After 20+ years in the business, there is one question that keeps popping up – and that’s the confusion around the relationship between Non-conformity and Corrective Action. Many people use NCR and CAR acronyms rather loosely and sometimes interchangeably – and that adds to the confusion.
Perhaps an illustration will help clear things up. First let’s look at an example that occurs within your own operation (we will look at 3rd party services/products later on with SCARs).
Case Study A
An operator in your facility is moving a tray of 20 products from Point A to Point B and stumbles dropping them on the floor. He/she stoops over to pick them up and after proper inspection (by inspection personnel), it is determined that 15 meet all criteria for usability but 5 have suffered damage. It is further determined that these 5 can be reworked, they are split from the lot, a new traveller is created for the re-work and the 15 good parts are delivered to Point B. A Non-Conformity Report is prepared to describe the non-conformity, cost, disposition, resolution and record of approvals.
Do you need to also set in motion a Corrective Action?
That is determined by your QA procedures. In some companies this is automatic even though it results in a lot of extra, dare I say unnecessary, work. In my view the NCR is sufficient and here’s why.
Non-conformance Report (NCR)
First of all, let’s define non-conformity as a nonfulfillment or failure to meet the expectations, need or obligation of your process. It can be stated or implied. So a service or product that doesn’t meet (conform to) specifications has a nonconformity. In the case above, you expected to have 20 products delivered to Point B but only 15 got there and 5 were damaged, so you prepare a NCR.
The NCR serves 5 main purposes:
- describe the non-conformity
- determine the disposition of the non-conformity
- track the non-conformity
- assign cost(s) to the non-conformity
- record a pprovals
It is important to record and track all NRCs in order to make informed productivity and efficiency decisions. Data is compiled into reports, charts and trend diagrams to provide insight for decision making. [Of course CIS compiles all NCR information and provides you with data to make informed decisions.]
A key takeaway is that a non-conformance report (NCR) does more than simply track or log the occurrence of the nonconformity – it also describes the disposition.
But isn’t that a corrective action?
Not at all - not unless you want to go through the redundancy of rewriting all of this information on a new report (or your company procedures force you to). Why would you? The key question to ask is whether or not you need to make a change to your process and need to go through a root cause analysis. In the above case your process does not need to be changed. The product was dropped, the disposition was affected, the costs are were assigned and the non-conformity recorded. Nothing more is required.
Case Study B
Let’s look at another example. Say you have a bottle-filling line that has some limitations and you expect that some (less than 1%) of the filled bottles will not conform to your requirement. Your process expects this and you have a simple way of identifying these and disposing of them (rework, regrade, scrap, etc.). In this case you only prepare a NCR when the limitations from your process exceed the 1% limit.
This number can be easily obtained from the in-process inspection results that should be tracked in your system. You want to track these to be able to make an informed decision later. In this instance, when a NCR is created, it should result in a Corrective Action to address the change in process that has increased the rejection/rework expectations. If the rate of non-conformances is high enough or if the non-conformance is severe enough in effect, then you may want to move to a corrective action.
CIS software tracks and reports on all non-conformances AND records what corrections were made. CIS also links NCRs to Work Orders or Process Release Travellers to record that the resolutions/dispositions were completed AND link to Corrective Actions should a manager decide this is necessary.
Again, not all NCRs require Corrective Action.
Corrective Action Request (CAR)
So when do you use a Corrective Action? Going back to our first example…
As you review the Non-Conformance reports over time, you discover that 4-5 times per month product is being dropped and damaged in this same transfer from Point A to Point B.You determine that this is something that needs to be corrected, so you prepare a Corrective Action Request to investigate what is causing this and to make changes to eliminate the non-conformances.
As a general rule, if the rate of non-conformances is high enough, or if the non-conformance is severe enough in effect, then you proceed to a corrective action.
[As a side note, the CAR puts a Corrective Action in motion and is often used to mean the entire Corrective Action process. Although CAR stands for Corrective Action Request, most companies use CAR to mean the entire process. That’s okay as long as we all use the same interpretation.]
During the investigation a root cause is discovered as to why operators are stumbling. It seems there is unevenness in the floor and an obstruction that, if removed, should eliminate the problem. The repairs will take a month since it can only be affected during an upcoming shutdown.
