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Welcome![edit]

Here are a few links to pages you might find helpful:

Content policies and guidelines:

  • WP:NOT (what WP is, and is not -- this is where you'll find the "accepted knowledge" thing. You will also find discussion of how WP is not a catalog, not a how-to manual, not a vehicle for promotion, etc)
  • WP:OR - no original research is allowed here, instead
  • WP:VERIFY - everything has to be cited to a reliable source (so everything in WP comes down to the sources you bring!) Please note that writing content that interprets a source, and then citing the source you interpreted is not OK. Content in Wikipedia summarizes sources, it doesn't interpret sources. (this is discussed in WP:OR)
  • WP:RS is the guideline defining what a "reliable source" is for general content and WP:MEDRS defines what reliable sourcing is for content about health
  • WP:NPOV and the content that gets written, needs to be "neutral" (as we define that here, which doesn't mean what most folks think -- it doesn't mean "fair and balanced" - it means that the language has to be neutral, and that topics in a given article are given appropriate "weight" (space and emphasis). An article about a drug that was 90% about side effects, would generally give what we call "undue weight" to the side effects. Of course if that drug was important because it killed a lot of people, not having 90% of it be about the side effects would not be neutral) We determine weight by seeing what the reliable sources say - we follow them in this too. So again, you can see how everything comes down to references.
  • WP:BLP - this is a policy specifically covering discussion about living people anywhere in WP. We are very careful about such content (which means enforcing the policies and guidelines above rigorously), since issues of legal liability can arise for WP, and people have very strong feelings about other people, and about public descriptions of themselves.
  • WP:NOTABILITY - this is a policy that defines whether or not an article about X, should exist. What this comes down to is defined in WP:Golden rule - which is basically, are there enough independent sources about X, with which to build a decent article.
  • WP:DELETION discusses how we get rid of articles that fail notability.

Key behavior norms:

  • WP:CONSENSUS - already discussed
  • WP:CIVIL - basically, be nice. This is not about being nicey nice, it is really about not being a jerk and having that get in the way of getting things done. We want to get things done here - get content written and maintained and not get hung up on interpersonal disputes. So just try to avoid doing things that create unproductive friction.
  • WP:AGF - assume good faith about other editors. Try to focus on content, not contributor. Don't personalize it when content disputes arise. (the anonymity here can breed all kinds of paranoia)
  • WP:HARASSMENT - really, don't be a jerk and follow people around, bothering them. And do not try to figure out who people are in the real world. Privacy is strictly protected by the WP:OUTING part of this policy.
  • WP:DR - if you get into an content dispute with someone, try to work it out on the article Talk page. Don't WP:EDITWAR. If you cannot work it out locally, then use one of the methods here to get wider input. There are many - it never has to come down to two people arguing. There are instructions here too, about what to do if someone is behaving badly, in your view. Try to keep content disputes separate from behavior disputes. Many of the big messes that happen in Wikipedia arise from these getting mixed up.
  • WP:COI and WP:PAID which I discussed way above already. This is about preserving the integrity of WP. A closely related issue is WP:ADVOCACY; COI is just a subset of advocacy.
  • WP:TPG - this is about how to talk to other editors on Talk pages, like this one, or say Talk:Electronic cigarette aerosol and e-liquid. At article talk pages, basically be concise, discuss content not contributors, and base discussion on the sources in light of policies and guidelines, not just your opinions or feelings. At user talk pages things are more open, but that is the relevant place to go if you want to discuss someone's behavior or talk about general WP stuff - like this whole post.

Communication and Change Management[edit]

copying comment here, that was left at the top of my talk page in this diff Jytdog (talk) 00:45, 10 March 2017 (UTC)[reply]

Is there no way to contact you directly? It looks like you made several pregenerated changes to my talk page, but none of them were applicable to either my last attempted update, your lack of justification for reverting my update, or the nature of your authority regarding either medical device risk management, specifically, or Wiki content, generally. I did not site references and then interpret or reinterpret them, as you seem to be indicating. I referenced the exact locations within the referenced documents where others can easily go and verify/confirm the truth (not an interpretation of the truth). This is more than can be said for the existing content of that section of the article. As an example, there are 2 instance where the existing text doesn't even use the appropriate words/phrases for the content ("as low as possible" vs. "as far as possible" and "labeling" vs. "information given to the users"). The incorrect words/phrases are not actually used in the relevant sections of the referenced documents ("as low as possible" and "labeling" are not used in the relevant sections of the MDD or EN ISO 14971:2012 Z Annex deviations). Why is the use of these incorrect words/phrases in the existing article not original research or reinterpretation? Why is this content allowed, but my correction of these words/phrases is not?

