Beware of Quick ISO 9001 or APIQ1 Certification Offers

Posted on July 31, 2011 by Bill

Beware of quick ISO 9001 or ISO TS29001/API Q1 certification offers.  To be clear, it’s highly improbable that anyone can deliver on this promise and here are a couple reasons why.

First, the Registrar’s Auditor is required to verify that the organization has established and implemented the following QMS documentation, procedures and activities prior to obtaining certification.  ISO TS29001/API Q1 requirements are more extensive than ISO 9001 and require additional procedures, control features and records.

  1. Quality manual
  2. Quality policy
  3. Quality objectives
  4. QMS procedures (six required)
    1. Control of documents
    2. Control of records
    3. Control of nonconforming product
    4. Internal audits
    5. Corrective actions
    6. Preventive action
  5. QMS training
  6. Completion of a QMS internal audit
  7. Completion of a Management review

Secondly, most Registrars require at least two (2) to four (4) months of QMS records to be available as evidence of conformity to ISO 9001 and/or API Q1 requirements.

So, obtaining ISO 9001 or API Q1 certification within just a few weeks is doubtful at best.  “If it sounds too good to be true, it probably is”.

In my opinion, promises to provide quick certification are a “hook” intended to sell a one size fits all, low cost generic quality manual and procedures.

The cognizant Registrar’s Auditor will quickly identify existing disconnects between the quality manual and procedures versus the company’s actual operating conditions or processes.  The end result of this situation will be that the company is left with the task of finding a “competent QMS consultant” to resolve all the findings/nonconformities documented during the Registrar’s audit.  Additionally, the company may have to reapply for a certification audit and pay associated expenses.

Key Points:

  1. Beware of promises to provide QMS certification within a few weeks
  2. Beware of a QMS quote that’s not based on a site visit or gap analysis of your company
  3. Beware of a QMS quote that doesn’t specifically identify deliverables, provide a development and implementation schedule or include an estimated completion date.

All comments and/or inquiries are welcomed.  Thanks for visiting ATCS Q-Blog.  For all QMS audit and QMS certification needs, please visit us at www.astontechconsult.com.

ISO 9001 & ISO TS29001/APIQ1, Customer Satisfaction

Posted on June 26, 2011 by Bill

Many suppliers and a few consultants struggle with understanding as well as implementing ISO 9001 and ISO TS29001/API Q1 requirements for monitoring and measuring customer satisfaction.  There’s a common belief that an organization is required to perform customer surveys.

Although ISO 9001 and ISO TS29001/API Q1 do reference surveys as a possible method of obtaining customer feedback to determine satisfaction, it’s not the only way.  As a matter of fact, conducting online surveys is probably the least productive method to obtain customer feedback.

According to information available from www.constantcontact.com, the industry open rate for online surveys is less than 20%.  Based upon this information, I’m willing to go out on a limb and say that the industry open rate for direct mailed surveys is even less.

So how can customer satisfaction best be measured or monitored?  If we look at the big picture and consider the use of data that should already be available, the task of monitoring or measuring becomes readily achievable.  As opposed to conducting satisfaction surveys, let’s take a different approach.  Let’s monitor and measure the following.

  1. Warranty claims filed
  2. Customer reported field failures
  3. Customer complaints or positive feedback received (via phone call, email, face to face meetings or direct mail)
  4. Number of late vs. on time/early deliveries completed
  5. Number of repeat customer orders
  6. New customer orders received

The results of monitoring and measuring these key performance indicators (KPIs) can be used to calculate a customer satisfaction rating.  This rating can be tracked over to determine or to assess trends (a rise or fall) in customer satisfaction.

In my opinion, this approach is much more practical and provides real time information that is directly related to customer satisfaction.  Please see ISO TS10004:2010, Quality Management – Customer Satisfaction, Monitoring and Measurement Guideline for additional information.

ISO 9001 and ISO TS29001/API Q1 only identify the requirement for monitoring and measuring customer satisfaction.  Each organization is responsible for the development of a procedure that will provide evidence of conformity.  I look forward to hearing your opinion.

