from the Document Control world where a form is required for everything (that's an observation, not a criticism). You are quite correct that there is not a preventive action for everything, but the CA and the PA are typically symbiotic. I have done over 275 GxP audits in my career, and I have never seen a CAPA SOP that allowed for the fact that there may not be a PA for some of the CAs. It is quite an interesting concept.

As far as not using a term that "causes confusion and leads to incorrect application of the processes", I must say while I have yet to see it cause confusion, I have seldom see either process executed per written procedures, guidance or regulations. I am, therefore, not convinced that even if we could remove these phrases from our industry lexicon there would be any appreciable difference in how corrective actions and preventive actions are developed, executed and perceived.

I also largely agree with your statement about "to assume there is a root cause is to fail to understand how problems arise". I have seen the "5 questions" approach used and completely fail to reach anything resembling a credible "root cause"; that does not mean this method should be categorically discarded, as it comes closer to working most of the time than not. Nothing is perfect, which is job security for most of us. 

Alas, much like the indescribably irritating "up-speak" that has made its insidious way into our society's speech patterns, I am afraid there is no way to eradicate "CAPA" and "root cause". You appear to be of an age that indicates your school actually taught something about English, grammar and correct usage of words, otherwise you would not find these terms so objectionable. Perhaps you can find some comfort in the knowledge that those of us who can write in cursive, tell time on an analog clock, and figure out how to use a phone on a land-line are going to have the last laugh when all is said and done.

While true that " 'root cause analysis' and 'CAPA' are commonly used terms in both drug and device industries as well as many others" it just means there is a common mistake. Root cause implies there is one cause for the problem investigated. This is rarely, if ever true. A problem needs a sequence of events, more than one thing, to arise. Multiple things need to go wrong at the same time. (There is a lot of work on this problem as an application of the Swiss Cheese Model.) To assume there is a "root cause" is to fail to understand how problems arise.

Note that neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term. The best approach is to stop using a term that causes confusion and leads to inadequate investigations.

"CAPA is found in 820.100 and many other locations." This is a misunderstanding. Neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term "CAPA". 820.100 is named "Corrective and preventive action", not CAPA. In ISO 13485:2016, the corresponding section is 8.5 Improvement.

In addition, GHTF/SG3/N18:2010 advises against the term saying, "The acronym 'CAPA' will not be used in this document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action."

I often hear that someone wants to "open a CAPA". This is not correct because CA and PA are two different processes with two different applications; each address a different type of problem and are not used together.

The best approach is to stop using a term that causes confusion and leads to incorrect application of the processes.<o:p></o:p>

You have a variety of potential root causes. The first that comes to mind is inadequate training in SOPs (purchasing group); inadequate SOPs; and there are likely to be some others I cannot list as I am not familiar with your organization. The CAPA for the inadequate training is retraining and likely to include a few other points (such as scheduled refresher training). The preventive part could potentially be to improve the SOP on approved suppliers, or perhaps improve access to the list of approved suppliers. This could also be the corrective part if the root cause is an inadequate SOP.

Considering that the purchase of this critical material from an unapproved supplier persists, I would recommend that QA and regulatory meet with this group and have a "come to Jesus" talk about compliance and meeting regulatory commitments, and the potential impact of failing to do both. If all else fails it may be necessary to involve HR or executive management.

For the record, "root cause analysis" and "CAPA" are commonly used terms in both drug and device industries as well as many others; CAPA is found in 820.100 and many other locations. 

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.

Avilla,

I'm a device guy and don't venture into pharma or biologics unless there is a combination product.

You say, "I have never seen a CAPA SOP that allowed for the fact that there may not be a PA for some of the CAs. It is quite an interesting concept".

Let me use this to illustrate a common misunderstanding in devices, paraphrasing the definitions from ISO 9000:2015.

A correction eliminates a detected nonconformance.

A corrective action eliminates the cause of a detected nonconformance.

A preventive action eliminates the cause of potential nonconformance.

If the manufacturer has a detected nonconformity, then a correction fixes the problem. Corrections include rework, repair, and regrade.

If the manufacturer wants to avoid recurrence of the non-conformity, then corrective action is the appropriate method.

If the manufacturer has a potential nonconformity, (it hasn't happened yet) then preventive action is the appropriate method.

The correct pairing is correction and corrective action.

The incorrect pairing, which is the problem, is corrective action and preventive action.