I am willing to work it out on the talk page of the article in question as a general rule but I have a few concerns. Regardless of whether or not anyone responds (agree, disagree, or no response at all), how is that to be interpreted, and who is the arbiter of whether a change can be made or no change is allowed (neither has any preferred position without appropriate rationale). I am experienced in Medical Device Risk Management, I have discussed this and share this understanding with every expert in medical device risk management that I have encountered (including co-chairs and contributors to ISO 14971:2007, AAMI instructors, and Industry SMEs, and the changes I identified are consistent with the position of the Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012, version 1.1 (dated October 13th, 2014) from the Notified Bodies Recommendation Group. I would like to understand the level of expertise that you have in medical device risk management that you are leveraging in order to reject the corrections I have attempted to make.

Wikipedia is not a democracy or an anarchy. Wikipedia is a cluocracy. Disputes are resolved in favor of whoever offers the best reasoning – not in terms of rhetoric but in terms of his or her understanding[1] of the established policies and guidelines of Wikipedia and of knowing what works and what doesn't.

I want to be harmonious and give you the respect that you may deserve, but your actions to revert the article without providing a justification do not seem to be consistent with your own accusation and/or judgment of the changes I attempted to make. The massages I have received seem to indicate that I am guilty of starting an edit war, but from my perspective, you initiated the edit war and although you seem to have authority over the content of the article, you have yet to justify your actions.

Help me out here, please. What am I missing? John Walters (talk) 00:26, 10 March 2017 (UTC)[reply]

John:
first new comments go at the bottom of talk pages. I had moved your prior post at my talk to the bottom of it, and replied there. See the bottom of my Talk page. I have also replied to you at the article talk page, after I moved your comment to the bottom. I just moved this one here (and put it at the bottom of your talk page, where new posts go) so you will actually see my reply. Btw if you click the "new section" tab at the top of any talk page, the Wikipedia software will open a new section at the bottom of the page. That is where experienced editors look for new discussions. Will reply to the substance above in a moment. Jytdog (talk) 00:51, 10 March 2017 (UTC)[reply]
second when you write that I have not provided a justification, you are ignoring the edit notes and replies I have given to you when I have said that your content violated WP:OR. Here they are:
Do you now see that I have provided the justification four times? Communication is a two-way street and if you are not even reading what I am writing, we are not communicating, are we?
third Above you write about your RW (real world) experience. That is great (really) but it is not relevant to this discussion. This can be maddening for experts when they first come here, as they expect this to be like the real world, where who you are matters. It doesn't matter here. (crazy right?) This place is built from the ground up to crowdsourced by anonymous editors. Some of those anonymous editors are RW experts but their RW status doesn't matter here. What matters here is the quality of sources you bring, how well you summarize them, and how you behave. That is what a WP reputation is built from.
fourth Above you write a lot about how bad the article is. I agree. This article needs a lot of improvement, and could really benefit from someone with your expertise. But adding policy-violating content isn't actually an improvement. Pointing to existing content that is bad, is not a valid justification for yet more bad content.
fifth to explain a bit more about what was wrong with your edit. You cited what we call "primary sources" and your content interpreted those primary sources. (the ISO standards themselves). But this is the WP:OR - as Wikipedia editors we cannot interpret primary sources. All that we do here is summarize sources. That is all. (It is hard for experts to wrap their minds around this too) Wikipedia content is built from secondary sources (like an article about one of the ISO standards) or tertiary sources (like a textbook about medical device risk management). This is very, very intentional, and goes back to the place being built from the ground up to be created and maintained by anonymous editors. What is authoritative here are sources -- if you bring high quality secondary sources and tertiary sources, and summarize them well, your edits will "stick". (Wikipedia is an encyclopedia - a tertiary source that is built by summarizing secondary and tertiary sources; primary sources are allowed but must be used with extreme care.)
The reason why we love experts in Wikipedia is not so they come here and write what they know - it is because a) they know the literature in their fields and can quickly and efficiently bring it to bear; and b) knowing the field, they can know at a glance if the WP:WEIGHT of an article is skewed somehow - if some part of is blown way out of proportion, or if there is some gaping hole in it. And they can fix either problem efficiently by summarizing the great sources they have at their fingertips. Likewise experts can easily see if some part of an article is outdated or is just of bad quality, like the section you want to fix. I want it fixed too! It just needs to be fixed correctly.
Does that help? Jytdog (talk) 01:09, 10 March 2017 (UTC)[reply]

