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View Full Version : Shall vs. Is - Don't use the term 'shall' in your quality manual


Lucinda
15th January 2002, 12:12 PM
In two of the ISO courses I took, the instructors said that you don't use the term "shall" in your quality manual, you say it as if it "is" being done. Ex. Design changes are reviewed, approved, and documented...rather than....Design changes shall be reviewed, approved, and documented.

I was very good about doing this in the QM and the earlier upper level procedures, but I find myself straying from it as I write some of the departmental procedures. The reason is that I'm writing these procedures specifically to address some problems that we're having and so the tone I've adopted is more of a "you will do it this way" than a "this is the way that we do this". For ex.: "When one of the offices is managing a contract that was bid out of another office, a job file shall be maintained by both offices."

Is this wrong? I find it really hard to always speak in the present because what I have to cover here are all the variables. Many times part of the sentence is something like:. .. "In these instances, the regional office shall continue to follow ....."

JRKH
15th January 2002, 01:30 PM
I think you are on the right track. In the QM, and top level doc's you are trying to codify what you do, thus you say "we do these things", for example, "Adequate resources ARE provided".

However when writing instructions, it needs to be more direct and active. I don't even like using "shall" in instructions. I prefer "will", or "must", or "needs to". They leave little room for squirm.

It really comes down to who you are writing to. The QM is written to those outside of the org. i.e. customers and registrars. Therefore you say "Yes we do these things". Procedures are internally addressed and you say, "This is HOW WE WILL do this thing." (and ve hav vays off meeking you:vfunny: )

Well enough of my rambling.

Anyone else?

James

energy
15th January 2002, 02:19 PM
A quick check of our consultant supplied QPM shows approx. 50% of it uses the word XXXXX “shall” and the other half says, XXXXXX “ensures that”. The QPM is written pretty much like the standard. As we have a lot of Consultants here at the Cove, as evidenced by the latest poll on Company size, what does use the word “shall” indicate to the rest of you? Managers are welcome. Inspectors. Anybody. For example, we say that in the event of a fire or emergency an alarm will be sounded and all employees “shall” assemble in the parking lot for attendance. There is no other choice. I guess we could say that company XXXXXXX assembles in the parking lot. This would be the Tier 2 document that Lucinda refers to. That appears to be talking to outside sources. Before I use the “Find and replace” feature in “Word”, can anybody else jump in here and tell me that this is really necessary. No disrespect Lucinda or James. But sometimes we have question things said in a classroom. The QPM is for use in the Company, more so than Customers who want a copy. No? It acts like a blueprint to locate procedures. No? I’m confused.

db, where is the shall?

CarolX
15th January 2002, 02:26 PM
Hi Lucinda,

My system is set-up along the lines described by James.

Policy manual states what we are doing....
Procedures are how we shall accomplish this.

Lots a Luck!

CarolX

Lucinda
15th January 2002, 02:42 PM
Originally posted by JRKH
...However when writing instructions, it needs to be more direct and active. I don't even like using "shall" in instructions. I prefer "will", or "must", or "needs to". They leave little room for squirm....

You may find this interesting...In the list of terms that I defined in the Quality Manual for use throughout our Quality System, I drew a distinction between the use of the word "shall" and "will".

"Shall" = Use of this word means the action described is mandatory; "Will" = Use of this word shows intent; use of this word means the action described is not mandatory.

Maybe I didn't need to do this but thought it might be prudent to provide an "out" for some actions that "should" be done but don't "have" to be done exactly that way, every time. And I confess that I lifted this out of another company's definitions:) thinking it was a good idea.

But "shall" is not used in my QM - Those statements are all affirmations that we "do" things as I described above.

Except for the temptation to use it in the body of my procedures, the only real home for it is in the Responsibilities section of each procedure. As in : The Procurement Manager shall: (bullet) ensure XXXX (bullet) ensure XXXX, etc.

