Requirements Identification in Documentation

L

Lillian0924

#1
I was wondering if I could get some feedback from this group on two main questions:

Question 1: How the companies you’ve worked for, or are working for, have structured your document hierarchy/framework.

The company I currently am with only has high-level policy documentation that explains the philosophy of how (at a high-level) we complete certain tasks. There are lower level ‘guidelines’, of sorts, that give best business practices and options for completing the tasks. There is no centralized group of documents that detail, step-by-step, the steps for completing tasks. These types of documents are all created, approved and maintained within the functions.

Question 2: What type of document does your company use to identify the minimum requirements the company must meet for certain business processes? These requirements could come from regulatory, statutory, or even internal company requirements. If your company has such a document that identifies these requirements to map them to implementing policies/procedures, how does that mapping/linking/cross-walking work?

Thanks in advance for any assistance.
 
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Mikishots

Trusted Information Resource
#2
I was wondering if I could get some feedback from this group on two main questions:

Question 1: How the companies you?ve worked for, or are working for, have structured your document hierarchy/framework.

The company I currently am with only has high-level policy documentation that explains the philosophy of how (at a high-level) we complete certain tasks. There are lower level ?guidelines?, of sorts, that give best business practices and options for completing the tasks. There is no centralized group of documents that detail, step-by-step, the steps for completing tasks. These types of documents are all created, approved and maintained within the functions.

Question 2: What type of document does your company use to identify the minimum requirements the company must meet for certain business processes? These requirements could come from regulatory, statutory, or even internal company requirements. If your company has such a document that identifies these requirements to map them to implementing policies/procedures, how does that mapping/linking/cross-walking work?

Thanks in advance for any assistance.
Quality Manual is top level.

Procedures and incorporated manuals (who does what and when) is the next level down.

Work instructions (how to do it) is the next level down.

Forms and records.

For question 2, these points are addressed using the quality manual.
 

qusys

Trusted Information Resource
#3
I was wondering if I could get some feedback from this group on two main questions:

Question 1: How the companies you?ve worked for, or are working for, have structured your document hierarchy/framework.

The company I currently am with only has high-level policy documentation that explains the philosophy of how (at a high-level) we complete certain tasks. There are lower level ?guidelines?, of sorts, that give best business practices and options for completing the tasks. There is no centralized group of documents that detail, step-by-step, the steps for completing tasks. These types of documents are all created, approved and maintained within the functions.

Question 2: What type of document does your company use to identify the minimum requirements the company must meet for certain business processes? These requirements could come from regulatory, statutory, or even internal company requirements. If your company has such a document that identifies these requirements to map them to implementing policies/procedures, how does that mapping/linking/cross-walking work?

Thanks in advance for any assistance.
If you are ISO 9001 certified, you should have a documented procedure for document control where the organization describes how to meet 4.2.3 clause of ISO 9001. Inside this documented procedure, the organization shall also state how to manage documents of external origin.
Each organization has peculiar processes and activity, so it is very difficult to suggest. However the pyramid of document starting from the level 1 ( Policy and Quality) to finis to level 4 ( mgmt of forms etc), passing through level 2 of documented procedure of QMS and level 3 work instruction etc.., is the most common approach.
Given that the 4.2.3 is a cross organziation requirment, my oadvice is to work in multidisciplinary approach with QMS process owners to put in place an effective process.:bigwave:
 

insect warfare

QA=Question Authority
Trusted Information Resource
#4
I was wondering if I could get some feedback from this group on two main questions:

Question 1: How the companies you?ve worked for, or are working for, have structured your document hierarchy/framework.

The company I currently am with only has high-level policy documentation that explains the philosophy of how (at a high-level) we complete certain tasks. There are lower level ?guidelines?, of sorts, that give best business practices and options for completing the tasks. There is no centralized group of documents that detail, step-by-step, the steps for completing tasks. These types of documents are all created, approved and maintained within the functions.

Question 2: What type of document does your company use to identify the minimum requirements the company must meet for certain business processes? These requirements could come from regulatory, statutory, or even internal company requirements. If your company has such a document that identifies these requirements to map them to implementing policies/procedures, how does that mapping/linking/cross-walking work?

Thanks in advance for any assistance.
At my company, we use a 3-tiered hierarchy for all documentation that requires formal document control. It goes like this:

LEVEL 3: Required forms

LEVEL 2: Procedures/Work Instructions (This includes overall process flows for each area, such as production, for each customer we do business with, plus written manuals/procedures outlining specific facets of our business, like environmental, health/safety, recycling, etc. We don't differentiate procedures from WI's as many other companies do because we link forms with both types, so as a result of planning it turned out not to be necessary for us to do so.)

LEVEL 1: Business Management System Manual (contains a high-level flowchart overview of our business management system; we are currently integrating 9K, 14K and 18K so we don't refer to it as just a "Quality Manual" anymore)

Approval requests are sent using the Microsoft Outlook voting feature. From that we generate electronic approval records, so no handwritten signatures are ever required from our process owners (with the exception of our BMS Manual).

Beyond that, other aspects of document control are outlined in our control of documents procedure, so we try to sew it up as much as we can.

Now I must add that I had the privilege and the pleasure of designing this document control system. I understand that not everyone has the luxury of doing so, but I wanted to give you a glimpse of what we do anyway.

Brian :rolleyes:
 

somashekar

Staff member
Super Moderator
#5
Level 1 ... The quality manual and this references the top level procedures
Level 2 ... The top level procedures as required by the standard + company requirements
Level 3 ... The working procedures (more from the production and service provision requirement)
These are planned as Flow charts in which are identified stages and which have Process instructions and quality instructions depending on a process stage or inspection stage.
Level 4 ... The records formats
What comes out of records formats are the records which are in control again.

As we are into contract manufacturing, we have impressed upon our principles our documentation style and they have fallen in line to approve this for the products we make for them. The level 3 refers level 4 that is to be used. The level 2 also refers the level 4 that is to be used where necessary. This is also meeting our business process.
It is elaborate to certain extent, but its working.
Can we reduce it .... Yes
Will we reduce it .... No
 
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