The content you added[edit]

Jytdog: * Your first edit cited no references at all. This is not OK per WP:VERIFY and WP:OR. There are citations in the 2nd edit, but they are not the sources that you are summarizing - rather they are what your content is referring to and explaining. This is not how Wikipedia content and references work. In Wikipedia, content is completely slaved to sources -- anyone needs to be able to go to the source cited and find what you are saying actually discussed there; the content needs to just summarize the source. Do you see? Jytdog (talk) 01:25, 10 March 2017 (UTC)[reply]

John Walters: I understand and agree. These were my earlier edits (no worse than the original again, but I get it - the powers that be on Wikipedia would rather have stable incorrect info than slightly less stable, but more correct info). My last edit had numerous references and no WP:OR, but was rejected immediately. Please review my last edit and tell me what specifically you find reject worthy. I can only improve your content if I understand what your target is and agree that it is valuable to hit that target.John Walters (talk) 01:33, 10 March 2017 (UTC)[reply]

Jytdog: There are citations in the 2nd edit.

John Walters: There are.
Jytdog: They are not the sources that you are summarizing - rather they are what your content is referring to and explaining. This is not how Wikipedia content and references work.
John Walters: In an Article on "Risk Management", in a section on "Areas", in a sub-section specifically referencing "Medical Device", and in a paragraph discussing the relevant international standard and related regulations, what would be the "sources" that would be "summarized" if these cannot be the various ISO 14971 versions and the MDD, AIMDD, and IVDD? Does your position mean that this whole paragraph should be removed?
Jytdog: In Wikipedia, content is completely slaved to sources.
John Walters: That is what I did on my last edit. The only thing that I could possible add to improve the elucidation of the primary sources would be to note that the Z Annexes in EN ISO 14971:2012 are only relevant in that they leverage the legal/regulatory power of the MDD, AIMDD, and IVDD. In this regard, EN ISO 14971:2012 is not even a primary source. I could also add references to the IEC 60601 Series of Medical Device Product Standards, but these would also leverage ISO 14971:2007 and the various relevant regulations (ie MDD, 21CFR820, etc...).
Jytdog: Anyone needs to be able to go to the source cited and find what you are saying actually discussed there; the content needs to just summarize the source.
John Walters: That is exactly what my last edits did. I removed editorial comment, summarized the content, and provided references so that anyone can find the exact text within the primary sources (the various ISO 14971 versions and the MDD). Please identify and provide specific instance where I am identifying the wrong primary source, providing editorial comment, or failing to reference specific text or section of text that supports the "summarization".John Walters (talk) 02:16, 10 March 2017 (UTC)[reply]

Jytdog: ::Hm, you are not getting it - the key thing you missed is "They are not the sources that you are summarizing - rather they are what your content is referring to and explaining. This is not how Wikipedia content and references work." Look at your first "reference" which says: "Compare the actual text of the EN 14971:2012 standard body to the actual text of ISO 14971:2007 standard body. Note also the text at the top of the British National Forward in BS EN ISO 14971:2012 that states that BS EN ISO 14971:2012 "is identical to ISO 14971:2007"." You are not citing a source in which that comparison was done -- you did the comparison and you ask the reader to do the same comparison. That is not what we do here. The appropriate citation would be say an article published in a trade journal, or a book chapter, or a textbook, where the author of that reference did that comparison and discussed it. A Wikipedia editor would summarize that discussion, and cite the source that they were summarizing. Does that help? Jytdog (talk) 03:29, 10 March 2017 (UTC)[reply]

