Document control is a common function within quality management systems for ISO, JCAHO, FDA, GMP, ITIL, SOX, and many other standards or regulations.  Document control has been around for decades.  In the old days it was all about controlling paper documents.  Then, along came electronic documents and a whole new world was created.  Yet, paper based systems remain today in many organizations that have yet to upgrade to more modern methods.  This leads us to make many common document control mistakes.

Do you make any of these document control mistakes?

1.       Assuming your document files are backed up on a regular basis.
Sometimes files are backed up and sometimes there not.  The only way to make sure that your files are backed up is to recover a missing file.  How long does it take? Hours or days to recover a file?  Who knows how to do it and has time to get your file?  Many assumptions are made about the backup process at any company.  Unfortunately, most people don’t test their assumptions until it is too late and they really need a file.  Products like OnPolicy archive all of your documents automatically and prevent you from deleting released documents.

2.       Saving document revision files under a new name.
Most people use MS-Word and MS-Word does not have a very good revision system.  It has a feature to “Track Changes”, which adds a lot of comments and colored text from each reviewer.  It used to have a version control feature (prior to Word 2007) that was removed.  If you are like most than you are probably saving your documents with a new name like document-name-Rev-1.  Then you have to remember to save the new version as Rev-2 or else you will overwrite your original and you will have to test your backup recovery system (see 1 above).  OnPolicy saves each file version for you, separate from the original document.

3.       Using a shared hard drive to store your documents and files.
Shared hard drives are easy to implement.  Just purchaser a network hard drive and connect it to your network.  Now everyone has access to the new hard drive space, but who has control.  Setting up access controls can be an issue.  So most people don’t have any access controls.  The result: document files get deleted, changed, renamed, or moved.  If you do not have access control then you do not have document control either.  ).  OnPolicy provides access control by department, category, and by user roles as an editor or reader to prevent unauthorized changes.

4.       Not using document templates.
If all of your employees write procedures from scratch every time then you will end up with different styles, formats, and structures that will confuse anyone trying to use your documents.  Document templates provide a standard format.  What is even better is having access to a library of best practices that you could edit to make your own.  Bizmanualz provides standard content in MS-Word for easy editing and customization.

5.       Printing paper drafts for review.
Paper is easy to print but it is not so easy to distribute to reviewers.  Document reviewers will mark-up your paper and give it back to you.  Now you have to implement the revisions.  If you had it all online in a system like OnPolicy, then you could route your documents to your document reviewers electronically.  They could enter their changes electronically, and then you could edit them electronically.  This works even better if you have a lot of locations.

6.       Using MS-Word to distribute your final documents to employees.
Most people use MS-Word to write their policies and procedures.  But if you send the original MS-Word file to your employees, your employees could make changes that others will not know about.  OnPolicy uses PDF files to distribute your documents which allows you to maintain control over your documents and keep unauthorized changes in check.

7.       Distributing paper documents to employees.
Paper and three-ring binders have been used for decades to house and distribute policies and procedures.  But paper is a lot harder to control.  Paper gets lost.  And paper gets forgotten.  Today, everything is moving online and onto the internet.  More and more employees have computers, smart phones, or access to one during the workday.  Eliminating paper save trees, improves document control, and allows for a more effective management system.

8.       Not collecting older revisions from your employees.
It is a lot harder to retrieve outdated pieces of paper hanging around the office.  It is common to find an old employee handbook that was given to an employee on their first day – 10 years ago.  Electronic online controls ensure that only the latest, most up-to-date copy of any important document is maintained and managed in the system.

9.       Designing your own document control system.
Many organizations decide to design their own document control software.  SharePoint is the most common platform.  But SharePoint is not a document control system and unless you are a SharePoint Designer you will end up with an expensive IT project with software designed by software engineers that are not document compliance and control experts.  Many such projects eventually are abandoned.  It is a lot easier to purchase a pre-built system, designed by document control experts, then to build your own software product.

10.   Receiving document control audit findings.
The most common ISO audit finding is document control.  Procedures are not followed, controlled, backed-up appropriately, retained, or kept legible.  In just about any audit you can find a document control audit finding if you wanted to.  But, using electronic document control software will virtually eliminate any such finding.  Document control software prompts you to review, approve, release, and even read documents.  They remain legible, get backed-up, and provide the access control you need to stay in compliance.

Now you should be better prepared to prevent making these Top Ten Document Control Mistakes.  Bizmanualz new OnPolicy software will eliminate these document control mistakes.  Try OnPolicy FREE for 30-days to make managing your policies, procedures and forms easier.

1.       Assuming your document files are backed up on a regular basis.

2.       Saving document revision files under a new name.

3.       Using a shared hard drive to store your documents and files.

4.       Not using document templates.

5.       Printing paper drafts for review.

6.       Using MS-Word to distribute your final documents to employees.

7.       Distributing paper documents to employees.

8.       Not collecting older revisions from your employees.

9.       Designing your own document control system.

10.   Receiving document control audit findings.

We are currently testing our new policies and procedures document compliance software, and plan to release it for customer testing in the near future. Potential testers have been asking a number of questions. Here are questions, and the answers:

Is your policy management software accessed as a service over the Internet (Software as a Service – SaaS) or must your policy solution be installed on your computers?

Bizmanualz policy management software is in fact a ‘software-as-a-Service’ available as a subscription over the Internet. The first time a user accesses the service, a small amount of code loads on the client machine in about 30 seconds, similar to when using GoToMeeting or any number of on-line services. The user never is required to install, launch or maintain any software.

Can we upload our existing documents into the system?

You can upload all your existing documents into the system, and open them, so long as your local machine has the software that was used to create the document. For example, MS WORD documents are can be uploaded. In fact, Bizmanualz publishes the world’s most complete set of pre-written policies and procedures, all in MS WORD format. Any policies and procedures template that you buy from us comes pre-loaded in the software. We keep the templates up to date; but we don’t change any documents that you save, upload or change, even if the document started as a Bizmanualz template.

Are documents easy to update?

Documents are edited in their native software on your local machine; they are saved to our server. Our system tracks and controls all document revisions so everyone accesses the latest version. It’s easy to roll back to a previous version if necessary.

Are employees or other users notified when a policy changes or is updated?

Notifications of policy changes are sent by e-mail to policy document authors and ‘followers.’  Administrators and document authors can assign ‘follower’ rights to any user for any document. Users can independently follow any document to which they have permission. Followers receive e-mail notifications of all policy changes. There are also announcement and action item screens within the policy management software that can be used to communicate information about documents.

Can multiple users access policies and procedures at the same time?

Yes, any number of users can access your policy and procedure documents. If two people work on the same document at the same time, their work will be saved (but not released) as two separate drafts. Built-in compliance workflow assures that only one draft can be released, so there are never multiple releases of the same policies and procedures document floating around.

How do you price your policy management software? Do you charge by the seat, or do you sell one license for the whole organization?

We charge per seat. Released policy and procedure documents are published to a web-based reader module which can be viewed by anyone you want. Typically, that would include all your employees and your auditors if you have a formal quality system.

We have an Intranet for reading our documents on-line. How does your software work with Intranets?

If you already have an intranet or a document publishing platform (SharePoint for example) and want to keep using it, our editor module can ftp documents to your existing publishing platform so that user’s viewing habits don’t have to change. But your editors and document managers would benefit from using our editor module for policy and procedure document control, workflow, version control, notifications, etc. while your general employee population would continue to read documents as they’re doing now.

Can I assign different levels of access to users and documents?

We offer a full access control at the document, user and department level. That is, all users assigned to, for example, the accounting department can be granted permission to all accounting procedures with a global command. Additional restrictions can be placed on individuals within a department. Access privileges can also be set at the document level.

Is your policy management software compliant with my quality management or document control requirements?

Yes, the Bizmanualz policy management software is consistent with the document control requirements of all ISO quality management systems, government and industry standards and regulations.

Does your organization talk about quality? Does it put quality concepts into practice in every aspect of the business, from design and development to product delivery? Is your firm practicing quality from top to bottom, from the chief executive to your newest hires?

Commitment to quality starts at the top and flows from there throughout the organization. Whether management is sold on the notion of “quality in everything we do” or they’re not, the rest of the company follows suit. Here are ten indicators that your company’s top management is making the quality commitment:

1. You have a quality budget for Corrective and Preventive Action, Training, and Internal Audits. If management puts money on the table, they’re obviously committed to quality.  Quality requires a budget to prevent problems from occurring and recurring.  Quality requires training.  And Quality requires gentle prodding from internal audits, to ensure the quality system is continuously improving, not stagnating.

2. You’re allowed to use the quality budget for Corrective and Preventive Action, Training, and Internal Audits. Having a monetary budget for Quality is great but if you can’t use it because there are too many orders that need to get out or there are never enough worker-hours to work on Quality, do you really have a budget for Quality? Don’t forget — time has to be budgeted, too.

3. You track the cost of quality in your budgeting process. Your cost of quality includes scrap, defects, rework, corrective actions, preventive actions, quality training, audits, management reviews, lost business due to customer complaints (i.e., returns), warranty claims, and other such “quality” costs.  If you’re actively tracking and comparing your cost of quality to your revenues, expenses, and profits, you’re displaying a keen sense of what quality means to your business.

4. Top management actively participates in your regular (weekly/monthly) management reviews. Quality management reviews are critical to management’s understanding of the future of the business.  Top management’s attendance demonstrates that the future of the business is important to it and the results of management reviews are a valuable input to management’s strategic direction and execution.

5. Quality management participates in regular (weekly/monthly) management meetings, planning sessions, and decision processes. Quality management’s attendance at the management meetings demonstrates that input from quality is important.  Can your company expand, add new products, contract, cut costs, or implement strategic actions without understanding how it may impact the operation’s quality?  Cross-functional teams at all levels provide an early warning to management that improves the execution of your plans.

6. Quality management reports directly to top management. Quality management’s input is vital to strategic execution and requires that quality management be a peer (equal) at the top management level.  Quality management needs to attend critical meetings, needs resources to act on Quality issues, needs to act across the organization chart, and needs the active support of top management for quality success.  Can you really achieve high levels of quality by delegating quality to lower levels of the organization’s management?

7. Top management champions quality, communicates it, and understands its bottom line impact. In order for top management to appoint a quality manager at the top management level, that quality manager has to have a budget and has to interact with all other departments. To ensure the future of the business is secure, top management needs to understand how quality impacts the company and it needs to communicate that impact to the entire organization.  Quality takes discipline and only top management can instill the discipline required for success.

8. Management’s strategic plan includes quality milestones. The road to quality takes time measured in years.  Top management can communicate its commitment to quality through the successive achievement of quality awards over the years (e.g., ISO 9001, Shingo, state Quality awards, Baldrige).  I have seen one organization that, after winning Baldrige, required its individual operating units to all go for Baldrige.  Top management can keep on the continuous improvement road by driving quality milestones deeper into the organization.

9. Management allows people to fail, make mistakes, experiment, and improve without serious repercussion. Improvement is really about failure. If you’re allowed to fail, you can learn from your mistakes. Conversely, if you’re not allowed to make mistakes, you’re being deprived of learning and growth opportunities.

Without learning, there is no quality.  When top management allows people to fail, they allow people to learn and grow.  Fire people for failure and people will stop reporting failures…and they will stop learning, too.

10. Quality is implemented as a strategic requirement to build competitive advantage, not as a customer requirement to qualify for new business. A committed top management is focused on quality because it represents improvement, being better than others, and the future.  If a customer has to ask you for proof of quality, do you have a problem?  Even worse, if you only implement quality because the customer asks and not because you want to, then do you really have quality?  Committed top management doesn’t wait for customers to ask for quality — they integrate quality into their strategy.

Top Ten Signs of Management’s Commitment to Quality

1. You have a quality budget for Corrective and Preventive Action, Training, and Internal Audits.
2. You’re allowed to use the quality budget for Corrective and Preventive Action, Training, and Internal Audits.
3. You track the cost of quality in your budgeting process.
4. Top management actively participates in regular management reviews.
5. Quality management participates in regular management meetings, planning sessions, and decision processes.
6. Quality management reports directly to top management.
7. Top management champions quality, communicates it, and understands its impact.
8. Management’s strategic plan includes quality milestones.
9. Management allows people to fail, make mistakes, experiment, and improve.
10. Quality is implemented as a strategic requirement to build competitive advantage.

Your thoughts?

Last week, our Chris Anderson wrote a blog post about the root causes of business problems.  In the post, after he listed ten root causes, Chris went on to write, “People don’t make mistakes. Systems make mistakes.”  One reader (let’s call her Rachael) took exception to that statement.  ”Isn’t it inherent for humans to err?”, Rachael asked.

Rachael is right, of course.  As human beings, we all make mistakes (the statement “to err is human” has more than a grain of truth in it).  The bigger question, however, is this: Does the system have policies, procedures, and processes in place that help minimize the likelihood of mistakes?

The example I provided to Rachael was about writing articles.  In the absence of any policy or process for editing and revising articles, the author might not catch his/her spelling errors or typos (humans err – that’s why newspapers used to have proofreaders).  So when customers read the article — multiply the writer’s two eyes by thousands, maybe millions — the likelihood is great that at least one of them will catch the error.

On the other hand, if there is a process in place where a second set of eyes reads the article and necessary corrections are made (or the central idea is validated) before releasing it, the likelihood of mistakes getting out to the reader are vastly minimized.

That’s exactly the process change we implemented here at Bizmanualz, when we realized that our articles or blog posts were sometimes going live with spelling errors, typos, formatting issues, or a confusing theme.  We installed a WordPress plugin (Peter’s Collaboration E-mails) that lets the author save the post as “pending review”.  Editors get an email alert about the article needing review.  The editor can release the article “as is”, release it with minor corrections, or send it back to the author for more comprehensive changes.

This doesn’t mean that mistakes won’t happen.  (You may recall that Chris’s post states that 20% of all errors can be attributed to an individual).  But here too, the system might have a role to play.  Is the individual in the right place? If writing is a requirement for the job, was the individual properly screened or trained?  Of course, there are situations where the person is clearly not qualified to do the job — here, too, the system comes into play (i.e., is the selection process foolproof?).

Quality standards and tools are there precisely to increase the likelihood of positive outcomes.  You may be surprised at how a simple process change can result in a big drop in error rates.

Do your quality personnel speak the language of business?  Do business people speak the language of quality?  I read an interesting blog post a while back that raised this question.

The confusion highlights a core problem with ISO 9000 implementation—communication.  An effective quality implementation is really about effectively communicating with customers, suppliers, employees, and management to indentify, meet, or exceed requirements.  Quality, sales, marketing, design, manufacturing, accounting, and management must all communicate using the same language.

It starts with collecting the customer’s requirements from the customer (i.e., voice of the customer), communicating customer requirements to design/development, and design/development communicating what they think the customer wants back to the customer for confirmation through verification and validation.  Then design/development communicates specifications to purchasing, manufacturing engineering, and quality/testing to ensure it is made as designed.

Quality must communicate to management via internal audits, management reviews, and quality objectives that the system is capable of consistently reproducing the product or process.  The company communicates its consistency to its stakeholders via its quality policy, ISO certification, and management commitment.

Management communicates its quality commitment by allocating budget for continuous improvement using corrective action and preventive action, training, and infrastructure expenditures.  Waste is produced as a result of poor communication between one or more of the groups or departments within an organization.  Total up the cost of all of your nonconformities, defects, and deviations from plan and you get the cost of poor communications.

When we talk about effective communication, we are talking about a real two-way exchange of information.  Both the sender and receiver must be actively engaged and providing feedback for it to be effective.  Implement an effective quality management communication system and the savings will be huge.