Author: Ask the Standards Experts

Audit Versus Inspection?

Audit, audit by exception

Question

Would you please tell me what the differences between audit and inspection are?

Answer

This is a great question.   We can start with the definitions of inspection and audit per the new ISO 9000:2015 standard.  Inspection is “Determination of conformity to specified requirements”  (3.11.7)  and Audit is “systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled”  (3.13.1).

Without parsing the words to much, the difference is one of scale:  Inspection is most often associated with inspecting a product or a service to make sure it is right, and an audit is most often associated with a higher-level review of the system that is designed to produce and inspect the product or service.

An audit of a manufacturing process wouldn’t just inspect the product, it would ensure (at a system level) that required inspections had already been performed on the product.  I have often made the differentiation in the following way… “An inspection is down in the grass, but to do an audit, you have to climb a tree.”  The reflects the difference in purpose and perspective for an audit.   Other authors, such as Arter, Sayle, and Russell refer to inspections as ‘backward looking’, that is, what was actually done to provide a product or service, while audits are ‘forward looking’.   Audits ensure that proper management controls are in place to ensure product quality into the future.   Instead of inspecting quality in (to a product produced in the past), an audit evaluates how well a quality system will predict and prevent quality problems (in the future).   My three favourite references are Quality Audits for Improved Performance by Dennis Arter, Management Audits, by Allan Sayle, and the ASQ Auditing Handbook, edited by JP Russell.

Thanks very much,

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

Transitioning to ISO 9001: 2015

Analysis, Statistics, Control Charts, Statistical Methods, Audit, Auditing

Question

ISO 9001: 2015 has a 3 year implementation period. I recertified in 2014 and need to recertify in 2017. At this point I have a little under one year to transition instead of the 3 years identified. What alternatives are there that I might take advantage of so I have a longer transition period? My 3rd party registrar has been no help.

Answer

I would suggest that this individual approach their registrar/auditor and reason with them. I have heard of 3rd party auditors who are willing to help organizations with their transitions in numerous ways, including finding a comfortable way to transition without losing investment made in the current standard.

Second, the requirement to transition over to the new standard is not demanding that people wait until their current certificate runs out.  This company can begin a gradual transition right away. Stretching it over a couple years gives a company plenty of time to ‘learn’ and transition. Therefore, 2017 would be a possible time for a smooth change over to the new standard.

Registrars are our helpers; not some strangers lurking in the dark. They should be approachable and willing to help.

Also ASQ, as well as other sources, offer various forms of transition training and information.  The new standard can seem a bit intimidating at first glance but once thoroughly examined, it is actually more simple in several areas.

Atychiphobia – a persistent fear of failure can lead us to see stumbling blocks ahead of us. You can turn those stumbling blocks into stepping stones with some support from your registrar and a positive attitude.

Bud Salsbury, CQT, CQI

For more on this topic, please visit ASQ’s website.

Switching Rules

Manufacturing, inspection, exclusions

Question 

We are planning to implement ANSI/ASQ Z1.4-2003(R2013) sampling inspection plan with our Finish products which are currently 100% inspected by QC Inspectors.  I read  about the importance of the switching rules  on a continuing stream of lots and have the following  questions:
1.Is it acceptable to select a specific plan (tightened, normal or reduced ) and use it without the switching rules?
2.Are there any exceptions which allow us to use a specific plan without applying  the switching rules?

Answer

  1. You can use any plan without using the switching rules but it does run the risk of not meeting the alpha risk in the end. These plans were developed to be used as documented. A normal plan is generally used and the switching rules come in when the clearance number has been obtained.  Some processes may never switch.  If you choose a plan that is tightened or reduced to start with, you potentially will either spend too much on inspection (tightened) or risk having bad product go to the customer (reduced).  It is a business decision for you to make if your customer is not demanding it.  The switching rules are there to protect the producer when the product is running very well or it has problems.
  2. If your customer is not requiring a particular plan, you can use what you want. It is a business decision, no reason for any exceptions.

I hope this helps.

Jim Bossert
Sr Performance Improvement Specialist
JPS Hospital
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CSSMBB
Fort Worth, TX

For more about this topic, please visit ASQ’s website.