Thanks for your continued interest and the comments.

ATCS, Q-Blog

Quality is 24/7/365

Corrective & Preventive Actions Explained

Posted on June 10, 2011 by Bill

A standard requirement for every ISO 9001 and ISO TS29001/APIQ1 quality management system is to have documented procedures for corrective and preventive actions.

Explanation: A corrective action is “REACTIVE” and a Preventive action is “PROACTIVE”.  Any action taken to prevent the reoccurrence of a nonconforming condition will always be a corrective action, not a preventive action.  This is because the action taken addresses a nonconforming condition that has already occurred.

A preventive action is “PROACTIVE”.  It’s an action taken to prevent a potential nonconformity or a nonconforming condition from occurring. Consider a preventive action as a form of risk management.  If an organization determines there to be a high probability for a nonconforming condition to occur and this potential nonconforming condition poses an unacceptable or unnecessary risk of loss to the organization, its customers or other stake holders, any action taken to prevent its occurrence would be considered as a preventive action.

A fairly common situation that I encounter during the development of quality management systems as well as while performing audits is the occasional Consultant, Auditor and organization QMS Management representative that does not understand the differences between a corrective action and preventive action.

This tends to perpetuate the spread of the misinformation that a corrective action and a preventive action are one of the same or worst yet, that preventive actions are just pie in the sky.

The definitions of corrective actions and preventive actions are provided in ISO 9000:2005, “Quality management systems, Fundamentals and vocabulary”.  In my opinion, it’s essential for every quality professional to fully understand the standard definitions of terms used in ISO 9001 and ISO TS29001/API Q1.  Operating without this basic information makes the responsibility of educating others that are not aware of the difference between a corrective and prevention action, all the more difficult.

Thanks for your continued interest and the comments.

ATCS, Q-Blog

Quality is 24/7/365

Supply Chain Management & Quality Audits, Part 4

Posted on May 22, 2011 by Bill

Supplier Management and Quality Audits has been the primary focus of our past discussions presented in parts 1, 2 and 3.  The key points covered in each of these parts are as following.

Supplier Chain Management & Quality Audits, Part 1:

  1. The importance of conducting supplier quality audits
  2. Which suppliers should be audited
  3. The potential impact that poor supplier performance can have on customer satisfaction.
  4. The Purchaser’s duty to control outsourced processes and ensure requirements have been met.

Supplier Chain Management & Quality Audits, Part 2:

  1. Auditor selection, training, experience and qualification requirements
  2. Proactive management of customer satisfaction
  3. Short and long term suggestions for supplier quality auditing

Supplier Chain Management & Quality Audits, Part 3:

  1. Defining the differences between supplier quality, quality system certification and internal auditing.
  2. Supplier quality audit planning strategies
  3. Reporting the results of supplier quality audits.

Although I have attempted to provide as much information and guidance as possible regarding supplier quality audits, it should be noted that this is an area that can and should be approached in a manner that will meet your organization’s requirements.

Neither ISO 9001 nor ISO TS29001/API Q1 is prescriptive with regard to the methodologies to be used to monitor, measure or analyze supplier performance.  Every organization must consider and select the approach that works best for them.

Thanks for your interest and the comments.

ATCS, Q-Blog

Quality is 24/7/365

ISO TS29001/API Q1 Requires Control of Documents

Posted on May 21, 2011 by Bill

QUESTION:

From: Mike G.
Sent: May 12, 2011
To: Ask the Expert – ATCS
Subject: ISO TS29001/API Q1, Clause 4.2.3, Control of Documents

Is it acceptable to stamp QMS documents as uncontrolled and then post it in a work area? An audit is in progress and we are having a little bit of a debate over this point.

RESPONSE:

From: Bill Aston, ATCS –Q-Blog, Ask The Expert
Sent: May 12, 2011
To: Mike G.
Subject: ISO TS29001/API Q1, Clause 4.2.3, Control of Documents

Dear Mr. Mike G.,

Yes, uncontrolled documents can be used or posted in the work area.  However, a sunset clause is usually included in the “Control of Documents” procedure.  As an example, “this document is uncontrolled if printed and not valid beyond the indicated date printed”.

