When Quality Needs Clean Temperature Data

Can a Thermometer and a Software Development Kit

Enable Integrated Quality Measurement and Real-Time Alerts?

Introduction:

Integrating an automated temperature measurement solution into a processing

facility and/or supply chain is required or at least optimal in multiple industries.
In some regulated lines of business, such as the food industry, temperature
measurement provides one of the few clear quality inputs. Processors must
maintain food at temperatures that inhibit the growth of pathogens which cause
consumer foodborne illnesses. Failure to do so can result in recalls, lost
revenue, increased expenses, and damage to the brand. As a result, food
processing and downstream supply chain operations must monitor their
products to assure that temperatures have not risen above widely accepted
levels where pathogens multiply.

For fifty years or more, quality measurements across many industries

were conducted with paper and pencil on a clipboard, then manually
filed. As technology advanced, quality technicians entered the data
collected from the processing floor or the loading docks at change-
of-possession into a local computer. However, both of these methods
proved to be fraught with errors, even by the most careful quality
technicians and managers. Whether transcription errors in recording,
data entry errors into the computer, or misfiled reports, errors in
quality data recording are the rule, not the rare exception.

As a next step, automated data collection and storage solutions emerged that
digitally stored the data directly at the time of measurement. Unfortunately,
most vendors offering such a solution tacked on proprietary software solutions
that required multiple steps to actually enter the data in their customers’
databases. In a typical “How Not to Do It” scenario, the vendor provides a
proprietary software that requires connection to the digital thermometer. When
connected to the local QA computer, the temperature data uploads only to the
vendor’s proprietary software. To integrate the data into the company’s
database, the QA technician must then download a comma-separated (.csv)
data file and upload it to the company’s database. This is a cumbersome task
that may or may not occur promptly and may also be subject to errors. This
approach does not allow direct two-way communication with the thermometer
to change or update settings and defaults.

“Why does this matter?” you might ask. The three-fold answer is auditability,
traceability and cost. All of the previously described temperature measurement
processes have multiple inherent disadvantages for each of these
characteristics. In a commercial temperature measurement environment,
auditability and traceability translate to “no human interaction between
thermometer and server”. 5-star traceability also means that the data exhibits
a clear chain of custody, which is not possible if there’s human intervention
between measurement and the server. Of course, the data is meaningless
unless the thermometer is accurate. In that vein, any integrated solution needs
to document that the instrument has been regularly tested for accuracy.

Perhaps most importantly, delays in generating out-of-range temperature

alerts at any stage of the value chain multiply the production cost. A fully
integrated, Bluetooth® enabled automated temperature measurement
platform enables nearly instantaneous alerts. Whenever temperature
measurements generate an alert, that product can be quickly identified and
diverted out of the value chain. For the food industry, this translates to
preventing, or in the worst case, limiting the scope of a recall due to product
that may contain unacceptable levels of foodborne pathogens. Further, a
prompt alert dramatically reduces all the tangible and intangible costs
associated with such an incident. For regulated industries, such a direct
thermometer-to-server solution means that measurements are traceable and
easily audited in a matter of minutes. This eliminates all human interaction with
the data as versus the “How-not-to-do-it” examples noted below.

How NOT-To-Do-It: Recording temperature readings on

paper and maintaining those records in physical files
potentially results in a wide variety of unnecessary costs
and errors. The most expensive is the cost of a neglected
out-of-range reading that may either be delayed or
overlooked and leads to a recall (for example in the food
processing industry). Apart from the lost cost-of-goods of
the recalled merchandise, the company’s brand and
market position will almost certainly suffer. Including legal
costs, the liability can potentially run into the millions. For
food processors, the clipboard and pencil method also
introduces a potential source of food contamination. Pencil & Clipboard (Fig. 1)
Further, there’s no absolute chain-of-custody of the data.
Lesser, but more tangible costs include the simple cost of
storage space and filing cabinets.

How NOT-To-Do-It: In an upgrade to the paper and pencil

method, the quality technician or an admin records the data
(still recorded with a pencil/paper) and then manually enters
the data into either a local or enterprise database file. A
variety of studies have documented data entry error rates,
which range between 6.5% and 10.7%. Data entry errors
from paper to computer actually compound the shortcomings
of the straight pencil and paper method in Fig. 1.
Manual Data Entry (Fig.2)
How NOT-To-Do-It: Again, the integrity of the data suffers
from the potential for human error, such as forgetting one
or more process steps. Out-of-range readings may also be
missed until data is uploaded to the enterprise database.
This method also makes it is impossible to document a
clear chain-of-custody of the data.

