Information Technology Workgroup Partnership for Food Protection

Transcription

1 Information Technology Workgroup Partnership for Food Protection DATA ELEMENTS AND DEFINITIONS July 2014 Background During the Partnership for Food Protection (PFP) cycle, the Information Technology Workgroup (ITWG) developed and delivered a comprehensive landscape of data elements collected by state food manufacturing programs during licensure and inspection of food manufacturing firms. The information in the data landscape was analyzed, evaluated and used to recommend the development of a common data dictionary as a means of developing a common lexicon in moving towards a shared vision of data sharing and exchange among regulatory partners. Current Project The PFP ITWG focused on this project in the PFP cycle and has completed the data dictionary; a compilation of the 27 most common and usual data elements used by both FDA and state food safety programs. The dictionary definitions provide a platform for accepted terms and usage to assist in aligning the variety of definitions which currently exist across jurisdictional lines. Scope The intended use for the data dictionary is an information guide for FDA/states to use when updating or replacing IT systems. Additionally, the ITWG believes states will find the dictionary useful when updating food manufacturing firm licensure or inspection policies. The use of more standardized language in across IT systems and platforms holds to the potential to increased and more effective data sharing across jurisdictional lines when FDA and states incorporate tools such as the data dictionary into their daily business routines. This standardized language allows anyone in the public health continuum to; trend and analyze data across jurisdictions assist in work planning allow for more accurate data transfer enable data to be leveraged to assist in protecting public health align Official Establishment Inventory (OEI) with state manufacturing food firm inventories Road Ahead The ITWG will maintain configuration control over the Data Elements and Definitions to ensure currency and relevancy of the value of this document. 1

2 PFP IT Workgroup Data Elements and Definitions The IT Workgroup envisions a wide variety of food safety stakeholders with a diverse inventory of IT systems, functionality, and compatibility. The establishment of Data Elements and Definitions continues the process of creating a repository of artifacts that stakeholders can refer to as they move towards a more integrated and harmonized IT environment over time. The PFP IT Workgroup will treat this small collection of elements as a living document in that it will be reviewed from time to time for ongoing relevancy. Sections: 1 Data elements Firm Fields 2 Data elements Inspection Fields 3 Notations on Data Fields Section 1: Firm Fields Field Legal Firm Name Firm Alias Firm Type Mailing Address Physical Address Geospatial Coordinates Phone Number Unique Facility Identification (UFI) Number Owner/Operator Name Agency Term (if different) PFP Baseline Definition The firm's legal name. Other names for the firm, including "doing business as" (dba), "also known as" (aka), and past names of a merged firm. The type of establishment associated with the firm (e.g., manufacturer, processor, repacker, etc.). The firm's mailing address. This includes street address, city, state/province, zip code/mail code, county, and country. The firm's physical address (street, city, state, zip, county, country, mail code). The latitude and longitude of the firm The firm's phone number and area code. The firm's address. The unique ID number of a firm. The first and last name of the owner and/or operator of the firm. 2 Agency Definition

3 Interstate Commerce Firm Products/Processes Risk Category Operating Status Firm size Number of Employees Are there interstate products? The types of products and processes present at the firm. The risk category of the firm (correlates to inspection priority). The operational status of the firm (operational, out of business, not OEI, etc.). The estimated size of the establishment based on revenue. An estimate of the firm's aggregated fulltime, part time, and contract workers. Section 2: Inspection Fields Field Agency Term (if PFP Baseline Definition Agency Definition different) Inspection Purpose Reason for the inspection. Inspection Start Date and Time The date (and time) the inspection began. Inspection Completion Date and Time The date (and time) the inspection concluded. Samples Collected Samples collected during inspection. Products Reviewed Products undergoing manufacture during the time of the inspection that were reviewed. Observations Narrative description of observations during inspection. Inspection Citations Reference codes and accompanying text descriptions of citations issued during inspection. Outcome Grades or score to reflect outcome. Inspector Name of the inspector. Person in Charge Person in charge at the facility during the inspection. Compliance/Enforcement Action Taken Description of compliance or enforcement action taken (hold, embargo, seizure, follow up inspection, etc.). Footnote: FDA will be initiating the use of the Dun & Bradstreet DUNS number as a unique identifier for firms in the FDA inventory. To the extent that state and local programs can incorporate a field in their firm inventory databases for the DUNS number, future electronic communications and sharing of electronic inspection and enforcement data may be facilitated. 3

