Stg Enabler Fit To Quality Culture Behavior (QB) and Quality System Maturity (QM)

		QB	QM
	Preventive Maintenance
D01	We have a formal program for maintaining our machines and equipment		x
D02	Maintenance plans and checklists are posted closely to our machines, and maintenance jobs are documented		x
D03	We emphasize good maintenance as a strategy for increasing quality and planning for compliance	x
D04	All potential bottleneck machines are identified and supplied with additional spare parts		x
D05	We continuously optimize our maintenance program based on a dedicated failure analysis	x
D06	Our maintenance department focuses on assisting machine operators perform their own preventive maintenance	x
D07	Our machine operators are actively involved in the decision-making process when we decide to buy new machines	x
	Housekeeping
D15	Our employees strive to keep our plant neat and clean	x
D16	Our plant procedures emphasize putting all tools and fixtures in their place		x
D17	We have a housekeeping checklist to continuously monitor the condition and cleanness of our machines and equipment		x
	Process Management
E01	In our company, direct and indirect processes are well documented		x
E02	We continuously measure the quality of our processes by using process measures (e.g., OTIF delivery rate)	x
E04	In our company, there are dedicated process owners who are responsible for planning, management, and improvement of their processes		x
E05	A large percentage of equipment on the shop floor is currently under statistical process control (SPC)		x
E06	We make use of statistical process control to reduce variances in processes		x
E07	For root cause analysis, we have standardized tools to get a deeper understanding of the influencing factors (e.g., DMAIC)		x
E08	We operate with a high level of PAT implementation for real-time process monitoring and controlling		x
	Cross-Functional Product Development
E09	Manufacturing engineers (e.g., industrial engineers) are involved to a great extent in the development of a new drug formulation and the development of the necessary production processes		x
E10	In our company, product and process development are closely linked to each other	x	x
E11	Owing to the close collaboration between the R&D and manufacturing departments, we could significantly shorten our time for product launches (“scale-ups”) in our plant
E13	For product and process transfers between different units or sites, standardized procedures exist and ensure a fast, stable, and complied knowledge transfer		x
	Customer Involvement
E15	Our customers frequently give us feedback on quality and delivery performance		x
E16	We regularly survey our customer's requirements		x
	Supplier Quality Management
E20	Quality is our number one criterion in selecting suppliers		x
E21	We rank our suppliers. Therefore, we conduct supplier qualifications and audits		x
E22	We mostly use suppliers that we have validated		x
E24	Inspections of incoming materials are usually performed in proportion to the past quality performance or type of supplier		x
E26	We have joint improvement programs with our suppliers to increase our performance		x
	Setup Time Reduction
F06	Optimized setup and cleaning procedures are documented as best-practice process and rolled out throughout the whole plant		x
	Direction Setting
G01	Our site has an exposed site vision and strategy that is closely related to our corporate mission statement
G02	Our vision, mission, and strategy are broadly communicated and lived by our employees	x
G03	Goals and objectives of the manufacturing unit are closely linked and consistent with corporate objectives. The site has a clear focus		x
G04	The overall objectives of the site are closely linked to the team or personal objectives of our shop-floor teams and employees		x
G05	Our manufacturing managers (head of manufacturing, site leader, etc.) have a good understanding of how the corporate/divisional strategy is formed	x
G06	Our manufacturing managers know exactly what the most important criteria for manufacturing jobs are (low costs, delivery, quality, etc.)	x
	Management Commitment and Company Culture
G07	Site management (committee) empowers employees to continuously improve the processes and to reduce failure and scrap rates	x
G08	Site management (committee) is personally involved in improvement projects	x
G11	The site has an open communication culture. There is a good flow of information between the departments and the different management levels	x
G13	Problems (e.g., complaints) are always traced back to their origin to identify root causes and to prevent doing the same mistakes twice	x
G14	The achievement of high-quality standards is primarily the task of our QA/QC departments	x
G15	Our employees continuously strive to reduce any kind of waste in every process (e.g., waste of time, waste of production space)	x
G16	Command and control is seen as the most effective leadership style rather than open culture	x
	Employee Involvement and Continuous Improvement
G17	We have implemented tools and methods to deploy a continuous improvement process		x
G18	Our employees are involved in writing policies and procedures (concerning site vision down to standard operating procedures)		x
G19	Shop-floor employees actively drive suggestion programs (not excl. linked to a suggestion system in place)	x
G20	Our work teams cannot take significant actions without supervisor's or middle manager's approval	x
G21	Our employees have the authority to correct problems when they occur		x
G22	Occurring problems should be solved by supervisors		x
G23	Supervisors include their employees in solving problems	x
G24	Our plant forms cross-functional project teams to solve problems	x
G25	The company takes care of the employees	x
	Functional Integration and Qualification
G28	Each of our employees within our work teams (in case workers are organized as teams) is cross-trained so that they can fill in for others when necessary		x
G29	At our plant, we have implemented a formal program to increase the flexibility of our production workers. Employees rotate to maintain their qualification		x
G30	In our company, there are monthly open feedback meetings		x
G31	The information of these official feedback meetings is used systematically in further training.	x
G32	We continuously invest in training and qualification of our employees. We have a dedicated development and qualification program for our workers		x
	Standardization and Simplification
H01	We emphasize standardization as a strategy for continuously improving our processes, machines, and products	x
H02	We use our documented operating procedures to standardize our processes (e.g., setups)	x
H03	Optimized operating procedures (e.g., shortened setups) are documented as best-practice processes and rolled out throughout the whole plant	x
	Visual Management
H07	Performance charts at each of our production processes (e.g., packaging) indicate the annual performance objectives		x
H08	Technical documents (e.g., maintenance documents) and workplace information (e.g., standardized inspection procedures, team structures) are posted on the shop floor and are easily accessible and visible for all workers		x
H09	Charts showing the current performance status (e.g., current scrap rates, current up-times) are posted on the shop floor and visible for everyone		x
H10	Charts showing current takt times and schedule compliance (e.g., Andon boards) are posted on the shop floor and visible to everyone		x

Some Stg Enabler's do not match either QB or QM and are therefore not considered in the analysis (no corresponding “x”).