So we have a solution (Plan) and an action (Do) in place but we need to wait for it to take effect. In the meantime we can expect that the operators will continue to stumble and drop product. When that happens, we still go through the NCR process to record the non-conformity, but we do not initiate another CAR as we already have one in place to address this issue. We may also take an immediate action to change the route from A to B, that may take longer and cost more, until the actual corrective (preventive) action is complete.
In general, CARs are only initiated because of a process needing to be improved to addressas a result of:
- Customer feedback
- Near Miss
- Accidents & Incidents
- Continuing Non-conformance
One of these must precede a CAR. Typically these issues require a root cause analysis and a correction to your process to prevent further occurrences.
After the shutdown, the operators return to a level floor without any obstructions and continue to move product from Point A to Point B.
As the QA manager, you watch for further NCRs from this area (Check) and you log a follow-up date in your system to remind you verify in 6 months that the problem has been resolved (Check again). If there are re-occurrences at that time you then initiate a new CAR to get to the root cause (Act). If there are no re-occurrences you close the CAR and archive it.
CIS - Continuous Improvement Software does an excellent job of tracking and linking the entire corrective action life-cycle:
PLAN – root Cause and Effect, Ishikawa
DO - Follow Up Action, Corrective Actions
CHECK – Confirmation of the effectiveness of the Corrective Action
ACT - Share the successfully implemented actions
These steps are managed by any Follow-Up Actions, Responsibilities and Due Dates and are linked to work orders (if required) and the originating report (CF, NM, Accident, Audit, NCR)..
So now let’s look at how this relates to your suppliers.
Let’s say your supplier ships you product that doesn’t conform. In this case we are looking at a service – their service of providing product to you. Your role in this case is to create a NCR and advise the supplier. Since it is the supplier’s process and not yours that needs changing, you do not open a CAR. Instead you notify the supplier and request they to make a Supplier Corrective Action or SCAR. You request a disposition of the goods received and a correction to your supplier’s process so that the non-conformity does not reoccur. They should have procedures in place to catch errors in their supply chain well before the product gets to you, so you now want to make sure they have corrected their process. As a general rule, NCRs raised with a supplier always result in a corrective action request called a SCAR.
Now let’s say that the damage occurred in transit. If the supplier is responsible for transport (FOB your place) a SCAR is warranted as it is part of the process they are responsible for. If your vehicle picked up the product (FOB your supplier) than you need to decide if a CAR is required – it is part of the process you are responsible for. Perhaps your NCR will suffice.
Supposing a 3rd party supplier was responsible for transport on your behalf. Again this is a service to you and you would send a SCAR to the 3rd party transport company (their responsibility), not the original supplier who provided the product.
Preventive Action Request
An additional Special Versions of CAR…
PAR, or Preventive Action Request, is very similar to CAR. Many organizations actually combine the 2 into a single term CAPA because they follow similar procedures. Preventative action is often issued from management meetings, Risk Assessment meetings, or Health, Safety & Environment (HSE) meetings where a potential risk has been identified and you wish to take steps to eliminate or mitigate the risk.
PARs are used to conduct an investigation of a potential problem and determine a solution so that this possible problem does not come to pass. As with CAR, PAR refers to all steps of Preventive Action, not just the Request portion as the name might imply. PARs look to possible future events while CARs focus on the present and past.
- Not all Non-Conformances (either product or process) require corrective action.
- For most product Non-conformances only correction is required.
- Corrective action is initiated to correct an internal process (not a single-event non-conformity)
- Corrective action may be requested if the rate of non-conformances is high enough or if the non-conformance is severe enough in effect.
- Corrective action is initiated by Customer feedback, Near Miss, Accidents & Incidents, Continuing Non-conformance and Audits.
- Service Non-Conformances result in a SCAR being issued to your service provider.
- A Supplier Corrective Action is initiated for all supplier non-conformities.
- Many organizations link PAR and CAR into a single CAPA process.
So in the spirit of continual improvement, sort out what the different terms mean for your company and then apply them consistently. Understanding the differences and proper use will go a long way to making your quality system more effective and efficient.