E Wall
15th January 2002, 04:05 PM
I cannot believe we're alone here, but our manual isn't just written for outsiders...it is our core Management tool. Simply, it is the foundation that directs, and is supported by, all of our processes. Every new staff member is told to read it, learn what is applicable to their functions, and review it and any associated procedures periodically (this usually happens before an internal audit that includes thier involvment).

The manual we have uses both phrases "to ensure" and "shall ensure". The most recent update (now posted on an intranet) does a much better job of stating what is done and then provides the hyperlinks to a referenced QC Procedure, but it too includes shall statements.

Brief Example:
Standard states: "The supplier shall review..."
Our QM states: "It is XXX policy to review all..." then goes on to say "The review process shall ensure that...."

We are working on putting all plant level WI on the intranet also and, as applicable, hyperlinks will be created in the QCPs leading to WI for each facility (goal is to standardize whenever feasible). This will actually happen as we each transition to the y2k version.

Energy: There is no requirement that you not use shalls in your QM. It is up to you and how you use the word (IMHO).

Alf Gulford
15th January 2002, 04:50 PM
Gotta go with Eileen, here. We emphasize that the Quality Manual is for our people to use (not that they do, much) as well as a potential marketing tool.

I've had auditors that say we shouldn't use the word and others don't seem to care one way or another. We use it when it fits and don't worry about it.

Alf

Hey, what gives here? My picture was supposed to show up this time. I read the instructions on Avatars and thought I had it figured out. I guess when you grow up using slide rules instead of computers, it takes a little longer to get these things right.

And besides that, I'm sure I saw some mention of a bottle of whiskey when you pass the 100 entry mark.

db
15th January 2002, 05:15 PM
quote:
-------------------------------------------------------------
Originally posted by energy
db, where is the shall
-----------------------------------------------------------

I wasn’t going to respond to this thread, but seeing as though energy is going to demean my character (by challenging me to respond)….Actually considering my “Where’s the Shall”, I understand his comment. :biglaugh:

To some “shall” indicates future tense. To others “shall” indicates a legal requirement. To me, I really don’t care if you use “shall”, “will”, “does” or whatever. Isn’t the important thing to have an effective system?

I recommend using present tense when it makes sense, and future tense where it makes sense. Please don’t get too wrapped up in the linguistics! The importance of words diminishes with the effectiveness of the system. If it works with “shall”, use shall, if it works with “do” use do. If it doesn’t work, fix it.

Good enough, energy?

db
15th January 2002, 05:17 PM
Alf,

What's a slide rule? Was it used to measure 8-tracks?:vfunny:
(I still have mine, too)

Alf Gulford
15th January 2002, 06:23 PM
Slide Rule #1

The first kid on the playground gets to be the first one on the slide.

Alf

And just to go you one better, my 1960 Ford Convertible (Red, of course) had a 4 track. The sound was OK but you couldn't get a whole album on one.

energy
15th January 2002, 06:35 PM
Originally posted by db
quote:
-------------------------------------------------------------
Originally posted by energy
db, where is the shall
-----------------------------------------------------------

Please don’t get too wrapped up in the linguistics! The importance of words diminishes with the effectiveness of the system. If it works with “shall”, use shall, if it works with “do” use do. If it doesn’t work, fix it.
Good enough, energy?
db,
Yup, works for me. I have enough to worry about. But, Lucinda has a way of opening my eyes to things I can't see through the bloodshot lines. We love you , Diver Girl!:bigwave: :ko: :smokin:

Lucinda
15th January 2002, 07:21 PM
Then I shall use "shall" wherever it seems to make sense.

If no one has gotten flack from auditors regarding the use of this word, then I won't worry about it. I was just trying to follow the guidance given by the two consultants who were teaching the courses and, while understanding their point with the quality manual, was wondering if it really applied to the procedures.

I'm glad that it doesn't really matter!

(tried to blow you a kiss energy, but just a bunch of bubbles came out) :bigwave:

Jim Biz
16th January 2002, 12:27 AM
As I recall from an old business law textbook >
there are some differences in the use of Shall and Will and Must

Shall is often fond legally by courts & such to be "the most difinitive means of describing an action" that needs to be taken.