John Walters: Not so much. The explanations for you rejecting my content does not align with either my content or your own WP:OR documentation, as far as I can tell. My content is indeed summarizing the relevant sources (more explicitly, and in a more valid manner relative to the relevant sources than the existing revision). Regarding the comparison text within a citation, there is no separate source that indicates they are the same. One of the sources themselves indicates that they are the same. I included citations of this very fact. I have another explicit citation if this will help. If we can't rely on a more fundamental source as reliable, how can we ever hope that a separate and weaker source can be reliable? Needing to cite a separate source in which this comparison is done, when one of the sources explicitly indicates that it is the same as the other source, seems ludicrous to me. Regarding doing the comparison and asking the reader to do likewise. Neither I, nor the reader need to do this comparison if we trust the source. If we don't trust the source, this is not asking them to do the comparison but providing them with the information needed for the issue to be verified (per your own WP:VERIFY expectations). Again, one of the sources themselves included the comparison/discussion statement. My content merely summarizes the relevant sources and my citations directly support this summarization.

@Jytdog:

Lets try this... Please let me know exactly where I am noncompliant relative to your own documented standards for WP:OR. I would really like to get to a point where I had confidence that revisions I might make won't be rejected without appropriate review time and expertise or without the ability to identify what the specific criteria of acceptance are. If certain words are hanging you up, why not ask? If certain formats for citations are an issue, why not point me to repeatable and reproducible standards for these things? If certain arguments are not clear to you, why not focus on those instead? If you let me, I can help you where you don't understand. Maybe there is another method of actually working on revisions and getting the review and approval of you sage rulers before a revision is submitted? If we can't figure it out here, then perhaps it could be done by trial and error in a sandbox or draft workflow of some kind...

WP:OR: Reliable sources Any material that is challenged or likely to be challenged must be supported by a reliable source.

John Walters: The reliable sources for the Medical Device section of the Risk Management Article are ISO 14971:2007, the European Union Medical Devices Directive (MDD) (93/42/EEC and 2007/47/EC), and EN ISO 14971:2012 (and national versions of CEN/CENELAC member nations). FDA and other relevant Regulatory requirement documents as well as other international standards (such as the IEC 60601 series of product standards are also relevant, but generally leverage one or more of the first three sources noted above. All of these are either Regulatory Requirements/Directives (with legal authority) or well-reviewed international industry standards. These sources have a higher level of reliability than any of sources listed as the most reliable sources in the WP:OR article. The use of these sources is appropriate and displays both good editorial judgement and common sense. Primary, Secondary, and Tertiary sources have been used.

Primary Sources:

  • ISO 14971:2007
  • The European Union Medical Devices Directive (MDD) (93/42/EEC and 2007/47/EC)

I didn't explicitly identify 93/42/EEC and 2007/47/EC. Would it make my changes acceptable if I included these in the citations for the MDD? The existing revision does not include these, so my changes here are not making this specific issue any worse, while making the rest of the article better (both factually and RE. WP:OR.)

Secondary Sources:

  • EN ISO 14971:2012

This is one step removed from both primary sources and includes analysis, evaluation, interpretation, or synthesis of the facts, evidence, concepts, and ideas taken from primary sources.
This source is not independent or a third party source.
This source relies on both of the primary sources for its material and makes analytic and evaluative claims about them.

  • IEC 60601-1 General Medical Electrical Equipment Standard (and the full IEC 60601 Series of Standards)

This is one step removed from both primary sources and includes analysis, evaluation, interpretation, or synthesis of the facts, evidence, concepts, and ideas taken from primary sources.
This source is partially independent and is from a third party source (albeit a source that works closely with ISO and EU representatives).
This source relies on both of the primary sources for its material and makes analytic and evaluative claims about them.
I didn't explicitly cite or reference IEC 60601-1. I am not sure that it is needed as an additional secondary source, but I could. Would it make my changes acceptable if I included these additional citations?