A potential problem with posting or using uncontrolled documents in the work areas, is tracking them or making supervision responsible for ensuring that obsolete documents are marked as such or destroyed.

Side Bar:  A Registrar’s Auditor would have no hesitation with issuing an AAR or audit finding if obsolete documents are found in the work areas, even if they are marked as “Uncontrolled”.  Proceed with caution.

I hope this helps.

Bill

API Q1 Certification Costs

Posted on April 26, 2011 by Bill

QUESTION:

From: Fred R.
Sent: April 18, 2011
To: Ask the Expert – ATCS
Subject: How much will API Q1 Certification Cost?

Our company is interested in getting API Q1 certified.  How much does it cost for certification?

RESPONSE:

From: Bill Aston, ATCS –Q-Blog, Ask The Expert
Sent: April 18, 2011
To: Fred R.
Subject: How much will API Q1 Certification Cost?

Dear Mr. Fred R.,

The cost of ISO TS29001/API Q1 certification can’t be estimated without first identifying the differences between the present quality system verses ISO TS29001/API Q1 requirements.    For this purpose, I’d highly recommend that a Gap Analysis be conducted to identify how much work will be involved to meet ISO TS29001/API Q1 requirements for certification and to provide your company with a realistic estimated cost for certification.

I hope this helps.

Best regards,

Bill

Supply Chain Management & Quality Audits, Part 3

Posted on April 25, 2011 by Bill

An audit is an audit, right?  Absolutely not!  Knowing how to differentiate between a supplier quality audit, quality system certification audit and an internal audit is essential for effective audit planning. Let’s quickly review the primary purpose of each of these audit types.

  1. Supplier quality audit:  The primary intent of a supplier quality audit should be to   assess the supplier’s ability to provide a product or service that meets industry and customer requirements.
  2. Quality system certification audit:  The primary purpose of this audit is to assess an organization’s conformance with defined quality system requirements such as ISO 9001 or ISO TS29001/API Q1.  Of particular importance during a quality system certification audit is the verification of an established quality policy and measurable quality objectives.  The Registrar’s Auditor is focused on verifying that all requirements of ISO 9001, clause 4.1, and when applicable, ISO TS 29001/API Q1 and its supplements have been established and implemented.
  3. Internal audit:  The purpose of an internal audit is to assess the effectiveness of the quality system and its processes, which includes product conformity.  The internal audit is top management’s most important tool for determining and monitoring how well the quality system is functioning. Another key point of the internal audit is to identify opportunities for improvement.

The supplier quality Auditor’s time is better sent assessing  those areas and processes that are directly related to the product or services to be procured, such as control of documents, control of records, qualification and certification of personnel, control of outsourced processes, change management, quality planning, etc.  Consider this:  At the end of a supplier quality audit, the audit client wants to know one thing, and that is can the supplier produce a product or service that will meet their organization’s and industry requirements. That’s the bottom line.

Most audit clients will quickly lose interest in hearing about problems found with the supplier’s quality policy, quality objectives or how management reviews not being conducted on time.  After all, those items should be picked up by the supplier’s Registrar during their periodic audits.  Unless there is a direct or immediate impact on the audit client, most don’t consider it as a part of their mission to assist a supplier with maintaining their ISO 9001 or API Q1 certification via the performance of a supplier quality audit.

Our next blog “Supply Chain Management Quality Audits, Part 4″ will include an overview of our previous discussions and conclude this subject.   Thanks for your interest and all the comments.

ATCS, Q-Blog

Quality is 24/7/365

Quality System Poll & Results

Posted on March 26, 2011 by Bill

ISO 9001, ISO TS 29001/APIQ1, Six Sigma, Lean and 5S, which management system ranks highest among Q-Blog readers?  See instant results here.  http://tinyurl.com/QMS-Poll


Supply Chain Management & Quality Audits, Part 2

Posted on March 25, 2011 by Bill

The effectiveness of your organization’s supplier quality program hinges on one key item; that is selecting experienced and trained Auditors. Assigning inexperienced or untrained personnel to conduct an audit will sabotage the audit before it begins.  If your organization is willing to invest the resources required to conduct supplier quality audits, then it should ensure that a plan is in place to identify the persons best suited to conduct the audit.  Consider the following when selecting personnel to serve as Auditors.