"WE SHALL do this or that" > no way to get around it.

Using "Will" often times means the action can be "skirted"

"Will" we do this or that -- is like sayng yes BUT -
we will --- when ever we decide to or I "will" if you make me.... someday.

"Must" be done - again vague used by itself unless the why consequences of "Must" is described along with it.
"A) Must be accomplished in order to complete B)

JRKH
16th January 2002, 06:43 AM
Based on what I am reading here, I am the one who must rethink my use of the terms. I always understood the opposite of what Jim Biz indicates. That "shall" was less firm than "will".

Oh well live and learn. Score one for the cove.

James;)

SteelMaiden
16th January 2002, 09:58 AM
Originally posted by Lucinda


"Shall" = Use of this word means the action described is mandatory; "Will" = Use of this word shows intent; use of this word means the action described is not mandatory.



Well, I don't know about everyone else, but when I tell my kids that the "will clean up their bedrooms before I get back from the grocery store" they don't think that I am making a suggestion that gives them a choice:biglaugh:


Actually, I pretty much write, or edit any tier document to read like common speech. I very seldom ask one of my crew to perform a task using shall, or will. Basically, I train someone by saying You take the sample, inspect it to ensure that the surface has been ground enough to remove any foreign particals. If the surface is good, place it in the test fixture. If the surface is bad, regrind it.

Therefore, my instruction would read like this.

>Inspect the sample to ensure that the surface is free for detrimental surface contamination.
>>>If the surface is contaminated, regrind to remove the foreign particals, and reinspect.
>>>If the surface is acceptable, place the sample in the test fixture and continue with testing operation.

There are a few shalls and a few wills, but a wise manager once told me, (back when I was new to the field) "This ain't brain surgery, and these guys ain't a bunch of pencil pushers! If you want them to respect you, don't be talkin' down to em! You gotta be one of the guys or they'll treat you like one of them uppity so and so's in the office." Now I don't want to start any wars between office workers and plant employees, but I learned (right quick, my southernism for the day) to write at a level used by the people that are performing the job. Shalls, I think not!

Of course, poor ol' Miss Jenkins, my Sr. Comp instructor from high school would probably spin in her grave if she saw some of the sentences I use in our QMS!:ko: (there's no way she could still be living....could there, that would make her something like 580 million years old, right?)

Laura M
16th January 2002, 08:16 PM
I don't use shall or will. They sound like "future tense"
I use more "command" language like #3 below, or #1 in more descriptive procedures..

1. A CAR is completed for customer complaints vs.
2. A CAR shall be completed for customer complaints vs.
3. Complete a CAR for customer complaints.

M Greenaway
17th January 2002, 08:44 AM
Laura

The trouble with your sentences is that they do not say who is responsible for doing the activity. As soon as you add that to the sentence you have to put in a 'shall' or a 'will'.

i.e. The Customer Services Engineer will complete a CAR for customer complaints.

Do you define who does these activites some other way ?

D.Scott
17th January 2002, 09:16 AM
We use basically the same approach as Laura. I am concluding Laura has abreviated the sentence and in the actual instruction/procedure she states the responsibility similar to us:

"The customer services engineer is responsible for completing a CAR when customer complaints are received" - or some such.

I agree that the shall and will sound like "future tense". I am also in agreement with the earlier statements that "shall and will" should be left out of the manual. It should be proactive and describe what your system IS, not what it will be.

Just my opinion.

Dave

Al Dyer
17th January 2002, 09:21 AM
Below is a partial sample of a proceddure that does not use "shall". I edited some names out but this is a currently approved procedure.
---------------------------------------------------

4.1 Corrective Action

4.1.1

All customer complaints and internal nonconformities are directed to the Q.A. Manager. If parts are to be returned to ACF Tech they will be issued a return authorization number by Quality Assurance. (see wi-141-08) Q.A. will access the corrective action system in XXXXX, input the required general information, and print out a corrective action report. The due dates for the Corrective Actions are based upon the magnitude, risk, and urgency of the problem. The quantification of these factors is subjective as evaluated by the Q.A. Manager.

