What Was Old Is New Again

By Michael Haycock, Sr. BRC Consultant

Just about the time we get comfortable with what we’re doing – there is change.

Documentation as a requirement has been in place for the ISO 9001 standard for a long time. Back in 1987 and 1994 there were 20 requirements (if you were 9001) and most required a documented procedure and even if it wasn’t required – it was expected (you know…that unruly and pushy auditor). When ISO 9001:2000 came along there were only 6 requirements where documented procedures were specifically required. This carried over into ISO 9001:2008. Many of you maintained documented procedures for all requirements because you recognized the value of doing so OR you were “strongly urged” to do so by your external auditor (registrar). In the past, ISO 9001 always specified a “Quality Manual” (ISO 9001:2008 requirement – 4.2.2).

In all cases documents kept as evidence of required activities were called records. While there were cosmetic changes over the years, very little actual change in detail.

Now the big change – maybe…

ISO 9001:2015 no longer identifies procedures, records or even a Quality Manual. It does require us to “maintain” documentation, or “retain” documentation, or to have and control documented information.

To start with (the good news) is that while it is necessary to meet requirements, you are not required to use the structure or “specific terminology” of this standard. (Introduction, 0.1 General, about 3^rd paragraph down). This is good because some of you have been calling your documentation procedures, work instructions, records, etc. for many years – and certainly may wish to continue doing so.

Let’s talk about what the requirements are and even if not specifically identified, what you may actually need. Where the standard indicates you need to “maintain” documentation this is equivalent to having procedures, work instructions or other controlled documents that create the expectation for the activities to be carried out. Where the standard indicates the need to “retain” documentation, this is equivalent to having records or documents that provide evidence that required activities have been carried out.

A little detail on application and usage of documentation.

A Quality Manual is not specifically identified or required. My opinion however, is that the Quality Manual is the means to link all requirements of the standard and the Quality Management System together. This “policy” manual details the requirements of the standard (because it is your policy to do so). Policy is the upper level of expectations when you are using the standard to identify the requirements to which you apply your system. This policy then provides the common link to the procedures (who, what, where, when, why) and the work instructions (how) you actually carry on the work of the organizations.

I have had a “mostly” gentle argument (with others) over the years that the Quality “policy” Manual may actually be a close mirror image of the standard – and if that is the case then why would it be necessary. In the past this was moot because you were required to have a manual (regardless of how constructed).

I still prefer this structure because most people in the organization never actually use, or have access to, the standard. As previously described the “manual” is a document that should allow anyone, regardless of their understanding of the standard, to access any part of the system needed for any reason. It only needs be created once, and if kept sufficiently generic would never have to be revised until the standard changed again.

The detail of these requirements, when kept in procedures or work instructions, are much simpler to change or control. Without the detail in the procedures and work instructions, this manual is a document that could be shared with customers, interested parties and throughout the organization. While it represents the system used by the organization, created properly it does not…and should not…compromise any sensitive information.

Procedures will still be necessary to detail the who, what, where, when and why. Much of what you already have may still be used. The manual (using the ISO 9001:2015 numbering) may be used extensively to link to your current procedures. After trying a number of different methods, I have found this to be most simple and effective. Where there are work instructions to support the procedures they may be referenced (identified as “maintain” documentation 4.4.2a).

Work instructions are mostly the “how”, and if used should be linked back to procedures. Documentation should be developed so the detail for information is only provided in one place. Less opportunity for conflicting information – more opportunity for simple control and change (managed the same as procedures.)

Records are documents that provide evidence supporting the activities actually carried out (identified as “retain” documented information or documentation – 4.4.2b).

There are a variety of word combinations used for documents and documentation.

Repeating, for clarity:

4.4.2a) Maintain – procedures, work instructions or other doc’s providing expectation

4.4.2b) Retain – records – documents providing evidence

The standard does not use the words “manual”, “procedures”, “records”, etc. Can you? Of course! The standard and more specifically the system to which it relates when applied to ”your” system – belongs to your organization. While you have to cover the requirements, you do not have to use their terminology or structure (ISO 9001:2015, Introduction, 0.1 General, pg vi). My preference is to use the standard terminology because I “teach” and “do” and want to avoid any confusion. You should do what will be most understood and will create the least confusion.

Just for clarity – you can always do more than is required. (You are then responsible for this, of course.) We have seen concern that because a Quality Manual wasn’t a specific requirement that it was something not allowed and could not be included.  Absolutely not the case – the standard is the base and as long as that is in place, you can build anything else you wish. Again – what you build, you are responsible for.

The means by which you address these requirements is still up to you. Hard copy, electronic and any combination of these methods are possible. Processes are required to be identified but this should be in the detail and by the means most valuable to you including flow charts, process mapping or simple words.

There are definite and distinct changes to the ISO 9001:2015 standard. This does not prevent you from using the best tools and methods available to you – including what has worked for you in the past. We are always available to answer your questions.

