It’s time to turn the page on Quality Manuals, Part 3

How to make your manual a part of your routine processes, workflows and analyses? By making it simple to upload, intuitive to use and integrating it with every aspect of your QMS to deliver value

In the first part of our series on Document Management, we noted with some surprise that many vendors still take a one-dimensional, ‘analog’ view of the quality manual. What interests these vendors is whether the document is compliant or not, and compliance is all they deliver. Job done, they then close the door on the quality manual until the next audit.

At AlisQI, we keep that door wide open and invite everyone in. A shop floor operator, even one with an imperfect command of English or the native language of the region where the plant is situated, can call up a flowchart of the production process on his tablet, tap on ‘his bit’ of that process and have all the relevant documentation at his fingertips.

This is just one of the ways in which the AlisQI QMS transforms your quality manual from a book into a hub, tilting the focus from compliance to performance.

Document Management an opportunity to boost quality

Compliance is not neglected, but in AlisQI, Document Management becomes an enabler (instead of a box-ticking exercise). Manufacturers are also guilty of box-ticking of course and they often relegate DM to a management exercise instead of a business opportunity.

We often say to them: “Why would you go through the effort of compiling and maintaining a complex quality manual and not use it as an everyday tool to improve quality management?”

Why indeed?

The user-friendly approach to Document Management

We make it as easy as possible to get started. Manufacturers can either ask AlisQI to upload the quality manual as is or refine its tree and permissioning structure before uploading the document manually.

Thoughtful workflows for document modification and notification impose consistency and ensure compliance.

Through what we call ‘models’ you can link the manual and other documents to diagrams created in Visio (or in any graphical tool of your preference). Using simple drag and drop you can create a digital twin of your production processes – and the quality procedures and protocols that underpin them.

You can also link your documents to AlisQI forms, bringing together measurements (QC and QESH) and their relevant procedures as described in the quality manual.

The video above explains the intuitive procedure. Documents can be assigned to every facet of a final product inspection, such as the date, batch number, refractive index, pH, and so on. In this example, we link a document to the pH field. Now, during the final product inspection, a book icon appears next to this field; users can open the pH procedure by clicking on this icon.

In this way, operators and lab technicians always work with the current version of all the documents in your quality manual.

In our blog It’s time to recall ad hoc Quality Management, we traced the history of a complaint and product recall through the different workflows and documents in the AlisQI platform. A complex yet every-day series of circumstances had resulted in the pH content of a batch being mislabelled. The AlisQI document trail and workflow systematically revealed the root causes of the problem; AlisQI workflows also dictated how these issues were to be resolved. A change of procedure (the manual labeling of batches) would lead to a modification of the quality manual, a process-driven and automated by the platform.

Prepared at all times

A textbook use case of the integration between QC and Document Management is a Lean Sigma protocol known as an Out of Action Plan or OCAP. Pioneered at Philips by a former Dutch marine, the motto of the OCAP technique is ‘Do not call a meeting when under enemy fire’.  In other words, be prepared to respond adequately, right away.

The quality manual describes the entire operation of the organization; deviation management is part of that. Whenever a deviation is detected, the operational team should respond. But how? Figuring that out ‘under enemy fire’ is definitely not the best way; while your team is devising a solution, your machines might still be spitting off-spec parts. Thinking about possible deviations beforehand and setting down clear instructions in the quality manual on how to handle them when they occur will help you adjust your machine or products – and get back to normal – much quicker. In this way OCAP, reduces waste and improves the stability of your processes and products.

Standardizing these deviation drills in your manual reduces variation between operators, as they all have the same instructions.

‘Everyone is equal before the law’ – and we would argue that when it comes to quality everyone is equal too. A manual that is up-to-date, inclusive, and complete reduces reliance on experience and ‘gut feeling’ and gives everyone an equal opportunity to enhance quality across the factory. This is what it means to deliver omnipresence. 

How to prepare for Quality Intelligence?

In this era of smart manufacturing, quality will become smart as well. This transition will not happen overnight and this will not happen in a linear way, but we know that integration and automation play a key role. This white paper presents a springboard to change and asks organizations to self-assess to what extent they are ready for Quality Intelligence and to leverage tomorrow’s possibilities.