See

wi-141-03 Opening A Corrective Action XXXX
wi-141-04 Initial Quality Action
wi-141-06 Customer CA Requirements
wi-141-07 Certifying of Material to Customer

The Quality Manager will compile a problem solving package (see below) and submit the package to the responsible Department Manager. Problem Solving Package includes the XXXX corrective action form and:

qs-141A Problem Solving Worksheet
qs-141B Fishbone Diagram
wi-141-01 Problem Solving Steps
wi-141-02 Corrective Action Process
wi-141-05 Script for Customer Call
wi-141-06 Customer CA Requirements
qs-022C Team Project Roster
qs-022D Task Tracking Sheet
qs-022E Process Snapshot
wi-022-02 Project Team Responsibilities
Meeting Minutes

4.1.2

The Manager initiates a problem solving team and performs the corrective action per instructions and forms found in the Problem Solving Package.

4.1.3

Department Managers are responsible for ensuring that all Corrective Action steps including documentation have been performed per work instruction wi-141-02 and that the Corrective Action taken is effective. If a Corrective Action requires a change to any Level 1 or Level II documentation, the Department Manager will contact the Management Representitive.

4.1.4

When complete, the Department Manager will meet with the Quality Assurance Manager to review the corrective action package and resolve any open issues.

4.1.5

The Quality Assurance Manager is responsible for the following:

-Ensuring that any changes to procedures due to corrective actions are processed through the document control system. (see QS-051, Thru QS-053.)

-Documenting the corrective action in the XXXX Corrective Action System. Instructions for accessing the MPACT corrective action process can be found in wi-141-08 Using XXXX For Corrective Action

-Answering any customer-requested Corrective Actions in the Customer-Designated Format, if there is one. The default format for ACF Tech is the 8D.

-Coordinating the Certified Material Program. See wi-141-07

-Ensuring that all corrective actions are completely documented and closed and that these measures are reviewed monthly by management. See qs-011A Meeting Minutes

etc...

SteelMaiden
17th January 2002, 09:31 AM
M,

I won't presume to speak for Laura, but her example was similar to mine. If a work instruction is written for one job, you don't have to repeat that job title within each sentence, step or whatever. Typically we define who is responsible for what within a section called "responsibility and authority" If we have a procedure that includes multiple jobs or functions, than we typically have subsections for each step as performed by an individual function.

Don't make life hard for yourself. If the responsibility ever changes to another function it is so much easier to change it in the responsiblity section, or a couple of activity subsections, than to find and replace it in every line.

M Greenaway
17th January 2002, 09:41 AM
I am trying to think what the difference would mean to an auditor, or to the guys that work to the procedure.

If we used the word 'shall' and it was interpreted as being written in the future tense could an operator turn around and say 'well it only says I shall do it - not necessarily when' ?

Laura M
17th January 2002, 11:18 AM
Originally posted by M Greenaway
Laura

The trouble with your sentences is that they do not say who is responsible for doing the activity. As soon as you add that to the sentence you have to put in a 'shall' or a 'will'.

i.e. The Customer Services Engineer will complete a CAR for customer complaints.

Do you define who does these activites some other way ?

Thanks D. Scott, SteelMaiden - of course responsibility is established elsewhere. Greenway - Do you look for trouble? Did you really think that was my whole procedure? Try and be a little less negative around here. Nuf said.

Laura

energy
17th January 2002, 11:38 AM
Let's not forget that are ten(10) shalls in the Ten Commandments.
:vfunny:

ASQ's Code of ethics has 16 line items that all begin with "will".:eek:

I believe that these are directives. Not implying future actions.

