ISO 9001: 2015 Clause 8.4.3

Mr. Pareto Head and Supply Chain comic strip

Question

It’s not clear to me who an external provider may be. Could it be an electrical contractor, a lunch truck, a caterer, or other similar? That thinking is tremendously different than just the traditional “supplier” which is what this company has using been for many years. So there’s that concern. Also, advising our external providers what equipment to use, how to use it and how to train their people? Is that really what’s said here? That would require tremendous knowledge in our organization that most likely is not here. What exactly is being said here? I’m a little confused how to address this requirement. Finally, section (e): we must communicate to the external provider how we are going to measure them? Can it be done through email, or phone, or what is a common method for meeting the requirement? Thanks much.

Answer

Who is an external provider?

ISO 9001:2015, 8.4.1 states, the organization shall determine the controls to be applied to externally provided processes, products and services when:

  1. products and services from external providers are intended for incorporation into the organization’s own products and services;
  2. products and services are provided directly to the customer(s) by external providers on behalf of the organization;
  3. a process, or part of a process, is provided by an external provider as a result of a decision by the organization.
    1. Refers to a product that becomes part of your product; for example, a bolt incorporated into a seat assembly. You purchase these.
    2. Refers to a product that is “dropped shipped” to a customer. Think of an Amazon purchase where the product comes from a second party under the Amazon logo.
    3. Refers to a process that is outsourced as a result of the organization’s decision to have the process managed externally. For example, the heat treating of a part where the part needs to be heat treated but the organization does not have that process internally.

Therefore, an electrical contractor, a lunch truck, etc. are not included since they are outside the scope of the QMS.

Secondly, “advising our external providers,” refers to the type and extent of control.  Will you perform 100% incoming verification, or require material certifications, or require certification to a quality management standard? In certain instances, you may want to specify the equipment or training an external provider must implement.  For example, for outsourced welding, your requirement might be that welders are certified by the American Welding Society or your calibration company be accredited to ISO 17025.

How will you measure an external provider?  It can be on-time delivery, responsiveness to requests, PPM targets.  Communicating the measurement (8.4.3 e) is related to 8.4.1, “retain documented information of these activities and any necessary actions arising from the evaluations”.  Therefore, a record must be retained.

George Hummel

ISO 2859-3 Skip-lot Sampling 5.1.1, 5.2.1

Suppliers, supplier management

Q: Our quality team is trying to improve inspection efficiency and enhance supplier management by employing ISO 2859-3:2005 Sampling procedures for inspection by attributes — Part 3: Skip-lot sampling procedures.

Here are two questions on product qualification related to clause 5.2.1 Generic requirements for product qualification.

1. The standard requires that:

b) The product shall not have any critical classes of nonconforming items or nonconformities.

First, my understanding is that the risk level with any potential failure or nonconforming of the product should be low to customer — is this correct? Second, if a candidate product carries some critical features (dimension of mechanical product), but also carries a number of low risk features, can we apply the skip lot concept only to the non-critical features? And continue to perform lot-by-lot inspection with critical features? We are concerned the definition of “product” in the standard is a generic term and could be interpreted as feature of a physical product.

2. The standard requires that:

c) The specified AQL(s) shall be at least 0,025 %.

Does this mean the AQL value should be less than or greater than 0.025%? I assume “greater.” In our company, the most often used is AQL 1.0 and AQL 2.5, which I think meets the requirement.

We would greatly appreciate your help.

A: My name is Dean Neubauer and I am the U.S. Lead Delegate to Subcommittee 5 on Acceptance Sampling and co-author of Acceptance Sampling in Quality Control, 2nd edition., 2009. CRC Press. I hope I can help you.

Let’s start with question 1.

The general idea of skip-lot sampling is to reduce the number of times incoming lots inspected due to exceptional quality on behalf of the supplier.  ISO 2859-3 states this in the beginning as:

The purpose of these procedures is to provide a way of reducing the inspection effort on products of high quality submitted by a supplier who has a satisfactory quality assurance system and effective quality controls.

The reduction in inspection effort is achieved by determining at random, with a specified probability, whether a lot presented for inspection will be accepted without inspection.

A skip-lot sampling plan is also known as a cumulative results plan.  In general, such plans require certain assumptions to be met regarding the nature of the inspection process:

  • The lot should be one of a continuing series of lots
  • We expect these lots to be of the same quality
  • The consumer should not expect that any lot is any worse than any of the immediately preceding lots
  • The consumer must have confidence in the supplier not to pass a substandard lot even though other lots are of acceptable quality

Under these conditions, we can use the record of previous inspections as a means of reducing the amount of inspection on any given lot.  ISO 2859-3 states the above in 5.1.1 Requirements for supplier qualification:

The requirements for supplier qualification are as follows.

a) The supplier shall have implemented and maintained a documented system for controlling product quality and design changes. It is assumed that the system includes inspection by the supplier of each lot produced and the recording of inspection results.

b) The supplier shall have instituted a system that is capable of detecting and correcting shifts in quality levels and monitoring process changes that may adversely affect quality. The supplier’s personnel responsible for the application of the system shall demonstrate a clear understanding of the applicable standards, systems and procedures to be followed.

c) The supplier shall not have experienced any change that might adversely affect quality.

The underlying assumption here is that the supplier quality is exceptional (low nonconforming level).  The skip-lot plan is applied to each characteristic, or feature, separately.  If several characteristics are present, then try to test for at least one of them.  In your situation, if you have critical characteristics you should not be doing skip-lot inspection due to the risk of ignoring (skipping) a potentially dangerous lot.  On the other hand, you can use a skip-lot plans for non-critical (major and minor) nonconformities and they will have different AQL levels associated with them.  Your listing of AQLs of 1.0% and 2.5% are typical for major and minor nonconformities.  Critical defects will typically have an AQL less than 1.0%, such as 0.25% to 0.65% (0% is preferred but theoretically unattainable as you would have to do a perfect 100% inspection, i.e., no inspection error).

The subclause referenced in question 2 states that the AQL level must be greater than or equal to 0.025%. Your levels of 1.0% and 2.5% can be used.

Dean Neubauer

U.S. Lead delegate for Subcommittee 5 on Acceptance Sampling on ISO Technical Committee 69 on Applications of Statistical Methods.