Quality Objectives and Quality Policy

For many companies, quality objectives and quality policy fall into oblivion; the focus rather lies on the QM-Systems's conformity with ISO 9001 and ISO 13485, and, above all, the respective certificate.

Quality Policy, Quality Objectives, and KPIs

Quality Policy Picture

Companies should deduce quality objectives from oftentimes steady quality policies and define KPIs for them to be able to determine the objectives' degree of achievement. Many companies change nominal values of those KPIs over time (usually tightened up).

Quality Policies

Definition

Definition: Quality Policy

„Overall intentions and directions of an organization with regard to quality concerns, as formally expressed by the top management“

Source: ISO 9000

Meaning and Synonyms

Many find the term "policies" rather unfortunate. Policy could be understood as (quality) strategy or even as a (quality) guideline.

Referring to those synonyms, the meaning of quality policy becomes clearer. Corporate philosophy, vision and mission are also elements of quality policy. You can understand quality policy as the great, overarching vision, as the appealing picture of the future which is aspired by the company in the long term.

Often, companies define quality policies aiming at becoming "the leading provider" in a certain industry. However, this has little to do with quality in the sense of meeting customer requirements. You will find better examples below.

Examples

Two examples may help to better understand the term quality policy:

  1. Manufacturer of medical devices for diabetics
    The quality policy of this manufacturer is: We provide a comprehensive range of products and services due to which patients are impaired as little as possible by their diabetes. This quality policy addresses quality in its most original sense, namely the degree of fulfillment of a product's or service's characteristic which meets the real requirements.
  2. Johner Institute
    The Johner Institute expresses its quality policy in the form of a mission and its values:

    • Mission: The Johner Institute's mission is to support manufacturers of active medical devices in developing and approving secure products quickly and professionally while avoiding and reducing quality management bureaucracy respectively. You can read the complete mission here.
    • Values: The Johner Institute's values are the guidelines, the ethical corset for the implementation of the mission. These values include the constant strive for excellence and higher competence, taking care of customers, and the indispensable honesty and reliability.

Quality policy should be very specific to the company. Examples of typical formulation errors can be found below.

Quality Objectives

Definition

Definition: Quality Objectives

„Objectives regarding quality“

Source: ISO 9000

Meaning, Synonyms

The quality goals are specific, measurable (using key figures), and time-bound (SMART) intermediate steps to fulfil the quality policy. These goals should be more specific than the quality policy. For many companies, it is easier to remove the term "quality" from the expression and speak only of goals. These goals can affect all areas of the company:

  • Company as a whole: Turnover, profit, new customers
  • Process: Error rates, complaints, processing times, process costs
  • Products: Number of new products, error rates, complaints

Hierarchy of quality objectives

For many companies, it is easier to not derive the specific (SMART) quality objectives directly from the quality policy, but to rather formulate "high-level" quality goals first and then derive concrete quality goals from them.

Examples

This example is intended to illustrate the path from the quality policy via "high-level" to concrete quality objectives:

  • Quality policy: We provide a comprehensive range of products and services due to which patients are impaired as little as possible by their diabetes.
  • Quality objective ("high-level"): We develop a medical device that avoids painful measurement of blood sugar and injections of insulin.
  • Quality objective (specific): By the end of the year, we will have studied all relevant publications, patents, and products and have evaluated all known alternatives by means of a benefit analysis.

More examples can be found below.

KPIs and Target Values

For each quality objective, one or more KPIs should help to determine progress and degree of achievement. Useful KPIs are

  • specific, i.e. they truly measure to which extend the quality objective will be met,
  • easy, i.e. can be captured without causing unnecessary efforts and are
  • easy to understand.

Examples of KPIs for the quality objective " We achieve our objectives through highly trained employees" would be the percentage of employees actually trained in a given period, the number of certificates awarded to them, or the number of publications and conference contributions published by employees of the company.

Eventually, it is important to define a target value for each KPI and to actually measure it.

Typical Mistakes When Formulating Quality Policy and Quality Objectives

  • Quality policy is abstract, without passion, and random. This neither awakens forces nor does it a create a commonly understood and aspired purpose. Often, I must read documents that make any anesthetic superfluous. Something like that should fall within the narcotics law! 
  • These quality objectives are replaceable. Cross out everything that does not apply to every other company of the same kind. Which company does not want "high customer satisfaction"? If there is nothing left after eliminating these banalities, chuck the whole manual in the dustbin. QM systems must be set up top-down. And if even the top is worthless, it doesn't get any better on the lower levels.
  • The QM manual confuses quality policy with quality objectives.
  • Management commitment: The manager is not committed to the QM system and even delegates formulating quality policy to third parties such as the QM officer. Such QM systems tend to resemble Potemkin villages.
  • No continuous improvement of the QM system: While quality policy often is a slowly changing variable, you should continuously assess whether the metrics (KPIs) and their target values are still suitable for tracking the objectives' degree of achievement. Few specific KPIs which are acknowledged by the team will better serve your efforts to improve quality than a static, increasingly extensive Management Cockpit.

Examples of Quality Objectives

Examples of "high-level" quality objectives

  1. We develop products with which cancer patients can always be treated according to latest scientific findings.
  2. For our customers, we generally solve critical errors in our software as quickly as possible.
  3. We increase our productivity by working with latest technologies.
  4. From now on, our employees will be optimally prepared for their tasks also by receiving regular and comprehensive further training.
  5. For our customers' data, we ensure highest IT security.
  6. We gain the trust of our customers through honesty and transparency.

In a next step, these quality objectives should be translated into more specific quality objectives.

Examples of specific quality objectives

Companies should "break down" the "high-level" quality objectives into very specific, measurable, and time-bound targets:

  1. We solve all software bugs which either are security-relevant or hinder usage within two days and deliver updates within three days.
  2. By the end of the year, we will have five product managers trained as usability and requirements engineers.
  3. By the end of the quarter, we will have installed a backup solution for all central servers and have validated the corresponding process.
  4. We are revising our "Software Development Procedural Instruction" until the next release so that it can also be implemented in an agile manner.
  5. We will have completed the CAPA list by the end of the month after next.

Examples of KPIs

Development

  • Number of new patents
  • Number of new projects
  • Percentage of projects completed on time and within budget
  • Time it takes to correct errors
  • Number of reclamations, bugs

Support

  • Percentage of problems directly solved by support
  • Time until problems are solved
  • Number of contacts with the customer until a problem is solved

Sales

  • The sales department often works based on KPIs, too. Examples are the number of
  • attempts at contact
  • customer contacts
  • offerings
  • closings
  • new customers

Further Information

Click on this link to download the free starter-kit providing you with an overview of the regulatory landscape and illustrating the 6 steps to your medical device's "approval".

Quality Objectives and QM Manuals: Support

Do you need support with

  • formulating your quality policy?
  • deriving quality objectives?
  • defining KPIs and metrics?
  • writing a slim and precise QM manual?
  • establishing, assessing, and certifying your ISO 13485-compliant QM system?

In this case, get in touch with us! We are specialized in setting up an ISO 13485-compliant QM system within a few days. Read here how we do it.

We are looking forward to your message!

Author:

Prof. Dr. Christian Johner

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