To "open a CAPA" is to make the incorrect pairing, i.e., putting together two things that don't fit.<o:p></o:p>

You do make some very good points, Dan O'Leary. I notice you cite device-related sources only. I am strictly biotech and am completely unfamiliar with the device world's guidance and acronyms. 

I suspect the phrase "open a CAPA" comes from the Document Control world where a form is required for everything (that's an observation, not a criticism). You are quite correct that there is not a preventive action for everything, but the CA and the PA are typically symbiotic. I have done over 275 GxP audits in my career, and I have never seen a CAPA SOP that allowed for the fact that there may not be a PA for some of the CAs. It is quite an interesting concept.

As far as not using a term that "causes confusion and leads to incorrect application of the processes", I must say while I have yet to see it cause confusion, I have seldom see either process executed per written procedures, guidance or regulations. I am, therefore, not convinced that even if we could remove these phrases from our industry lexicon there would be any appreciable difference in how corrective actions and preventive actions are developed, executed and perceived.

I also largely agree with your statement about "to assume there is a root cause is to fail to understand how problems arise". I have seen the "5 questions" approach used and completely fail to reach anything resembling a credible "root cause"; that does not mean this method should be categorically discarded, as it comes closer to working most of the time than not. Nothing is perfect, which is job security for most of us. 

Alas, much like the indescribably irritating "up-speak" that has made its insidious way into our society's speech patterns, I am afraid there is no way to eradicate "CAPA" and "root cause". You appear to be of an age that indicates your school actually taught something about English, grammar and correct usage of words, otherwise you would not find these terms so objectionable. Perhaps you can find some comfort in the knowledge that those of us who can write in cursive, tell time on an analog clock, and figure out how to use a phone on a land-line are going to have the last laugh when all is said and done.

While true that " 'root cause analysis' and 'CAPA' are commonly used terms in both drug and device industries as well as many others" it just means there is a common mistake. Root cause implies there is one cause for the problem investigated. This is rarely, if ever true. A problem needs a sequence of events, more than one thing, to arise. Multiple things need to go wrong at the same time. (There is a lot of work on this problem as an application of the Swiss Cheese Model.) To assume there is a "root cause" is to fail to understand how problems arise.

Note that neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term. The best approach is to stop using a term that causes confusion and leads to inadequate investigations.

"CAPA is found in 820.100 and many other locations." This is a misunderstanding. Neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term "CAPA". 820.100 is named "Corrective and preventive action", not CAPA. In ISO 13485:2016, the corresponding section is 8.5 Improvement.

In addition, GHTF/SG3/N18:2010 advises against the term saying, "The acronym 'CAPA' will not be used in this document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action."

I often hear that someone wants to "open a CAPA". This is not correct because CA and PA are two different processes with two different applications; each address a different type of problem and are not used together.

The best approach is to stop using a term that causes confusion and leads to incorrect application of the processes.<o:p></o:p>

You have a variety of potential root causes. The first that comes to mind is inadequate training in SOPs (purchasing group); inadequate SOPs; and there are likely to be some others I cannot list as I am not familiar with your organization. The CAPA for the inadequate training is retraining and likely to include a few other points (such as scheduled refresher training). The preventive part could potentially be to improve the SOP on approved suppliers, or perhaps improve access to the list of approved suppliers. This could also be the corrective part if the root cause is an inadequate SOP.

Considering that the purchase of this critical material from an unapproved supplier persists, I would recommend that QA and regulatory meet with this group and have a "come to Jesus" talk about compliance and meeting regulatory commitments, and the potential impact of failing to do both. If all else fails it may be necessary to involve HR or executive management.

For the record, "root cause analysis" and "CAPA" are commonly used terms in both drug and device industries as well as many others; CAPA is found in 820.100 and many other locations. 

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.

Avilla,

I'm a device guy and don't venture into pharma or biologics unless there is a combination product.

You say, "I have never seen a CAPA SOP that allowed for the fact that there may not be a PA for some of the CAs. It is quite an interesting concept".

Let me use this to illustrate a common misunderstanding in devices, paraphrasing the definitions from ISO 9000:2015.

A correction eliminates a detected nonconformance.

A corrective action eliminates the cause of a detected nonconformance.

A preventive action eliminates the cause of potential nonconformance.

If the manufacturer has a detected nonconformity, then a correction fixes the problem. Corrections include rework, repair, and regrade.

If the manufacturer wants to avoid recurrence of the non-conformity, then corrective action is the appropriate method.

If the manufacturer has a potential nonconformity, (it hasn't happened yet) then preventive action is the appropriate method.

