document & data control system

Document Control :

Document Control Basics of Good Documentation and Document (And Data) Control Systems Presented by: Sumant Kumar

Document Control: What is it.:

Document Control: What is it. Document Control activities focus on the adherence to the document lifecycle steps (i.e. preparation, review, approval, release, use/distribution, and change control).

Document Control:

Document Control Advantages: Assures that the most current version is used Ensures availability when needed Standardize the Processes & Work Methods Facilitate improvement and to track the changes made in Processes / SOPs Ensure we hold on to the gains made through small improvements

Steps to Building an Effective System:

Steps to Building an Effective System Elements of Good Documentation How Much do I Need? Outline Your Document Control System Documentation Infrastructure Hardcopy System Manage in a Database Document Control Software Packages Implementation Steps for Documentation Control Common Problems with Documentation

Annual Quality Survey Report:

Annual Quality Survey Report Identifies Document Control as the most difficult clause to implement... And the most difficult clause to maintain.

Step 1 in Building an Effective System Is::

Step 1 in Building an Effective System Is: To Have Good Documentation!

Good Documentation is::

Good Documentation is: Clear Concise User friendly

Essential Features in a Document:

Essential Features in a Document Identify document uniquely Identify revision number and/or date Number pages Show end of document e.g. “Page 4 of 7” Show who authorised

Avoid Drowning in Detail…..:

Avoid Drowning in Detail….. “The purpose of this procedure is to document the aforementioned activities, herin after referred to as the prescribed tasks in terms that preclude their execution in an inconsistent manner, wherin such inconsistency may potentially result in the prescribed tasks delivering a result that is not repeatable or reproducible”

And poorly written procedures:

And poorly written procedures Why use ten words when one will do? “The items hereinunder referenced in some cases fell excessively outside normal parameters.” “The procedures contained herin are applicable to all operations in the following departments within their functional ambit”

Make procedures user friendly:

Make procedures user friendly Use short sentences starting with a verb. Avoid using the passive voice. Make it clear who is performing the task. Use white space for easy reading.

Step 2: Have the Right Amount of Documentation:

Step 2: Have the Right Amount of Documentation But how much documentation do I need?

Avoid Creating too much::

Avoid Creating too much: Work instructions written for virtually everything Overlap and repetition - Including a process in more than one work instruction. Ask yourself: Will it really Impact Customer Requirements? Or…

Too little::

Too little: Lack of work instructions where the process affects the quality of the product. Employees have their own way of performing processes There is variation in the process because it is not well documented

Documentation: The right amount:

Documentation: The right amount Remember that the goal here is consistency for your processes. If two trained employees were to perform this task, would they do it the same way? If the answer to this is “Maybe not” a work instruction is appropriate.

Step 3: Outline Your Document Control System:

Step 3: Outline Your Document Control System

Outline document control system:

Outline document control system

Clarify Your Terminology::

Clarify Your Terminology: Procedure: Describes the process. Work Instructions: Tells how to perform the process. Attachment: Information attached to the procedure to help clarify the procedure. Forms, Tables, etc.: Places to record the results of tests, audits, etc. Records Procedures describe an overall process such as "Purchasing", where as work instructions would describe a more detailed portion of the procedure such as "Completing a PO" or "Ordering supplies".

More on Terminology:

More on Terminology Documents: written policies, process descriptions, procedures, and blank forms Used to communicate information Records: worksheets, forms, charts, labels, Used to capture information, activities, or results when performing a procedure May be paper or electronic

Why are Records Essential?:

Why are Records Essential? For continuous monitoring For Order tracking throughout process To identify failures in equipment To revisit information; reference For use as a management tool

What Will You Control?:

What Will You Control? Procedures Work Instructions Forms Attachments Records External Docs: Customer Drawings Prints Drawings Routers/Traveler

Step 4: Where will you keep your documents?:

Step 4: Where will you keep your documents?

Planning Your Infrastructure:

Planning Your Infrastructure You may choose: A Hardcopy System A Soft-copy System An existing database program A packaged document control software.

Hardcopy Systems:

Hardcopy Systems

Simple Hardcopy System:

Simple Hardcopy System The master electronic documents are stored in “Word” or “Excel”. A Master list is prepared and kept in “Excel”. Hard copies are copied on to paper that is marked “CONTROLLED”.

Simple Hardcopy System:

Simple Hardcopy System The hardcopies are distributed to an identifiable ‘file’ throughout the facility. The master list indicates what procedures and work instructions need to be in each book. Copies are kept to a minimum by only distributing relevant documents to each area.

Simple Hardcopy System:

Simple Hardcopy System One person is designated as the Document Control Coordinator. This person keeps the master list up-to-date Makes revisions to documents Distributes revised documents Collects the outdated documents

Simple Hardcopy System:

Simple Hardcopy System A “Change Request Form” is available for employees to initiate revisions to documents. Changes must be approved before they are made. Changes are indicated by using the revision tool in Word. Staff must be aware of revisions.

Documents of External Origin:

Documents of External Origin These documents must be included in your document control system. For example: Customer Prints Industry Regulations ISO Standards References used for your documentation.

Documents of External Origin:

Documents of External Origin Control these by having a section on your master list for documents of external origin. Include: Document Name Current Revision Document Location(s) Document Number ( Assigned by your company).

Implementation Steps:

Implementation Steps

Implementation Steps:

Implementation Steps Collect existing documents and records Review and update Determine additional needs Develop or obtain Documents, forms, worksheets, logbooks, reports Involve stakeholders Notify staff of change / new document Old documents replaced by new Master list of documents updated

Common Problems with Document Control:

Common Problems with Document Control

Common Problems:

Common Problems Employees writing documents do not understand the difference between a Procedure and a Work Instruction. Terminology has not been defined, and is not used in a consistent manner. Revisions take too long, documents are not kept current.

Common Problems:

Common Problems There is no process for tracking changes or training on changes Inconsistent use of other documents such as: forms attachments drawings documents of external origin

Common Problems:

Common Problems Approval Distribution Keeping distribution current

Common Problems:

Common Problems Too many documents are distributed. The system cannot be maintained. Lack of control of documents of External Origin . Avoid these problems by planning ahead…

Slide 38:

And all the pieces will fall in place.