  1. Their level of expertise as related to the product/process being audited
  2. Work experience
  3. Auditor training and knowledge of the audit process

W. Edwards Deming:  “It is not enough to do your best you must know what to do, and then do your best.”

Although some organizations don’t recognize Auditor selection as a critical/important process, make no mistake about it, it certainly is an activity that has a large impact on the effectiveness of your supplier audit program.  If your organization doesn’t have any established criteria for selecting personnel as Auditors, do yourself a big favor and consider using ISO 19011, “Guidelines for quality and/or environmental management systems auditing” as a starting point.  ISO 19011 defines basic Auditor training criteria as 40 hours of classroom time and audit experience as the completion 20 audit days in the last 3 years.  Oops!  Don’t have anyone already on board that meets these criteria?  Not to worry, in the short term, outsource the audit to an experienced and qualified Auditor.

I know this suggestion may go against the grain from some who are opposed to bringing in consultants or others in from the “outside”, but independent Auditors can be a great source for obtaining unbiased opinions, as well as a wealth of knowledge from past experiences.  The contracting of an experienced and certified QMS Consultant/Auditor will be time and money well invested.  In the long term, select employees from within your organization to attend Auditor training and assign them to accompany the Consultant/Auditor during future audits. WOW! This is a great opportunity for them to gain some “On the Job Training” from someone who performs audits for a living.

Let’s talk INVESTMENT!  Consider this.  Just as your organization is making an investment by conducting supplier quality audits, so is the supplier.  The bottom line for many organizations that conduct supplier quality audits is RISK MANAGEMENT and the proactive management of CUSTOMER SATISFACTION. Most suppliers consider the time and resources spent to accommodate purchaser requests for onsite audits as an opportunity to MAINTAINING OR EXPANDING MARKET SHARE.

Remember that your organization has requested a supplier to disrupt their normal business activities to accommodate your request for an onsite audit.  The last thing to do is to waste the supplier’s time and resources by sending in an audit team that is not prepared or is inexperienced in QMS/product auditing.  This is a waste of everyone’s resources.  Little wonder why some suppliers and auditees may become a bit testy during an audit.  This can be avoided, and the effectiveness of the supplier audit improved, by ensuring the assignment of experienced and trained Auditors that are familiar with the product or processes to be audited.

Our next blog, “Supply Chain Management & Quality Audits, Part 3”, will discuss the criteria that should be considered for assessing supplier quality systems and knowing the differences between a supplier quality audit, internal QMS audit and a QMS certification audit.  Knowing the differences could improve the success of your future supplier quality audits.

ATCS, Q-Blog

Quality is 24/7/365

Supplier Product Quality Criteria

Posted on March 20, 2011 by Bill

ATCS – Q-BLOG, ASK THE EXPERT – Aug. 2009

QUESTION:

From: Sam Z.
Sent: August 7, 2009
To: Ask the Expert – ATCS
Subject: Supplier product quality criteria

Which standards are for Mechanical Inspections?

RESPONSE:

From: Bill Aston, ATCS –Q-Blog, Ask The Expert
Sent: August 7, 2009
To: Sam Z.
Subject: Supplier product quality criteria

Dear Mr. Sam Z,

In order to determine the applicable mechanical inspection standard for any product, the standards or other criteria used for the design and manufacture of the product must first be identified.

As an example, if you are inspecting a tank and the tank was designed and built in accordance with API 650, customer and manufacturer requirements, then mechanical inspection criteria would be developed to verify the product’s conformity with API 650, customer and manufacturer’s requirements, such as welding, NDT, materials and other essentials.  I hope this helps.

Best regards,

Bill