A little something from the past…

In the rugged veldt of South Africa, the lion and antelope awaken from their night’s sleep. The lion knows it must run faster than the antelope or starve. The antelope knows it must run faster than the lion or be eaten. Regardless of whether you are the lion or the antelope, in the morning the one thing you know – you must be running. Seemed appropriate…

Audit Scenario – Product Realization

By Lynn Clyde, BRC Quality Consultant

The following is a typical auditing scenario that might be found when auditing an ISO 9001:2008 quality management system for clause 7.1 Planning of product realization. Read the scenario to determine if you think it would be conforming or nonconforming, then read the answer and explanation.

Support Information – ISO 9001:2008 Clause 7.1

The organization shall plan and develop the processes needed for product realization.  Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).

In planning product realization, the organization shall determine the following, as appropriate:

a)     quality objectives and requirements for the product;

b)     the need to establish processes and documents, and to provide resources specific to the product;

c)      required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;

d)     records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

The output of this planning shall be in a form suitable for the organization’s method of operations.

NOTE 1  A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract can be referred to as a quality plan.

NOTE 2  The organization may also apply the requirements given in 7.3 to the development of product realization processes.

Scenario

When interviewing the operations manager, the auditor asked to see information on production planning.  Specifically, she wanted to see quality objectives for every product they made.  The operations manager said that they developed quality objectives on a line by line basis but not for each product, although they did have a product specification document for each product.  The auditor felt they should have objectives for each product.

Answer

Conforming

Explanation

The standard states that quality objectives and requirements for the product shall be determined “as appropriate”. This provides flexibility for the organization to set objectives as they see fit. Some companies do this on a product by product basis, on a product line basis, a project basis, or an overall business basis.  The extent and type of planning that is done will be dependent upon many factors: size of the organization, complexity of the product and processes, quantity of the product produced, type of industry, regulations, education level of employees, etc.

The Practical “Process Approach” (Part 3)

By Michael Haycock, Sr. BRC Quality Consultant

In Part 2 of this series of articles we began to get into the details of identifying your organization’s processes.  As a review:

Step 1 – Implement the Process Approach

Step 2 – Identify the processes of the organization

a)  Define the purpose of the organization

b)  Define the policy and objectives of the organization

c)   Determine the processes in the organization, including ownership

d)  Define process “supporting” documentation

This gives us the big picture…the “map of Canada”.   To connect all the pieces you need to move into more detail…

Step 3 – Plan the process

a) Define the activities within the process

Having identified a MACRO process of the organization, how do we know, or believe these processes work? The amount, detail and complexity of the process should lead us to the amount of detail necessary in this exercise.

b) Define the monitoring and measuring requirements

What measurements are taken (or need to be taken) to give the organization the confidence the activities are being completed as required? This could be conducted carrying out our inspection and test techniques, our audits (internal and external) and the gathering of data to confirm our objectives and expectations have been met.

c) Define the resources needed

Who are the people involved in these processes and what are their qualifications? How are people identified as competent to carry out these activities? Do we have expectations for previous or prior demonstration of competency – or does the organization share those responsibilities? Are there legal requirements to carry out these activities (licenses, demonstrated ability, etc) and does the organization have the evidence to support these requirements?

d) Verify the process against the planned objective

Are we able to get done what we need and expect to get done – in the prescribed manner and time frame? Are we able to process 3 requests in an hour – if that is the expectation? Is our scrap rate at a certain percentage? Does our flight take off and land us at our destination on time?

I worked for an organization centuries ago (seemed like it) that had issued 55,000 credit memos in one year.  This looked huge but as a new “Quality” manager I took this on as one of my initial tasks. No one had ever tried to understand or deal with this and my simple question was – “How can you stay in business like this?” We didn’t!

Step 4 – Implement and measure the process

Whether it is at a macro level or micro level how do we implement and measure? As stated at the beginning – unless you’re starting from a vacant lot there are processes in place. The challenge in that case is to identify and confirm what is already there – then to implement or modify what is missing or is not there as you need and expect.

Step 5 – Analyse the process

The information that we gather and accumulate needs to be analyzed and evaluated. Do we have the detail up to and including statistics to clearly understand results?

(You have a need to cross a river but you can’t swim. You have a report that, on average, the river is only 4 ft deep. You are 5 ft tall. Do you cross the river? Based on the information available you COULD be OK – but – my opinion would be to wait for a boat – the information does not seem to support the risk!)

Step 6 – Carry out Corrective Action and improve the process

Is your performance expectation as you expect and need? There will be a need from time to time just to fix a problem (Correction). There will be a need from time to time to actually look for the root cause (Corrective Action). There will also be circumstances where the process is working as expected but you recognize the need for improvement – and the opportunity has just presented itself.

Where we need to correct we should do so – or – look for improvement opportunities and perhaps even innovation. (With no restriction – money, time, people – how would the ideal process look?)

Hopefully this will be useful and practical both in understanding and application. To repeat ourselves, you could use the complete package – or – just the portions that will benefit you. Even if you have had your system in place for some time (or especially if it has been in place for some time) – there have been changes. What we have described to you is just a tool. Some of you may wish to use – some of you may already have a better tool.

“Live as if you were to die tomorrow. Learn as if you were to live forever”.

– Mahatma Gandhi

We just try to help with the learning.