raw materials

  1. I

    AS9100 8.4.2 Type and Extent of Control - External provider test reports

    Plain English and how in the world to implement it (because apparently our process does not address how to handle this - and stating that we only use test reports to verify product when its required by the customer ~ very, very rarely does not meet the requirement) When external provider test...
  2. J

    Supplier choice limitation - Many of them dont have PSCR, VDA or even ISO 9001

    Good morning. My name is Javier Ruisoto and I work as auditor for the supply management for a tires factory company. In the diferent visits to suppliers I found that many of them dont have PSCR, VDA or even ISO 9000 (or any other quality system) and the company have no...
  3. B

    AS9100 Multiple Distributor warehousing locations under same Company

    Greetings all, As a company, we currently utilize "raw material cards" that receiving uses to verify certificate requirements and other receiving information. During the receiving process, we match both the manufacturer of the material and the supplier (distributor), as listed on the raw...
  4. P

    Material selection - How do we select a raw material? Bolt made of SAE J994 grade 2

    Hey, How do we select a raw material? For example: Customer demand a bolt made of SAE J994 grade 2. Which metal should i buy for this grade result!
  5. A

    SPC for Eddy Current Testing

    Hi,i would like to ask your opinions/advices on some matter, We are producing cold drawn steel bars. And one of the steps of the production is crack control operation (Eddy current). During the 3. party audit (IATF 16949), auditor told that we should be doing process control using data gathered...
  6. S

    CQI-12 - Applicability to Raw Materials

    Hello all. I am more or less pasively monitoring some interesting discussions, but now I bumped into a problem, where our customer requires us to get CQI-12 self assessment from our suppliers of lamination steel for electromotors and rotor/stator stacks which we produce. Because this steel is...
  7. D

    Raw Material chemical/Tensile Requirements Specifications (QQ-A-250/4, etc)

    When I receive raw material (aluminum, steel, etc) and verify the actual properties to the specification (QQ-A-250/4, etc) I have to have the actual specification, in the latest revision. Is there a place or a service that provides the chemical/tensile requirements for raw material such as this...
  8. Q

    Do we have to prove a link between the mill and our raw material supplier?

    We order our raw material from our distributor. The distributor sends us mill certs from the mill that supplied them the raw material. The mill cert states that the mill has sold the raw material to the distributor. The distributor sends us a packing slip (along with the mill certs). So far...
  9. R

    AS9100D Cl. 8.4.2 - Identify Raw Material as a Significant Operational Risk

    The last sentence in this section says: "When a customer or organization has identified raw material as a significant operational risk (e.g., critical items), the organization shall implement a process to validate the accuracy of test reports." It would appear to me that the first use of the...
  10. J

    AS9100 - Validation of Test Reports for Al 304 Raw Material

    Question in regards to validation of test reports. To give some background information we perform verification of all incoming material. We perform visual inspection and compare it to received documentation to ensure the material and paperwork match. additionally, we compare the certificate...
  11. Q

    Nonconformance Raw Material Treatment in ISO 9001

    Hi everybody I have an ISO 9001 certified system. Recently I had the next case. A non conformance raw material was found in the storage area. For me, it is clear, if it is a non conformance product during the fabrication I apply the treatment as such, if it is detected when arrived from...
  12. J

    Double-Retest of Nonconforming Material to Accept the Material

    When meeting the requirement for raw material validation, by sending out a sample of raw material to an independent lab for test, I encountered a rejection for tensile strength. The results were low. The original material test report showed compliance. I asked the independent lab if they could...
  13. C

    What is considered a "Critical" Raw Material? (Re: DNA Synthesis)

    This was the closest forum to my question. We a re a start up DNA synthesis company looking to get certified for ISO 9001:2015. I am seeking advice on what is considered a "critical" raw material. We track the raw materials we use, but we have no process of inspection before use. The raw...
  14. J

    IMDS: How to manage same Raw Material from Two Suppliers?

    Hello all! I have a big doubt about this issue. Since now we have got one supplier for raw materials, so these suppliers send to us their IMDS, and finally we use this info to compile the IMDS of our final product. But now we are thinking about to have a second source for each raw material...
  15. S

    Use of Published IMDS Data from our Raw Material Supplier

    Dear all, If I make use of published IMDS data from our raw material supplier in my component MDS and submit it to my end customer, will they be knowledgeable of our material supplier as a result ? - sinned
  16. M

    ISO9001:2015 Clause 8.4 Control of External Processes and Purchased Goods & Materials

    I'm trying to interpret how the requirements for "purchased goods" have changed from 2008 to 2015. We purchase raw materials / commodities to manufacture our finished product. I get it that what were "purchased goods" are now "external processes", and there is a nuance there that should...
  17. P

    FDA On-Site Inspection - Raw Material Manufacturing (Medical Devices)

    Does the FDA need to be contacted for a site visit if we are a contract manufacturer who will begin to manufacture raw materials? We currently get raw materials from a supplier but for cost purposes our customer is interested manufacturing raw materials in house that will end up in final goods...
  18. D

    Requirements for Storage of Food Allergen Ingredients

    Can someone answer the following question for me? What are the requirements for storage of Allergen ingredients? I work for a dietary supplement company, we do not manufacture our own products, they are sent to contract manufacturers to be produced. We purchase all our ingredients and I do...
  19. A

    Product status has changed from "tested" to "listed" in the EU Pharmacopoeia

    Hi, we have received an info on a raw material we use which says that the products status has changed from "tested" to "listed" in the EU Pharmacopoeia. The memo didn't mention what will be the consequences to the raw material on this change. Can anyone explain me what...
  20. K

    TS 16949 Planning Phase: Raw Materials purchased from Distributer and the PPAP impact

    Hi Folks. We are looking at TS 16949 and were reviewing the PPAP requirements through the manual. Table 3.1 in the PPAP manual refers to Customer Notification. Point 5 indicates a new PPAP is required for Parts, Non-equivalent materials, or services. We are not a big fish and therefore...
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