FDA Regulation for Food and Beverage Labels

Inspection, FDA, Packaging, Requirements

Question
I have been asked to do a quality audit of a label manufacturer whose products are used on beverages and food packaging. They are currently asking to be audited using 21CFR211 (pharmaceuticals). Is there another standard that is more appropriate for their product?

Answer
21CFR211 is the FDA regulation for cGMP for finished pharmaceuticals. This regulation does not apply to the labeling of food and beverages. The proper FDA regulation is 21CFR101. I suggest that you first start on the FDA web page on food labeling and nutrition.

John G. Surak, PhD
Surak and Associates
Clemson, SC
A member of Stratecon International Consultants
www.stratecon-intl.com/jsurak.html

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

Dock to Stock

Suppliers, supplier management

Q: I have been tasked with implementing a dock to stock policy. Does an expert have any advice or information to share towards forming a dock to stock policy?

A: To begin, here is a brief definition of dock to stock (DTS):

Dock to stock is a receiving method whereby materials are delivered directly to point of use (storage or manufacturing), skipping the normal receiving inspection.

For most organizations, parts which are given a DTS status are those which have been “proven” to be compliant. It is common practice to perform a receiving inspection on the parts for a minimum of five deliveries (some companies choose 10).

After a supplier has proven to deliver a compliant product five times, that individual item/part number is given DTS status. It is then general practice for production/assembly departments or line personnel to verify compliance as needed. If a product is found to be noncompliant, it is put on a contingency list and must prove its validity again — usually through five to 10 compliant shipments before it is returned to DTS status.

Keep in mind that the DTS process is rarely used in some industries/companies. For example, a company certified to ISO 13485 (medical devices) would not use DTS due to FDA regulations — here’s an excerpt from 21 CFR 820.80 (b):

“Receiving Acceptance Activities: Incoming product shall be inspected, tested or otherwise verified as conforming to specified requirements.”

In short, determining how many acceptable shipments to qualify a supplier for DTS status is up to the company. Requesting a certificate of compliance with each shipment can tend to encourage a supplier to ensure their own quality, as does a yearly audit of the supplier’s facilities (if appropriate).

I hope using the guidelines above will help lead you toward your goal.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Related Content:

Chinese OEM Reduces Returns With Improved Product Testing, ASQ case study

Cost-Effectiveness Based Performance Evaluation for Suppliers and Operations, Quality Management Journal

Ask A Librarian

Is it Legal to Require Certification to an ISO Standard?

Contract, requirement, legal, standard

Q: Can a contract include a requirement stating that the manufacturer of the materials to be installed as part of the job must be ISO 9001 and ISO 14000 listed? My question is in reference to a contract I received that is requiring this.

A: In general, contracts between business entities are enforceable unless they violate laws or are contrary to public policy. Private businesses entering into commercial contracts have a great deal of freedom in establishing contract terms.

One of the common uses of ISO standards is to clearly delineate requirements in commercial contracts.   This can, and often does, include requirements for third-party certification of suppliers to ISO 9001-2008: Quality management systems–Requirements and/or ISO 14001-2004: Environmental management systems – Requirements with guidance for use.

This requirement is usually met by providing a copy of the certificate issued by a third-party certification body (registrar) that lists the name of the organization certified and the scope of the certification.

Based on the information provided along with your question, it appears that the question actually relates to a material specification that was included as part of a request for proposal (RFP) from a governmental entity. Note: the contract has not been included with this post to protect the anonymity of the questioner and the governmental entity.

The authority of governmental contracting officers is more limited.  They must comply with applicable purchasing statutes and regulations.  Whether or not a requirement for certification to ISO 9001 and/or ISO 14001 is permissible would be determined by reviewing these contracting rules.  These rules also often provide mechanisms for contesting the award of a contract if it is believed to be unfair.

There are often opportunities to request clarification of information included in a government-issued RFP. This may be something to consider in this situation since the requirements in this RFP appear to be unclear, such as:

  •  There is no comprehensive “list” of certified companies so there is no mechanism for a manufacturer to be listed.
  • There is no ISO 14000 standard.  There are over 20 different standards in the ISO 14000 family – each with a different number.  I assume the RFP is referring to ISO 14001.
  • It is not clear which of the materials specified in the contract must be manufactured by an organization that is certified to the ISO 9001 and ISO 14001 standards.

