ISO9001 in 2021 Week by Week - Week 26 - 8.1 Operational planning and control

This is a 52 week discussion of ISO9001:2015. Each week, we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat. (As a member of TAG/TC176, the committee responsible for review and revision of ISO9001, (possible revision in 2023), I’ll keep you posted on what I learn all year!)

(It is strongly recommended that you purchase a copy of ISO9001:2015  for reference).  And, be sure to do your homework!

8.1 Operational planning and control

This week, we change gears from higher level planning of the quality management system overall, to the nitty gritty of operational planning and control.  In Week 7 of this challenge, we identified the processes necessary to maintain full control of the quality (or business) management system.  There is some overlap between that section and this new one, so be sure to cross reference back to the processes initially defined as critical to ensure there is a good symmetry and alignment when pushing forward with this clause.

Back in 4.4, we identified our processes and things like “inputs, sequence, performance indicators, resources, responsibilities, risks and opportunities, methods for monitoring/measuring and opportunities for improvement”.  We’re doing much of the same work here, but at a new level of detail as it applies specifically to processes for products and services.  For example, there may be a broad-brush approach in the QMS overall to address things like order fulfillment or the manufacturing process.  And now, there may be more detailed processes specific to different product lines or business units.  Just as a business plan may outline main objectives of throughput, acceptable quality levels (AQL), etc, they are later rolled out in greater detail to each department/work cell/operational location with subgoals intended to achieve the overall objectives and desired outputs of the business.

Let’s take a look at the wording inside the standard.  And notice that it points back to both 4.4 (QMS and its processes) and 6.1 (Actions to address risks and opportunities).  In my opinion, this is a critical point, and missing these connections when creating a QMS can result in a disjointed system that fails to lead back to the main objectives.  If these aren’t carefully considered and connected, there’s likely to be a gap in compliance with all of the requirements.  I really don’t like the way this whole thing is structured, because there has always been a struggle with a “process approach”, and this is part of the reason.  I would have preferred all 3 of these sections be integrated in a clear and understandable way rather than referencing one another pages apart.  There, I said it.

“The organization shall plan, implement and control the processes, as outlined in 4.4, needed to meet requirements for the provision of products and services and to implement the actions determined in 6.1, by

a)  determining requirements for the product and services;

b)  establishing criteria for the processes and for the acceptance of products and services;

c)  determining the resources needed to achieve conformity to product and service requirements;

d)  implementing control of the processes in accordance with the criteria;

e)  retaining documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements.

The output of this planning shall be suitable for the organization’s operations.

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that outsourced processes are controlled in accordance with 8.4.”

In addition to circling back to 4.4 and 6.1, the section finishes with a reference to 8.4 (Control of externally provided products and services).  So, once we’ve looked at the QMS processes, we must break things down to a detailed plan for controlling product and service fulfillment.  And finally, we must consider the same for externally provided products and services.  So, there you have it.

THIS WEEK’S HOMEWORK

Hopefully, you have created (or reviewed) your QMS thus far with a series of interactive and sequenced processes, and you’ve been able to review each of the processes with the criteria provided.  Look at your system so far.  Are the processes clearly defined?  Are each of the criteria clearly defined and communicated?  If this is done well, other requirements like training, competence, process monitoring, corrective action will clearly roll out with each process and the system will be tidy and simple and easy for all users within your organization.  Unfortunately, these links can often be severed or missing altogether, and this is usually where a QMS can become really challenging to manage.

Do your best to streamline and make the proper connections so that your system is lean, easily understood and easy to use.

This weekly series is a DIY guide including lots of FREE STUFF like templates, examples and tutorials.  So, SUBSCRIBE today and we’ll keep it coming to your inbox weekly.

Here are some other LIVE or VIRTUAL options,  Connect with us today and we'll create an exciting and engaging experience for your team on:

• SWOT Analysis - We'll facilitate and help your team capture your Strengths, Weaknesses, Opportunities and Threats as the foundation of your quality strategy
• Process Maps - We'll help your team learn to create an Interactive Process Map and Subprocess maps to create a roadmap to navigate your entire business

Or perhaps your organization is more advanced and is ready for some training that will transform your organization and start solving problems and diving deep into identifying and reducing your risks:

• Problem Solving Training - We'll teach your team 3 powerful problem solving techniques ("5 Why", "Fishbone" and "Pareto") with a workshop to solve one of your organization's REAL LIFE problems
• FMEA Failure Mode & Effects Analysis - We'll lead a dynamic, hands-on workshop to teach your team how to perform an FMEA and how that tool can be leveraged to launch powerful lean, Six Sigma and Continuous Improvement

And the options don't stop there.  

Watch this 3-minute video about another great resource to accompany this series.   Get the self-directed, on demand, online learning series  ISO9001 in Plain English, today and you'll get:

• A clear understanding of the requirements of ISO9001:2015
• Proven tips to build a robust quality system that's easy to use
• Ways to reduce documentation and paperwork (yes, really!!)

Each video is about 15 minutes and targets a specific element of ISO9001, (with over 6 hours of total content!).  We translate all the gobbledegoop into Plain English you can understand and leverage the requirements to get maximum VALUE from your quality efforts. 

For a deeper dive into the process side of your quality system, get Tribal Knowledge - The Practical Use of ISO, Lean and Six Sigma Together, a simple guide to UNITE ISO9001, lean and Six Sigma to create a robust quality system with better results.  Read what ASQ American Society for Quality – Quality Progress Magazine  had to say about it. 

We look forward to continuing this YEAR LONG journey with you.  SUBSCRIBE today and the series will come to you weekly to get you off to a great start and your quality system reinvigorated.