Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)


  1. H

    Communication plan according to ISO9001 - Pharmaceutical field

    hey everyone, I am new here My boss asked me to prepare communication plan and procedure regarding to ISO9001 which cover all clauses especially risk management. would you have a professional one? HOW can I evaluate our customers as we are a toll manufacturing company?? thanks in advance...
  2. Q

    ISO planning annual meeting?

    Hello everybody While reading on internet,I saw an article regarding the PDCA cycle which recommends annual plannings, where it revised interested parties, vision/mission/quality policy, operational objectives, budgets, risk management actions, documented information standards...
  3. T

    Relevant internal and external communication - ISO 9001:2015 section 7.4

    As per ISO 9001:2015 section 7.4: What will be communicated? When to communicate? with whom to communicate? How to communicate? Who communicates? I am looking for examples from other companies on the above questions. I know training and refresher training is documented on paper and electronic...
  4. A

    Operating criteria for production processes - ISO 14001 Cl. 8.1

    I am struggling to identify operating criteria for processes (not those clear ....for production processes) - according to 8.1 ISo 14001:2015 - for Purchasing, Training, communicatin, marketing etc. Any suggestion? Thanks.
  5. Q

    How to comply with ISO 9001:2015 Clause 7.4 Communication

    Hello What is the correct method to comply with this requirement of communication. Can someone share a procedure to review the method? We are currently ISO 9008, however, I noticed ISO 2015 req. 7.4 content is different. Thanks
  6. H

    Conveying Form Fit and Function

    Manufacturing is telling me that I should convey FFF or engineering intent. I agree, but I've looked around and haven't found any formats for doing so. I can always make a few notes on the drawings, but that doesn't seem like it will always be practical. Inventor has a feature called the...
  7. Jane's

    Do you have an SOP for communicating with regulatory authorities

    Do you have an SOP which states the steps and records required for communicating with regulatory bodies (renewing licenses, etc.)
  8. K

    Does ISO 13485:2016 - 7.2.3 Customer Communication include Marketing?

    13485:2016 7.2.3 states that the organization shall plan and document arrangements for communicating with customers in relation to product information. Can anyone refer me to a source that states that this clause was intended by the standard writers to include marketing into a QMS? I have...
  9. R

    Defect Display Area for Employee Shift Change Information

    I have seen several companies designate an area to display defects in their process and use this area as a "show and tell" to educate and inform the operators during daily "huddle" or "toolbox" type meetings. has anybody put one of these together and if so what best practices might you be...
  10. Q

    Thoughts on Communications relevant to the Quality Management System

    Hi all, This is quite perplexing to me. How can we show we met this requirement? "7.4 Communication The organization shall determine the internal and external communications relevant to the quality management system, including: a) on what it will communicate; b) when to communicate...
  11. J

    ISO 9001:2015 8.3.2 f) - Interfaces between Persons in Design & Development

    My question might seem amateurish, but in ISO 8.3.2 f) "the need to control interfaces between persons involved in the design and development process". This does not necessarily mean they HAVE to interface just that that they have a process of who works with who on what correct? I'm doing a...
  12. M

    How to Document Internal & External Communications - Suggestions/examples pls

    Does anyone have any suggestions/examples on how to document internal & external communications?
  13. A

    CSR - How do you share them within your organization?

    Hi folks! When you receive new CSR what are the best practices you use to share them with necessary people? Can you please share ideas, eg not just only send by email... Training in a room? You create a presentation and share? Let's share the great practices around!
  14. M

    Complying with AS9100 D Section 8.4.3 m. Ensuring that persons are Aware of...

    Section AS9100 D Section 8.4.3 adds a bunch of new requirements. For starters, how are you folks planning to comply with 8.4.3.m The organization shall communicate to external providers its requirements for: m. ensuring that persons are aware of: - their contribution to product or service...
  15. V

    Language is not a barrier if you know the "thing/subject" and "art of communicating"

    Language is key enabler, but it is not to be equaled to high-vocabulary-alone!!! real when it comes to a work place, can it be compensated by other skills ? we stumbled upon this topic during our coffee break....and could not conclude... So here's the deal. 1. quite a few examples of...
  16. L

    Communication Needs Identification and Communication Model Development

    Dear Friends After carrying out a gap analysis using the RADAR tool for enablers in the EFQM model, we came across a lacuna in many of our processes. :D Actually we are still not over with the exercise. Under the People Criteria we do not have a robust method of identifying communication...
  17. S

    ITAR Document Communication Options and Requirements

    Good morning, everyone. I have a question regarding the controlled communication of ITAR technical data (engineering drawings) through e-mail. Would zipping the data in a password-protected .RAR file be compliant with ITAR regulations as long as the recipient is a U.S. citizen or national?
  18. L

    Inspector who gossips - Need of a Communication Plan

    Hello everyone! Here is my problem: I have an inspector who “talks too much” to the customer . He creates false panics . His gossips are concerning, for ex., rejection rate (exaggerated or not) or other corporate issues we struggle with (flags not heard by Management, etc.). If a problem...
  19. N

    What is the Best Way to Promote/Communicate our Goals?

    Hello Covers - I would like to pick your brains on the best way to promote our Quality Objectives. We hold monthly Production Meetings, where we briefly discuss our goals and where we stand with each one, but last year it seemed like it went in one ear and out the other. After our recent...
  20. Scott Catron

    Communication in the Workplace

    Had this recent email exchange: (details changed to protect the confused) I'm QA in a chemical manufacturing plant, we have a customer that changed names of a bunch of products back in October, except for this one low-volume straggler. -------------------------- From: Scott Catron To...
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