Where to Place Process Maps in our Documentation

T

tracey

Good afternoon Cove members, I am curious to hear where you have placed your process maps. I was initially going to make them part of the quality manual but decided that the less in there the better because everytime one is updated I will have to reissue the Qualtiy Manual. Then I thought I would place them seperately in with our controlled documents. Now I am thinking that am going to place them in our procedures maunal that way they are seperated for new revisions yet placed in a more appropriate place. It's late and it's Monday...I may be making an issue out of nothing but I thought if I had some different ideas on this issue, it may save me some time later.

Tracey :rolleyes:
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
Hey Tracey! It's never late around here...I've learned that some of the best advice comes when it's late, we're tired, and our brains are allowed to think outside of the box...that's why Happy Hour was invented!

But, getting to your question, we have a general process map shown in our Quality Manual. It's so basic and just shows the general flow of our main production processes.

We refer to all department based process maps within the Quality Manual, but maintain them outside of the Tier 1 document for the very reason you stated (makes the QMS bible too subject to change).

The software package that we use for document control, takes Process Maps into account and has developed a PCD acronym for our maps (Process Control Document), along with fields for Inputs, Outputs, Work Environment, Resources, etc.

Hope that helps!
 
J

Jimmy Olson

Hi Tracey. We us a similar method for our process map. We have a high level map in the quality manual that gives an overview of everything.

We then maintain an electronic copy that has built in links for the more detailed maps. For example, out high level map has a block for the build portion of the process. If you click on that in the electronic version it will bring up a detailed map of the build process. Some of the maps have several levels depending on what process is being covered.
 

SteelMaiden

Super Moderator
Trusted Information Resource
We kind of follow the same path or at least similar. There is a section of our QMS that we call data and reference sheets. They are not really work instructions, and not a "record" but more or less a quick reference or guide. All of our org charts, process maps, and "look ups" reside here. Our quality manual does have links to the the process interaction maps and org charts
 
Hi Tracey,

Just like RCBeyette we put only the process overview map in the Manual.

Most of our written procedures contain a process map these days. We do that for several reasons:

Parts of our staff find it easier to follow a process map than the written word.
A process map within the document allows us to put much less in writing.
If the document needs updating the map is updated at the same time.

If we find it hard to describe the process graphically, chances are that there is something wrong with either the process or it's description.

Now... This is our way of doing things... It suits us, and it may or may not suit you. Just make certain that you have thought it through before you start working on it....

/Claes
 
T

tracey

Well I could use happy hour right now :frust: I appreciate everyone's advice. Claes when you said you had a process map for each of your procedures I look at what I had and there is a process map for all created so far except for purchasing....I think I'll add one because I agree with you totally; they are easier for a lot of employees to follow and it make total sence that if we are having a hard time describing the process graphically, that something is wrong. It a great way to test it. Thanks.
:)
 
H

htanaka

What is it?

Please - what is a 'process map'? Same as flowchart? Different?

What is its purpose?

Thank you
 

Raffy

Quite Involved in Discussions
Hi Claes,

Where is specifically do I put the Process Map. Can I place it under the Clause 4.1 Quality Management System, General Requirements? :confused: Sorry, If I speak too literal on where I could possibly put the Process Map. And besides, does the new standard requires a Process Map in the Quality Manual? :confused:


Thanks in advance.

Best regards,
Raffy
 
htanaka said:
Please - what is a 'process map'? Same as flowchart? Different?

What is its purpose?

Thank you

Hi htanaka, and welcome to the Cove :bigwave:

Yes, at least in my case it's a flowchart describing a process. Now we have to describe our processes (ISO9001:2000, clause 4.1). We do not have to do it graphically, but it's often most convenient to do so.

/Claes
 
Raffy said:
Hi Claes,

Where is specifically do I put the Process Map. Can I place it under the Clause 4.1 Quality Management System, General Requirements? :confused: Sorry, If I speak too literal on where I could possibly put the Process Map. And besides, does the new standard requires a Process Map in the Quality Manual? :confused:


Thanks in advance.

Best regards,
Raffy

Hi Raffy,

I have not numbered our manual acc to the std clauses, but yes: 4.1 would be the place to put it if you do.

ISO 9001 :2000, clause 4.2.2c does not require a process map in the manual, but it does require a description of the interaction between the processes of the quality management system. A process map is often the best way to do that.

/Claes
 
Thread starter Similar threads Forum Replies Date
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
Q Where to place our Safety Program in our QMS? Occupational Health & Safety Management Standards 9
shimonv Where do you place Human Factors report in a 510(k) application? Other US Medical Device Regulations 3
M Testing criteria - where to place Design and Development of Products and Processes 2
L Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
Q Where to place a Down Stream Gage Inspection on an FMEA FMEA and Control Plans 5
S Where is a good place to get IMDS (International Material Data System) Training? IATF 16949 - Automotive Quality Systems Standard 3
N Putting SOPs in place in preparation for ISO certification - where to start? Service Industry Specific Topics 5
ScottK Where's your favorite place for Lunch? Coffee Break and Water Cooler Discussions 36
T Definition Gemba is a japanese term for place (Where the action is) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
A Is there a place where I can purchase ISO 9001:2000 posters? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R ISO Publications - Where the best place to purchase ISO 9001 publications? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
E Class II symbol - where to apply it? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T Good Documentation Practices (GDocP) - Where are these described in the regulations? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
A Where 60601-1 represented in the 510k submission? US Medical Device Regulations 6
Q Where did my Alignment go wrong? MCOSMOS Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
MaHoDie Where to show the Software version IEC 62304 - Medical Device Software Life Cycle Processes 2
E Where can i get latest toyota and honda Supplier Quality Assurance Manual (SQAM) Customer and Company Specific Requirements 3
I Where to find MDR compliance device? EU Medical Device Regulations 6
N Writing Risk Management procedure for small manufacturing and we don't know where to start. Manufacturing and Related Processes 9
I ISO 9000 Where to Start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 93
Ajit Basrur Where to find a pagination requirement as "Page x of y"? ISO 13485:2016 - Medical Device Quality Management Systems 7
T Assessing risk where harm is indirect - Generic devices / accessories / intermediates ISO 14971 - Medical Device Risk Management 8
J Incoming Stock QC, where to start? Manufacturing and Related Processes 6
J Stock Traceability Methods, where to start? Manufacturing and Related Processes 0
B Where do the definitions of the types of processes come from? IATF 16949 - Automotive Quality Systems Standard 9
Awais Where to get started on DFM / DFMA Manufacturing and Related Processes 2
S Where to start for MDSAP for Canada? Canada Medical Device Regulations 5
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
J UDI - Where to document it? EU Medical Device Regulations 8
J Where to get a Black belt certification ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 13
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 2
J Where is the definition of a critical supplier? ISO 13485:2016 - Medical Device Quality Management Systems 5
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
B When Travel is allowed - Where are you going? Travel - Hotels, Motels, Planes and Trains 24
G Where to buy Template / sample SCSMS Manual, checklist Supply Chain Security Management Systems 1
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
B Where to acquire EN 868-5 required dye (Amaranth red)? Other Medical Device Related Standards 2
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
H Where to get EK MED 1927/16 Other Medical Device Regulations World-Wide 3
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
O EN 301 489-1 and EN 301 489-17 - Where do we get the information of the Published versions? CE Marking (Conformité Européene) / CB Scheme 1
A AS9100 Training - Where do I start? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
qualprod Records where apply and stop recording everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4

Similar threads

Top Bottom