I think we think too much, sometimes.:ko: :smokin:

Kissee, Kissee, Kissee to all!:ko: :smokin:

E Wall
17th January 2002, 11:47 AM
I believe (and I'm not asking whether anyone agrees with this interpretation) the comment by M Greenaway was based on a 'No assumptions made' standpoint rather than a judgement of your entire system.

M Greenaway specifically asked in an earlier post Laura, ....Do you define who does these activites some other way ?Making any assumption can lead to a problem so I applaud that this wasn't done. I would encourage all of us to not take comments made personally...and try to look at the question without adding responses of that nature.

This comment is being made because the thread was report to the moderator (a feature anyone can use). Private replies were made and this post is just an attempt to keep the peace not start a debate. I hope it is respected as such.

Anyone can send me an e-mail or pm if they feel it is necessary but let's not banter blame or make comments taking sides in the thread okay?

Respectfully, Eileen V. Wall - A Forum Moderator

Laura M
17th January 2002, 06:54 PM
I'm in the process of rewriting procedures for a company where my predecessor wrote like when you needed to write a 300 word essay for English - and you added meaningless words to get there! No kidding, here is a quote "At the end of the shift the set up person will record the number of rejects on the form in the column below the hour within the shift that the rejects occurred."

I changed it to "Record the total number of rejects in the corresponding shift/hour box." It was already designated as a procedure for the set-up people.

I also think of instructions you get when you have a DIY "some assembly required" projects. The instructions say "Attach panel A to panel B." Not, "You will attach panel A to panel B."

As to the original question, there is no diff between shall and will IMHO. I'm not saying I've never used them - but my current philosophy is to avoid it.

Laura-2002
18th January 2002, 07:08 AM
The Manual, saying this is what we do.

QPs are usually done as flows with resp and auth documented on the left hand side and a commentary stating what we do on the roght hand side.

Desk top instructions are the responsibility of the local area and advice is given basically saying write down the facts not your aspirations.

When writing procedures I think you need to bear in mind that they are subject to audit and by putting in anything other than what you do, then you are setting yourself up for a hanging!

I also tend to advise against specific timescales. Phrases like quartely and every six months are discouraged and replaced with 4 times or two times a year.

This is b/c if you have a pernickety assessor it is likely that he will pull you up if you did not do something on a quarterly basis; i.e if you are one day out. This one day probably may not affect your operations and it certainly isn't the end of the world, but not all assessors will let it slide and they will non-conform you b/c your QMS is at fault.

JMHO

Lau.

It's POETS day WOHOOOOO!!

Claes Gefvenberg
14th May 2002, 06:26 AM
Laura M said:

I'm in the process of rewriting procedures for a company where my predecessor wrote like when you needed to write a 300 word essay for English - and you added meaningless words to get there! No kidding, here is a quote "At the end of the shift the set up person will record the number of rejects on the form in the column below the hour within the shift that the rejects occurred."



:vfunny: I have exactly the same problem. Whenever I rewrite one of our older procedures I habitually end up whith far less than half the size of the previous document.... And it gets a lot easier to read. Fortunately, not many of these old documents remain.

Unfortunately, the fact that they *have* existed means that a quite a number of our staff long since have decided that written procedures are unreadable and not to be botherd with... I'm not saying that it's inpossible to turn them around, but it's certainly not easy. (..sigh)

/Claes

CarolX
14th May 2002, 12:06 PM
When I set out on my first set of procedures here (about 7 years ago) the VP handed me the procedures written by the ISO consultant. He told me, do what ever you want with these. I reviewed the procedures and found them full of nothing but gobbledy gook!!!! I took the procedure for First Piece Approval from 6 pages down to 1!!!! I showed it to the VP, and his jaw was agap!!! He asked me how quickly I could have the others done...to which I promptly responded...already done...ready to print!

My point being....keep it as simple as needed for it's indended purpose. If this procedure is meant to be used by a factory worker who's education level may be below yours...write the procedure that way. Make it usable, make it mean something.

rambling again...