4 Section 3: Notations on Data Fields Legal Firm Name The firm's legal name. Typically, this will be a single data point storing the text that makes up a firm's name. However, systems may have different limitations on how long a name can be stored. Furthermore, and particularly for systems that include information on foreign firms, there may be firm names that include non English, or even non Latin, characters; some systems may account for this by requiring Romanization s of names, while others record the characters as is. Different groups may include things like store numbers for retail chains or plant numbers for egg suppliers. Particularly for legacy electronic systems, this is a popular field for storing information that has little or no relation to the field's intended purpose. Firm Alias Other names for the firm, including "doing business as" (dba), "also known as" (aka), and past names of a merged firm. In some systems, this could be a single field, in others there could be many firm aliases. Firm alias largely performs a service for users: it makes a standard location to place information about the name of a firm that should never be included in the firm's legal name. This could include items like the name you see when you walk in the firm's door or it could be information to disambiguate one site of business from similar ones such as between retail locations in a chain. Firm Type The type of establishment associated with the firm. This is determined by processing, storage, retail, or service operations performed on site. Predominant activity determines the firm type (e.g. Processor/Manufacturer, Re packer, Warehouse, Farm, or Salvage). Firm types will be pre defined, rather than allowing for arbitrary types. In some systems, firm type may also complement other fields, such as firm products/processes. Mailing Address The firm's mailing address. This includes street address or P.O. Box, city, state/province, zip code/mail code, county, and country. Like physical address, the mailing address is made up of several data points that are commonly captured separately. While a mailing address may refer to a physical location, they may also include post office boxes, mail service centers, or other external locations. Physical Address The firm's physical address (street, city, state, zip, county, country, mail code). Physical address is a combination of several data points and most systems capture each component separately, rather than as a single block. Ideally, the street address should always be a physical location that can be mailed and travelled to. The street address should not be a post office box. To the greatest extent possible is should not contain directions (e.g., next to the creek behind the large red building). State, for domestic firms, might be a standard U.S. state abbreviation, the full name, or both. Zip codes may include the standard zip code and four digit extensions together or separately. Mail code is a more generic term for identifiers used by a country's mailing system. A U.S. zip code is one example of a mail code. Depending on the system, zip codes and mail codes may be the same field. 4

5 Geospatial Coordinates The latitude and longitude of the firm. Sometimes misidentified as GPS coordinates, after their common association with the U.S.'s Global Positioning System satellites that are used for navigational purposes, geospatial coordinates quantify a location on the Earth's surface numerically; typically in the form of a latitude and longitude. There are several different formats used for latitude and longitude coordinates. The most common for storing electronically is in decimal degrees, where the y (Latitude) and the x (Longitude) are recorded as single numbers with a decimal point each (e.g., N, W or , for the location of the American White House). Values are always in relation to the Earth's equator for latitude and to the Earth's prime meridian for longitude. Phone Number The firm's phone number(s) of record for: a. most responsible for the facility; b. most responsible at the facility; and/or c. emergency point of contact. Telephone numbers are comprised of country code, area code, exchange, line number, and extension, though not all telephone numbers include each of these components. The International Telecommunication Union's E.164, also called the International Public Telecommunication Numbering Plan, describes a standard for representing telephone numbers. Under this standard, a number is represented as a 1 to 3 digit country code followed by a string of up to 15 additional digits indicating network and individual subscriber; this does not include extensions. It should be noted that most, but not all, countries telephony networks conform to the E.164 standard. Therefore, some valid phone numbers may include more than the subscribed 15 digits. Under the E.164 standard, country codes are preceded by a plus (+) symbol. Another plus may be used to indicate an extension number. For storage purposes, all other delimiters and formatting characters should be removed. a U.S. phone number with country code b U.S. phone number without country code c U.S. phone number with country code and extension d U.S. phone number without country code and with extension e U.K. phone number with country code Other formatting may be used when presenting the stored numbers to users (e.g becomes ). The firm's address. For the purposes of this data set, the recommended e mail address is for the person most responsible for the firm or for food/feed inspections. Agencies may collect multiple e mail addresses for various reasons. Collecting s is useful for cutting costs and improving communications, as many pieces of correspondence can now be sent electronically. Having s is also useful for notifying firms in the event of a recall. 5