Tertiary Sources:

  • Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012, version 1.1 (dated October 13th, 2014) from the Notified Bodies Recommendation Group.

This is a consensus paper that summarizes the primary and secondary sources.
This source is helpful in evaluating due weight as the primary or secondary sources are sometimes incorrectly interpreted to contradict each other (either explicitly or implicitly), when they do not in actually contradict one another (either explicitly or implicitly).

WP:OR: Material for which no reliable source can be found is considered original research. The only way you can show your edit is not original research is to cite a reliable published source that contains the same material. Even with well-sourced material, if you use it out of context, or to reach or imply a conclusion not directly and explicitly supported by the source, you are engaging in original research; see below.

John Walters: I cited the reliable published sources noted above. I used citations and sources within context. I did not reach any conclusion that are not directly and explicitly supported by these sources. The information I cited is easily verifiable in the references cited. I did not include or reference unsourced material from my personal experience.

WP:OR: Any interpretation of primary source material requires a reliable secondary source for that interpretation.
John Walters: I have not provided any interpretation of primary source material, so no reliable secondary sources are needed for the non-existent interpretation of primary source material.

WP:OR: A primary source may only be used on Wikipedia to make straightforward, descriptive statements of facts that can be verified by any educated person with access to the primary source but without further, specialized knowledge.

John Walters: The material I provided consists of the collection and organizing material from existing sources. Prior editors had already identified the most reliable primary sources on the topic and I corrected/improved the “summarizing” of what these sources indicate, with each statement in the article attributable to a source (or sources) that make that statement(s) explicitly. Source material was carefully summarized or rephrased without changing its meaning or implication. Care was taken not to go beyond what is expressed in the sources or to use them in ways inconsistent with the intention of the source. Material was not used out of context. The material provided is not a new discovery and the content is supported by reliable primary, secondary, and tertiary sources.

WP:OR: Wikipedia articles must not contain original research. The phrase "original research" (OR) is used on Wikipedia to refer to material—such as facts, allegations, and ideas—for which no reliable, published sources exist.[1] This includes any analysis or synthesis of published material that serves to reach or imply a conclusion not stated by the sources. To demonstrate that you are not adding OR, you must be able to cite reliable, published sources that are directly related to the topic of the article, and directly support the material being presented.
John Walters: The material I provided does not contain any original research. The material I provided used primary sources to make straightforward, descriptive statements of facts that can be verified by any educated person with access to the primary source but without further, specialized knowledge. Material within the cited primary sources has not been analyzed, evaluated, interpreted, or synthesized with any other primary source. This includes any analysis or synthesis of published material that serves to reach or imply a conclusion not stated by the primary sources. I cited reliable, published sources that are directly related to the topic of the article, and directly supports the material being presented. All of the material I added to the article was attributable to a reliable, published source. I provided an inline citation to a reliable source for all quotations and for any statement likely to be challenged. To the best of my knowledge I have not plagiarized or violated any copyright, and have only quoted small selections of text useful to the discussion. I have rewritten source material in different words, while substantially retaining the meaning of the references, which is not considered to be original research.
WP:OR: In general, article statements should not rely on unclear or inconsistent passages, or on passing comments. Passages open to multiple interpretations should be precisely cited or avoided. A summary of extensive discussion should reflect the conclusions of the source. Drawing conclusions not evident in the reference is original research regardless of the type of source.
John Walters: My content does not rely on unclear or inconsistent passages within primary sources, or on passing comments. Passages open to multiple interpretations have either been precisely cited or avoided. The existing revision of the article fails to cite or avoid inconsistent passages or interpretation and actually introduces misinterpretations without citation or justification. The material I provided actually removes this introduced misinterpretation from the existing revision. Conclusions are evident in the primary sources. Material from multiple primary sources has not been combined to reach or imply a conclusion not explicitly stated by any of the primary sources, and different parts of one source have not been combined to reach or imply a conclusion not explicitly stated by the source. Indeed, I have removed an instance of this in the existing revision. John Walters (talk) 21:44, 10 March 2017 (UTC)[reply]