ISO 9001:2015 Documented Information Requirements

ISO documentation practices, requirements

Question

I am trying to ascertain if I need to write a Quality Manual to comply with ISO 9001:2015. I see some clauses require ‘documented information’. Do I just address those or the entire document?

Answer

Thank you for the question.

To begin with, the new ISO 9001:2015 standard does not present a requirement for a Quality Manual. Those requirements are now part of Clause 4.3 and 4.4 of the new standard. That information “shall” be maintained as documented information.

You would be wise to 1] Acquire a copy of the 9001:2015 standard if you haven’t already done so. 2] Check in ASQ.org for information explaining the new terminology related to the standard. 3] Consider pursuing the services of a quality consultant for thorough guidance.

Respectfully,

Bud Salsbury
ASQ Senior Member, CQT, CQI

For more on this topic, please visit ASQ’s website.

Value Stream Mapping

Certification, ISO 9001

Question

We produce plastic fittings and pipes. We only have one process: only one machine is needed to produce a product.  Can we still benefit from Value Stream Mapping? If yes, could you please explain how?

Answer

Thank you for your question.  Value Stream Mapping (VSM) can benefit organizations of any size.  The fundamental question you want to answer is: How quickly can I receive an order, build it, and be paid for it?    This is “order-to-cash”.  Along the way, we look primarily at two things – how quickly and smoothly can I get a build order to flow through my factory, and how do I minimize raw material inventory and work-in-process inventory during that process?

Value stream mapping can benefit your organization by answering some of the following questions…. How long do I wait for raw material (e.g., am I buying from down the street, or does it take months to arrive from China)?  How long is a customer order in hand before I start up my machines to produce it? How long is my machine set-up?  How long does work in process sit between machines?  How long does material sit in the back of the plant before it is shipped?   How long does it take me to get paid?    Value stream mapping can help to answer these questions and challenge your organization to continuously shrink these times.     I had one client who got very good at this.  They insisted on payment from key customers within 30 days, and had payments terms of 60 days with their suppliers.    In many cases, they were paid for their products before they even had to pay for their raw materials.  That’s lean!

Denis.

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
www.DevosAssociates.com

For more on this topic, please visit ASQ’s website.

ISO 9001: 2015 Deliverables and Processes

About ASQ's Ask the Standards Expert program and blog

Question

Under the revised ISO 9001: 2015 standard, what do you see as the key deliverables and processes owned by the Quality manager or QA department?

Answer

A project or process is made up of primary components aimed toward successful completion of the project/process objectives.  Those individual components are the deliverables.

In other words; you have Inputs and Outputs. An Output is a deliverable resulting from the process (Input).

The old aphorism “Everyone is responsible for quality” is strongly encouraged throughout ISO 9001:2015. Therefore, with the adage of Risk Based Thinking to the new standard, the Quality manager and the QA department would be responsible for the deliverables of their department and its processes. They would also be responsible for discerning any risks to the company’s goals and objectives.

Bud Salsbury
ASQ Senior Member, CQT, CQI

For more on this topic, please visit ASQ’S website. 

ISO 9001: 2015 Design and Development Clause

Prepare for ISO 9001: 2015

Question

We are service providers in NDT and inspection field. I want to know how to implement the design and development clause from ISO 9001: 2015.

Answer

There are two ways to approach this:

One is to use the process developed in ISO 9001:2008, 7.1 where you probably have a “quality plan” for the execution of the service delivery (ISO 9001:2015, 8.1).

The second approach is to design the process itself (ISO 9001:2015, 8.3).  That involves these activities:

INPUT
• Development of a design plan
Who will do what when with what?
Necessary control points
• Identification of customer requirements as inputs, along with inputs from similar previous service offerings
• Identify any special service characteristics, such as safety issues, regulatory compliance
Consequences of failure
• Identify products/services to be purchased/outsourced
THROUGHPUT
• Documentation of these inputs
• Preparation of an output in a format appropriate to the organization
OUTPUT
• A comparison of the outputs with the input requirements and an approval, if required
Outputs should include process monitoring and measuring requirements
• Outputs can include verification, design review and validation*
• A mechanism to handle process design changes

George Hummel
Voting member of the U.S. TAG to ISO/TC 176 – Quality Management and Quality Assurance
Managing Partner
Global Certification-USA
http://www.globalcert-usa.com/
Dayton, OH

For more information on this topic, please visit ASQ’s website.