6 Unique Facility Identification (UFI) Number The preferred unique ID number of a firm includes the Dun & Bradstreet Data Universal Numbering System (DUNS) number. Dun & Bradstreet (D&B) provides a D U N S Number, a unique nine digit identification number, for each physical location of a business. Owner/Operator Name This field captures the first and last name of the owner and/or operator of the firm in instances where the facility is controlled by a sole proprietorship. In the case of a corporation, partnership, or LLC, provide the President, CEO, or Resident Agent of that facility. This might be handled as a single field, but could also break the name up into parts. Like with the legal firm name, you may also have to deal with non English characters. Interstate Commerce Is the firm engaged in interstate commerce for some or all products? Interstate commerce may be a single field (Yes / No). This field is typically used for establishing jurisdiction. Firm Products/Processes The types of products and processes observed at the firm to include Process Indicator Code(s) (PIC) and Industry Code(s). Preferred data capture includes all Industry Code(s) and PIC(s) for products produced and processes conducted by the firm/facility. This data should be updated during subsequent inspections as needed. Risk Category The risk category of the firm (correlates to inspection priority). Under current Manufactured Foods Regulatory Program Standards (MFRPS) guidelines, there are three risk categories: low, medium, or high. Any regulatory program that assigns risk categories should have a documented process for how risk is determined. Risk is useful for work planning, for determining inspection frequency, and for prioritizing resources during an emergency response. Operating Status This field captures the operational status of the firm (e.g. operational, seasonal, inactive, temporary, out of business, not OEI, etc.). With records retention laws, even if a firm closes down or stops being within an agency's jurisdiction, it is necessary to maintain records. Legal requirements aside, firms that close may always open back up, or the same players that closed down one firm may start a new venture. There are plenty of reasons for not immediately removing the records of firms that no longer require regulatory action. That means it's important to capture the status of a firm to track what actions, if any, may be required. The possible values for operating status should be predefined so that systems and users understand the business rules for a particular status. Firm Size The estimated size of the establishment based on annual sales/receipts/revenue. Firm size could be recorded as a specific value, but generally the purpose of firm size is in performing risk assessment. As such, firm size is typically represented as categories that indicate a dollar range. The following ranges are based on FDA FACTS and are recommended: 6

7 a. $0 $24,999 b. $25,000 $49,999 c. $50,000 $99,999 d. $100,000 $499,999 e. $500,000 $999,999 f. $5,000,000 $9,999,999 g. $1,000,000 $4,999,999 h. $5,000,000 $9,999,999 i. $10,000,000 $24,999,999 j. $25,000,000 $49,999,999 k. $50,000,000 and over l. Unknown Number of Employees An estimate of the firm's aggregated fulltime, part time, and contract workers reported as a single numerical value to indicate the largest number at any given time during the year. (NB: This definition may be further refined as the FSMA Rules and Guidances are finalized and provide additional fidelity in defining Employee.) Inspection Purpose The field captures the reason for the inspection (e.g. Routine, Complaint, Compliance, Investigatory, Foodborne Outbreak, BSE Inspection, License Renewal, Equipment Check, etc.). It is possible for an inspection to have multiple purposes (e.g. Check all that apply.). Inspection Start Date and Time The date (and time) the inspection began and is best recorded as a standard database date/time field. Some groups may record just a date, while others capture this down to the minute, the exact meaning for what constitutes the start of an inspection may also vary, this might be defined as the moment an inspector pulled up to the firm, it might be when the person in charge at the firm formally acknowledged the inspection, it could be when the inspector began travelling to the firm, or it could when information about the firm and past inspections began being reviewed prior to showing up on site. Inspection Completion Date and Time The date (and time) the inspection concluded and is best recorded as a standard database date/time field. The issues surrounding an inspection completion date are the same as for the start date. In addition, some groups do not record inspections as having a start time and an end time, but instead use a start time and duration. Samples Collected Samples collected during inspection. A sample includes ingredients, finished products, environmental, water, etc. and this field may be delineated by as many as four elements. a. Were samples collected may be a single field; Yes or No. b. If collected, what type of sample was collected; Environmental, Micro, or Chem. c. If collected, what was the basis for the collection; Surveillance, Compliance, Surveillance Environmental, Compliance Environmental, Evidentiary, Unofficial. 7