The correct pairing is correction and corrective action.

The incorrect pairing, which is the problem, is corrective action and preventive action.

To "open a CAPA" is to make the incorrect pairing, i.e., putting together two things that don't fit.<o:p></o:p>

You do make some very good points, Dan O'Leary. I notice you cite device-related sources only. I am strictly biotech and am completely unfamiliar with the device world's guidance and acronyms. 

I suspect the phrase "open a CAPA" comes from the Document Control world where a form is required for everything (that's an observation, not a criticism). You are quite correct that there is not a preventive action for everything, but the CA and the PA are typically symbiotic. I have done over 275 GxP audits in my career, and I have never seen a CAPA SOP that allowed for the fact that there may not be a PA for some of the CAs. It is quite an interesting concept.

As far as not using a term that "causes confusion and leads to incorrect application of the processes", I must say while I have yet to see it cause confusion, I have seldom see either process executed per written procedures, guidance or regulations. I am, therefore, not convinced that even if we could remove these phrases from our industry lexicon there would be any appreciable difference in how corrective actions and preventive actions are developed, executed and perceived.

I also largely agree with your statement about "to assume there is a root cause is to fail to understand how problems arise". I have seen the "5 questions" approach used and completely fail to reach anything resembling a credible "root cause"; that does not mean this method should be categorically discarded, as it comes closer to working most of the time than not. Nothing is perfect, which is job security for most of us. 

Alas, much like the indescribably irritating "up-speak" that has made its insidious way into our society's speech patterns, I am afraid there is no way to eradicate "CAPA" and "root cause". You appear to be of an age that indicates your school actually taught something about English, grammar and correct usage of words, otherwise you would not find these terms so objectionable. Perhaps you can find some comfort in the knowledge that those of us who can write in cursive, tell time on an analog clock, and figure out how to use a phone on a land-line are going to have the last laugh when all is said and done.

While true that " 'root cause analysis' and 'CAPA' are commonly used terms in both drug and device industries as well as many others" it just means there is a common mistake. Root cause implies there is one cause for the problem investigated. This is rarely, if ever true. A problem needs a sequence of events, more than one thing, to arise. Multiple things need to go wrong at the same time. (There is a lot of work on this problem as an application of the Swiss Cheese Model.) To assume there is a "root cause" is to fail to understand how problems arise.

Note that neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term. The best approach is to stop using a term that causes confusion and leads to inadequate investigations.

"CAPA is found in 820.100 and many other locations." This is a misunderstanding. Neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term "CAPA". 820.100 is named "Corrective and preventive action", not CAPA. In ISO 13485:2016, the corresponding section is 8.5 Improvement.

In addition, GHTF/SG3/N18:2010 advises against the term saying, "The acronym 'CAPA' will not be used in this document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action."

I often hear that someone wants to "open a CAPA". This is not correct because CA and PA are two different processes with two different applications; each address a different type of problem and are not used together.

The best approach is to stop using a term that causes confusion and leads to incorrect application of the processes.<o:p></o:p>

You have a variety of potential root causes. The first that comes to mind is inadequate training in SOPs (purchasing group); inadequate SOPs; and there are likely to be some others I cannot list as I am not familiar with your organization. The CAPA for the inadequate training is retraining and likely to include a few other points (such as scheduled refresher training). The preventive part could potentially be to improve the SOP on approved suppliers, or perhaps improve access to the list of approved suppliers. This could also be the corrective part if the root cause is an inadequate SOP.

Considering that the purchase of this critical material from an unapproved supplier persists, I would recommend that QA and regulatory meet with this group and have a "come to Jesus" talk about compliance and meeting regulatory commitments, and the potential impact of failing to do both. If all else fails it may be necessary to involve HR or executive management.

For the record, "root cause analysis" and "CAPA" are commonly used terms in both drug and device industries as well as many others; CAPA is found in 820.100 and many other locations. 

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.

In my world, "open a CAPA" is short for "open a CAPA project", meaning to start investigating something under the SOP that describes the process for corrective actions and preventive actions.

That probably doesn't help. :-)

Every newbie still has to learn the distinction between corrections, corrective actions, and preventive actions. But it still feels like they all belong in the same SOP, the CAPA SOP.

Avilla,

I'm a device guy and don't venture into pharma or biologics unless there is a combination product.

You say, "I have never seen a CAPA SOP that allowed for the fact that there may not be a PA for some of the CAs. It is quite an interesting concept".

Let me use this to illustrate a common misunderstanding in devices, paraphrasing the definitions from ISO 9000:2015.