CarolX

Mike S.
14th May 2002, 01:11 PM
Carol (and others),

You're not rambling -- you're talking sense!!! You gotta consider the user -- our procedures/WI's for the tech folks using complex equipment naturally use bigger, more technical words where appropriate (this can save space in the end) than procedures intended for a HS grad (maybe) on the shop floor. As far as length -- I even catch myself getting too wordy sometimes, but I personally don't like to cut it down to "Attach panel A to door B. Use screw C, qty. 4" like I see in some DIY things. That's a little dry even for me, but as someone said, I like to write like I talk, maybe only with a little more brevity.

I have often ran into the problem of Engineers writing overly complex, overly long procedures/work instructions for the general shop floor employees where the KISS principle definitely needed to be considered. (That's not a cut on Engineers -- sometimes I is one!) Example: At my last company I had a Sr. Process Engineer -- a very smart guy with many years of industry experience -- who wrote a 50 (that's not a typo, I mean fifty!) page WI for a task that up until that time had nothing in writing and was done only by relatively short training sessions!!! It was loaded with digital pics and covered everything from setup, running the machine, maintenance stuff, to how to wash your hands after using it! I was stunned, but could not convince him to shorten it. Some of his "short" ones were 10-15 pages. How effective do you think these WI's were? Win some, lose some.

Mike S.

JRKH
14th May 2002, 01:14 PM
Be careful.
Some people do not like it when you "talk down to them", or try to tell them exactly what to do.
Then, when something goes wrong, these same individuals will declare that "It wasn't in the procedure".:frust:

Just a note from the trenches

James

db
14th May 2002, 01:29 PM
Just a note from the trenches
James, you are not making sense. How can you talk from the trenches, while seated in the cockpit? How low can you fly that bird anyway? :vfunny:

On the other hand the rest of your post makes good sense. Several of us have mentioned that you must write in a manner that the user (not necessarily the reader) will understand. That must include not writing over their heads, nor insulting their intelligence.

JRKH
14th May 2002, 06:10 PM
db said:


James, you are not making sense. How can you talk from the trenches, while seated in the cockpit? How low can you fly that bird anyway? :vfunny:



I guess I should revise that to:
"Just a note from Flak alley." Come to think of it that does kind of fit better.

As far as flying low, Can you say, "cut the grass"?

Truthfully though in a Million Dollar bird that is over 50 years old you fly veeerrrrry carefully. Nice birdee

James

db
15th May 2002, 08:40 AM
James, I'm glad you fully understood my comment.

At times I think your comment about "flak" is true. As a former cop (like Randy), sometimes I wish I would have kept my Second Chance (bullet proof) vest! :eek:

Marc
22nd July 2003, 03:31 PM
Energy: There is no requirement that you not use shalls in your QM. It is up to you and how you use the word (IMHO).
True. I was an old stickler about verbiage (and still am to some degree). I always avoid the use of 'Shall' just because it implies the future. Ten years ago I would not have accepted 'shall' in a manual.

CarolX
24th July 2003, 01:54 PM
You may find this interesting...In the list of terms that I defined in the Quality Manual for use throughout our Quality System, I drew a distinction between the use of the word "shall" and "will".

"Shall" = Use of this word means the action described is mandatory; "Will" = Use of this word shows intent; use of this word means the action described is not mandatory.


Back in my old days (DoD stuff), that was the guidelines we had to follow. "Is" wasn't even an option.....LOL.

Carol

betterlife
2nd June 2005, 09:22 AM
An interesting discussion. But I find no posts after July 2003. I don't know if any useful purpose will be served by posting my views on this now, but I will like to share them with the members.

Whenever a document is prepared by someone independent of the people going to use it, the term "shall" or "should" are used, shall indicating a mandatory requirement and should as a suggestion or recommendation. The example is ISO 9001: 2000 or any other standard prepared by an independent organization to be used by other people.

But when a document is prepared to inform others about the manner of complying with the requirements of the above standard, the term "is being done" or such other similar term is used. The example here is the Quality Manaual (prepared by or on behalf of the management), through which management of any company informs the users that how the company complies with the requirements of ISO 9001: 2000.

