Hi to all, I am struggling with the validation of a machine that tightens 5 screws (same screws with the same tightening parameters) on our product. Is it sufficient to validate the cpk and cp only on one of the 5 screws? Thank you very much ..read more

the shop is in a tiny bit of a financial crisis. we've been sorting through no longer used equipment. most of it is either out of calibration or defective. I just need a general consensus of the item found and what they can be sold for. I can't attach photos but everything Is in good condition appearance wise GENRAD 1423-A Standard Decade Capacitor - Out of calibration Kepco KS8-50M - calibrated HP 182C oscilloscope/8755C swept amplitude analyzer - out of calibration Tektronix DSA 602 +... Need help pricing calibration equipment for sale ..read more

Hi all, We are a small company that produces software for medical devices. We are a supplier for a company that is certified ISO 13485 and we are following the client's processes and procedures. We have also our procedures and we are certified ISO 9001. We want to get certified ISO 13485. I am not sure if the clause 7.5.6 Validation of processes for production and service provision is applicable to us, especially regarding the procedures for validation of the application of computer... 7.5.6 Validation of processes for production and service provision ..read more

Hello, Are there recommended cleaning solutions/disinfectants for cleaning an ISO Class 7 CER (i.e., walls, floors, ceiling)? This would be done once a week. The CER is for medical devices that are later EO sterilized if that makes a difference. Also, is it still industry standard to switch between different types of cleaning agents (e.g., phenolic based vs peracetic acid based) to prevent microbial resistance? Thank you. Flyonthewall ..read more

Good morning. I'm a Quality Control Manager in the world of forging. Many of the DWGs we manufacture to state (in the form of a note on the DWG) to forge or manufacture per AMS-F-7190 (Forging, Steel for Aircraft/Aerospace), Grade A or Grade C. So here is my question: Grade A requires the following: Tensile Hardness Magnetic Particle or Fluorescent Penetrant Grain Flow (1st time producing the part) Chemical Composition For all of our parts and their many components we maintain quality... Forging World ..read more

Hello! I’d like some feedback about monitoring and measurement. My employer manufactures gas detection instruments and is audited against ISO 9001:2015 and ISO/IEC 80079-34 (which covers quality management systems for manufacturers of products for explosive atmospheres). ISO 9001:2015 clause 7.1.5 and ISO 80079 clause 7.1.5 states, “When monitoring or measuring is used to verify the conformity of Ex Products, the measuring equipment shall be calibrated and a valid calibration certificate... Multimeter verification ..read more

Thank you for allowing me to join the forum. I've worked successfully in Quality leadership for 20 years, in many industries. Recently, I have been working closer to design engineering following the Covid pandemic. But I am keeping my head above water ..read more

If a device has not been released from production, and fails final test, then is reworked (not a deviation) should the failed test and related NCMR be apart of or referenced in the DHR ..read more

Hello, I am doing some research for my company on CAPA databases. We are working on implementing a QMS and want to avoid tracking Corrective and Preventive Actions (CAPA) through an excel spreadsheet. Can anyone suggest some good products to look at? So far Intelex and MasterControl have come up through Google U. Has anyone used Microsoft Access? Other suggestions ..read more

Now that AIAG has broken up the Control Plan and APQP manuals, we're in the process of converting all of our control plans to the new prescribed format. However, I'm getting stuck on a few items that we had previously included in our control plan, that I am now questioning if they even need to be present at this point. 1st Article Approval and Part Validations (Both done on an annual basis)....should these even be part of the control plan if they are covered in a procedure? Also, what... Control Plan - 1st Edition Guidance Needed ..read more