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Using Document Control Software to Comply With Iso Requirements
The objective of a document control software system is to make sure that good manufacturing methods are recorded and improved on. ISO standards require that the process and the documentation directing the manufacturing methods, and any changes to them, are restricted to authorised personnel with any changes recorded for future examination. Therefore ISO certified organisations are required to have a system for controlling the changes to their documents.
One of the challenges of having an ISO system, whether it is certified or not, is to be able to continuously maintain it after it has been set-up. A paper or hybrid electronic/paper systems will require diligence and perseverance on the part of the organisation and senior management in particular for the processes to be maintained and updated. It is in fact not unheard for a system to be left unattended once certification has been achieved and for it to be resurrected only when an audit is imminent because the organisation has considered it to be too time consuming to maintain. Manual systems can also be error prone with uncontrolled documents being made available or new versions not appearing in time. In order to eliminate these problems organisations are increasingly turning to quality management software systems.
This article focuses on the document control element of a quality management system and on how its processes allow an organisation to increase the efficiency of maintaining its processes, controlling the distribution of documents and generally improving profitability.
We will now cover the areas that we think need to be considered when deciding to opt for a document control software system:
1. RESTRICTIVE ACCESS
• User/Password protection – The system must require a unique Username/Password combination for each user with access to the system. In addition the password must be an alphanumeric combination to further ensure that it cannot be logically recreated.
• Intruder lockout – An account should be automatically locked out if a user attempts to login using an inaccurate login combination. This is activated when a preconfigured number of false attempts have occurred and protects against unauthorized attempts by individuals to access the system. The System Administrator is the only individual who can re-set a locked out account.
• Document access restrictions – Each person within an organisation has a role. While each role is unique it may or may not interact with another role in the same organisation. As a result a system needs to be able to restrict access on the basis of their role with the documentation. In most cases this is Viewing (Read Access), Authoring (Write Access) and Approving, with users being given one or more roles for the documentation in question.
2. DOCUMENT MANAGEMENT
Document management capabilities ensure that the iterative elements that are required for an ISO system are automated or simplified thereby increasing efficiency.
• Application independence – A system must be able to control documents from a variety of commonly used applications i.e. Word, Excel, video, audio etc…
• Lifecycle management – Documents must follow a strict lifecycle from Draft to Published to Archived. While this can be based on the type of document it must however restrict access at its various stages.
• Document history – All events that a document goes through must be automatically recorded and accessible by the approved users.
• Central and safe storage - Documents must be stored in such a way to ensure only authorised access while at the same time shielding against loss or destruction.
3. AUTOMATIC VERSION CONTROL
Version control of a document is both time consuming and can lead to embarrassing mistakes when a new version needs to replace an older version. A document control system can provide some key automation benefits:
• Availability of the latest version – Only the latest approved version of a document needs to be available with no confusion to the people who need to use them.
• Automatic routing – As defined by its type a document should follow a routing whereby approvers are automatically notified when a document is to be approved, reviewed or when a change request ha been issued.
• Automatic document replacement – Newer approved versions of a document must automatically replace the older version and shift into archive.
• Automatic email notifications – E-mail notifications should be provided to inform users when they are required to perform a task or need to be aware of an event. This should be able to be deactivated but at the same time there must always be some alternative form of notification that cannot be able to be deactivated. For required tasks this should apply for reviews, approvals and change requests. For events this should apply for publishing, confirmed rejections and rejected change requests.
• Approval history – Managers should be able to view the complete approval status and history of a document as it is going through its workflow routings.
• Automatic publishing on approval – Once a document is approved it should automatically be published to users who have been given access to it and replace any prior versions which are then archived.
4. SIMPLE SYSTEM ADMINISTRATION
An easy to use system administration should ensure that any user can understand the system while having a minimal IT understanding or appreciation:
• Preconfigured routing – Routings rules should be set and fixed under the bonnet with an easy to understand attribute setting all governed by Document Types also known as Approval Types.
• Configurable user access rights – While keeping with the concept of keeping things simple the system administrator should be able to configure read and write access rights by grouping of documents.
• System reporting – A simple report builder should be integrated with the system giving administrators the ability to create reports while at the same time benefiting from a selection of standard built in reports.
5. GENERAL USABILITY
A document control system should provide users with an easy to learn experience:
• Platform independence – No restriction as to the platform the system works on or as it integrates with different databases.
• No installation requirements – No need to install software on a client’s infrastructure ensures that the system can be easily evaluated and be up and running in a flash.
• Web-based client access – Ability to connect to the system from any Internet connection regardless of physical location. This means that geographically dispersed clients as well as suppliers and customers can access the system without any additional software or hardware infrastructure requirements.
• Search capability – Ability to search for documents using keywords and only list documents that meet the search criteria and the user’s access rights.
• Grouping of documents – An easy to use graphical interface similar to the Windows treeview with folders and sub-folders where documents can be grouped and searched for logically.
• Training for system administrators and regular users – Training to be available to both of the users using a simple method which can be delivered over the Web and can be easily interrupted and started up where left off.
6. DOCUMENT GROUPING AND ACCESS RIGHTS
Once a document control system has been chosen a clear identification of responsibility for each type or class of document must be well thought out and planned. This is to ensure that the system is an effective one and is focused only on the people who have a role in the system. The specific groupings for a system that groups both documents and users are as follows:
• Grouping of documents – Documents within a document control system have a purpose and when that purpose is identified then the documents can be logically grouped. This is to ensure that ultimately only the users who need to have a role in those documents can be given that role.
• Readers of documents – Access to documents must be restricted to the users who effectively need to use the documents as part of their job responsibility. This is where a document control system starts and ends and time must therefore be invested in grouping documents and determining which people have access to each grouping of documents. Certain software system only provide access to groups of users so in addition to grouping the documents the users having access to the document groups in themselves need to be grouped.
