Issue 54 – Clause 8.1: Operational Planning and Control
Clause 8.1: Operational Planning and Control
What’s the intent of Clause 8.1?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 53) we discussed the topic of “documented information”, and now here in Clause 8.1 we address the area of “plans and controls”. The intent of this Clause is to “plan” how you will produce your products and provide your services, IN ADVANCE of taking a Customer order. They’ve added some new words from the 2008 version such as “services”, “planned changes”, “unintended changes”, as well as making a reference to actions determined back in Element 6.0 (Planning), however the intent remains the same.
Note A: This Clause DOES include requirements for “documented information”.
Note B: For those of you who may not be aware, the content for these Newsletters comes from working in the field with my Clients, and with their ISO Certification Bodies. I gain a lot of hands-on experience from conducting training workshops, gap audits and internal audits, where the requirements of the Standard have to be interpreted and applied to each unique situation. A popular training request is our on-site Internal Process Auditor Training for ISO 9001:2015 since you will need to do a complete round of internal audits to the new Standard prior to your external upgrade audit. On that note, some organizations are opting to use an outside resource to assist with their internal audits in order to meet deadlines (…more details on this service, as well as the training sessions we offer, can be found below).
The new numbering format…
Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement
Clause 8.1 Operational Planning and Control consists of zero (0) Sub-Clauses.
This Clause spells out all of the activities an organization should undertake to instill confidence that there is “plan” in place to handle Customers, and a way to “control” that plan. For existing products your “plans” and “controls” are already implemented so you should start by auditing the “shall” requirements to make sure nothing has been missed, and then simply refer to these “plans and controls” in order to address the requirements within this Clause.
What you need to keep an eye out for in Clause 8.1 is those “services” you listed way back in Clause 4.3 (Determining the scope of the quality management system). Lets be very clear here… I am talking about outbound services directed at your Customers. Each of those services need to have a corresponding “plan” and associated “controls”. If your “services” have been in existence for some time, then you likely have them described within your current QMS documentation, if not, then you will have to add them in.
Once you’ve addressed BOTH your products AND services (…and don’t forget about “plans and controls” for outsourced processes… hint: how you address Clause 8.4 will be the way to deal with this), then you can now look at how you handle “changes”, both planned and unintended. Although handling changes was implied in the old 2008 version, they have made it more explicit this time. The idea here is that if “planned changes” occur within your QMS processes, then decide how you will “control” them, since you know about them in advance… and if “unintended changes” occur, then how will you review their consequences, including what actions you will take in order to mitigate any adverse effects.
What “changes” are we talking about? Well, based on the wording in the first sentence of Clause 8.1, you could assume it first applies to any QMS process changes that are needed to meet product/service requirements… and secondly, any changes to QMS processes needed to implement the actions you determined back in Clause 6.1 (Actions to address risks and opportunities).
One last point to keep in mind, Clause 8.1 also applies to brand new products that you introduce, as well as any new services launched. The trigger here would be if you revise your Scope Statement.
Be sure to watch for our next Newsletter issue where we will cover another section of ISO 9001:2015…
PS: Don’t forget to look at the Q&A section below for some final thoughts…
To view all of our past Newsletters or to sign up to receive them… click here
For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy the Internal Audit requirements in the ISO Standards. We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together. This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.
This Documentation Development Training Workshop for ISO 9001:2015 Session is intended to be a very interactive, hands-on session (hence the name Workshop) where your QMS documentation will be created/revised, with guidance from an experienced facilitator. This type of session can help launch your transition efforts by getting a lot accomplished within a compressed time-frame. If your organization has already begun the re-write then this session can be used to validate what you’ve accomplished so far, or if you haven’t yet begun, it can be the catalyst to get things started (…which is usually the hardest part). Deciding how to move from your current QMS structure into a new one can be a daunting task and this session can help you navigate through it. A copy of a sample Quality Manual (re-iterating the “shall” requirements found within the ISO 9001:2015 Standard) will be provided to each participant. As always, our focus will be on how to develop a simplified and streamlined quality management system, that helps to drive improvement in your business.
The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.
This combines the ISO 9001:2015 Essentials Session with a Gap Audit – This approach is used to assist organizations in launching their transition efforts for this new ISO Standard. This event accomplishes two things: a) it provides education on the new ISO 9001:2015 Standard for your key personnel (i.e. internal auditors; etc.), by highlighting the differences from the 2008 version; and b) assesses the gap from where you are today to where you need to be to achieve compliance to this new ISO Standard. Training certificates covering education on the new ISO 9001:2015 Standard, as well as issuing of a Gap Audit Report for distribution to your Top Management, are the two deliverables from this event. On a final note, a closing meeting can be arranged with key individuals so they can hear first hand the results of the Gap Audit that was performed. PS: We’ve also done this session with just the QMS Management Rep attending, which allowed them to quickly get up to speed on this new Standard, as well as to see how much of an effort the transition will be… and of course they receive their own Training Certificate as part of this event. This also allowed them to avoid traveling offsite to get the training they needed anyways, as evidence for their Certification Bodies.
Q: How do you perform an audit for Clause 8.1 of ISO 9001:2015?
A: For Clause 8.1, an Audit Checklist should cover these areas:
– How does the organization plan and control the QMS processes needed to provide those products listed within its Scope?
– How does the organization plan and control the QMS processes needed to provide those services listed within its Scope?
– How does the organization plan and control the QMS processes needed to implement those actions identified in Clause 6.1?
– How does the organization determine the requirements for those products and services listed within its Scope?
– How does the organization establish the criteria for the performance of its QMS processes?
– How does the organization establish the criteria for the acceptance of its products?
– How does the organization establish the criteria for the acceptance of its services?
– How does the organization determine the resources needed to achieve conformity to the product and service requirements?
– How does the organization implement controls for the processes in accordance with the criteria?
– How does the organization determine, maintain and retain documented information to the extent necessary to have confidence that the processes have been carried out as planned?
– How does the organization determine, maintain and retain documented information to the extent necessary to demonstrate the conformity of products and services to their requirements?
– How does the organization ensure that the output of this planning is suitable for its operations?
– How does the organization control any planned changes to the QMS processes?
– How does the organization review the consequences of any unintended changes to the QMS processes? Are actions taken to mitigate any adverse effects?
– How does the organization control any outsourced QMS processes?
– Has the organization added any products or services to its QMS Scope? If yes, how does the organization ensure planning and control is implemented for these added products or services?
(Make sure to interview more than one person and obtain examples for the items listed above)
Until next time…
Helping Business Professionals Reduce Risk and Remove Waste!