What a train wreck. You are uninterested in learning and I have other things to do. Too bad for everybody. I work in the field and if I ran across a consultant who took as little time to understand my business as you are taking to understand Wikipedia, I'd shake your hand and smile, and throw your card away when you left. Like I said too bad for everybody. Jytdog (talk) 22:36, 10 March 2017 (UTC)[reply]

@Jytdog:

John Walters: I took the Wikipedia Adventure over the weekend, thinking that it would be able to explain or clarify some of the things you seem to have been attempting to communicate to me where you have been unable and/or unwilling to do so. What I found was some good stuff. - be bold (offer your expertise and do not be afraid to make mistakes - the site is looking to improve the quality of content, but is aware that it is a journey.) - be respectful (be harmonious and be willing to discuss or suggest changes to generate and improve content - outright rejection of revisions is not what the Wiki Training seems to be indicating is a best practice). - provide appropriate rationales for your changes (good rule of thumb in every rational and non-tyrannical interaction.)

I admit that my initial post did not have adequate references and included language that was opinion-like. Were improvements suggested? No. The complete revision was rejected with only a reference to WP:OR. I improved this in subsequent posts.
I further admit that I did not provide adequate revision comments on my posts. I will improve this going forward, but if rejections are to be the preferred or expected interaction (instead of suggestion and discussion), then I am not sure what the value of incremental comments are.

I will not admit to not wanting to learn. I asked numerous questions (see posts above), and received few answers. I asked specific questions (see posts above), and received only vague criticism when I did get a response. I asked for a justification of your expertise or authority early on, but didn't receive any kind of answer on that until your last post. We could have had a discussion and both potentially benefited from it, though from your last post, it seems as though you are still (and will continue to be) unwilling to have this discussion. My revisions were rejected outright instead of having questions asked or suggestions made. My revisions and questions were not treated with respect. You started an edit war. When I defended my content and intent against the accusation that I am not meeting the letter and/or intent of "your" supposed expectations (via Wiki guidelines), I am further assaulted/disrespected (ad hominem).

I try my best to limit my exposure to people who are unwilling to actually read, understand, and respect relevant content (be it a regulation, standard, or a simple on-line post), unwilling to provide answers and justifications for their own positions/decisions, or who are willing to be tyrants or bullies. Unfortunately, these types of people are more common than I would hope. Fortunately, I want to improve quality generally, and so, I find it difficult to turn my back on problems.

I was not welcomed into the community by you, and that is sad. Hopefully my experience with others (most importantly my own interactions with other people's revisions) will be a better example of how this community and site are supposed to work.

Thank you for reinforcing the importance of understanding, respect, and justification. John Walters (talk) 17:35, 13 March 2017 (UTC)[reply]

Whatever. If you want to try to build content that complies with the policies and guidelines, I'll be happy to work with you. I (and everyone else here) will remain uninterested in the rest, which we call WP:DRAMA. Jytdog (talk) 19:56, 13 March 2017 (UTC)[reply]

Notifications[edit]

This page is on my "Watchlist", as it the Risk management article and its talk page. So I will see it, when you (or anybody) posts something on any of those talk pages. Everyone has a watchlist - you access it by clicking "Watchlist" in the upper right corner (way up at the top). You can add any page in Wikipedia to your watchlist (the associated Talk page is automatically included) by clicking the star that is up near the top of the page, in the same row as the "search Wikipedia" box. To the left of it, is the "More" filed, and to the left of that, is the star. It turns blue after you click it. If you don't think the other editor has the page on their watchlist you can notify them using @USERNAME: or User:USERNAME - there is no point doing that if you know the person has the page on their Watchlist, however. Jytdog (talk) 03:36, 10 March 2017 (UTC)[reply]

Welcome to The Wikipedia Adventure![edit]

Hi John Walters! We're so happy you wanted to play to learn, as a friendly and fun way to get into our community and mission. I think these links might be helpful to you as you get started.

-- 22:15, Friday, March 10, 2017 (UTC)

Hi![edit]

I see you are back. Glad that you didn't give up. Since we talked last time, I have developed a one-page "how-to" guide for WP, that covers how this place works in principle, as well as some of the logistics. Please have a look! User:Jytdog/How Jytdog (talk) 03:42, 22 July 2017 (UTC)[reply]