8 d. If collected, was the sample found to be violative; Yes or No. Sample Basis Surveillance Sample Collected on an objective basis where there is not inspectional or other evidence of a problem with the product. Compliance Sample Collected on a selective basis as the result of an inspection, compliant or other evidence that there may be a problem with the product. Surveillance Sample Environmental Environmental Sample collected on an objective basis where there is not inspectional or other evidence of a problem with the product. Compliance Sample Environmental Environmental Sample collected on a selective basis as the result of an inspection, compliant or other evidence that there may be a problem with the product. Evidentiary Samples collected for purposes of documenting an alleged violation. Unofficial Samples collected outside of regulatory authority that may be part of an investigation. Products Reviewed Products listed by FDA Product Code(s) undergoing manufacture during the time of the inspection that were reviewed. Unlike the firm products/processes field, this field indicates, not all of the products present at the firm, but just the ones reviewed during a particular inspection. Observations This field captures narrative description of observations during inspection. Being a narrative, observations can be recorded as text. This text though, might be entered manually, or it might be fully or partially canned observations. Also, the observations could be stored as a single block or broken up into a list of observations. Inspection Citations Reference codes for all observations cited during an inspection for the purpose of sharing with regulatory partners. Each citation for distinct observations should be listed separately for trending and search purposes at a state and nationwide level. Citations are captured to at least at the Section level (i.e. 21 CFR Part Plants and Grounds). If the state utilizes a state codification for regulations equivalent to the CFR, the state should create a bridge table detailing the state citation and the equivalent CFR citation. Ideally each citation would include a linked field providing the text observation issued to the firm. This requirement does not impose on regulatory partners any expectation to include this degree of specificity in the report provided to the regulated entity during an inspection. Outcome This field documents the outcome of the inspection as NAI, VAI, OAI, or RTS. a. No Action Indicated (NAI): No objectionable conditions or practices were found during the inspection (or the significance of the documented objectionable conditions found does not justify further FDA action). b. Voluntary Action Indicated (VAI): Objectionable conditions were found and documented but the District and/or Center is not prepared to take or recommend any of the regulatory (advisory, administrative, or judicial) since the objectionable conditions do not meet the threshold for regulatory action. The district may use an Untitled Letter, Regulatory Meeting or other 8

9 communication with responsible individuals to inform the establishment of findings that should be corrected. A VAI classification should be made only if a FDA 483, or state equivalent, has been issued unless the only significant observations are non reportable as specified by IOM A VAI classification can be made only if the Inspection Conclusion is CI. c. Official Action Indicated (OAI): Objectionable conditions were found and one of the regulatory actions listed below should be recommended. Includes inspections resulting in recalls where the district has decided conditions warrant regulatory (advisory, administrative, or judicial) action. An OAI classification is most often made if an FDA 483, or state equivalent, has been issued and the documented evidence supports the action recommended unless the only significant observations are non reportable, as specified by IOM , or in matters referred to Office of Criminal Investigations (OCI). An OAI classification may also be made when a state contract inspection is determined to be violative and the Investigations Branch management, in consultation with Compliance Branch and/or the State Contract Agency determine FDA follow up or action is required. An OAI classification can be made only if the Inspection Conclusion is CI. d. Referred to State (RFS): Referred to state, local, or other federal office. This classification may be used when either there is no federal jurisdiction over the apparent violation in question or it is determined state action is the most efficient method of obtaining the establishment s compliance with applicable federal laws, regulations or administrative requirements. An RTS classification can be made only if the Inspection Conclusion is CI. Inspector This field captures the name of the inspector. This might be handled as a single field, but could also break the name up into parts. Like with the legal firm name and owner/operator name, you may also have to deal with non English characters. Person In Charge This field captures the most responsible person in charge at the firm/facility during the inspection. Compliance/Enforcement Action Taken This is a description of compliance, enforcement, or regulatory control action taken (e.g. hold, embargo, seizure, follow up inspection, letter of warning, destruction, etc.). This entry may have multiple fields. Depending on the system, this might be a narrative or collection of narratives, but it could also be a scripted process with predefined choices and values. In the context of a system, this might not even have a text representation, but rather record and display this information in some other manner (e.g., showing a follow up inspection below the original inspection). 9