For this week's simulation, an NCMR report would definitely have to be filled out for CamTech. CamTech would hear complaints rapidly once they heard about the volatile smell from there pouches. The PM and associates would have to have a meeting and understand why these pouches made it past the quality control department. The chemical hazards could have really injured someone once the package was opened. One would never sell a product such as this however, people are unethical.

Do you believe this was a quality problem and/or an ethics-related problem?

I always like to give my suppliers the benefit of the doubt, I wouldn't assume it's an ethics issue.

An NCMR is a Non-Conforming Material Report and it would be opened for anytime a material related non-conformance is found. This could be in receiving inspections of the raw materials and components, on the manufacturing line, during in-process inspections or final inspection. The report would include a description of the non-conformance, bounding information (this means how much material is affected), and an escalation decision. The escalation decision is generally made by the MRB after reviewing the other information. An NCMR can be escalated to created a CAPA. If the non-conforming material is received from a supplier it might be escalated to a SCAR (Supplier Corrective Action Request). In the case of this simulation a Supplier Corrective Action Request could have been issued except that this supplier was completely unreponsive and not familiar with requirements of the medical device industry.

Any item, part or product with one or more characteristics which depart from the requirements of the specification, safety, legality, regularity & quality or other approved product description. Nonconformity refers to a failure to comply with the requirement.A requirement is a need, expectation, or obligation; it can be stated or implied by an organization, its customer, or other interested parties. There are many types of requirement .some of these include the quality requirement, customer requirement, management requirement, product requirement and legal requirement .whenever any organization fails to meet one of this requirement, nonconformity occurs.

Purpose of NCMR:
1. Strong controls of non - conforming materials reduce the risk of receiving a product that is not compliant or that does not meet quality expectation.

2. It is the policy to ensure the procedure is in place to identify: segregate and dispose of Non-Conforming Material Report related to safety, legality or quality in a systematic manner and to establish corrective action with the goal of preventing future reoccurrence.
3. The purpose of this procedure is to describe how Non -confirming material, components, partial assemblies & final product are controlled.

The Non-Conformance Material Report is used to report and disposition non-conforming material identified during inspection (Quality or Warehouse Inspection) or during the movement of the materials and/or when the material is in stock. The material is inspected to verify that the items conform to the relevant specifications and/or drawings. During the material inspection process, if a non-conformance is detected, the material is immediately isolated. This process is used for various materials, such as purchased materials, materials issued for production orders, finished goods, and materials associated with sales orders. This report serves as primary documentation of nonconformance and the actions associated with it. When product is identified as nonconforming, corrective actions need to be implemented to prevent recurrence. Procedures need to include the requirement for planning corrective actions, containing product that is nonconforming, correcting nonconformities and implementing actions to prevent any future nonconformities, The effectiveness of CAPA processes requires a well-designed CAPA form ,Proper training on root cause analysis,Performing effectiveness checks. The NCR is generated for following order origins with or without quality inspections executed as part of quality management Purchase,Purchase Schedule,Sales,Sales Schedule,SFC Production,ASC Production,Storage Inspection,Service,Maintenance Work,Batch Repair
Service Call.

In any company ISO 9001 certified, managing non-conforming materials is a must. It is a must not only to satisfy the ISO requirements, but also to reduce costs and ensure product defects are recorded and handled appropriately. When you identify a product or material that does not match the specifications, you record it as a non-conforming material. This action will trigger an assessment, which will determine the type of defect or non-conformance, establish the root cause and decide the disposition for the non-conforming material.

A non-conforming material report (NCMR) is something that must get taken up with the current vendor to prevent the incorporation of defective equipment into a medical device project. An NCMR is generated by either the quality department or during a warehouse inspection and requires identification inputs regarding its condition. This requires mentioning 1) the defect at hand and how it negatively impacts the product/project, 2) the lot number that the defective material was manufactured, and 3) the identity of the on-site investigator carrying out the examination. Once the NCMR is submitted, a course of action is taken to address the issue, which includes refunding the material to the vendor, scrapping the material to prevent its further use, use it as is and accept its risk, reclassify the material and rework it to another project/product, or repair it so that it is compliant with manufacturing standards.

There was a situation at my company where a cell bag that holds cell culture/medium would leak during processing, which ultimately contaminated and compromised the product. If one material in a lot shows fault, then how would the remaining materials in that lot be treated? Would the size of the lot determine how the potential defects will be handled? Would defective materials in this nature also be treated differently if being applied to a Class I project as opposed to a Class III?

As it is defined, Non-Conformance Material Report (NCMR) allows an individual to report non-conforming material identified during an inspection of items or material or during the movement of the materials. The purpose of the nonconforming material process is to ensure that the material is not inadvertently used or released for use without further evaluation. Therefore, the process has controls to ensure that the material is identified and segregated and that there are a documented evaluation and final disposition of the material by an authorized group, which is commonly referred to as the MRB (Material Review Board). Materials that are listed in the NCMR are there only because it has failed to meet it's acceptance criteria or specification. Once they are improved and solved, materials are removed from it.

The official definition- Non- Conformance Material Report(NCMR) is a standard way to report non-conforming material that is identified during inspection of times or material, or during the movement of the materials when the materials is in stock. These are products that do not conform to product requirements. They are identified and controlled to prevent their unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a document procedure.

Posted by: @ih37

A non-conforming material report (NCMR) is something that must get taken up with the current vendor to prevent the incorporation of defective equipment into a medical device project. An NCMR is generated by either the quality department or during a warehouse inspection and requires identification inputs regarding its condition. This requires mentioning 1) the defect at hand and how it negatively impacts the product/project, 2) the lot number that the defective material was manufactured, and 3) the identity of the on-site investigator carrying out the examination. Once the NCMR is submitted, a course of action is taken to address the issue, which includes refunding the material to the vendor, scrapping the material to prevent its further use, use it as is and accept its risk, reclassify the material and rework it to another project/product, or repair it so that it is compliant with manufacturing standards.

There was a situation at my company where a cell bag that holds cell culture/medium would leak during processing, which ultimately contaminated and compromised the product. If one material in a lot shows fault, then how would the remaining materials in that lot be treated? Would the size of the lot determine how the potential defects will be handled? Would defective materials in this nature also be treated differently if being applied to a Class I project as opposed to a Class III?

This is definitely an interesting case and its interesting to see how when a material does not meet the appropriate specification, what action needs to be taken. In Dr. Simon's lectures and in the previous mini simuation 3, we learned that when an item did not meet specification listed in the DSD (Design Specification Document), a new item would have to be chosen to go through verification testing to meet the listed specification. Otherwise, a whole new DSD would have to be created in order to satisfy the listed specification. In regards to this, the NCMR would be previous revisions of materials that failed verification and have to go through testing to meet the DSD requirements. 

My company provides repair and maintenance service for general biomedical equipment, so we deal with a lot of parts and suppliers. Every now and then we come across a brand-new component that is defective or damaged. In this case, we fill out an NCMR form and return the component to the supplier. It is important to document each defective component for both my company and also the supplier. My company can use this information to determine whether a supplier is sufficient or not. The supplier can use the NCMR information to track their mistakes and improve their processes for the future.