• Writers of documents – These are the people who have management responsibility over the documents. They will be originators or authors of the documents and will have the responsibility for updating them. They may also be readers of the documents. Generally, this may either be at a department or functional level or at an organisation level depending on how large or complex the organisation is. When changes are made to a document they will be required to report on the reason and the detail of the changes.
• Approvers of documents – Controlled documents must go through a review and approval process. These are the users who have the task of making sure that the documents are accurate. They will tend to be experts in their relative fields so they may be required only to review and approve documents in their functional areas. They may also be readers and writers of documents.
In identifying these four groupings the supporting structure of the document control system is built and from there a smooth running system can be configured. It is of overwhelming importance that plenty of time is allowed for this stage as it will pay dividends in the long run.
7. CONCLUSION
Companies that have moved from a manual to an electronic document control system will say that their day-to-day task has been made easy and that they have made a speedy return on their investment (ROI). However, they will also agree that the transition has required an important investment in time to ensure that the structure of the new system has been well planned out. Finally, they will also have been relieved that when they chose a hosted document control system that it did not necessitate any upgrades in their IT infrastructure.
About the Author
Written by Christopher Stainow of Lennox Hill Ltd. Lennox Hill http://www.lennoxhill.co.uk is a provider of hosted quality management software for effective management of the ISO 9000, ISO 14000 and OHSAS 18001 standards.
The Garmin Nuvi 260W Car GPS System - The Top In Its League
One particular primary element needed with regard to a car GPS system is ease of use. And thus the Garmin Nuvi 260W is the leader in its class. This GPS is lightweight and can be fixed to any car. It's the preferred product for customers on the lookout for the purpose of simple navigation aid. It is supplied in a number of mountable choices as to where it should be fitted, like friction mount/windshield mount.
Among several other desirable features of this device is the text-to-speech feature that allows the unit to speak aloud the name of the road one is turning on to, with the distance and direction, which is often especially helpful in downtown parts. It's ease of use of this product is of great value, because there is no necessity for a person to read the manual to work it (even for somebody who hates to control electronics). The Garmin web site lets the consumer to download new voices for the text-to-speech feature plus also update it with new maps and firmware and this web-site also, is very user friendly. It has the auto up-scale feature in it, i.e if the map is set to a quite small scale to see a great part of the journey, the unit automatically scales the map larger to give extra detail of a turn, while the owner draws near it.
There is an SD card slot that can be loaded in the Nuvi, that may be used to add fresh maps and keep it updated. The 4.3 inch wide display features impressive readability and does not lose its readability any time the consumer uses Polaroid shades. There's the detour option in this GPS which comes in very convenient whenever the driver wants alternative routes and to avoid specific points in the route, if he/she is knowledgeable before hand that there's a construction going on in that specific route or something else. In case the driver misses a turn off and goes in the wrong direction, it routinely recalculates the new way that must be taken within just seconds.
The battery life is definitely as assured by the Garmin. It can easily go for 2 hours straight without losing a single green bar. What is more, the battery life may be prolonged simply by lowering the brightness level to the lowest suitable. The actual dimensions is definitely one further feature in favour of the system. Its sleek pattern allows for transportability and consequently is convenient to carry even in ones pocket. The Points of Interest (POI) accessible in this device are ample amounts and the ease of access connected with these points is also rather good.
The satellite acquisition is not always sufficient in the Garmin Nuvi 260W. It sometimes may not obtain signals to recognize the current location when the unit is switched on in a few circumstances, and possibly may lose signal during a trip. There are some locations that aren't recognized by the unit also and this happens to be considered a disadvantage for the product. The documentation is an additional downside for the Garmin Nuvi 260W. Aside from the quick start manual, there isn't a added information, even being hard to discover on the Garmin website, on how to use the unit to get added features to function.
The disadvantages are somewhat minute and not particularly serious actually when compared to those things the system can give overall. Hence it's a extremely reliable and recommended product.
Why is documentation generally the weakest part of a system design?
I can't seem to figure out any reasons. Please Help.
Because people who are good at systems design tend to suck at writing things meant to be read by humans. And because writing documentation is a real pain in the....you get the idea. I'm speaking as a developer here. I hate writing documentation. Fortunately I'm in a situation where almost everything I write has a local userbase so I can sit everyone down in a meeting and teach them how to use it via show and tell.
GAO-12-22, Arizona Border Surveillance Technology: More Information on Plans and Costs Is Needed before Proceeding, November 04, 2011 (gao.gov)
In Process In recent years, nearly half of all annual apprehensions of illegal
aliens along the entire Southwest border with Mexico have occurred along the
Arizona border. Keeping illegal flows of people and drugs under control
remains a top priority for the Department of Homeland Security's (DHS) U.S.
Customs and Border Protection (CBP). In 2005, the Secure Border Initiative
Network (SBInet) was conceived as a surveillance technology to create a
"virtual fence" along the border. After spending nearly $1 billion, DHS
deployed SBInet systems along 53 miles of Arizona's border that represent the
highest risk for illegal entry. In January 2011, in response to concerns
regarding SBInet's performance, cost, and schedule, DHS cancelled future
procurements. CBP developed the Arizona Border Surveillance Technology Plan
(Plan) for the remainder of the Arizona border. Funding for this Plan for
fiscal year 2012 is $242 million. GAO was requested to assess the extent to
which CBP (1) has the information needed to support and implement the Plan and
(2) estimated life-cycle costs for future investments in accordance with best
practices. GAO analyzed Plan documents and cost estimates, compared those
estimates with best practices, and interviewed CBP officials. CBP does not
have ...
Building a living documentation system with SpecLog and SpecFlow
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