(Note: the contract has not been included with this post to protect the anonymity of the questioner and the governmental entity).

I hope this helps.

Thea Dunmire, JD, CIH, CSP
Chair, ASC Z1-Audit Subcommittee
ENLAR Compliance Services, Inc.
Largo, FL
www.enlar.com

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

Z1.4 Split Sampling

Chemistry, micro testing, chemical analysis, sampling

Q: I have two questions about Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes.

1. Does the plan allow one to “split” sampling plans among multiple items, or is only one item per plan intended?

2. The plan states a 95% confidence level, which means the findings of the sampling will statistically show that the findings (or number of defects) will be consistent with the findings of the entire inspected lot. So, if we split the sampling, how can you determine what happens to the confidence level?

A: Thank you for submitting your question to ASQ’s Ask the Experts Program. Answers to your inquiries follow.

1. In attempting to answer any given question, one needs to understand the question with respect to its gist and terms used.

Z1.4 uses the term “unit” to represent an individual “product” entity (unit here can represent a discrete fairly simple product, such as a bolt or nut), or it can represent a complex product (such as a computer, or a large piece of machinery, or even a square meter of cloth or other material, a length of wire or other material, etc.).

It is assumed here that the use of the term “item” in the question refers to a “unit.” It might, however, refer to a quality characteristic, and the explanation given here will attempt to explain either case.

Now, units can have a single principal quality characteristic or they can have many different quality characteristics.

Z1.4 allows for some of these quality characteristics to be of greater importance (severity for example, with respect to quality and/or economic effects) than others, whereby separate sampling is applied to each group with different sampling parameters (such as sample size, acceptance number, lot size). Hence, units with a single quality characteristic can be checked by sampling via Z1.4 and units with multiple quality characteristics can be checked by sampling via Z1.4.

In each case, the chosen Acceptable Quality Limit (AQL) and what it stands for applies to whatever is included in the inspection made on each unit. It is also assumed that this separate handling of units and quality characteristics is what the question means with respect to the term “split.”

Furthermore, it should also be understood that sampling inspection can be conducted with respect to two distinctly different statistics. One is the number of nonconforming units found in the sample. These are sometimes referred to as “defectives.” The second is the number (sum) of nonconformities found on all units in the sample, where any given single unit can have multiple nonconformities. These are often referred to as “defects.”

A “nonconforming unit” is defined as a unit with one or more nonconformities (defects) — but counted only as one “defective” unit. A “nonconformity” is any departure for any quality characteristic being considered in the inspection of each unit. In Z1.4, one can use either statistic as desired. The choice is largely dependent on the nature of product units and the reason for doing the sampling inspection — whether it is to control or oversee defective units or to control or oversee defects.

In the tables of Z1.4, note the top line above the range of AQLs: “Acceptance Quality Limits (AQLs), Percent Nonconforming Items and Nonconformities per 100 Items”. It should also be pointed out that Z1.4 is intended to be a sampling scheme or system, not just a selection of a given sampling plan. Please review the standard and any number of excellent books available on sampling inspection covering Z1.4, ISO 2859, and etc.

2. If one examines the Z1.4 standard from cover to cover, one will not encounter the term “confidence level.” Z1.4 contains no confidence intervals (or levels) related to any of its features.

Furthermore, the 95% figure is a very general figure associated with the expected “probability of acceptance” at the designated (selected) AQL. This is NOT a confidence level! In fact, the AQL is NOT a statistic!

Setting an AQL is generally an agreement/negotiation process between the customer and supplier. It is more of an index. Essentially, it refers to a level of nonconformity that is generally “acceptable” — a value of 0 being desired of course — but otherwise, a compromise figure.

And it is not by any means a constant, as can be seen by examining the Operating Characteristic (OC) Curves for the various code letters A through R using the same AQL in every table.

For example, for an AQL of 2.5% with the code letter C plan, incoming quality p must be 1.03% for Pa to be 95%, and Pa at 2.5% is less than 90%; for the code letter F plan, p must be 1.80% for Pa to be 95% and Pa at 2.5% is between 90% and 95%, etc.

If confidence intervals at chosen levels are desired for any given sampling plan, one most resort to the theory and methodologies of statistical inference with the available information provided by the sample statistics.

Kenneth Stephens
ASQ Fellow
ASQ Quality Press Author

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