Inspection Sample Size

Analysis, Statistics, Control Charts, Statistical Methods, Audit, Auditing

Question

  1. The customer expects certain levels of inspection: pull 157 bottles for visual testing, but then they also want 20 pulled for dimensional testing. Can’t the 20 additional bottles be a subset of the original testing sample?
  1. When calculating the lot, do you pull the samples before or after your calculations? Do the samples get included in the produced quantity or not?  For example: If the customer orders 10,000 bottles and the level 2 inspection pulls 200 bottles that drops the total shipped to the customer to 9,800 pieces.  If 10,200 bottles are produced then the inspection level increases so that 315 bottles need to be pulled for testing.  What is the correct sample size and production number?

Answer

Here are the responses to your questions:

  1. Yes since the first inspection is visual, you can use a subset for the additional testing.
  1. The lot size is 10,000. You should be putting the samples back into the lot if they are not destroyed by the testing. You send what is contracted for.  You are sampling with replacement.

Jim Bossert

SVP Process Design Manger, Process Optimization
Bank of America
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CSSMBB
Fort Worth, TX

For more on this topic, please visit ASQ’s website.

Sampling and Daylight Savings Time

Pharmaceutical sampling

Question

We are wondering if there is any generally accepted procedure to account for seemingly duplicate sample times when operating over the time period when clocks ‘fall back’ one hour for the end of daylight savings time? Our standard practice is to analyze a chemistry sample every half hour, so we foresee two each of the 01:00, 01:30 & 02:00 AM samples this next Sunday morning. Please advise on any generally accepted practice to account for such seemingly duplicate samples.

Answer

I do not know an industry accepted standard for this yet.

If used for control charting, just plot as normal, noting when the sample was taken. For the second 2:30am sample, just note it was after the time change… continue monitoring the process as normal.

If used for lot sampling, analyze the results as normal.

If doing a daily average, then adjust the calculation for the two extra samples, i.e. divide by 26 instead of 24.

At most it may require a slight change to calculations based on the number of samples, otherwise it’s just not a big issue that may require at most a comment or note about the seemingly duplicate sample times or two missing times (in spring).

Cheers,

Fred

Fred Schenkelberg
Reliability Engineering and Management Consultant
FMS Reliability
(408) 710-8248
fms@fmsreliability.com
www.fmsreliability.com
@fmsreliability

For more on this topic, please visit ASQ’s website.

DMAIC Guidelines

Question

Are there general guidelines or target durations for each phase of DMAIC?

Knowing that we have fruit salad in our portfolio – apples, oranges, grapes, melons, plus 10 more – are there recommendations on how to generate meaningful guidelines for duration where trying to categorize a project may have a considerable number of characteristics and be quite different?

Answer

DMAIC process

Duration is a good metric but in the operational definition you need to add a complexity component.  You are seeing what happens when it is not added.  I have defined complexity as the number of groups/departments that need to be engaged in the project.  A simple example is when IT gets involved, there may be some additional time lags that need to be added so they can do their due diligence.  Likewise if you have a project that involves finance or legal, it will add time to the project.  Organization wide projects take more time than departmental ones so when scoping a project, consider how much longer it will take with more groups needed to be involved.  This may help in your estimates and tracking.

As for general guidelines for DMAIC, what I have told executives and belt candidates is that Define should take about 3 weeks, Measure about 8 -12 weeks (depending on how good your data is).  Analyze 3-4 weeks, depending on complexity and that you have data flowing consistently.  Improve 3-4 weeks depending how quickly you can get the improvement in place, training completed, and process stabilized. Control is generally 4 weeks, just to make sure that everything is running as expected and you can show the magnitude of the improvement.

These are mine but it all depends on the Measure phase and getting the baseline well defined and data flowing.  That is the most critical phase in DMAIC and shortcuts there will impact the project.

I hope this helps.

Jim Bossert

Sr Performance Improvement Specialist
JPS Hospital
Fort Worth, TX

For more on this topic, please visit ASQ’s website.