The procedures or Process Approach documents are prepared by respective Process Heads to inform how a process is carried out, and in this case the term "is being done" is generally used. But when the Process Head prepares a Work-Instruction to be used by the machine operators, the terms "shall" or "should" are used.

In the end I can say that these terms are used depending on the intent of the document and who has prepared them.

Jim Wynne
2nd June 2005, 09:28 AM
As long as this thread has been resurrected, I'll point out that the difference being discussed is between the "passive" (shall) and the "active" (is) voices. In general, the latter is best for procedures and work instructions, because it tells what the company does, as opposed to what it will do. I think that either is OK, (after all, it's substance that counts) but as a matter of style, writers should choose one form and use it consistently.

Rob Nix
2nd June 2005, 02:39 PM
Good points. Every document should be written with its intended audience in mind. Sometimes there are two groups (e.g. an auditor or employee reads same "manual"). Still, the ultimate user should be primary. For example:

STANDARD: "...Company shall measure all critical dimensions"

QUALITY MANUAL: "...Company measures all critical dimensions"

PROCEDURE: "All critical dimensions are measured by the inspector"

or

PROCEDURE or INSTRUCTION: "INSPECTOR: Measure all critical dimensions."

Now don't get your shorts all in a bunch; these are just comments, not mandates. As JSW05 says, consistency's the key.

Jim Wynne
2nd June 2005, 02:48 PM
PROCEDURE or INSTRUCTION: "INSPECTOR: Measure all critical dimensions."
In addition to the passive and active voices, there is also the imperative, which, as Rob points out, usually involves a command or direct instruction. The imperative voice is usually appropriate for work instructions.

betterlife
3rd June 2005, 08:46 AM
Further to the points explained in my last post, there is a term, "User Friendly Document (UFD)". Now a document is prepared to be followed by 'someone' in the organization (mind it that company does not prepare documents for the auditor). And that 'someone' should find the document easy to understand and it should be implementable by using existing resources.

I have always found it helpful to define, which document will be repared by whom, who will review it for adequacy, and who will approve it. If that 'someone' is one of these three then document will be seen as a UFD by him or else it will be treated as a document forced upon him. In the case of a UFD, using 'Shall', 'Should' or 'Is' is only a matter of language. In any company all applicable requirements are 'shall' requirements. These requirements have to be met and the top management has to provide adequate resources for meeting them or else face a NC in the audit.

aerospaced
8th November 2006, 03:49 PM
I have seen these terms defined as follows:

Shall : Mandatory requirement - requires QA approval in advance for deviation
Must: Regulatory requirement
Should: Preferred method - deviations need to be justified
May - Guidance info

dgreen07
27th February 2007, 11:02 AM
Sometimes we have "instructions" and sometimes we have "guidelines". Both of these drill down from "procedures", which are essentially overviews of a process.

Processes required by the QMS (identified in the Quality Manual) are usually standard business processes (training, HR, purchasing, management review, etc.). Company-specific processes are grouped under "product realization" with one umbrella procedure showing how the rest of them relate to one another (usually shown in a process flow chart).

I _never_ use "shall" in my QM, Procedures, or Work Instructions/Guidelines. Most of our step-by-step instructions are broken down into "chunks" of information specific to individual workstations. This is so that they can be laminated and posted at the point of use when a run is set up. It's a 1) do this, 2) do that format, usually with pictures.

We also have occasion to reference more general information; for instance, our bouillon press document has some specific instruction steps and general guidelines and references out to the press operation manual. It is therefore called a "guideline" but it still has an IN (instruction) prefix and the information is presented in an active voice.

I hope that all helps!

Dgreen07

António Vieira
27th February 2007, 12:06 PM
I also never use the term shall in any Instruction or Procedure.
Of course that in a Quality Manual for sure I wouldn't do it. A QM is a place where we must tell what we do and not what we shall or should do.
:rolleyes: