A key part of any quality professional’s remit is to ensure an organization’s documents are correct and up to date. Anthony Lea gives an insight into how he helped one company revamp its approach.

I was recently asked to help an organization to rewrite completely their quality management system and the greatest difficulty lay in ensuring document control. The business works with chemicals; mixing, bottling and shipping them. It has a mature process with little variation and a robust training regime based on OHSAS 18001 and ISO 9001, as well as touching on ISO 14001.

Following ISO 9001 audits by the firm’s certification body and parent company, there were some grave concerns about the quality system documentation, audits and practices within the company.

Initial observations showed that the site made products well, and there were no intrinsic issues with the quality of the outgoing product. The next step was to map the working system and concentrate on the problem areas, while fine-tuning the working parts.

The problem with document control became obvious when I discovered that there were two quality manuals; one was dated from 2003 and the other was a cut and paste of another company’s manual. The second was not reflective of site operations, nor was it clear whether it had been issued or not. Some cursory audits soon revealed that the factory’s operations were based on the 2003 manual, although they had developed since then.

The quality manual has since been rewritten using the skeleton of the 2003 document, but updated to reflect the current structure and working practices. There are now six mandatory and seven site-specific quality procedures, underneath which sit the working instructions. These have been reduced in number, but each now includes greater content to deal with the majority of factory processes. Below the working instructions lie the standard forms; a series of check-sheets representing production quality check records.

The quality manual and procedures have been published as electronic documents accessible over the company’s intranet and combining, as closely as practicable, with its health and safety and environmental management systems’ manuals and procedures. The electronic format allows much greater interaction with the site training and competency programmes which are linked to at this point, along with the corrective-action processes.

The new system has also enabled a revamp of the company’s approach to document control, which now works to the following principles:

  • Control only what needs to be controlled
  • Keep the system as simple as possible, don’t have any more complex identifiers than are necessary
  • Use descriptive file names
  • Don’t make the system so unwieldy as to discourage improvement
  • Changing processes can affect the system, the product, and the procedures – consider them all in the control method.

The top two layers of the quality manual – the procedures and working instructions – are in Word document format to allow hyperlinks, while the quality checklists are all in PDF format to prevent unauthorized change. The change administrator remains the quality manager, and a programme of change control has been initiated whereby improvements are incorporated through the system, rather than the many unofficial documents outside of the system, which was the case previously.

To protect the Word documents, a document change tracker was applied and the whole system mirrored to a hidden drive that can only be accessed by the quality manager. This means that in the event of tampering the whole system can be restored simply by the change control manager.

Where users wish to have regular use of documents, they are required to embed links to the source document, rather than saving copies to personal accounts. However, there still remains a problem with photocopies.

Document control methods used include:

  • PDF document forms – to prevent change
  • Password control on documents – so only authorized staff can change files
  • Laminating printed documents
  • Date-based obsolescence
  • A traditional change index
  • Single master copies with links to the document – this ensures the file will always be current and updates only require a small amount of work, rather than trailing documents all over the premises or multiple sites.

Alongside an understanding of effective document control techniques and which will be most effective for your organization, the introduction of a new, more rigorous document control process requires effective interpersonal skills. This is a change process and there will be some resentment at constraints being applied. To tackle this, quality managers need to negotiate and explain, but they must be resolute in implementing the change, or it will fail.

You will also require management acceptance of the existing problem and your solution, as well as dogged persistence in grinding away resistance and apathy among your colleagues. At this organization, we used concept-selling training courses to help ensure employee engagement. After the courses were held, there was a grace period to allow people to remove unapproved documents that were then deleted in a server-cleansing sweep. The efforts of the quality manager have proven successful, with the new process being readily accepted and initial audits show it to be working well.

 

Credits: The CQI Quality World 2010(c)