Why Develop an Integrated Temperature App?

From an organizational perspective, quality managers often
realize the need for an integrated, automated temperature
measurement solution. They recognize the need to
Missing Steps (Fig. 3)
accelerate the temperature collection and recording
process while simultaneously eliminating collection errors.

Quality managers’ goals for temperature recording

processes:
a. Eliminate manual data entry.
b. Eliminate all manual process steps including data
entry and downloading/ uploading .csv files from a
vendor’s proprietary program.
c. Enable immediate out-of-range alert capabilities to
prevent potentially contaminated products from
shipping.
d. Two-way communication to the thermometer
platform to change or update defaults and settings.
Thermometer-to-Server Direct
e. Direct thermometer-to-server interface from quality
(Fig.4)
technicians’ Windows, iOS or Android smartphones
via Bluetooth® into the enterprise IT platform.

Business managers need to see clear justification for implementing the project.

To proceed, business managers usually seek to achieve these goals:

a. Lower the cost and time to integrate the temperature collection
platform by the IT department.
b. A clear case of ROI, especially cost savings, such as detecting out-
of-range product almost immediately and reducing QA time entering
or manipulating reports.
c. Risk and waste reduction. In the case of a food processing facility,
reduce both the risk and exposure of a costly product recall and
reduce the volume of waste from out-of-range product (due to near
real-time alerts).
d. Relative ease-of-implementation.
e. Clear and clean chain-of-custody of the data.
IT managers will be asked to assess the time and resources needed to
implement an enterprise-wide solution. IT managers appreciate a Software
Development Kit (SDK) provided by the thermometer platform vendor.

Goals for an integrated temperature measurement IT project:

a. Direct thermometer-to-server data collection and recording.
b. Data collection from an easy-to-use instrument.
c. Practical relevant code examples.
d. Uses commonly available programming tools such as Integrated
Development Environment (IDE)

What should the SDK provide?

1. Bluetooth LE adapter and documentation integration with Windows 7,
8.1, and 10.
1. Integration with Windows, Android™ and iOS mobile operating
systems.
2. Examples of Windows 10 executable applications, source code, and
build instructions. Includes all two-way access and management of
the thermometer platform.
3. Reduce hard coding from scratch to integrate the thermometer
platform.
4. Responsive technical support.

How-To-Do-It: Implement a direct thermometer-to-server integrated

temperature measurement solution. This provides a clear and documented
chain-of-custody of the temperature data. It also eliminates human interaction
with the data and related recording errors.

Conclusion: The $1-$10-$100 Rule

This frequently cited rule, applied to business
management practices reinforces the age-old saying that
an ounce of prevention is worth a pound of cure. The Total
Quality Management site1 graphically presents the rule as
follows:

Applied to temperature measurements in a process

environment, for every $1 spent on prevention, it will cost
$10 to correct or clean up an issue, and $100 or more per
record if nothing is done. Failure costs include lost
customers, brand damage, and legal liabilities. The $1-$10-$100 Rule (Fig. 5)

In summary, an automated temperature measurement

system fully integrated with an enterprise IT system delivers immediate

1Joel E. Ross, “What is 1-10-100 Rule?”, on the Total Quality Management blog,
February 25, 2009. See:
https://totalqualitymanagement.wordpress.com/2009/02/25/what-is-1-10-100-rule/
thermometer-to-server data with no human intervention. The data’s chain-of-
custody is completely transparent and documented. As a result, the system
can deliver immediate out-of-range alerts to prevent potentially contaminated
from shipping to customers. A vendor supplied, well documented Software
Development Kit to support the automated temperature collection enables
faster process development for IT. The resulting integrated solution improves
quality processes and produces a high ROI while minimizing implementation
costs versus hard coding from scratch.

Is the Solution Here Now?

The short answer is, YES. TEGAM, the industry leader in integrated
enterprise-scale temperature measurement automation, produces two
different lines of temperature collection solutions. The TEGAM SDK
supports the TEGAM 920 and 930 series thermometers to deliver direct
temperature measurement-to-server performance and near real-time
alerts.

To schedule a live personal webinar or schedule an in-plant demo,

please contact TEGAM, Inc at: 800.666.1010 or sales@tegam.com