A correction eliminates a detected nonconformance.

A corrective action eliminates the cause of a detected nonconformance.

A preventive action eliminates the cause of potential nonconformance.

If the manufacturer has a detected nonconformity, then a correction fixes the problem. Corrections include rework, repair, and regrade.

If the manufacturer wants to avoid recurrence of the non-conformity, then corrective action is the appropriate method.

If the manufacturer has a potential nonconformity, (it hasn't happened yet) then preventive action is the appropriate method.

The correct pairing is correction and corrective action.

The incorrect pairing, which is the problem, is corrective action and preventive action.

To "open a CAPA" is to make the incorrect pairing, i.e., putting together two things that don't fit.<o:p></o:p>

You do make some very good points, Dan O'Leary. I notice you cite device-related sources only. I am strictly biotech and am completely unfamiliar with the device world's guidance and acronyms. 

I suspect the phrase "open a CAPA" comes from the Document Control world where a form is required for everything (that's an observation, not a criticism). You are quite correct that there is not a preventive action for everything, but the CA and the PA are typically symbiotic. I have done over 275 GxP audits in my career, and I have never seen a CAPA SOP that allowed for the fact that there may not be a PA for some of the CAs. It is quite an interesting concept.

As far as not using a term that "causes confusion and leads to incorrect application of the processes", I must say while I have yet to see it cause confusion, I have seldom see either process executed per written procedures, guidance or regulations. I am, therefore, not convinced that even if we could remove these phrases from our industry lexicon there would be any appreciable difference in how corrective actions and preventive actions are developed, executed and perceived.

I also largely agree with your statement about "to assume there is a root cause is to fail to understand how problems arise". I have seen the "5 questions" approach used and completely fail to reach anything resembling a credible "root cause"; that does not mean this method should be categorically discarded, as it comes closer to working most of the time than not. Nothing is perfect, which is job security for most of us. 

Alas, much like the indescribably irritating "up-speak" that has made its insidious way into our society's speech patterns, I am afraid there is no way to eradicate "CAPA" and "root cause". You appear to be of an age that indicates your school actually taught something about English, grammar and correct usage of words, otherwise you would not find these terms so objectionable. Perhaps you can find some comfort in the knowledge that those of us who can write in cursive, tell time on an analog clock, and figure out how to use a phone on a land-line are going to have the last laugh when all is said and done.

While true that " 'root cause analysis' and 'CAPA' are commonly used terms in both drug and device industries as well as many others" it just means there is a common mistake. Root cause implies there is one cause for the problem investigated. This is rarely, if ever true. A problem needs a sequence of events, more than one thing, to arise. Multiple things need to go wrong at the same time. (There is a lot of work on this problem as an application of the Swiss Cheese Model.) To assume there is a "root cause" is to fail to understand how problems arise.

Note that neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term. The best approach is to stop using a term that causes confusion and leads to inadequate investigations.

"CAPA is found in 820.100 and many other locations." This is a misunderstanding. Neither FDA QSR, nor ISO 13485:2016, nor ISO 9000:2015 use the term "CAPA". 820.100 is named "Corrective and preventive action", not CAPA. In ISO 13485:2016, the corresponding section is 8.5 Improvement.

In addition, GHTF/SG3/N18:2010 advises against the term saying, "The acronym 'CAPA' will not be used in this document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action."

I often hear that someone wants to "open a CAPA". This is not correct because CA and PA are two different processes with two different applications; each address a different type of problem and are not used together.

The best approach is to stop using a term that causes confusion and leads to incorrect application of the processes.<o:p></o:p>

You have a variety of potential root causes. The first that comes to mind is inadequate training in SOPs (purchasing group); inadequate SOPs; and there are likely to be some others I cannot list as I am not familiar with your organization. The CAPA for the inadequate training is retraining and likely to include a few other points (such as scheduled refresher training). The preventive part could potentially be to improve the SOP on approved suppliers, or perhaps improve access to the list of approved suppliers. This could also be the corrective part if the root cause is an inadequate SOP.

Considering that the purchase of this critical material from an unapproved supplier persists, I would recommend that QA and regulatory meet with this group and have a "come to Jesus" talk about compliance and meeting regulatory commitments, and the potential impact of failing to do both. If all else fails it may be necessary to involve HR or executive management.

For the record, "root cause analysis" and "CAPA" are commonly used terms in both drug and device industries as well as many others; CAPA is found in 820.100 and many other locations. 

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 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 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.