Good Quality Document Management

Good Quality Document Management

Let’s face it, documents are often the last item to get updated after an org change, process change, the implementation of a new platform, changed websites, new tools, or changes to training packages.?But it’s the first on the list for auditors to review.?The questions usually start something like this, “Tell me about the process you follow.”?Then inevitably the auditor will ask for the documents to support the answer provided.

Documentation is the very core of consistent, repeatable, quality procedures. Complex procedures must be written - to prevent loss of team knowledge as members move on to new roles. It also supports the smooth transition of onboarding new employees, to ensure knowledge transfer.

Company’s often assure they have solid quality products and services.?Some companies will take it a step further and achieve a Quality Certification, such as ISO9901 or ISO13485. ?Therefore, the documentation that supports a company's commitment to quality products and services, must also be of excellent quality.?So how does one assure their department documents are quality documents?

As a former auditor, I want to share a few items I would look to review:

1.??????Accuracy – Are the steps the same steps as the auditee mentions? Are there any deviations or records to confirm the process is being followed, such as training records, software records, or procedural outputs that can be reviewed?

2.??????Clarity – More often than not, I received documents that are just shy of being a “War & Peace” essay. Longer does not make it better. Short, clear sentences are better, and organizing complex content in a table makes the content easier to digest.

3.??????Last Review Date- If the document is as old as the hills, what are the chances this document is accurate, complete, current or even followed??If the company requires an annual review date, ensure teams review and approve the document before the set review date. One day late, is well…late. If the company does not have a requirement for document reviews – establish it. ??

4.??????Approver – Is there a digital signature or wet stored signature from the approver??A word of wisdom here – have as many reviewers as desired, but reserve the approver to one person responsible for oversight.?I have seen many docs missing one formal approval, from a long list of approvers.?So that makes the document – NOT APPROVED. It is a whole lot easier to chase one executive down for that approval, than a team of executives.

5.??????Compliance – How does the team ensure compliance? Are there any quality checks or monitoring in place, and a corrective action plan for non-compliance?

6.??????Awareness – Can the employees provide a copy of the procedure they follow?? Employees are likely to have little awareness if they cannot find the procedure to follow.

7.??????Training – Do employees need training for specific procedures??If so, can you pull training records to ensure all employees have been trained??After every training session record the attendees and date(s) attended to prove that your employees know and follow their critical processes. ?

Ten Recommendations:

1. Know your audience and state exactly who it includes in the scope section.
2. Write shorter documents and write shorter sentences.
3. Rules for policies: Consider one sentence for each rule- with the word “must” in it.
4. Put complex content in tables.
5. Get clear on your message and get to the point quickly.
6. Have multiple cross-functional reviewers.
7. Assign one approver and ensure they formally approve the document.
8. Put all documents on a regular review cycle and track monthly.
9. Save records of training, dates, and attendees.
10. Include where the single, official copy of procedural documents are stored in the training.

When training teams on quality documents users sometimes ask, this all seems petty and not related to the quality of goods and services. ?Or - our team does not deliver products or services.?My answer to that is does your team support teams who deliver products or services??Are your teams committed to the support of those products or services??Then your documentation supports the company’s quality commitment to your customers.

Special Request: Quality of Life For Those in Need For This Holiday Season

Getting control of documents is easy when you look through a quality lens.?Getting control of one’s life when it has gone astray is far more difficult.?This is why I applaud Bethel Colony of Mercy , a Christian residential program for those in bondage to addictions.?They provide in-house treatment based on Christian faith principles, charging only a $350 entry fee.?They need all the same types of items we have in our home, such as soaps, blankets, food, etc.?Bethel Colony of Mercy provides the shelter, books, and teaching items for their 65-day in-house treatment plan.

·??????For this holiday season, consider helping by giving a donation: https://bethelcolony.org/giving/

·??????Other ways to help: https://bethelcolony.org/other-ways-you-can-help-2/