By carefully integrating document control with Compliance and Quality processes large and mid-size manufacturers can significantly enhance their audit scores. Many organizations who viewed document control and quality control as separate initiatives in the past are now increasingly taking an integrated approach to compliance and quality building a robust quality infrastructure on a strong foundation of document controls.


Previously, we discussed best practices for implementing a well-designed audit program. In this issue, let us discuss how one can most effectively raise the audit scores of your organization by building effective document control processes. Document control and document lifecycle management have become increasingly important foundation for building and implementing a good compliance and quality system. With the growth of online manuals, standard operating procedures (SOP’s), supplier contracts, electronic material safety datasheets (MSDS), OSHA safety datasheets, plant and operator instruction manuals, most large and mid-size manufacturers are finding it difficult to enforce compliance with corporate procedures and quality standards. In many cases where such digital document repositories do exist, we find that these document repositories are not integrated with the underlying processes and quality standards of the organization. To make matters worse, as organizations look at managing large offshore supply chains, effective document control becomes even more challenging in establishing the quality baseline between all parties involved. A well implemented document control system, besides providing a document repository for global use, must enable seamless document and data control, closed-loop collaboration and process flexibility to turn organizational documents into living and breathing standards for global compliance and quality.

To put the problem in context, let us look at a specific use case scenario at a large manufacturer.

  • A large and diverse manufacturer selling hi-tech products has multiple plants through out the globe with increasingly many components and parts being sourced from specialized suppliers and outsourcers.
  • The manufacturer has several thousand business critical documents stored in a document management system implemented just a few years back. These documents are increasing in volume and scope and are often sent around in emails to facilitate collaboration across teams and organizations. The current process for managing documents mostly involves individuals and groups to work on certain documents and then file them electronically to the common document vault for record keeping or collaborative purposes.
  • While on the surface the document infrastructure may be adequate to keep the plants operational, the manufacturer often scores poorly on internal, customer or regulatory audits.

So where is the problem here? Why does the organization continue to have a challenge adhering to the quality standards, even though there exists a nice collaborative environment to document and follow the critical standards and procedures?

The simple but important realization which many large and medium size manufacturers have had over the last few years is that global quality management initiatives must take ownership of the global document management initiatives to ensure that quality processes and associated documentations on standard operating procedures are tightly coupled. Moving forward, document changes must lead to process changes and vice versa.

Here are some tips to raise quality audit scores, which we have seen work in many customer scenarios.


Requirements for an effective Document control process 

We believe that document control processes designed to improve your audit scores must achieve the following.

  • Provide immediate access to all of the plant and corporate documents at any level, across the extended enterprise based on appropriate roles and privileges. (Corporate, plants, distributors, suppliers etc.)
  • Establish a simple framework for document lifecycle management, which covers document creation, change management, management approvals, and regulatory filings, real-time as well as historical reporting.
  • Connect document changes with process changes and vice versa. For example, when standard operating procedures change, those changes must reflect in the process flows across the extended enterprise. On the flip side, as the processes change with business requirements, process documentation must reflect such process changes. Managing process and document flows in isolation can lead to compliance and quality failures and introduce gaps between documented objectives and process implementations.
  • Enable auditors to audit process and product document controls. For example, creating audit checklists based on stated procedures and documents could enable auditors to rapidly create relevant audit packages.
  • Ensure that changes in documented SOPs, process manuals trigger appropriate organizational training processes. Most regulations (such as FDA regulations) mandate evidence of appropriate training upon changes in the documented SOPs and procedures.
  • Facilitate document control in offline and email environments. As process documentations, SOP’s, supplier contracts are collaboratively managed, it is critical that offline and email based document controls are implemented. In many cases, documents must be worked on by remote suppliers without requiring access to your document management environment. It is critical that all those documentation changes and approvals are captured in your system in offline environments.


Top 5 Recommendations for raising your audit scores through effective documentation
  1. Look for a solution that automates the entire document lifecycle. A well-designed document control solution must facilitate complete management of document lifecycle.
    1. Enable creation, change management, approvals, filings, and storage of all documents.
    2. Ensure reuse of existing document lifecycle templates.
    3. Integrate seamlessly with existing document management infrastructure and document vaults for record keeping and storage.
    4. Facilitate role based ad-hoc work groups across the supply chain to collaborate throughout the document lifecycle.
  2. Look for a mobile solution, which is practical and usable by the entire extended organization. Many document control programs fail because users find it hard to use the system while they are in the field working on the documents. Forward thinking organizations are insisting on offline and mobile document solutions so that compliance and quality organizations can manage the document lifecycle in the field and not have to re-enter their updates when they come back to their office. Re-entry of document changes is a point of error, which we recommend is best avoided. Simple questions to ask and consider:
    1. Can quality organizations collaborate on documents through email? Can emailed documents be worked on remotely and automatically synced up with the centralized document control solution?
    2. Can hand-held devices like PDAs be used to manage document lifecycle?
    3. Are their built in real-time rules to check for approvals and document controls at the point where users are making changes to the documentation in the field?
  3. Look for a document control solution with built-in process management capabilities. A well-designed document control solution must be seamlessly integrated with process management capabilities to help raise your audit scores. Changes in SOPs and documentations should trigger process changes and vice versa.
    1. Can processes described in the SOP’s be implemented through process flows?
    2. Does the system provide automatic alerts when SOP’s change? These changes might mean following up with changes in the process itself.
    3. Can the Standard Operating procedures and controls be modified effectively based on audit findings?
  4. Look for a quality document control solution, which integrates training management programs. A well-designed document control solution must tightly integrate with training management processes:
    1. As SOP’s get created, are the right members of your organizations being trained on these new SOP’s?
    2. Can the feedback from end user training be incorporated to further update the SOP itself?
  5. Look for a document control solution, which is readily auditable. General-purpose document control solutions work fine as document repositories. However, when it comes to building a document control solution for compliance and quality, auditability and traceability becomes most important. Simple questions to ask and consider:
    1. Can you get complete visibility into any and all changes to documents for audit purposes?
    2. Can your auditors drill down into any aspect of your document repository and lifecycle and ascertain process compliance?
    3. Can you trigger compliance and quality alerts on documents based on rules set forth by the internal or external auditors?

By carefully integrating document control with Compliance and Quality processes large and mid-size manufacturers can significantly enhance their audit scores. Many organizations who viewed document control and quality control as separate initiatives in the past are now increasingly taking an integrated approach to compliance and quality building a robust quality infrastructure on a strong foundation of document controls.


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