1. W

    Scope of MRB (Material Review Board) Responsibilities

    I am preparing for THE CQE exam later this month. And I came across the question which asks: The duties of MRB doesn't include which of following: A. Development of CA plan to correct non-conformities. B. A review of non-conforming material C. Disposition of any set-aside non-conforming products...
  2. F

    Quality Objectives - Where in the QMS Quality Objectives should be located

    Hi Roxane, I'm relatively new to Quality. Please can you advise wherein the QMS the Quality Objectives should be located?
  3. Booker

    Main responsibility for Control Plans - creating and maintaining

    Dear in Cove, Which department in production organization should be mainly responsible for the process development and to describe the process by Process Flow Charts, PFMEAs, and Control Plans? The approach by CFT is considered. But, there is no common agreement for main responsibility. Thanks...
  4. T

    Why are most companies have Quality reporting to Engineering or Operations and not to CEO

    Hello, I have a general question about QMS or 9001 in particular. During several visits at different companies, which were all ISO 9001 certified, 90% of the Quality Mangers had to report to Engineering or Operations VP's. I wonder shouldn't Quality report to the Top Management or better to...
  5. JoCam

    Distributors Responsibilities - Medical Device Recalls

    Hi All, I'm looking for clarification of the definition for Field Safety Notice in MEDDEV 2.12-1, which is written as 'A communication to customers and/or USERs sent out by a MANUFACTURER or its representative in relation to a Field Safety Corrective Action'. Does this mean that a...
  6. V

    Who should define and own the Design and Development Plan and how to maintain the updates and revisions.

    1. per my understanding, it should be owned by "project / program manager", and shall be defined in consultation with the key stakeholders ( viz., technical lead and regulatory etc); also certain references., 2. as these...
  7. Mr Skeleton

    PV (Production Validation) test plan responsibility

    Hello, This is my first post here, so want to start with a thank you! I've been using Elsmar Cove since 2002 when I started my 1st (post Uni) job as a graduate quality engineer. Over the years I've never had to post a question - always found the answer I needed with a search. I'm now an STA/SQA...
  8. A

    Who champions your internal manufacturing training?

    Hello All, We are having some troubles with HR continuing to want to champion all our internal training as they have done for the last 20+ years. Now they only want to be responsible for parts of it so those of us in QA are scrambling to find another "owner" for all the other training that the...
  9. A

    Resident Engineer duties

    Hello, One of our suppliers proposed to put Resident Engineer in our plant. After discussion, we decided that they can do it. As time goes, we see that it is not easy to establish concrete Resident's duties. Do you have experience with resident solutions? What duties such person had in your...
  10. I

    Who owns your Competence, Awareness and Training process?

    ISO-9001 requires that companies address CA&T, but I'm wondering what group within your organizations past or present actually owns that process? Is it your HR team? Operations? Or do you have a separate Training group who owns it?
  11. C

    Person Responsible for Regulatory Compliance

    The MDR paragraph 34 states: 'Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a...
  12. S

    21 CFR 810 - Medical Device Recall Authority - Contract Manufacturing

    When a contract manufacturer produces a finished medical device for a customer/design owner, is one specific party expected to initiate the recall, or is it based on internal agreement between the design owner and the contract manufacturer? I work for on the contract manufacturing side and am...
  13. S

    Responsibilities between government owner and private subcontractor of a power plant seeking ISO 9001 certification

    Dear friends I have some questions regarding ISO 9001:2015, where there is a governmental body own a power planet station. The station is operated by a subcontractor who hires stuff and do all the operation and maintenance activities and submit report to the owner. The governmental body need...
  14. W

    Organizational Responsibility for Environmental Compliance of Products

    Hey everyone, I lead the Quality and Regulatory department for a medical device company and am interested in understanding what department or organizational umbrella environmental related product compliance (RoHS, REACH, Prop 65 etc) responsibilities generally fall under in other companies...
  15. A

    Who pays for correction and removal actions?

    Hello everyone, I am looking for information about who is responsible for (from a regulatory perspective) fixing an issue related to a recalled device? I cant find any statements in any regulations regarding cost responsibilities. Is there a way to decide when a manufacturer is responsible...
  16. M

    Where does our regulatory responsibility end?

    We have a good customer (let's call them ABC) that buys our medical device (software) and rebrands/relabels it for sale as a product with their name on it. They now want to sell our medical device in Mexico. This would not be an ABC-rebranded or relabeled version of our medical device, but...
  17. M

    Prescription Devices - Who is Responsible / Liable?

    Who is responsible for ensuring that devices designated prescription only are, in fact, used only under prescription conditions? I'd brought this up in a previous post regarding a number of discussions surrounding implications of a device designated as prescription only in the US, but the...
  18. S

    Pandora's box - OPENS

    There have been some shifts in responsibilities in the organization where I work, which has resulted in me taking over the Order Fulfilment complaints, as well as the Product Quality responsibilities. We've had 14 OF complaints in the last 13 months, so I figured it wouldn't add much to my...
  19. S

    Medical Device Manufacturer vs. Specification Developer

    Hello, US Company A is the MD device owner and holds the associate 510k & Company B out of the USA manufactures the Medical Device. Company A kits the devices with its accessories, packages, and labels. => Shall company A be considered Manufacturer or Spec Developer ?
  20. N

    Who shall manage PPAP process?

    Hi I sometimes wonder who shall manage a PPAP process and who is the process owner in a company? We have Quality dept as PPAP owner, but sometimes thinking isnt the owner of PPAP the production? Many companies has Q-dept that are collecting and creating all PPAP documents.. incl PSW is...
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